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Use of Statins in Healthy Men—Reply

Use of Statins in Healthy Men—Reply In Reply: The underlying premise of our Viewpoint was that the benefits of any prescribed medication should outweigh the risks for a given patient population. In the case of statins for healthy middle-aged men, that standard has not been met. Dr Beckman suggests that Ray et al1 should have used a fixed-effects model instead of a random-effects model. However, given the different types of studies involved, it is more appropriate to assume that the true effect varies between studies and perform a random-effects model. Furthermore, even with the fixed-effect model, the result is not significant (ie, the upper confidence limit includes 1.00) or no benefit from statins. In the case of the Cochrane meta-analysis of statin use,2 the authors note evidence of selective reporting of outcomes, failure to report adverse events, and inclusion of people with cardiovascular disease and conclude: “Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.” Beckman questions the association of statin use with cognitive impairment. The US Food and Drug Administration in February found this risk serious enough to require that statin labels reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs. The Food and Drug Administration also required the increased diabetes risk (48% adjusted increase in diabetes risk in women taking statins3) be added to the label. A recent randomized trial of more than 1000 patients found unfavorable effects of statins on energy and exertional fatigue.4 The final point concerning the use of thiazides supports our argument rather than contradicting it, as Beckman suggests. All medicines, including thiazides and statins, have adverse effects. We advocate the use of thiazides because they are the safest and most effective treatments for hypertension. They reduce mortality, strokes, and coronary heart disease.5 If treating elevated cholesterol in healthy men with statins was as effective at preventing heart disease and death with as few adverse events as treatment of hypertension with thiazides, we would support statin treatment in this group. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest none were reported. References 1. Ray KK, Seshasai SR, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010;170(12):1024-103120585067PubMedGoogle ScholarCrossref 2. Taylor F, Ward K, Moore TH, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011;(1):CD00481621249663PubMedGoogle Scholar 3. Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012;172(2):144-15222231607PubMedGoogle ScholarCrossref 4. Golomb BA, Evans MA, Dimsdale JE, White HL. Effects of statins on energy and fatigue with exertion: results from randomized controlled trial [published online August 13, 2012]. Arch Intern Med22688574PubMedGoogle Scholar 5. Wright JM, Musini VM. First-line drugs for hypertension. Cochrane Database Syst Rev. 2009;(3):CD00184119588327PubMedGoogle Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Use of Statins in Healthy Men—Reply

JAMA , Volume 308 (7) – Aug 15, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.8732
Publisher site
See Article on Publisher Site

Abstract

In Reply: The underlying premise of our Viewpoint was that the benefits of any prescribed medication should outweigh the risks for a given patient population. In the case of statins for healthy middle-aged men, that standard has not been met. Dr Beckman suggests that Ray et al1 should have used a fixed-effects model instead of a random-effects model. However, given the different types of studies involved, it is more appropriate to assume that the true effect varies between studies and perform a random-effects model. Furthermore, even with the fixed-effect model, the result is not significant (ie, the upper confidence limit includes 1.00) or no benefit from statins. In the case of the Cochrane meta-analysis of statin use,2 the authors note evidence of selective reporting of outcomes, failure to report adverse events, and inclusion of people with cardiovascular disease and conclude: “Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.” Beckman questions the association of statin use with cognitive impairment. The US Food and Drug Administration in February found this risk serious enough to require that statin labels reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs. The Food and Drug Administration also required the increased diabetes risk (48% adjusted increase in diabetes risk in women taking statins3) be added to the label. A recent randomized trial of more than 1000 patients found unfavorable effects of statins on energy and exertional fatigue.4 The final point concerning the use of thiazides supports our argument rather than contradicting it, as Beckman suggests. All medicines, including thiazides and statins, have adverse effects. We advocate the use of thiazides because they are the safest and most effective treatments for hypertension. They reduce mortality, strokes, and coronary heart disease.5 If treating elevated cholesterol in healthy men with statins was as effective at preventing heart disease and death with as few adverse events as treatment of hypertension with thiazides, we would support statin treatment in this group. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest none were reported. References 1. Ray KK, Seshasai SR, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010;170(12):1024-103120585067PubMedGoogle ScholarCrossref 2. Taylor F, Ward K, Moore TH, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011;(1):CD00481621249663PubMedGoogle Scholar 3. Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012;172(2):144-15222231607PubMedGoogle ScholarCrossref 4. Golomb BA, Evans MA, Dimsdale JE, White HL. Effects of statins on energy and fatigue with exertion: results from randomized controlled trial [published online August 13, 2012]. Arch Intern Med22688574PubMedGoogle Scholar 5. Wright JM, Musini VM. First-line drugs for hypertension. Cochrane Database Syst Rev. 2009;(3):CD00184119588327PubMedGoogle Scholar

Journal

JAMAAmerican Medical Association

Published: Aug 15, 2012

References