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

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HomeCirculationVol. 116, No. 1Response to Letters Regarding Article, “Risks Associated With Statin Therapy: A Systematic Overview of Randomized Clinical Trials” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBResponse to Letters Regarding Article, “Risks Associated With Statin Therapy: A Systematic Overview of Randomized Clinical Trials” Amir Kashani, JoAnne M. Foody, Yongfei Wang and Harlan M. Krumholz Christopher O. Phillips Sandeep Mangalmurti Dennis T. Ko Amir KashaniAmir Kashani Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn Search for more papers by this author , JoAnne M. FoodyJoAnne M. Foody Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn Search for more papers by this author , Yongfei WangYongfei Wang Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn Search for more papers by this author and Harlan M. KrumholzHarlan M. Krumholz Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn Search for more papers by this author Christopher O. PhillipsChristopher O. Phillips Department of General Internal Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio Search for more papers by this author Sandeep MangalmurtiSandeep Mangalmurti Ambulatory Health Clinic, United States Navy, Groton, Conn Search for more papers by this author Dennis T. KoDennis T. Ko Schlich Heart Centre, Sunnybrook Health Sciences Centre, Ontario, Canada Search for more papers by this author Originally published3 Jul 2007https://doi.org/10.1161/CIRCULATIONAHA.107.697227Circulation. 2007;116:e9The 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.DisclosuresDr 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.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.LinkGoogle Scholar2 Curtin F, Altman DG, Elbourne D. Meta-analysis combining parallel and cross-over clinical trials. I: Continuous outcomes. Stat Med. 2002; 21: 2131–2144.CrossrefMedlineGoogle Scholar3 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.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Kampmeijer R, Pavlova M, Tambor M, Golinowska S and Groot W (2016) The use of e-health and m-health tools in health promotion and primary prevention among older adults: a systematic literature review, BMC Health Services Research, 10.1186/s12913-016-1522-3, 16:S5, Online publication date: 1-Aug-2016. July 3, 2007Vol 116, Issue 1 Advertisement Article InformationMetrics https://doi.org/10.1161/CIRCULATIONAHA.107.697227 Originally publishedJuly 3, 2007 PDF download Advertisement SubjectsEpidemiologyLipids and CholesterolPrimary Prevention