Abstract: Methods and compositions for reducing the risks of adverse cardiovascular (CV) events associated with the administration of pharmaceutical agents which induce or increase the risk of one or more adverse CV events, particularly the non-steroidal anti-inflammatory drugs (NSAIDs) and especially the cyclooxygenase-2 (COX-2) inhibitors, are disclosed. The methods involve the administration of compositions comprising the adverse CV event-inducing agent and additional pharmaceutical agents for reducing the risk of adverse CV events. In specific embodiments, the agent is selected from the group consisting of hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins), angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs).