Re: Should people at low risk of cardiovascular disease take a statin?
Abramson et al.(1) question the benefit of statin therapy in low risk patients, as recommended by the new cholesterol treatment guidelines.(2)This conclusion is based on the author’s evaluation of a meta-analysis performed by the Cholesterol Treatment Trialists' (CTT) Collaborators.(3) First, Abramson et al.(1) state that in the setting of primary prevention statins have not been shown to have an impact on all-cause mortality. In the JUPITER trial 17,802 otherwise healthy participants were randomized to treatment with rosuvastatin 20 mg daily or placebo.(4) Over 97% of study participants had a 5 year risk of major vascular events (MVE) of less than 10%.(3) After a median follow-up of 1.9 years (maximum 5 years) rosuvastatin reduced the risk for all-cause mortality by 20% compared to placebo (HR 0.80, 95% CI 0.67-0.97, p=0.02). Furthermore, this reduction in mortality was seen after only a median follow-up of 1.9 years.(4)
In addition to the JUPITER study, two other trials conducted in predominantly low risk patient populations (AFCAPS/TexCAPS(5) and MEGA(6)) were included in the CTT meta-analysis that evaluated outcomes considered to be “serious adverse events” as defined by Abramson et al.(1) Over 95% of patients enrolled in these trials had an MVE of less than 10%.(3) In JUPITER, rosuvastatin reduced the rate of arterial vascularization or hospitalization for unstable angina (HR 0.53, 95% CI 0.4-0.7, p<0.00001).(4) In AFCAPS/TexCAPS, treatment with lovastatin 20-40 mg daily reduced the rate of coronary revascularizations (HR 0.67, 95% CI 0.52-0.85, p=0.001) and unstable angina (RR 0.68, 95% CI 0.49-0.95, p=0.02).(5) Finally, the MEGA trial showed that after an average follow-up of 5.3 years pravastatin 10-20 mg daily significantly reduced the risk for myocardial infarction and coronary revascularization (HR 0.52, 95% CI 0.29-0.94, p<0.03; HR 0.60 95% CI 0.41-0.89, p<0.01, respectively).(6) These studies also report no increased risk of fatal or non-fatal cancer or death from non-CV causes, further supporting the safety and efficacy of statin therapy in primary prevention.(4-6)
Lastly, the authors(1) state "Under the proposed 2013 standards…no level of risk would preclude statin therapy, raising the question of whether or not all people over the age of 50 should be treated." However, it is noted in the Guidelines that patients aged 40-75 years without clinical CHD (i.e. primary prevention therapy) with a baseline LDL of 70-189 mg/dL and an estimated 10-year risk greater than 7.5% should be considered for statin therapy. By specifying that the 10-year risk be elevated above 7.5% the guidelines note that not all patients over the age of 40 will be treated with a statin.(2) Furthermore, those patients with a 10 year risk below 5%, discussed extensively by Abramson et. al, (1) would be excluded from statin therapy.
Kyle A. Davis, Pharm.D, BCPS
Jackson Memorial Hospital
Eric Dietrich, PharmD, BCPS
Department of Community Health and Family Medicine
University of Florida
1. Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ. 2013 Oct 22
2. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Nov 7.
3. Cholesterol Treatment Trialists' (CTT) Collaborators, Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012 Aug 11;380(9841):581-90.
4. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, et al; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207.
5. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998 May 27;279(20):1615-22.
6. Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, et al; MEGA Study Group. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Lancet. 2006 Sep 30;368(9542):1155-63.
Competing interests: No competing interests