Table 1

Selected Investigational Cardiovascular Drugs Discontinued for Efficacy or Safety Reasons

Drug Name (Ref. #)Indication (Sponsor)Key Trial CharacteristicsReason for Discontinuation
DesignComparatorPrimary Endpoints
Cariporide (20)Unstable angina and non–ST-segment elevation MI (Sanofi-Aventis)Randomized, double-blindPlaceboDeath or MI at 36 daysFailure to demonstrate efficacy (no significant improvement vs. placebo)
DarusentanTreatment-resistant hypertension (Gilead/Abbott)Randomized, double-blindPlaceboChanges in sitting systolic and diastolic blood pressuresFailure to demonstrate efficacy in second pivotal trial (no significant change in blood pressure)
Lotrafiban (21)Acute coronary syndrome (GlaxoSmithKline)Randomized, double-blindPlaceboDeath, MI, stroke, severe recurrent ischemia, and urgent revascularizationHalted due to safety concerns (increased risk of death and serious bleeding)
Nolomirole (22)Heart failure (Chiesi)Randomized, double-blindPlaceboTime to death or hospitalization for heart failureFailure to demonstrate efficacy (no significant improvement vs. placebo)
Torcetrapib (23)Prevention of cardiovascular disease (Pfizer)Randomized, double-blindAtorvastatinTime to first major cardiovascular eventHalted due to safety concerns (increased risk of death and cardiovascular events)

MI = myocardial infarction.

  • The inclusion criteria for the cariporide trial also included patients undergoing a high-risk percutaneous coronary intervention or coronary artery bypass surgery.

  • The primary outcome was the time to the first occurrence of a major cardiovascular event, a composite that included 4 components: death from coronary heart disease (defined as fatal MI excluding procedure-related events, fatal heart failure, sudden cardiac death, or other cardiac death), nonfatal MI (excluding procedure-related events), stroke, and hospitalization for unstable angina.