CMAJ • November 8, 2005; 173 (10). doi:10.1503/cmaj.1050120.
© 2005 CMA Media Inc. or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
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Letters

Questioning the benefits of statins

Eddie Vos* and Colin P. Rose{dagger}

*Sutton, Que.; {dagger}Cardiologist, McGill University, Montréal, Que.

The assessment by Douglas Manuel and associates1 of the 2003 Canadian dyslipidemia guidelines2 is welcome, but they overlooked the all-cause mortality issue, where statins have essentially failed to deliver.1 There are no statin trials with even the slightest hint of a mortality benefit in women,3,4,5 and women should be told so. Likewise, evidence in patients over 70 years old shows no mortality benefit of statin therapy: in the PROSPER trial there were 28 fewer deaths from coronary artery disease in patients who received pravastatin versus placebo, offset by 24 more cancer deaths.6

The failure of statins to decrease all-cause mortality is possibly best illustrated by atorvastatin: while both the ASCOT7 and TNT8 trials found that atorvastatin therapy decreased the risk of cardiovascular events, in the ASCOT trial (placebo v. 10 mg atorvastatin daily) the all-cause mortality curves effectively touched at mean study end (3.3 years) and in the TNT trial (10 v. 80 mg of atorvastatin daily) there were 26 fewer deaths from coronary artery disease in patients taking the higher dose offset by 31 more noncardiovascular deaths at median study end (4.9 years). Incidentally, the ASCOT trial failed to find a cardiac benefit of statin therapy in women and patients with diabetes.

The Web site of the ALLHAT study says it best:9 "trials [primarily in middle-aged men] demonstrating a reduction in [coronary artery disease] from cholesterol lowering have not demonstrated a net reduction in all-cause mortality." What is the point of decreasing the number of "events" without decreasing overall mortality, when the harm caused by the side effects of statin therapy is factored in?

The failure of statins to reduce all-cause mortality clearly supports the call for more effective approaches. Guidelines should reflect this finding, certainly in their recommendations for women and probably in those for most men too.

REFERENCES

  1. Manuel DG, Tanuseputro P, Mustard CA, et al. The 2003 Canadian recommendations for dyslipidemia management: Revisions are needed [editorial]. CMAJ 2005;172(8):1027-31.[Free Full Text]
  2. Genest J, Frohlich J, Fodor G, et al.; the Working Group on Hypercholesterolemia and Other Dyslipidemias. Recommendations for the management of dyslipidemia and the prevention of cardiovascular disease: summary of the 2003 update. CMAJ 2003;169(9):921-4.[Free Full Text]
  3. Walsh JM, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004;291(18):2243-52.[Abstract/Free Full Text]
  4. Criqui MH, Golomb BA. Low and lowered cholesterol and total mortality. Am Coll Cardiol 2004;44(5):1009-10.[Free Full Text]
  5. Taylor D, Jenkins A, Conradi P. Prevention of coronary heart disease: statins are even less effective than paper shows [letter]. BMJ 2004;328:404.[Free Full Text]
  6. Shepherd J, Blauw GJ, Murphy MB, et al.; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk, pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002;360(9346):1623-30.[CrossRef][Medline]
  7. Sever PS, Dahlof B, Poulter NR, et al.; ASCOT investigators. 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 randomised controlled trial. Lancet 2003;361(9364):1149-58.[CrossRef][Medline]
  8. LaRosa JC, Grundy SM, Waters DD, et al.; Treating to New Targets (TNT) investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352(14):1425-35.[Abstract/Free Full Text]
  9. ALLHAT: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial [Web site]. Houston: Coordinating Center for Clinical Trials. Available: http://allhat.sph.uth.tmc.edu/study/study.cfm (accessed 2005 Oct 12).



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