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(Circulation. 2007;116:e9.)
© 2007 American Heart Association, Inc.

Correspondence

Response to Letters Regarding Article, "Risks Associated With Statin Therapy: A Systematic Overview of Randomized Clinical Trials"

Amir Kashani, MS, MD; JoAnne M. Foody, MD; Yongfei Wang, MS; Harlan M. Krumholz, MD, SM

Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn

Christopher O. Phillips, MD, MPH

Department of General Internal Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio

Sandeep Mangalmurti, MD

Ambulatory Health Clinic, United States Navy, Groton, Conn

Dennis T. Ko, MD

Schlich Heart Centre, Sunnybrook Health Sciences Centre, Ontario, Canada

The letters that address our analysis of risks associated with statin therapy¹ raise 2 important points: the generalizability of the data and the excess incidence of myalgias observed with atorvastatin therapy. Although inclusion/exclusion criteria required for clinical trials limit generalizability to patients in clinical practice, randomized controlled trials remain the best unbiased source of data to assess adverse effects.^2,3 However, there remains a need for additional, large, safety studies in populations previously not studied.

In their letter, Drs Brewster and van Montfrans indicate that some statin trials exclude patients with elevated creatine kinase levels (>1.5 to 6 times the upper limit of normal). We believe that these patients are appropriately excluded, as patients with extreme creatine kinase elevations have an underlying pathology and may represent a population inappropriate for statin therapy.

The issue of excess incidence of myalgia observed with atorvastatin, raised in the letter from Drs Rosenberg and Uretsky, merits further investigation. This observation reached marginal statistical significance (P=0.04) and was based on only 567 patients (19 of 375 patients versus 3 of 192 patients in the treatment and placebo groups, respectively). Accordingly, this finding is worth further pursuit, but should not be considered definitive at this time.

	Acknowledgments

 
Disclosures

Dr Foody received honoraria from and served as a consultant/advisory board member for Merck, BMS/Sanofi, and Pfizer. The other authors have nothing to disclose.

	References

Top References

 
1. Kashani A, Phillips CO, Foody JM, Wang Y, Mangalmurti S, Ko DT, Krumholz HM. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006; 114: 2788–2797.[Abstract/Free Full Text]

2. Curtin F, Altman DG, Elbourne D. Meta-analysis combining parallel and cross-over clinical trials. I: Continuous outcomes. Stat Med. 2002; 21: 2131–2144.[CrossRef][Medline] [Order article via Infotrieve]

3. Curtin F, Elbourne D, Altman DG. Meta-analysis combining parallel and cross-over clinical trials. III: The issue of carry-over. Stat Med. 2002; 21: 2161–2173.[CrossRef][Medline] [Order article via Infotrieve]

This Article Extract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Kashani, A. Articles by Ko, D. T. Search for Related Content PubMed Articles by Kashani, A. Articles by Ko, D. T. Related Collections Lipids Primary prevention Epidemiology