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Tag: cholesterol

  • A Look at the 5:2 Diet and the Fasting-Mimicking Diet  | NutritionFacts.org

    A Look at the 5:2 Diet and the Fasting-Mimicking Diet  | NutritionFacts.org

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    What are the effects of eating only five days a week or following a fasting-mimicking diet five days a month? 
     
    Instead of eating every other day, what if you ate five days a week and fasted for the other two? As I discuss in my video The 5:2 Diet and the Fasting-Mimicking Diet Put to the Test, the available data are similar to that of alternate-day fasting: About a dozen pounds of weight loss was reported in overweight men and also reported in overweight women over six months, with no difference found between participants on the 5:2 intermittent fasting regimen and those on a continuous 500-calories-a-day restriction. The largest trial to date found an 18-pound weight loss within six months in the 5:2 group, which isn’t significantly different from the 20 pounds lost in the continuous calorie restriction group. Weight maintenance over the subsequent six months was also found to be no different.
     
    Though feelings of hunger may be more pronounced on the 5:2 pattern than on an equivalent level of daily calorie cutting, it does not seem to lead to overeating on non-fasting days. One might expect going two days without food may negatively impact mood, but no such adverse impact was noted for those fully fasting on zero calories or sticking to just two packets of oatmeal on each of the “fasting” days. (The oatmeal provides about 500 calories a day.) Like alternate-day fasting, the 5:2 fasting pattern appeared to have inconsistent effects on cognition and on preserving lean mass, and it also failed to live up to the “popular notion” that intermittent fasting would be “easier” to adhere to than daily calorie restriction. 
     
    Compared to those in the continuous-restriction control group, fewer subjects in the 5:2 pattern group expressed interest in continuing their diet after the study was over. This was attributed to quality-of-life issues, with 5:2 fasting participants citing headaches, lack of energy, and difficulty fitting the fasting days into their weekly routine. However, as you can see below and at 1:53 in my video, there has yet to be a single 5:2 diet study showing elevated LDL cholesterol compared with continuous calorie restriction at six months. Nor has it been shown for a year. This offers a potential advantage over alternate-day regimens. 

    Instead of 5:2, what about 25:5, spending five consecutive days a month on a “fasting-mimicking diet” (FMD)? Longevity researcher Valter Longo designed a five-day meal plan to try to simulate the metabolic effects of fasting by being low in protein, sugars, and calories with zero animal protein and zero animal fat. By making the diet plant-based, he hoped to lower the level of the cancer-promoting growth hormone IGF-1. He indeed accomplished this goal, along with a drop in markers of inflammation, after three cycles of his five-days-a-month program, as you can see below and at 2:33 in my video. 

    One hundred men and women were randomized to consume his fasting-mimicking diet for five consecutive days per month or maintain their regular diet the whole time. As you can see in the graph below and at 2:47 in my video, after three months, the FMD group was down about six pounds compared to the control group, with significant drops in body fat and waist circumference, accompanied by a drop in blood pressure. 

    Those who were the worst off accrued the most dramatic benefits, as seen in the graph below and at 3:04 in my video. What’s even wilder is that three further months after completion, some of the benefits appeared to persist, suggesting the effects “may last for several months.” It’s unclear, though, if those randomized to the FMD group used it as an opportunity to make positive lifestyle changes that helped maintain some of the weight loss. 


    Dr. Longo created a company to market his meal plan commercially, but, to his credit, says “he does not receive a salary or a consulting fee from the company…and will donate 100% of his shares to charity.” The whole diet appears to be mostly dehydrated soup mixes, herbal teas like hibiscus and chamomile, kale chips, nut-based energy bars, an algae-based DHA supplement, and a multivitamin dusted with vegetable powder. Why spend 50 dollars a day on a few processed snacks when you could instead eat a few hundred calories a day of real vegetables? 
     
    How interesting was that? All-you-can-eat above-ground vegetables for five days would have the same low amount of protein, sugars, and calories with zero animal protein or animal fat. But we’ll probably never know if it works as well, better, or worse because it’s hard to imagine such a study ever getting done without the financial incentive. 

    To learn more about IGF-1, see my video Flashback Friday: Animal Protein Compared to Cigarette Smoking.
     
    In this series on fasting, I’ve covered several topics, including the basics of calories and weight loss, water-only fasting, and the types of alternate-day fasting, see them all in the related videos below. 
     
    I close out the series with videos on time-restricted eating: Time-Restricted Eating Put to the Test and The Benefits of Early Time-Restricted Eating. 
     
    If you want all of the videos in one place, I’ve done three webinars on fasting—Intermittent Fasting, Fasting for Disease Reversal, and Fasting and Cancer—and they’re all available for download now. 

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    Michael Greger M.D. FACLM

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  • Is Our Life Expectancy Extended by Intermittent Fasting?  | NutritionFacts.org

    Is Our Life Expectancy Extended by Intermittent Fasting?  | NutritionFacts.org

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    Alternate-day modified fasting is put to the test for lifespan extension. 

    Is it true that alternate-day calorie restriction prolongs life? Doctors have anecdotally attributed improvements in a variety of disease states to alternate-day fasting, including asthma; seasonal allergies; autoimmune diseases, such as rheumatoid arthritis and osteoarthritis; infectious diseases, such as toenail fungus, periodontal disease, and viral upper respiratory tract infections; neurological conditions, such as Tourette’s syndrome and Meniere’s disease; atrial fibrillation; and menopause-related hot flashes. The actual effect on chronic disease, however, remains unclear, as I discuss in my video Does Intermittent Fasting Increase Human Life Expectancy?. 
     
