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An article in the November 2014 issue of Worst Pills, Best Pills News discussed newly issued prescribing guidelines for statin drugs and criticized the validity of recommending statins for many more patients, especially for preventing a heart attack or stroke in patients who have not previously had one (primary prevention). These guidelines were partly based on a new patient risk calculator that had not been adequately tested and thereby overestimated the 10-year risk of cardiovascular...
An article in the November 2014 issue of Worst Pills, Best Pills News discussed newly issued prescribing guidelines for statin drugs and criticized the validity of recommending statins for many more patients, especially for preventing a heart attack or stroke in patients who have not previously had one (primary prevention). These guidelines were partly based on a new patient risk calculator that had not been adequately tested and thereby overestimated the 10-year risk of cardiovascular disease for patients, one important factor in deciding whether to prescribe statins.[1]
Since then, a study has been published analyzing the magnitude of this overestimation of risk by comparing the guideline-calculated risk with the actual risk outcomes in 27,500 patients, half of whom had been followed for more than 10 years.[2] The study found that the size of the calculated risk, depending on the particular patient group, varied from 40 to 90 percent higher than the cardiovascular diseases that actually occurred in the patients who had been followed.
Accompanying this study was a commentary by Dr. Steven Nissen of the Cleveland Clinic, criticizing the guideline-setting process and putting the above results into perspective.[3] He stated that the new risk-calculator-based guideline was “overestimating risk by at least 50%. ... While statins are valuable drugs, particularly in secondary prevention [for people with previous heart attacks or strokes], they do have downsides, and prudence requires not administering drugs to patients who will likely not benefit. The implications of the overestimation of risk are profound. A 50% overestimation by the guideline risk equations would likely add millions of Americans to the roles [sic] of patients for whom statins are recommended.”
Nissen’s opposition was so strong that he advised the American College of Cardiology and the American Heart Association to promptly revise the guidelines and, before finalizing them, allow public comment to avoid a repeat of the inadequately vetted guidelines.
An editorial in the U.K.’s The Lancet, titled “Statins: New US Guideline Sparks Controversy,” charged that the guidelines systematically overestimated cardiovascular risks and could “therefore lead to overtreatment of a substantial fraction of the 33 million Americans potentially affected by the guideline.”[4]
As discussed before in Worst Pills, Best Pills News, there is much less dispute about the need for statins for those with previous heart attacks or strokes. The controversy of the new guidelines centers on its recommendation of statins for primary prevention. In that case, millions of people needlessly would become statin users, with the risks of these drugs exceeding the often nonexistent benefits for these additional people.
An op-ed in The New York Times summed up this situation, stating the new guideline “essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills — namely statins — for undefined health ‘benefits.’ This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else.”[5]
References
[1] New cholesterol treatment guidelines recommend statins for more patients. Worst Pills, Best Pills News. November 2014. /newsletters/view/927.
[2] Cook NR, Ridker PM. Further insight into the cardiovascular risk calculator. The roles of statins, revascularizations, and underascertainment in the Women’s Health Study. JAMA Intern Med. 2014;174(12):1964-1971.
[3] Nissen SE. Prevention guidelines; bad process bad outcome. JAMA Intern Med. 2014;174(12):1972-1973
[4] Editorial: Statins: New US guideline sparks controversy. Lancet. 2013;382:1762-1765
[5] Abramson, J, Redberg, R. Don’t Give More Patients Statins. New York Times. November 23, 2013. http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html
