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Would you rather choose nutrition changes or statins?

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Instead of touting nutritional changes and how they can work together with lifestyle changes or exercise, new guidlines now deem 13 million more Americans eligible for statins, says recent research, "Application of New Cholesterol Guidelines to a Population-Based Sample," published online April 10, 2014 in the New England Journal of Medicine. The study is an analysis of health data. A team led by researchers at the Duke Clinical Research Institute found that most of the additional statin users under the new guidelines would be people older than age 60.

New guidelines for using statins to treat high cholesterol and prevent cardiovascular disease are projected to result in 12.8 million more U.S. adults taking the drugs, according to a research team led by Duke Medicine scientists. The findings for the first time quantify the impact of the American Heart Association's new guidelines, which were issued in November and generated both controversy and speculation about who should be given a prescription for statins.

"We sought to do a principled, scientific study to try to answer how the new guidelines might affect statin use, particularly as they focused eligibility on patients with an increased risk of developing cardiovascular disease," said lead author Michael J. Pencina, Ph.D., accordng to a March 19, 2014 news release, "New guidelines deem 13 million more Americans eligible for statins, based on a recent study from Duke University." Pencina is a professor of biostatistics at DCRI. "By our estimate, there might be an uptake in usage as a result of the guidelines, from 43.2 million people to 56 million, which is nearly half of the U.S. population between the ages of 40 and 75."

Pencina and colleagues from McGill University and Boston University used the National Health and Nutrition Examination Surveys (NHANES) for their analysis, focusing on 3,773 participants between the ages of 40-75 who had provided detailed medical information, including fasting cholesterol levels from blood tests.

The new guidelines expand the criteria for statin use to include people whose 10-year risk of developing cardiovascular disease, including stroke, is elevated based on a risk-assessment score

The DCRI-led research team determined that the new guidelines could result in 49 percent of U.S. adults ages 40-75 being recommended for statin therapy, an increase from 38 percent. The increase is much more pronounced among adults free of cardiovascular disease who are over age 60, with 77 percent recommended for statin use under the new guidelines vs. 48 percent under the previous standards. This contrasts with a modest increase from 27 percent to 30 percent among U.S. adults between the ages of 40 and 60.

Those most affected by the new recommendations are older men who are not on statins and do not have cardiovascular disease

Under the earlier guidelines, about 30.4 percent of this group of men between the ages of 60-75 were recommended for statin use. With the new guidelines, 87.4 percent of these men would be candidates for the therapy. Similarly for healthy women in this age group, those recommended for preventive statin use are projected to rise from 21.2 percent to 53.6 percent.

"The biggest surprise of the research was the age-dependent split for those affected by the new guidelines," Pencina said in the news release. "We anticipated that the impact would be age-dependent, but not to the degree observed. The changes for both men and women in the older age groups where huge compared to those between the ages of 40 and 60."

Overall, of the 12.8 million additional U.S. adults recommended for statin use under the new guidelines, 10.4 million are people who would be prescribed the drugs for preventive care. Of those preventive users, 8.3 million would be people over the age of 60.

The analysis also projects that an estimated 1.6 million adults previously eligible for statins under the old guidelines would no longer be candidates under the new standards. This group included primarily younger adults with elevated cholesterol but low 10-year risk of cardiovascular disease.

In real life people may decline to start statin therapy if there's hope nutrition can help with fewer side effects

Pencina said, according to the news release, that an important limitation of the study is the necessary assumption that the new guidelines would be followed to the letter; in real life, people may be recommended for statins but decline to start the therapy. "Recommendations are just that – recommendations," Pencina said in the news release. "These guidelines correctly call for a thorough discussion between the doctor and patient about the risks and benefits of statins. It's not like everybody who meets the guidelines should all of a sudden go on statins."

In addition to Pencina, study authors from Duke include Ann Marie Navar-Boggan, Benjamin Neely and Eric D. Peterson; with Ralph B. D'Agostino from Boston University; Ken Williams of KenAnCo Biostatistics; and Allan D. Sniderman from McGill University. The Duke Clinical Research Institute funded the study, along with grants from M. Jean de Granpré and Louis & Sylvia Vogel. It's up to the individual to research whether and how nutritional changes might work as each person, based on environment and genes, responds in a different way to specific foods or exercise changes.

Cholesterol-lowering drug may reduce exercise benefits for obese adults, University of Missouri-Columbia (MU) study finds

Statins significantly affected participants' exercise outcomes in a recent study, "Simvastatin impairs exercise training adaptations," which appears online August 20, 2013 in the Journal of the American College of Cardiology. Statins, the most widely prescribed drugs worldwide, are often suggested to lower cholesterol and prevent heart disease in individuals with obesity, diabetes and metabolic syndrome, which is a combination of medical disorders including excess body fat and/or high levels of blood pressure, blood sugar and/or cholesterol. However, University of Missouri researchers found that simvastatin, a generic type of statin previously sold under the brand name "Zocor," hindered the positive effects of exercise for obese and overweight adults.

"Fitness has proven to be the most significant predictor of longevity and health because it protects people from a variety of chronic diseases," said John Thyfault, according to a May 15, 2013 news release, "Cholesterol-lowering drug may reduce exercise benefits for obese adults, MU study finds." Thyfault is an associate professor of nutrition and exercise physiology at the University of Missouri (MU).

"Daily physical activity is needed to maintain or improve fitness, and thus improve health outcomes. However, if patients start exercising and taking statins at the same time, it seems that statins block the ability of exercise to improve their fitness levels."

Many cardiologists want to prescribe statins to all patients over a certain age

Thyfault says, according to the news release, that many cardiologists want to prescribe statins to all patients over a certain age regardless of whether they have metabolic syndrome. The drugs also are recommended for people with Type 2 diabetes. He recommends that cardiologists more closely weigh the benefits and risks of statins given this new data about their effect on exercise training.