    Alternate-day fasting has been put to the test for asthma in overweight adults, and researchers found that asthma-related symptoms and control significantly improved, as did the patients’ quality of life, including objective measurements of lung function and inflammation. As you can see in the graphs below and at 0:56 in my video, there were significant improvements in peak airflow, mood, and energy. Their weight also improved—about a 19-pound drop in eight weeks—so it’s hard to tease out the effects specific to the fasting beyond the benefits we might expect from weight loss by any means. 

    For the most remarkable study on alternate-day fasting, you have to go back more than a half-century. Though the 2017 cholesterol findings were the most concerning data I could find on alternate-day fasting, the most enticing was published in Spain in 1956. The title of the study translates as “The Hunger Diet on Alternate Days in the Nutrition of the Aged.” Inspired by the data being published on life extension with caloric restriction on lab rats, researchers split 120 residents of a nursing home in Madrid into two groups. Sixty residents continued to eat their regular diet, and the other half were put on an alternate-day modified fast. On the odd days of the month, they ate a regular 2,300-calorie diet; on the even days, they were given only a pound of fresh fruits and a liter of milk, estimated to add up to about 900 calories. This continued for three years. So, what happened? 
     
    As you can see below and at 2:16 in my video, throughout the study, 13 participants died in the control group, compared to only 6 in the intermittent fasting group, but those numbers were too small to be statistically significant. 

    What was highly significant, though, was the number of days spent hospitalized: Residents in the control group spent a total of 219 days in the infirmary, whereas the alternate-day fasting group only chalked up 123 days, as you can see below and at 2:38 in my video. 


    This is held up as solid evidence that alternate-day fasting may improve one’s healthspan and potentially even one’s lifespan, but a few caveats must be considered. It’s not clear how the residents were allocated to their respective groups. If, instead of being randomized, healthier individuals were inadvertently placed in the intermittent fasting group, that could skew the results in their favor. As well, it appears the director of the study was also in charge of medical decisions at the nursing home. In that role, he could have unconsciously been biased toward hospitalizing more folks in the control group. Given the progress that has been made in regulating human experimentation, it’s hard to imagine such a trial being run today, so we may never know if such impressive findings can be replicated. 

    Well, that was interesting! I had never even heard of that study until I started digging into the topic.  

    Check out my fasting series and popular videos on the subject here.  

    For more on longevity, see related videos below.



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    Michael Greger M.D. FACLM

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  • How Safe Is Alternate-Day Intermittent Fasting?  | NutritionFacts.org

    How Safe Is Alternate-Day Intermittent Fasting?  | NutritionFacts.org

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    Eating every other day can raise your cholesterol. 
     
    Are there any downsides to fasting every other day? For example, might go all day without eating impair your ability to think clearly? Surprisingly, as I discuss in my video Is Alternate-Day Intermittent Fasting Safe?, the results appear to be “equivocal.” Some studies show no measurable effects and the ones that do fail to agree on which cognitive domains are affected. Might the cycles of fasting and feasting cause eating disorder–type behaviors, like bingeing? So far, no harmful psychological effects have been found. In fact, there may be some benefit. However, the studies that have put it to the test specifically excluded those with a documented history of eating disorders, for whom the effects may differ. 
     
    What about bone health? No change in bone mineral density was noted after six months of alternate-day fasting despite about 16 pounds of weight loss, which would typically result in a dip in bone mass. However, the researchers did not note any skeletal changes in the control group either, and they lost a similar amount of weight using continuous caloric restriction. They suggested this is because both groups tended to be “more physically active than the average obese American,” getting about 1,000 to 2,000 more steps a day. 
     
    Proponents of intermittent fasting suggest it can better protect lean body mass, but most of the intermittent trials have employed less accurate methods of body composition analysis, whereas the majority of continuous caloric restriction trials used “vastly more accurate techniques.” So, to date, it is not clear if there’s a difference in lean mass preservation. 
     
    Improvements in blood pressure and triglycerides have been noted on intermittent fasting regimens, though this is presumed to be due to the reduction in body fat since the effect appears to be “dependent on the amount of weight lost.” Alternate-day fasting can improve artery function, too, as you can see in the graph below and at 1:55 in my video, though it does depend on what you’re eating on the non-fasting day. For study participants randomized to an alternate-day diet high in saturated fat, their artery function worsened despite a ten-pound weight loss, whereas it improved, as expected, in the lower-fat group. The decline in artery function was presumed to be because of the pro-inflammatory nature of saturated fat. 

    A concern has been raised about the effects of alternate-day fasting on cholesterol. After 24 hours without food, LDL cholesterol may temporarily bump up, but this is presumably because so much fat is being released into the system by the fast. As you can see in the graph below and at 2:33 in my video, an immediate negative effect on carbohydrate tolerance may stem from the same phenomenon—the repeated elevations of free fat floating around in the bloodstream. After a few weeks, though, LDL levels start to drop as the weight comes off. However, results from the largest and longest trial of alternate-day fasting have given me pause. 


    A hundred obese men and women were randomized into one of three groups: alternate-day modified fasting (25 percent of their baseline calories on fasting days and 125 percent calories on eating days), continuous, daily caloric restriction (75 percent of baseline), or a control group instructed to maintain their regular diet. So, for those going into the trial eating 2,000 calories a day, they would continue to eat 2,000 calories a day in the control group. The calorie-restriction group would get 1,500 calories every day, and the intermittent-restriction group would alternate between 500 calories a day and 2,500 calories the next. 
     
    As you can see in the graph below and at 3:32 in my video, with the same overall, average, prescribed calorie cutting in the two weight-loss groups, they both lost about the same amount of weight, but, surprisingly, the cholesterol effects were different. In the continuous calorie-restriction group, the LDL levels dropped as expected compared to the control group as the pounds came off. 

