Alternatives for those who suffer from statin side effects

by David Becker, M.D.

Published Apr. 15, 2016, 3:04 p.m. ET

If you have stopped your cholesterol lowering medication because of side effects, you may finally feel vindicated. Although as many as 10-20 percent of people taking statins have complained of muscle aching, previously doctors have not had many alternatives to suggest. Although it might be tempting to just discontinue the medication, two new studies published this week provide contrasting information and approaches to this problem.

The first study, called GAUSS 3, was published this week in the Journal of the American Medical Association. It suggests that people experiencing statin intolerance did well when they took an alternative cholesterol-lowering drug called Repatha. This is an injectable medication, given once or twice per month, and was approved by the FDA last summer. It lowered LDL (bad) cholesterol by 50% in this trial, without the disabling side effects that the same patients had experienced on multiple statins.

The second study, called HOPE 3, was published this week in the New England Journal of Medicine. Its focus was on Crestor, a costly, non-generic statin. It showed that people taking Crestor at low doses, who did not have heart disease or even high cholesterol values, may lower their risk of having a heart attack or stroke. Almost none of the participants had muscle aching or any side effects from the medication. This is important because Crestor could win FDA approval for doctors to prescribe this more expensive statin for people with normal cholesterol values. The lack of side effects seen during the study may even help build a case for eventual over -the -counter status, which could be quite profitable.

Why are studies finally being done to investigate statin intolerance? To answer that question, it is best to follow the money. Both studies were funded by pharmaceutical companies. HOPE 3 investigated a new use for Crestor and was funded by Astra Zeneca. It reported almost no side effects of muscle aching in over 6000 people taking the medication.

The GAUSS 3 trial was funded by Amgen, which makes Repatha. It looked into a group of people who had intolerable side effects from statins, emphasizing that this is a fairly common problem. If patients who experience statin intolerance begin taking this medication, it will be very expensive and profitable treatment. The wholesale cost of the drug is now around $14,000 per year.

The money trail points to a sad reality. Research costs a lot of money, and it is difficult to prove new medications work without doing a trial that may cost at least 500 million dollars. If a company is going to put up that kind of money, it wants a return on its investment.

What is the message for someone who cannot tolerate a statin? The two new studies suggest that low doses of statins are usually well -tolerated, and that the injectable medications may turn out to be an option for those who cannot tolerate statins at all.

There are other alternatives for people who cannot take statins because of muscle aching. For example, statins can sometimes be taken every other day with reduced side effects. A supplement called red yeast rice can also be an option for some people with statin intolerance.

Time will tell if these two new studies will lead to new indications for these medications. More information about the injectable cholesterol drugs is coming. If trials show that they decrease the chance of having heart attacks, they will likely have a major role in the future. They may help some people experiencing muscle side effects from statins, especially if the price comes down. For now, however, all the patients who have taken statins over the years and experienced intolerable side effects can feel redeemed that new research has validated their often disregarded complaints.

Dr. David Becker is a board certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown, Pa. and has been in practice for 25 years. In 1993, after extensive research, Dr. Becker launched Healthy Change of Heart™, an innovative 10-week program designed to reverse heart disease and improve quality of life through diet, exercise, and stress management. Since then, thousands of patients have participated in the program, achieving significant results in improving cardiac wellness.