"Statins have only been used for about 15-20 years, so we don't know what the long-term effects of statins will be on aerobic fitness and overall health," Thyfault said, according to the news release. "If the drugs cause complications with improving or maintaining fitness, not everyone should be prescribed statins."

Thyfault and his colleagues measured cardiorespiratory fitness in 37 previously sedentary, obese individuals ages 25-59 with low fitness levels. The participants followed the same exercise regimen on the University of Missouri (MU) campus for 12 weeks; 18 of the 37 people also took 40 mg of simvastatin daily.

Statins significantly affected participants' exercise outcomes

Participants in the exercise-only group increased their cardiorespiratory fitness by an average of 10 percent compared to a 1.5 percent increase among participants also prescribed statins. Additionally, skeletal muscle mitochondrial content, the site where muscle cells turn oxygen into energy, decreased by 4.5 percent in the group taking statins while the exercise-only group had a 13 percent increase, a normal response following exercise training.

Thyfault suggests that future research determine whether lower doses of simvastatin or other types of statins similarly affect people's exercise outcomes and thus their risk for diseases such as Type 2 diabetes. Starting a statin regimen after exercising and obtaining a higher fitness level may reduce the drugs' effects on fitness, he says.

Co-authors of the study, "Simvastatin impairs exercise training adaptations," included first author Catherine Mikus, who is now a postdoctoral fellow at Duke University, and MU researchers Leryn Boyle, Douglas Oberlin, Scott Naples, Justin Fletcher, Harold Laughlin, Kevin Dellsperger and Paul Fadel. Funding was provided by a grant from the MU Research Board, the Veterans Affairs' Career Development Award, an American Heart Association Midwest Affiliate Clinical Research Award and the National Institutes of Health.

The Department of Nutrition and Exercise Physiology is jointly administered by the College of Agriculture, Food and Natural Resources, the College of Human Environmental Sciences and the School of Medicine. Thyfault has a joint appointment in the Department of Internal Medicine in the Division of Gastroenterology and Hepatology in the MU School of Medicine.

If you may be wondering whether your statins are raising your risk of developing diabetes, McMaster University researchers uncovered a common heart drug's link to diabetes.

A new study provides insight into why statin drugs carry increased risk. McMaster University researchers may have found a novel way to suppress the devastating side effect of statins, one of the worlds' most widely used drugs to lower cholesterol and prevent heart disease. You may wish to check out the abstract of the new study, "Fluvastatin causes NLRP3 inflammasome-mediated adipose insulin resistance," published online June 10, 2014, in the journal Diabetes.

The research team—led by Jonathan Schertzer, assistant professor of Biochemistry and Biomedical Sciences and Canadian Diabetes Association Scholar—discovered one of the pathways that link statins to diabetes. Their findings could lead to the next generation of statins by informing potential combination therapies while taking the drug. Are you getting tired of hearing about one drug on top of another drug where the second drug suppressed the side effects of the first drugs instead of finding the root cause of the health problem and changing it through nutrition and exercise, getting rid of the toxins, or other means that have fewer side effects?

Researchers in the new study found that statins activated a very specific immune response, which stopped insulin from doing its job properly. They connected the dots and found that combining statins with another drug on top of it, Glyburide, suppressed this side effect.

Approximately 13 million people, or half of those over the age of 40, could be prescribed a statin drug in their lifetime

"Statins are among the most prescribed drugs in the world, and have been fantastic at reducing cardiovascular events," Schertzer says, according to a June 11, 2014 news release, Researchers uncover common heart drug's link to diabetes. "But the side effects of statins can be far worse than not being able to eat grapefruit. Recently, an increased risk of diabetes has been added to the warning label for statin use. This was perplexing to us because if you are improving your metabolic profile with statins you should actually be decreasing the incidence of diabetes with these drugs, yet, the opposite happened."

Schertzer's group investigated further. "We found that statins activated a very specific immune response, which stopped insulin from doing its job properly. So we connected the dots and found that combining statins with another drug on top of it, Glyburide, suppressed this side effect."

He says the finding has the potential to develop new targets for this immune pathway that do not interfere with the benefits of statins.

"It's premature to say we are going to change this drug, but now that we understand one way it can cause this side effect we can develop new strategies to minimize side effects. This may even include using natural products or nutritional strategies to subvert the side effects of statins," he says, according to the news release.

The next stage of their research is to understand how statins promote diabetes by understanding how they work in the pancreas, which secretes insulin. They also hope to better understand if this immune pathway is involved in other side effects of statins, such as muscle pain and life-threatening muscle breakdown.

Schertzer emphasizes that statins are important and widely prescribed drugs and understanding how they promote adverse effects may lead to necessary improvements in this drug class, which has the potential to affect a large segment of the population

"With the new federal warning label on the risk of diabetes with statin usage, people are heavily debating its pros and cons. We think this is the wrong conversation to have. Statins are a great drug for many people. What we really should be talking about is how to make them better and we are beginning to understand the basic biology of statins so we can do just that. The next step for our work is to understand if all of the major side effects of statins occur by acting on this specific immune-metabolism pathway."

Then again, not enough doctors have been trained in the biochemistry of how nutrition changes work with specific parts of the body. More testing and studies from functional, complementary, and integrative medicine need to be brought to the attention of consumers of health care and healthcare professionals. The recent recent is published in the medical journal Diabetes and was supported by funding from the Canadian Institutes of Health Research and the Canadian Diabetes Association. You may also wish to check out the abstract of another study, "The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial," published online August 28, 2012 in the journal BMC Public Health.

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