    But, in the alternate-day modified fasting group, they didn’t, as you can see below, and at 3:55 in my video. At the end of the year, the LDL cholesterol in the intermittent fasting group ended up being 10 percent higher than in the constant calorie-restriction group—despite the same loss of body fat. Given that LDL cholesterol is a prime causal risk factor for heart disease, our number one killer—or is even the prime risk factor—this strikes a significant blow against alternate-day fasting. If you want to try it anyway, I would advise you to have your cholesterol monitored to make sure it comes down with your weight. 


    If you’re diabetic, you must talk with your physician about medication adjustment for any changes in diet, including fasting of any duration. Even with proactive medication reduction, advice to immediately break the fast should sugars drop too low, and weekly medical supervision, people with type 2 diabetes who fasted for even just two days a week were twice as likely to suffer from hypoglycemic episodes compared to an unfasted control group. We still don’t know the best way to tweak blood sugar medications to prevent blood sugar from dropping too low on fasting days. 
     
    Even fasting for just one day can significantly slow the clearance of some drugs (like the blood-thinning drug Coumadin) or increase the clearance of others (like caffeine). Fasting for 36 hours can cut your caffeine buzz by 20 percent. So, consultation with your medical professional before fasting is an especially good idea for anyone on any kind of medication. 

    If you missed it, check out Alternate-Day Intermittent Fasting Put to the Test. 
     
    So, with ambiguous cognitive, lean mass, and bone effects, plus these cholesterol findings, I wouldn’t suggest alternate-day fasting for weight loss, but dropping pounds isn’t the only thing this way of eating is purported to do. Check out Does Intermittent Fasting Increase Human Life Expectancy?. 
     
    For other types of intermittent fasting, total fasting, and more on fasting, check out the related videos below. 



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    Michael Greger M.D. FACLM

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  • Any Pitfalls with Restricting Calories?  | NutritionFacts.org

    Any Pitfalls with Restricting Calories?  | NutritionFacts.org

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    How may we preserve bone and mass on a low-calorie diet? 
     
    One of the most consistent benefits of calorie restriction is that blood pressure improves in as little as one or two weeks. Blood pressure may even be normalized in a matter of weeks and blood pressure pills discontinued. Unfortunately, this can work a little too well and cause orthostatic intolerance, which can manifest as lightheadedness or dizziness upon standing and, in severe cases, may cause fainting, though staying hydrated can help. 
     
    What about loss of muscle mass? In the CALERIE trial, which I profile in my video Potential Pitfalls of Calorie Restriction, 70 percent of the body weight the subjects lost was fat and 30 percent was lean body mass. So, they ended up with an improved body composition of about 72 percent lean mass compared to 66 percent in the control group, as you can see at 0:51 in my video. And, even though leg muscle mass and strength declined in absolute terms, relative to their new body size, they generally got stronger. 

    Is there any way to preserve even more lean mass, particularly among older individuals who naturally tend to lose muscle mass with age? Increased protein intakes are commonly suggested, but most studies fail to find a beneficial effect on preserving muscle strength or function whether you’re young or old, active or sedentary. For example, during a 25 percent calorie restriction, researchers randomized overweight older men and women to either a normal-protein diet with 4 grams for every ten pounds of body weight or a high-protein diet with about 8 grams per ten pounds. That doubling of protein intake had no discernible effect on lean body mass, muscle strength, or physical performance. As you can see below and at 1:48 in my video, most such studies found the same lack of benefit, but when they’re all put together, one can tease out a small advantage of about one or two pounds of lean mass over an average of six months. 

    Unfortunately, high protein intake during weight loss has also been found to have “profound” negative metabolic effects, including undermining the benefits of weight loss on insulin sensitivity. As you can see in the graph below and at 2:14 in my video, if you lose 20 pounds, you can dramatically improve your body’s ability to handle blood sugars, compared to subjects in a control group who maintained their weight. But, if you lose the exact same amount of weight on a high-protein diet, getting about an extra 30 grams a day, it’s like you never lost any weight at all. 


    Though you can always bulk back up after weight loss, the best way to preserve muscle mass during weight loss is to exercise. The CALERIE study had no structured exercise component, and, similar to bariatric surgery, about 30 percent of the weight loss was lean mass. In contrast, that proportion was only about 16 percent of The Biggest Loser contestants, chalked up to their “vigorous exercise program.” Resistance training even just three times a week can prevent more than 90 percent of lean body mass loss during calorie restriction. 
     
    The same may be true of bone loss. Lose weight through calorie restriction alone, and you experience a decline in bone mineral density in fracture risk sites, such as the hip and spine. In the same study, though, those randomized to lose weight with exercise did not suffer any bone loss. The researchers concluded: “Our results suggest that regular EX [exercise] should be included as part of a comprehensive weight loss program to offset the adverse effects of CR [caloric restriction] on bone.” 
     
    It’s hard to argue with calls for increased physical activity, but even without an exercise regimen, the “very small” drop in bone mineral density in the CALERIE trial might only increase a ten-year risk of osteoporotic fracture by about 0.2 percent. The benefits of calorie restriction revealed by the study included improvements in blood pressure and cholesterol, as you can see in the graph below and at 3:54 in my video, as well as improved mood, libido, and sleep. These would seem to far outweigh any potential risks. The fact that a reduction in calories seemed to have such wide-ranging benefits on quality of life led commentators in the AMA’s internal medicine journal to write: “The findings of this well-designed study suggest that intake of excess calories is not only a burden to our physical homeostasis [or equilibrium], but also on our psychological well-being.” 
     


    Check out my other videos on calorie restriction, fasting, intermittent fasting, and time-restricted eating in the related videos below. 

     

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    Michael Greger M.D. FACLM

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  • Restricting Calories for Longevity?  | NutritionFacts.org

    Restricting Calories for Longevity?  | NutritionFacts.org

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    Though a bane for dieters, a slower metabolism may actually be a good thing.

