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In Reply: Dr Fresco comments that the primary end point showed progression in the pioglitazone treatment group for patients not treated with statins. We disagree and recommend caution in interpretation of subgroup data. In the pioglitazone group, the 95% CI for the primary end point for the subgroup not receiving statins ranged from –0.45 to 2.29. The lower limit of the CI being less than 0 was consistent with the overall study results. In any clinical trial, results in subgroups are considered hypothesis-generating at best because when multiple groups are assessed, the likelihood of an apparent difference occurring by chance alone is substantial. In this case, we think that even more caution is required. There were only 29 patients in the glimepiride group who did not receive statins and only 25 in the pioglitazone group. We did not stratify for statin use because we expected nearly all patients to receive . . . [Full Text of this Article]

Steven E. Nissen, MD
nissens@ccf.org

Stephen J. Nicholls, MD, PhD; Kathy Wolski, MPH
Department of Cardiovascular Medicine
Cleveland Clinic
Cleveland, Ohio

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RELATED ARTICLE

Comparison of Pioglitazone vs Glimepiride on Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes: The PERISCOPE Randomized Controlled Trial
Steven E. Nissen, Stephen J. Nicholls, Kathy Wolski, Richard Nesto, Stuart Kupfer, Alfonso Perez, Horacio Jure, Robert De Larochellière, Cezar S. Staniloae, Kreton Mavromatis, Jacqueline Saw, Bo Hu, A. Michael Lincoff, E. Murat Tuzcu, and for the PERISCOPE Investigators
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Pioglitazone vs Glimepiride in the PERISCOPE Trial
Claudio Fresco
JAMA. 2008;300(7):787.
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Pioglitazone vs Glimepiride in the PERISCOPE Trial
Rahman Shah
JAMA. 2008;300(7):787-788.
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