Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation: Dealing With an Agonizing Trend

Susan Anderson, Robert Cody, Milton Packer and Richard Schwarz
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Susan Anderson: University of Wisconsin, Department of Biostatistics and Medical Informatics
Robert Cody: University of Michigan, Department of Internal Medicine, Division of Cardiology
Milton Packer: University of Texas Southwestern Medical Center, Center for Biostatistics and Clinical Science
Richard Schwarz: CV Ventures, LLC

Chapter Case 14 in Data Monitoring in Clinical Trials, 2006, pp 209-219 from Springer

Abstract: Abstract The Prospective Randomized Milrinone Survival Evaluation (PROMISE) was conducted to clarify discordant findings in previous experimental and clinical studies with milrinone, a cyclic AMP-enhancing positive inotropic agent. Earlier studies had shown positive effects of milrinone on cardiac function and exercise performance in patients with chronic heart failure. To determine the effect of milrinone on mortality, patients with severe chronic heart failure who remained symptomatic despite conventional therapy were randomized to receive either active drug or a matching placebo. The trial was terminated after 20 months, before its scheduled completion, based on an observed adverse effect of milrinone on survival. This paper describes the experience of the Data Monitoring and Safety Monitoring Board (DSMB) in dealing with an emerging negative trend in survival when there were other known beneficial effects of the drug.

Keywords: Chronic Heart Failure; NYHA Class; Severe Chronic Heart Failure; Positive Inotropic Agent; Promise Trial (search for similar items in EconPapers)
Date: 2006
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-0-387-30107-5_19

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DOI: 10.1007/0-387-30107-0_19

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