    We’ve known for more than a century that calorie restriction can increase the lifespan of animals, and metabolic slowdown may be the mechanism. That could be why the tortoise lives ten times longer than the hare. Rabbits can live for 10 to 20 years, whereas “Harriet,” a tortoise “allegedly collected from the Galapagos Islands by Charles Darwin, was estimated to be about 176 years old when she died in 2006.” Slow and steady may win the race. 
     
    As I discuss in my video The Benefits of Calorie Restriction for Longevity, one of the ways our body lowers our resting metabolic rate is by creating cleaner-burning, more efficient mitochondria, the power plants that fuel our cells. It’s like our body passes its own fuel-efficiency standards. These new mitochondria create the same energy with less oxygen and produce less free radical “exhaust.” After all, when our body is afraid famine is afoot, it tries to conserve as much energy as it can. 
     
    Indeed, the largest caloric restriction trial to date found metabolic slowing and a reduction in free radical-induced oxidative stress, both of which may slow the rate of aging. The flame that burns twice as bright burns half as long. But, whether this results in greater human longevity is an unanswered question. Caloric restriction is often said “to extend lifespan in every species studied,” but that isn’t even true of all strains within a single species. Two authors of one article, for instance, don’t even share the same view: One doesn’t think calorie restriction will improve human longevity at all, while the other suggests that a 20 percent calorie restriction starting at age 25 and sustained for 52 years could add five years onto your life. Either way, the reduced oxidative stress would be expected to improve our healthspan. 
     
    Members of the Calorie Restriction Society, self-styled CRONies (for Calorie-Restricted Optimal Nutrition), appear to be in excellent health, but they’re a rather unique, self-selected group of individuals. You don’t really know until you put it to the test. Enter the CALERIE study, the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy, the first clinical trial to test the effects of caloric restriction. 
     
    Hundreds of non-obese men and women were randomized to two years of 25 percent calorie restriction. They only ended up achieving half that, yet they still lost about 18 pounds and three inches off their waists, wiping out more than half of their visceral abdominal fat, as you can see in the graph below and at 2:47 in my video. 

    That translated into significant improvements in cholesterol levels, triglycerides, insulin sensitivity, and blood pressure, which you can see in the graph below and at 2:52 in my video. Eighty percent of those who were overweight when they started were normal-weight by the end of the trial, “compared with a 27% increase in those who became overweight in the control group.” 

    In the famous Minnesota Starvation Study that used conscientious objectors as guinea pigs during World War II, the study subjects suffered both physically and psychologically, experiencing depression, irritability, and loss of libido, among other symptoms. The participants started out lean, though, and had their calorie intake cut in half. The CALERIE study ended up being four times less restrictive, only about 12 percent below baseline calorie intake, and enrolled normal-weight individuals, which in the United States these days means overweight on average. As such, the CALERIE trial subjects experienced nothing but positive quality-of-life benefits, with significant improvements in mood, general health, sex drive, and sleep. They only ended up eating about 300 fewer calories a day than they had eaten at baseline. So, they got all of these benefits—the physiological benefits and the psychological benefits—just from cutting about a small bag of chips’ worth of calories from their daily diets. 
     
    What happened at the end of the trial, though? As researchers saw in the Minnesota Starvation Study and in calorie deprivation experiments done on Army Rangers, as soon as the subjects were released from restriction, they tended to rapidly regain the weight and sometimes even more, as you can see below and at 4:18 in my video. 

    The leaner they started out, the more their bodies seemed to drive them to overeat to pack back on the extra body fat, as seen in the graph below and at 4:27 in my video. In contrast, after the completion of the CALERIE study, even though their metabolism was slowed, the participants retained about 50 percent of the weight loss two years later. They must have acquired new eating attitudes and behaviors that allowed them to keep their weight down. After extended calorie restriction, for example, cravings for sugary, fatty, and junky foods may actually go down. 
    This is part of my series on calorie restriction, intermittent fasting, and time-restricted eating. See related videos below.

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    Michael Greger M.D. FACLM

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  • The Safety of Keto Diets  | NutritionFacts.org

    The Safety of Keto Diets  | NutritionFacts.org

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    What are the effects of ketogenic diets on nutrient sufficiency, gut flora, and heart disease risk? 

    Given the decades of experience using ketogenic diets to treat certain cases of pediatric epilepsy, a body of safety data has accumulated. Nutrient deficiencies would seem to be the obvious issue. Inadequate intake of 17 micronutrients, vitamins, and minerals has been documented in those on strict ketogenic diets, as you can see in the graph below and at 0:14 in my video Are Keto Diets Safe?. 

    Dieting is a particularly important time to make sure you’re meeting all of your essential nutrient requirements, since you may be taking in less food. Ketogenic diets tend to be so nutritionally vacuous that one assessment estimated that you’d have to eat more than 37,000 calories a day to get a sufficient daily intake of all essential vitamins and minerals, as you can see in the graph below and at 0:39 in my video. 


    That is one of the advantages of more plant-based approaches. As the editor-in-chief of the Journal of the American Dietetic Association put it, “What could be more nutrient-dense than a vegetarian diet?” Choosing a healthy diet may be easier than eating more than 37,000 daily calories, which is like putting 50 sticks of butter in your morning coffee. 
     
    We aren’t just talking about not reaching your daily allowances either. Children have gotten scurvy on ketogenic diets, and some have even died from selenium deficiency, which can cause sudden cardiac death. The vitamin and mineral deficiencies can be solved with supplements, but what about the paucity of prebiotics, the dozens of types of fiber, and resistant starches found concentrated in whole grains and beans that you’d miss out on? 
     
