As more and more Americans take cholesterol-lowering drugs known as statins, Dr. Beatrice A. Golomb has carved out a niche investigating a less-publicized aspect of these cardiac wonder drugs: patients' complaints of memory loss, irritability and nerve and muscle pain.
Golomb, an assistant professor of medicine at UC San Diego, also leads a five-year, $5-million study funded by the National Institutes of Health. She is trying to determine statins' effects on other aspects of health, including mood, cognition, quality of life and blood chemistry.
As part of her research, she has come across hundreds of cases in which patients on statin drugs report that their doctors ignored complaints about side effects by attributing their problems to non-drug-related issues, such as age. Some doctors "don't understand how these drugs could cause such effects and therefore assume that they don't," Golomb said.
Although statins have been on the market nearly 15 years, researchers are only beginning to understand how they affect the body over the longer term. Statins reduce levels of cholesterol, a waxy substance made in the liver that in excess amounts can contribute to the clogging of blood vessels, setting the stage for heart attacks and strokes. But cholesterol also is essential to the proper functioning of every cell and some of it gets converted into such important hormones as cortisol, estrogen and testosterone.
By reducing low-density lipoprotein, or so-called bad cholesterol, statins can prevent heart attacks and save lives, particularly among middle-aged and slightly older men at high risk of heart disease.
At the same time, they may inadvertently disrupt other functions in the body, said Golomb, who describes herself as a "relatively lone voice" urging caution. Studies so far haven't demonstrated a survival benefit for women, lower-risk men and men and women older than 70, she said, raising important questions about risks versus benefits in those groups. For example, she said, impaired memory and thought are more likely to have a profound effect on seniors' independence, while muscle weakness from the medications could make them more vulnerable to the perils of falling.
Golomb, who has a doctorate in neurobiology along with her medical degree, said her fascination with statins' effects on brain chemistry began in medical school. She continued pursuing research into the drugs' neurochemical effects, eventually broadening her focus to all risks and benefits. In the UC San Diego Statin Study, 1,000 subjects with mild to moderate heart risk have been randomly assigned to getting six months of simvastatin (Zocor), pravastatin (Pravachol) or a dummy pill. Simvastatin is the statin most likely to cross the blood-brain barrier and penetrate all cells; pravastatin is only taken up in the liver, where it blocks production of cholesterol.
When completed in eight to 10 months, the study will be the largest to assess statins' cognitive effects, as well as mood changes, muscle pain, weakness and nerve pain, all of which can occur any time during treatment.
Golomb has drafted two papers based on statin users' reports of cognitive problems. One focuses on 25 patients who developed amnesia syndromes, the other on 100 statin users who developed premature Alzheimer's or unexplained memory loss. In one case, a Spanish-language translator lost his ability to speak Spanish completely. These problems resolved when the patients stopped the drugs or decreased the dosage.
Patients who are concerned about statin side effects can e-mail the UC San Diego Statin Study at firstname.lastname@example.org or call (858) 558-4950.