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For many patients who need to lower lipids to protect their heart health, statins are a blessing. But for some, these medications also cause troublesome side effects that their doctors ignore or don't recognize.
According to a recent survey of 650 patients, doctors dismissed or ignored patients' concerns about statin side effects more often than they acknowledged them.1 Among the symptoms encountered by patients were muscle pain, cognitive deficits, and finger and toe numbness—all side effects reported in the literature, says Beatrice Golomb, MD, PhD, the study's lead researcher and an associate professor of medicine at University of California, San Diego (UCSD).2 (It should be noted, however, that some research suggests statins may offer neuropathy protection [DOC News, August 2007, page 1]).
"What's troubling is that even for the best recognized side effects, which are the muscle effects, about 50% of these patients' physicians reportedly dismissed the possibility of a relationship to their statin medications," Golomb says. "That suggests holes in physician awareness that are gaping."
What might account for physicians' lack of side-effects awareness? John LaRosa, MD, president and professor of medicine at State University of New York Downstate Medical Center in Brooklyn, whose recent research has focused on intensive lipid lowering with statins, offers one possibility.
He says that physicians often think in terms of statistics and take their cues from the randomized trials on statin drugs. "The bias... is from all those trials that showed patients taking statins had the same level of adverse symptoms as patients given placebo," LaRosa says.3–8 "But of course there are no absolutes, and some patients clearly do experience adverse effects that we need to explore."
MISCONCEPTIONS ABOUT STATINS
Respondents for the ongoing UCSD Statin Effects Study were recruited through Internet, newspaper, and television reports about the survey. Most were college-educated U.S. citizens. The mean age was 63 years, and men and women were about equally represented.
Golomb says this survey and other data her team has reviewed point to several commonly held erroneous beliefs about statins:
ADDRESSING PATIENT COMPLAINTS ABOUT STATINS
The survey results indicate a need for increased physician sensitivity to potentially negative effects of statins, even though statins are well studied and, for the most part, safe, LaRosa says.
Take time to interview patients with an ear toward other possible sources of their symptoms, he suggests. If symptoms are vague and clearly not signs of a dangerous adverse event (e.g., rhabdomyolysis), it may help to urge patients to take a wait-and-see approach and to reassure them about benefits versus risks of their medication.
Indeed, though statin therapy is well proven to reduce cardiovascular disease (CVD) risk in patients with diabetes, in those with presumed statin intolerance, a very low dose of a more potent or less lipophyllic statin and/or the use of nonstatin agents such as fibrates, niacin, cholesterol absorption inhibitors, or bile-acid sequestrants can be tried, says John Buse, MD, PhD, CDE, American Diabetes Association president for medicine and science and chief of the endocrinology division at University of North Carolina School of Medicine in Chapel Hill. The primary issue is that these latter therapies have not been tested as rigorously as statins; it is not yet known if they reduce the risk of CVD as substantially as statins do, says Buse. A secondary issue is the reported risk of rhabdomyolysis in combinations of statins with fibrates or niacin.
When unexplained troublesome symptoms persist in patients on statins, they may benefit from a "statin holiday" with their physician's guidance, suggests cardiologist Gerald Gau, MD, professor of medicine at Mayo Clinic in Rochester, Minn.
Gau suggests having patients stop taking their statin medications for several days to see if symptoms resolve. If they do, the statin can be reintroduced to see if symptoms return, he says. Golomb suggests up to 2 months may be required for patients' statin-associated symptoms to resolve after discontinuing their medication.
The American Heart Association (AHA) offers the following recommendations for prescribing and monitoring statins:18
Footnotes
For more information and data the University of California, FROM SanDiego Statin Effects Study, go to http://medicine.ucsd.edu/ses/adverse_effects.htm.
References
2. Gaist D, Jeppesen U, Andersen M, et al.: Statins and risk of
polyneuropathy: A case-control study. Neurology 58: 1333–1337, 2002.
3. LaRosa JC, Grundy SM, Waters DD, et al.: Intensive lipid lowering
with atorvastatin in patients with stable coronary disease. N Engl
J Med 352:1425–1435, 2005.
4. Heart Protection Study Collaborative Group: MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial. Lancet 360:7–22, 2002.[Medline]
5. Sever PS, Dahlof B, Poulter NR, et al.: Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): A multicentre randomized controlled trial. Lancet 361: 1149–1158, 2003.[Medline]
6. Koren MJ, Hunninghake DB: Clinical outcomes in managed-care
patients with coronary heart disease treated aggressively in lipid-lowering
disease management clinics: The ALLIANCE study. J Am Coll
Cardiol 44:1722–1779, 2004.
7. The Long-Term Intervention with Pravastatin in Ischaemic Disease
(LIPID) Study Group. Prevention of cardiovascular events and death with
pravastatin in patients with coronary heart disease and a broad range of
initial cholesterol levels. N Engl J Med 339: 1349–1357, 1998.
8. Scandinavian Simvastatin Survival Study Group: Randomised trial of cholesterol lowering in 4,444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet 344: 1383–1389, 1994.[Medline]
9. McKenney J: A summary of The Report of the National Lipid Association Statin Safety Task Force. Am J Cardiol 97 (Suppl. 1):S1 –S98, 2006.
10. Li G, Larson EB, Sonnen JA, et al.: Statin therapy is associated
with reduced neuropathologic changes of Alzheimer disease.
Neurology 69:878–885, 2007.
11. Winblad B, Jelic V, Kershaw P, et al.: Effects of statins on cognitive function in patients with Alzheimer's disease in galantamine clinical trials. Drugs Aging 24: 57–61, 2007.[Medline]
12. Bernick C, Katz R, Smith NL, et al.: Statins and cognitive function
in the elderly: The Cardiovascular Health Study.
Neurology 65:1388–1394, 2005.
13. Schumaker SA, Legault C, Rapp SR, et al.: Estrogen plus progestin
and the incidence of dementia and mild cognitive impairment in postmenopausal
women: The Women's Health Initiative Memory Study: A randomized controlled
trial. JAMA 289:2651–2662, 2003.
14. Almeida OP, Flicker L: Association between hormone replacement therapy and dementia: Is it time to forget? Int Psychogeriatr 17:155–164, 2005.[Medline]
15. Muldoon MF, Barger SD, Ryan CM, et al.: Effects of lovastatin on cognitive function and psychological well-being. Am J Med 108:538–546, 2000.[Medline]
17. Shepherd J, Blauw GJ, Murphy MB, et al.: Pravastatin in elderly individuals at risk of vascular disease (PROSPER): A randomised controlled trial. Lancet 360:1623–1630, 2002.[Medline]
18. American Heart Association: Side effects of cholesterol-lowering drugs. Media advisory, May 23, 2005. Available online at www.americanheart.org/presenter.jhtml?identifier=3031067 <http://www.americanheart.org/presenter.jhtml?identifier=3031067>. Accessed October 15, 2007.
19. NCEP Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults: Executive summary of the third report of the
National Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment
Panel III). JAMA 285:2486–2497, 2001.
20. Grundy SM: The issue of statin safety: Where do we stand?
Circulation 111:3016–3019, 2005.
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