    Not surprisingly, constipation is very common on keto diets. As I’ve reviewed before, starving our microbial self of prebiotics can have a whole array of negative consequences. Ketogenic diets have been shown to “reduce the species richness and diversity of intestinal microbiota,” our gut flora. Microbiome changes can be detected within 24 hours of switching to a high-fat, low-fiber diet. A lack of fiber starves our good gut bacteria. We used to think that dietary fat itself was nearly all absorbed in the small intestine, but based on studies using radioactive tracers, we now know that about 7 percent of the saturated fat in a fat-rich meal can make it down to the colon. This may result in “detrimental changes” in our gut microbiome, as well as weight gain, increased leaky gut, and pro-inflammatory changes. For example, there may be a drop in beneficial Bifidobacteria and a decrease in overall short-chain fatty acid production, both of which would be expected to increase the risk of gastrointestinal disorders. 
     
    Striking at the heart of the matter, what might all of that saturated fat be doing to our heart? If you look at low-carbohydrate diets and all-cause mortality, those who eat lower-carb diets suffer “a significantly higher risk of all-cause mortality,” meaning they live, on average, significantly shorter lives. However, from a heart-disease perspective, it matters if it’s animal fat or plant fat. Based on the famous Harvard cohorts, eating more of an animal-based, low-carb diet was associated with higher death rates from cardiovascular disease and a 50 percent higher risk of dying from a heart attack or stroke, but no such association was found for lower-carb diets based on plant sources.  
     
    And it wasn’t just Harvard. Other researchers have also found that “low-carbohydrate dietary patterns favoring animal-derived protein and fat sources, from sources such as lamb, beef, pork, and chicken, were associated with higher mortality, whereas those that favored plant-derived protein and fat intake, from sources such as vegetables, nuts, peanut butter, and whole-grain bread, were associated with lower mortality…” 
     
    Cholesterol production in the body is directly correlated to body weight, as you can see in the graph below and at 3:50 in my video. 

    Every pound of weight loss by nearly any means is associated with about a one-point drop in cholesterol levels in the blood. But if we put people on very-low-carb ketogenic diets, the beneficial effect on LDL bad cholesterol is blunted or even completely neutralized. Counterbalancing changes in LDL or HDL (what we used to think of as good cholesterol) are not considered sufficient to offset this risk. You don’t have to wait until cholesterol builds up in your arteries to have adverse effects either; within three hours of eating a meal high in saturated fat, you can see a significant impairment of artery function. Even with a dozen pounds of weight loss, artery function worsens on a ketogenic diet instead of getting better, which appears to be the case with low-carb diets in general.  

    For more on keto diets, check out my video series here. 

    And, to learn more about your microbiome, see the related videos below.

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    Michael Greger M.D. FACLM

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  • Teva to pay $225M to settle cholesterol drug price-fixing charges

    Teva to pay $225M to settle cholesterol drug price-fixing charges

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    The generic drug maker Teva Pharmaceuticals agreed Monday to pay $225 million to settle price-fixing charges related to sales of a widely used cholesterol-lowering drug

    FILE – An Israeli flag flies outside a Teva Pharmaceutical Industries building on Dec. 14, 2017, in Neot Hovav, Israel. The generic drug maker Teva Pharmaceuticals agreed Monday, Aug. 21, 2023, to pay $225 million to settle price-fixing charges related to sales of a major cholesterol-lowering drug. The U.S. Department of Justice said the agreement also requires Teva to divest its business making and selling the drug, pravastatin, a generic version of the brand-name medicine Pravachol. (AP Photo/Tsafrir Abayov, File)

    The Associated Press

    WASHINGTON — The generic drug maker Teva Pharmaceuticals agreed Monday to pay $225 million to settle price-fixing charges related to sales of a major cholesterol-lowering drug. The U.S. Department of Justice said the agreement also requires Teva to divest its business making and selling the drug, pravastatin, a generic version of the brand-name medicine Pravachol.

    Another generic drug maker, Glenmark Pharmaceuticals, agreed to pay a $30 million criminal penalty and to divest its pravastatin business as well.

    In a statement, the U.S. arm of Israel-based Teva blamed a single former employee for striking agreements with Teva competitors that limited competition between 2013 and 2015. That employee left the company in 2016, Teva said.

    DOJ had charged seven generic drug makers, including Teva and Glenmark, with price fixing, bid rigging and market allocation schemes. The seven companies have settled their cases with deferred prosecution agreements. Had any of the cases gone to trial, guilty verdicts could have led to mandatory bans from participation in Medicare, Medicaid and other federal health programs.

    The companies collectively agreed to pay $681 million in fines in addition to other penalties.

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  • Promising drug could provide alternative to statins for those at risk of heart disease, new study finds

    Promising drug could provide alternative to statins for those at risk of heart disease, new study finds

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    A new study has found that a drug could replace statins for those who cannot tolerate them, a promising finding for millions of people who are at risk of heart disease.

    The study, published in the New England Journal of Medicine Saturday, found that in patients with increased cardiovascular risk, bempedoic acid was found to decrease heart-related complications, such as heart attacks, or the need for procedures like a bypass operation or a stent placement.

    “I take care of these patients,” cardiologist Dr. Steven Nissen of the Cleveland Clinic, who led the study, told CBS News. “They say, ‘Dr. Nissen, I know I need to lower my cholesterol. I’ve tried all these different statins. My muscles hurt. I can’t take those drugs.’”

    An editorial accompanying the study called the results “compelling,” and said they “will and should increase the use of bempedoic acid” in appropriate patients.

    “Let me first tell you what the drug didn’t do,” Dr. Nissen said, when asked about potential side effects from bempedoic acid. “It didn’t cause muscle pain. That was very important. It did increase the risk of gout by about an absolute of 1%. And it did increase the risk of gallstones by about one absolute percent. Neither of those do we consider to be particularly serious.”

    Bempedoic acid was approved by the Food and Drug Administration in 2020 as a way to reduce low-density lipoprotein (LDL) cholesterol levels.

