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To the Editor: The PERISCOPE trial by Dr Nissen and colleagues¹ needs to be considered in light of the results of the PROACTIVE trial,² which have been available for more than 2 years. In PROACTIVE, pioglitazone did not reduce the primary or preplanned secondary composite end points based on hard outcomes.² I question whether it was ethical to continue a trial with high-risk procedures (angiography) to test surrogate end points when another trial had already shown no benefit for hard outcomes.

In addition, several potentially confounding factors exist that could affect the findings. First, it is not clear if there was a difference in timing of follow-up ultrasound between the 2 groups (which could vary between 12 and 18 months). Second, there was a significant difference in the blood pressure change between the 2 groups. Third, the mean dose of glimepiride was low, presumably responsible for significantly higher levels of . . . [Full Text of this Article]

Rahman Shah, MD
shahcardiology@yahoo.com
Methodist University Hospital
Memphis, Tennessee

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
JAMA. 2008;299(13):1561-1573.
ABSTRACT | FULL TEXT  

RELATED LETTERS

Pioglitazone vs Glimepiride in the PERISCOPE Trial
Claudio Fresco
JAMA. 2008;300(7):787.
EXTRACT | FULL TEXT  

Pioglitazone vs Glimepiride in the PERISCOPE Trial—Reply
Steven E. Nissen, Stephen J. Nicholls, and Kathy Wolski
JAMA. 2008;300(7):788.
EXTRACT | FULL TEXT