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.
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.
Coplan
P M
PM
Merck Research Laboratories, West Point, PA, USA.
Nikas
A A
AA
Leavitt
R Y
RY
Doll
L
L
Nessly
M L
ML
DiNubile
M J
MJ
Guess
H A
HA
D019380:Anti-HIV Agents / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000209:etiology*; D017326:Clinical Trials, Phase III as Topic; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019469:Indinavir / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*; D012307:Risk Factors
D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019469:Indinavir