    “Yes, it’s approved, but not widely used,” Dr. Nissen said. “If you really want a drug to be widely used, it has to show evidence of benefit on the really important things. The kind of bad things that happened to patients with high cholesterol we now know can be reduced with bempedoic acid. And that’s what gives the drug now the opportunity to be paid for by the payers, and to be more available to patients.”

    Drugs like PCSK9 inhibitors and ezetimibe are other alternatives to statins, but Dr. Nissen said bempedoic acid is an important addition.

    “It’ll absolutely change the practice of medicine,” Dr. Nissen said of bempedoic acid. 

    Jon LaPook


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    Dr. Jonathan LaPook is the chief medical correspondent for CBS News.

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  • Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

    Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

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    CNN
     — 

    Bempedoic acid may be an alternative for people who need to lower their cholesterol but can’t or won’t take statins, according to a large study published Saturday in the New England Journal of Medicine.

    Statins are the most commonly prescribed cholesterol-lowering drugs that help lower what’s known as the “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol in the blood; more than 90% of adults who take a cholesterol-lowering medicine use a statin, according to the US Centers for Disease Control and Prevention.

    Statins are considered safe and effective, but there are millions of people who cannot or will not take them. For some people it causes intense muscle pain. Past research has shown anywhere between 7% and 29% of patients who need to lower cholesterol do not tolerate statins, according Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and co-author of the new study.

    “I see heart patients that come in with terrible histories, multiple myocardial infarction, sometimes bypass surgery, many stents and they say, ‘Doctor, I’ve tried multiple statins, but whenever I take a statin, my muscles hurt, or they’re weak. I can’t walk upstairs. I just can’t tolerate these drugs,’ ” Nissen said. “We do need alternatives for these patients.”

    Doctors have a few options, including ezetimibe and a monoclonal antibody called a proprotein convertase subtilisin/kexin type 9, or PCSK9 inhibitors for short.

    Bempedoic acid, sold under the name Nexletol, was designed specifically to treat statin-intolerant patients. The FDA approved it for this purpose in 2020, but the effects of the drug on heart health had not been fully assessed until this large trial. The new study was funded in part by Esperion Therapeutics, the maker of Nexletol.

    For the study, which was presented Saturday at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology, Nissen and his colleagues enrolled 13,970 patients from 32 countries.

    All of the patients were statin intolerant, typically due to musculoskeletal adverse effects. Patients had to sign an agreement that they couldn’t tolerate statins “even though I know they would reduce my risk of a heart attack or stroke or death,” and providers signed a similar statement.

    The patients were then randomized into two groups. One was treated with bempedoic acid, the other was given a placebo, which does nothing. Researchers then followed up with those patients for up to nearly five years. The number of men and women in the trial were mostly evenly divided, and most participants, some 91%, were White, and 17% were Hispanic or Latino.

    The drug works in a similar way that statins do, by drawing cholesterol out of a waxy substance called plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. If there is too much plaque buildup, it can lead to a heart attack or stroke.

    But bempedoic acid is only activated in the liver, unlike a statin, so it is unlikely to cause muscle aches, Nissen said.

    In the trial, investigators found that bempedoic acid was well-tolerated and the percent reduction in the “bad” cholesterol was greater with bempedoic acid than placebo by 21.7%.

    The risk of cardiovascular events – including death, stroke, heart attack and coronary revascularization, a procedure or surgery to improve blood flow to the heart – was 13% lower with bempedoic acid than with placebo over a median of 3.4 years.

    “The drug worked in primary and secondary prevention patients – that is, patients that had had event and patients who were very high risk for a first event. There were a lot of diabetics. These were very high risk people,” Nissen said. “So the drug met its expectations and probably did a lot better than a lot of people thought it would do.”

    In the group that took bempedoic acid, there were a few more cases of gout and gallstones, compared with people who took a placebo.

    “The number is small, and weighing that against a heart attack, I think most people would say, ‘OK I’d rather have a little gout attack,’ ” Nissen said.

    Bempedoic acid had no observed effect on mortality, but that may be because the observation period was too short to tell if it had that kind of impact. Earlier trials on statins showed the same; it was only after there were multiple studies on statins that scientists were able to show an impact on mortality.

    Dr. Howard Weintraub, a cardiologist at NYU Langone Health who did not work on this study, said that while he knows some people will not consider a medication successful unless it reduces mortality, he thinks that is short-sighted.

    “I think there’s more to doing medicine then counting body bags,” Weintraub said.”Preventing things that can be life changing, crippling, and certainly change your quality of life forever going forward, and your cost of doing things going forward, I think is a good thing.”

    He was pleased to see the results of this trial, especially since the people in this study are often what he called “forgotten individuals” – the millions who could benefit from lowering their cholesterol, but can’t take statins.

    “It’s not like their LDL was 180 or 190 or 230, their LDL was 139. This is about average in our country,” Weintraub said. He said often doctors will just tell those patients to watch their diet, but he thinks this suggests they would benefit from medication.

    “Both groups primary and secondary prevention got benefit, which I think is impressive with the modest amount of LDL reduction,” Weintraub said.

    There are some limitations to this trial. It was narrowly focused on patients with a known statin intolerance. Nissen said the trial was not designed to determine whether bempedoic acid could be an alternative to statins.

    “Statins are the gold standard. They are the cornerstone. The purpose of this study was not to replace statins, but to allow an alternative therapy for people who simply cannot take them,” Nissen said.

    Bempedoic acid is a much more expensive drug than a statin. There are generic versions of statins and some cost only a few dollars. Bempedoic acid, on the other hand, has no generic alternative and a 30-day supply can cost more than $400, according to GoodRx.

    “I think what insurance companies need to recognize that even though this drug is going to cost more than statins, having a heart attack or a stroke or needing a stent is expensive. A 23% reduction in (myocardial infarctions) is a considerable reduction,” Weintraub said.

