Statin benefits far outweigh the side effects

MEDICAL MATTERS:Can the wonder drug affect your memory?

I AM ONE of the many thousands of people in Ireland who take a statin drug on a daily basis to control our cholesterol levels. Statins are true wonder drugs, which have been shown to substantially reduce the risk of heart attack and stroke in those with established heart disease and for people at high risk of developing cardiovascular problems.

Like every pharmaceutical preparation, statins have side effects. Probably the main reason people stop taking them is if they develop severe muscle pain, which can rarely progress to rhabdomyolysis, a condition where the muscle fibres begin to break down.

Usually taken at night, occasionally patients return to say they are experiencing nightmares since starting the drug. This usually resolves when you advise taking the pill at teatime rather than just before going to bed.

Over the years, a number of patients have asked me could statins affect their memory. Not according to the detailed prescribing information provided to doctors was my response. But last week that advice has changed following a new safety alert from the US Food and Drug Administration (FDA).

Dr Amy Egan, deputy director for safety with the FDA, said that while dozens of well-controlled trials of statins have offered few indications that the drugs cause any kind of cognitive impairment, the agency had received many reports over the years that some patients felt unfocused or “fuzzy” in their thinking after taking the medicines.

Which rings a personal as well as a professional bell for me. I have occasionally wondered over the past few years if my memory was not as good as it once was. I’ve never been great for remembering names but I never forget a face. Rather than being a classical cognitive deficit, my short-term memory seems to occasionally switch itself off, but only temporarily and not completely. “Fuzzy” is the perfect one-word description for how I can feel.

This change came on shortly after I was prescribed statins. It now seems that the drug is the cause for my occasional and temporary lapses into “fuzzyland” and for the varying minor memory complaints of patients. The FDA is very clear that this is a class-effect involving all age groups and is not confined to one or two brands of the drug.

Will I now stop taking a statin? Absolutely not. Their benefits far outweigh most side effects. A major review of the long-term use of statins, published late last year in the Lancet, showed the benefits of statin therapy in reducing heart attack and stroke. The benefits increase the longer treatment is continued and persist for several years after treatment has stopped, according to the research. And the study by the Oxford Heart Protection Study Collaborative Group found no evidence of serious side effects such as increased cancer incidence during the long follow-up.

The lead author, Irish doctor Richard Bulbulia, said: “The reliable evidence of safety, with no excess risk of cancer or other major illnesses over 11 years’ follow-up is very reassuring for doctors who prescribe statins and the increasingly large numbers of patients who take them long term to reduce their risk of vascular disease.”

Just last week, the Irish Medicines Board’s drug safety bulletin advised doctors that statins may increase the risk of new onset diabetes in patients already at risk of developing the disease. But again, their advice, backed by the European Medicines Agency, is clear: “This risk is outweighed by the beneficial reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.”

The FDA has also reminded doctors that some other medications increase the likelihood that statins stay in the body for longer and thereby increase the risk of muscle pain. Among those that interact with statins in this way are some hepatitis C drugs and the antibiotics erythromycin and clarithromycin.

All drugs need to be taken with care and knowledge of their side effects; it is good to see drug regulators being more open about all side effects and not just the ones they consider to be a major problem.

mhouston@irishtimes.com