Controversies Surrounding Statin Drugs

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index2Statin drugs are routinely prescribed for lowering cholesterol levels, even if these are only slightly high and even more so if they are very high. After all, high cholesterol levels are a factor in heart attack. New studies and research caused the American Heart Association and the American College of Cardiology to set fresh guidelines for prescribing these drugs. Instead of just looking of the results of the lipid profile or panel test, doctors have been advised to look at the entire picture and then assess the patient’s requirement for a statin drug.

 

Assessment of risk factors

Among the factors that the doctor should take into account are: age, race, gender, blood pressure readings, blood pressure medicines, diabetes, smoking, cholesterol ratio, total cholesterol and other aspects. The risk calculator also assesses the risk factors for stroke and heart attack, because both have similar causal factors – one affects the brain and the other the heart.

There are seven different statin drugs in the market: fluvastatin (Lescol), lovastatin (Mevacor), pitavastatin (Livalo), pravastatin (Pravachol), atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor). Of these, the last three have shown better results in lowering cholesterol levels and preventing heart attacks. The new risk guidelines will result in the number of people taking statins to double.

Patients who should be advised statin drugs include those that have already suffered a stroke or heart attack; those over 21 who have an LDL cholesterol reading of 190 or more; those with diabetes; and patients of ages 40-75 years who have a greater than 7.5 percent risk of developing heart attack or stroke or other cardiovascular problems over the next 10 years. The larger the number of risk factors, the better the prognosis with statin drugs.

At the same time, the guidelines state that simply taking statin drugs should not be the end of the treatment as patients should also be advised to make lifestyle changes like including 40 minutes of exercise at least three to four times a week and make dietary changes and stop smoking.

Statin drugs for older people

The AMDA (American Medical Directors Association) suggests that statin drugs should not be routinely prescribed to people over 70 years who do not have any pre-existing cardiovascular disease. Doctors say that there is not enough scientific evidence to support the use of statin drugs in this category as most research studies feature subjects over wide age ranges.

Senior citizens may not experience too many benefits of taking statin drugs unnecessarily and these may actually do more harm than good. Doctors should take individual risk assessment factors into account and then prescribe drugs with some side effects that can compromise the quality of life of seniors, weighing the risk-reward ratio.

A research study published in the Journal of The American College of Cardiology analyzed data on eight randomized trials of 25,000 people 65 and older. The study concluded that those who took these drugs had a 39.4 percent reduction in heart attacks and 23.8 percent reduction in strokes. What is surprising, however, is that they did not live longer.

On the other hand, seniors have often suffered reversible side effects like diarrhea, aches and pains, tiredness, memory loss and more after taking statin medicines that disappeared after they stopped. This may partly be because older people are more prone to experiencing more side effects. In 2012, the FDA added safety alerts to prescribing information of statin drugs warning against memory loss, diabetes and muscle pain, especially after research studies pointed to increase risk of developing diabetes after taking statin drugs.

At the same time, it may be noted that older people who have greater risk of developing cardiovascular problems or who have an existing history of heart disease or heart attack should be taking cholesterol lowering drugs if they have high cholesterol levels and have been prescribed the drugs by a doctor.

Recent study shows that low dose statin drugs may work equally well

A study published on February 10, 2014 in the Annals of Internal Medicines and conducted by scientists at Johns Hopkins showed that lowering the dose of statin may reduce cholesterol levels, at the same time reducing the side effects. Data from 36 trials published till November 2013 were studied and the results showed that using low dose statin drugs combined with a non statin drug like a bile sequestrant decreased LDL cholesterol levels by 0-14 percent more than mid level dosage of statin drugs given alone. Similar or higher numbers were reached when comparing mid level dosage and high level dosage of statin given with ezetimibe.

The study, authored by Dr. Kimberly Gudzune, assistant professor of medicine, shows that perhaps statin drugs alone may not be as effective in lowering cholesterol levels when compared to statin drugs given with non statin drugs of different kinds. The combination therapy can help reduce the dosage of statin drugs require and so minimize unwanted side effects.

‘At least in the short term, this strategy seems to be as effective as the high-dose statin alone, although there were two major caveats: We don’t know much about side effects and we don’t know about long-term effectiveness,’ Dr Gudzune warned.

Generic statins versus brand name ones

There is yet another controversy surrounding statin drugs apart from the fact that many studies have implicated them in diabetes and that is about the use of generic statin drugs. While these are routinely prescribed – 80 percent of prescription medicines are generics – and are USFDA approved, often patients do not respond to generics.

That is because research has shown that at least 10 percent of the drugs procured from other countries like India and other emerging economies contain impurities that compromise their effectiveness. Often doctors advise brand names rather than generics, especially if the drug does not have the effect it is supposed to. While the FDA is taking action against companies manufacturing these drugs and penalizing them or banning their products there is widespread alarm about quality compromised drugs.

Sources:

Harvard Health Publication

The New York Times