    In an editorial in the New England Journal of Medicine that accompanied the study, Dr. John H. Alexander, who works in the division of cardiology at Duke Clinical Research Institute, Duke Health, Durham said that doctors should take these results into consideration when treating patients with high cholesterol who can’t take statins.

    “The benefits of bempedoic acid are now clearer, and it is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events,” Alexander wrote.

    Dr. Manesh Patel, a cardiologist and volunteer with the American Heart Association who was not a part of the study, said that providers are already prescribing bempedoic acid for some patients, but with this new research, he thinks they will quickly be used with more statin-intolerant patients.

    “We continue to see that if we can lower your LDL significantly, we improve people’s cardiovascular health. And so we need as many different arrows in our quiver to try to get that done,” Patel said.

    Heart disease is the No. 1 killer for men and women in the world. One person dies every 34 seconds in the US from cardiovascular disease, according to the CDC. About 697,000 people in the US died from heart disease in 2020 alone – about the same number as the population of Oklahoma City.

    “Given the number of people that are eligible for statins, which are tens of millions of patients already, the number of people who cannot tolerate statins is in the millions,” Nissen said. “This is a big public health problem and I think we’ve come up with something that directly addresses this.”

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  • What Are the Risks of HIV Treatment-Related Weight Gain?

    What Are the Risks of HIV Treatment-Related Weight Gain?

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    Most people with HIV gain weight after they start antiretroviral therapy (ART). In fact, it’s usually a good sign that your ART is working. You might hear your doctor call these early extra pounds a “return to health.” But too much treatment-related weight gain can sometimes lead to future health problems.

    “Three decades ago, when the HIV epidemic was fresh and new, we worried about malnutrition and wasting,” says Onyema Ogbuagu, MBBCh, an infectious disease specialist who treats people with HIV at Yale Medicine. “Now that we’ve done a better job of catching people earlier in the disease and have more effective treatments, we have a different kind of metabolic problem, which is obesity.”

    Tell your doctor if you’re worried about treatment-related weight gain. They’ll go over all the pros and cons of your ART. They’ll also help you find safe ways to lose weight.

    Here are some other topics you might want to go over with your health care team.  

    What Are the Health Risks of Treatment-Related Weight Gain?

    Ogbuagu says older kinds of ART might cause lipodystrophy. That’s when your body shifts how it stores fat. You can end up with the kind of belly fat that’s linked to insulin resistance, diabetes, and heart problems. But those kind of fat changes are a lot less likely to happen with newer drugs.

    But there is evidence that short-term treatment-related weight gain from modern ART can still raise your odds of certain metabolic problems. More research is needed to know all of the long-term effects of treatment. But ART-related weight gain might lead to the following:

    • Type 2 diabetes
    • High cholesterol (also known as hyperlipidemia)
    • Non-alcoholic fatty liver disease

    “The data for diabetes and liver fat is certainly present,” says John Koethe, assistant professor in the division of infectious diseases at Vanderbilt University. But he says there’s conflicting evidence when it comes to cardiovascular disease. Obesity and overweight up the chances anyone will get cardiovascular disease. But he says it’s still not known whether ART-related weight gain raises those odds even higher. We need more research to find out.

    “People with HIV are already at a markedly increased risk of cardiovascular disease,” Koethe says. “The issue there may be that any attributable risk from the weight gain hasn’t really turned up in studies yet.”

    Keep in mind that excess body weight, regardless of which ART you’re on, can raise your odds of certain health conditions. That includes the following:

    • Sleep apnea
    • Cognitive decline
    • High blood pressure
    • Heart disease and stroke

    When Should You Watch for Weight Gain?

    After you start ART, your odds of weight gain are highest within the first 12 to 18 months, Koethe says. In that period of time, studies show about 37% of people will gain 5% of their body weight. Another 17% will add 10% of their body weight.

    Your weight might keep going up for several years after the start of ART, Koethe says, “but at a much slower pace.” 

    Does All Treatment-Related Weight Gain Come With Risks?

    If you’re underweight or normal weight, a few extra pounds can be OK and even healthy. “Weight gain is not always a bad thing,” Ogbuagu says. “For some people, it’s desirable.” He says it might even boost your sense of well-being.

    But in general, Koethe says doctors usually start to worry about future health problems if you gain 5% of your body weight after starting ART. People store that weight in different ways, but he says your odds of certain medical problems go up if you hold fat in the area around your internal organs. 

    “Those folks are at a higher risk of also accumulating fat around the liver, around the heart, and within their skeletal muscles,” Koethe says. “It’s those individuals who are going to be at a higher risk for metabolic diseases like diabetes and other comorbidities down the road.”

    It’s hard to tell where your fat is just by looking at your body. But there are some tests your doctor can do to get a more detailed look. Koethe says that might include the following:

    • Measure around your waist. Your odds of diabetes and heart disease are higher if your waist is greater than 35 inches for women or 40 inches for men.
    • DEXA (or DXA) scan. This is a type of bone density test. But it can also show where your body stores fat and muscle.
    • CT scan. This is a more advanced tool that’ll give your doctor info on the fat in and around your liver, skeletal muscles, heart, or other organs.

    Who Is More Likely to Gain Weight on ART?

    Koethe and his colleagues found that 3 years after the start of ART, about 22% of healthy-weight people became overweight. Among those who were already overweight, he says about one-fifth became obese. But those numbers don’t help experts predict much.

    There’s ongoing research into how much of a role your genes play. Koethe says there’s emerging data that certain drug-metabolizing enzymes might affect weight gain. In the future, that might shine a light on who’s more likely put on extra pounds after the start of ART.

    Should You Change Your ART?

    Talk to your doctor about your treatment. They might want to switch you to a different drug if you’ve gained lots of excess weight. But there are a lot of things to think about it before you make a change.

    If you haven’t started treatment, current pre-ART guidelines include a consideration for weight gain or metabolic problems. Bring it up with your doctor if those are health problems you or other family members have had.

