Indinavir did not increase the short-term risk of adverse cardiovascular events relative to nucleoside reverse transcriptase inhibitor therapy in four phase III clinical trials

• Published in: AIDS (London) Vol. 15; no. 12; pp. 1584 - 1586
• Main Authors: COPLAN, Paul M, NIKAS, Alexander A, LEAVITT, Randi Y, DOLL, Louise, NESSLY, Michael L, DINUBILE, Mark J, GUESS, Harry A
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 17.08.2001
• Subjects: Anti-HIV Agents - adverse effects; Biological and medical sciences; Cardiovascular Diseases - etiology; clinical trials; Clinical Trials, Phase III as Topic; Drug Therapy, Combination; Drug toxicity and drugs side effects treatment; HIV Infections - drug therapy; Human immunodeficiency virus; Humans; indinavir; Indinavir - adverse effects; Medical sciences; Pharmacology. Drug treatments; Randomized Controlled Trials as Topic; Retrospective Studies; Reverse Transcriptase Inhibitors - adverse effects; Risk Factors; Toxicity: cardiovascular system; Short term; Phase III trial; Human; Nervous system diseases; Stroke; Infarct; Toxicity; Enzyme inhibitor; Cardiovascular disease; Angina pectoris; Coronary heart disease; Myocardial disease; Cerebral disorder; Vascular disease; Reverse transcriptase inhibitor; Central nervous system disease; Myocardium; Antiviral; Cerebrovascular disease; Indinavir
• ISSN: 0269-9370; 1473-5571
• DOI: 10.1097/00002030-200108170-00020

A retrospective person-time analysis of the randomized and non-randomized extension phases of four phase III trials was performed to assess the incidence of adverse cardiovascular events in 2680 HIV-infected patients receiving indinavir or nucleoside reverse transcriptase inhibitor therapy, or both. The observed rate of cardiovascular events was not increased in patients receiving indinavir-based regimens compared with therapy without a protease inhibitor. Extrapolation of these findings is limited by the brief length of therapy and the small number of cases.