    But right now, Koethe says there’s not enough scientific data to support a change from the standard guidelines. He says that’s because integrase inhibitors, which are linked to weight gain, “are just so much better when it comes to preventing (drug) resistance.”

    The best thing you can do, Koethe says, is to start or continue a healthy diet and exercise routine, especially at the start of ART. And keep your doctor in the loop about your weight gain. They can run routine checks on key health measures, such as:

    • Blood sugar
    • Blood pressure
    • Cholesterol levels

    Your doctor might not choose or change your ART based solely on excess weight concerns. But Ogbuagu says you should still talk to your doctor if it happens. “I think we should take action early, in the first few months or year, so that people don’t continue to gain weight and develop new complications along the way.”

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  • Don’t bother with dietary supplements for heart health, study says | CNN

    Don’t bother with dietary supplements for heart health, study says | CNN

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    CNN
     — 

    Six supplements that people commonly take for heart health don’t help lower “bad” cholesterol or improve cardiovascular health, according to a study published Sunday, but statins did.

    Some people believe that common dietary supplements – fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice – will lower their “bad” cholesterol. “Bad” cholesterol, known in the medical community as low-density lipoproteins or LDL, can cause the buildup of fatty deposits in the arteries. The fatty deposits can block the flow of oxygen and blood that the heart needs to work and the blockage can lead to a heart attack or stroke.

    For this study, which was presented at the American Heart Association’s Scientific Sessions 2022 and simultaneously published in the Journal of the American College of Cardiology, researchers compared the impact of these particular supplements to the impact of a low dose of a statin – a cholesterol-lowering medication – or a placebo, which does nothing.

    Researchers made this comparison in a randomized, single-blind clinical trial that involved 190 adults with no prior history of cardiovascular disease. Study participants were ages 40 to 75, and different groups got a low-dose statin called rosuvastatin, a placebo, fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for 28 days.

    The statin had the greatest impact and significantly lowered LDL compared with the supplements and placebo.

    The average LDL reduction after 28 days on a statin was nearly 40%. The statin also had the added benefit on total cholesterol, which dropped on average by 24%, and on blood triglycerides, which dropped 19%.

    None of the people who took the supplements saw any significant decrease in LDL cholesterol, total cholesterol or blood triglycerides, and their results were similar to those of people who took a placebo. While there were similar adverse events in all the groups, there were a numerically higher number of problems among those who took the plant sterols or red yeast rice.

    “We designed this study because many of us have had the same experience of trying to recommend evidence-based therapies that reduce cardiovascular risks to patients and then having them say ‘no thanks, I’ll just try this supplement,’ ” said study co-author Dr. Karol Watson, professor of medicine/cardiology and co-director, UCLA Program in Preventive Cardiology. “We wanted to design a very rigid, randomized, controlled trial study to prove what we already knew and show it in a rigorous way.”

    Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and a co-author on the study, said that patients often don’t know that dietary supplements aren’t tested in clinical trials. He calls these supplements “21st century snake oil.”

    In the United States, the Dietary Supplement and Health Education Act of 1994 sharply limited the US Food and Drug Administration’s ability to regulate supplements. Unlike pharmaceutical products that have to be proven safe and effective for their intended use before a company can market them, the FDA doesn’t have to approve dietary supplements before they can be sold. It is only after they are on the market and are proven to be unsafe that the FDA can step in to regulate them.

    “Patients believe studies have been done and that they are as effective as statins and can save them because they’re natural, but natural doesn’t mean safe and it doesn’t mean they’re effective,” Nissen said.

    The study was funded via an unrestricted grant from AstraZeneca, which makes rosuvastatin. The company did not have any input on the methodology, data analysis and discussion of the clinical implications, according to the study.

    The researchers acknowledged some limitations, including the study’s small sample size, and that its 28-study period might not capture the effect of supplements when used for a longer duration.

    In a statement on Sunday, the Council for Responsible Nutrition, a trade association for the dietary supplement industry, said “supplements are not intended to replace medications or other medical treatments.”

    “Dietary supplements are not intended to be quick fixes and their effects may not be revealed during the course of a study that only spans four weeks,” Andrea Wong, the group’s senior vice president for scientific and regulatory affairs, said in a statement.

    Dr. James Cireddu, an invasive cardiologist and medical director of University Hospitals Harrington Heart & Vascular Institute at University Hospitals Bedford Medical Center, said the work is going to be helpful.

    “They did a nice job collecting data and looking at the outcomes,” said Cireddu, who did not work on the study. “It will probably resonate with patients. I get asked about supplements all the time. I think this does a nice job of providing evidence.”

    Dr. Amit Khera, chair of the AHA Scientific Sessions programming committee, did not work on the research, but said he thought this was an important study to include in the presentations this year.

    “I take care of patients every day with these exact questions. Patients always ask about the supplements in lieu of or in addition to statins,” said Khera, who is a professor and director of preventive cardiology at UT Southwestern Medical Center. “I think if you have high quality evidence and a well done study it is really critical to help inform patients about the value, or in this case the lack of value, for some of these supplements for cholesterol lowering.”

    Statins have been around for more than 30 years and they’ve been studied in over 170,000 people, he said. Consistently, studies show that statins lower risk.

    “The good news, we know statins work,” Khera said. “That does not mean they’re perfect. That doesn’t mean everyone needs one, but for those at higher risk, we know they work and that’s well proven. If you’re going to do something different you have to make sure it works.”

    With supplements, he said he often sees misinformation online.

    “I think that people are always looking for something ‘natural’ but you know there’s a lot of issues with that terminology and most important we should ask do they work? That’s what this study does,” Khera adds. “It’s important to ask, are you taking something that is proven, and if you’re doing that and it’s not, is that in lieu of proven treatment. It’s a real concern.”

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