10th Conference on Retroviruses and Opportunistic Infections


Boston, MA USA - February 10 -14, 2003


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Protease Inhibitors May Increase Risk of Cardiovascular Disease in HIV-infected Patients.

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 746
U. Iloeje1 , Y. Yuan2, A. Tuomari2, G. L'Italien1, J. Mauskopf3, R. Moore4
1Bristol-Myers Squibb, Wallingford, CT; 2Bristol-Myers Squibb, Plainsboro, NJ; 3Medtap Intl, Research Triangle Park, NC; and 4Johns Hopkins Med Inst, Baltimore, MD


BACKGROUND: PIs are associated with hyperlipidemia, insulin resistance, fat redistribution, hypertension (HTN), and diabetes mellitus (DM). These risk factors in turn are established risks for cardiovascular (CVD). Our objective was to quantify the association between PI exposure and subsequent CVD events.

METHODS: This is a retrospective cohort analysis. The study population was derived from a prospectively collected database of HIV+M patients (pts) from eight clinical sites in the U.S. Adult pts (318) from January 1996-June 31, 2002, were deemed eligible. Pts were followed to the first CVD event (myocardial infarction, angina, coronary artery disease, PTCA/CABG, Stroke, TIA, PVD) or censored at end of study follow-up. Co-variates included age (18-34, 35-49, 50-64, 65+) gender, race (white, black, other), weight, PI exposure (ever vs never), hyperlipidemia, CVD, DM, HTN, smoking (current, past, never), IV drug (IVDU), and cocaine use. Hyperlipidemia was defined according to current ATPIII guidelines, diagnosis of hyperlipidemia, or use of lipid lowering therapy. Diagnoses or treatment defined DM and HTN. Cox proportional hazards regression was used to provide the adjusted hazard ratios.

RESULTS: A total of 6,711 pts were studied with a median follow-up of 2.8 yrs. Baseline demographic and risk factor distributions were as follows: males 86%, whites 59%, blacks 28%, mean age 39 yrs, mean weight 169 lbs, PI use 77%, current smokers 37%, past smokers 14%, cocaine use 1.9%, HTN 5.2%, DM 1.1%, pre-existing CVD 0.1%, and pre-existing hyperlipidemia 6.5%. The CVD-event rate was 1.64% for pts in the PI group and 0.52% for non-PI pts. Unadjusted hazard ratio (HR) for PI exposure was 2.1 (95% CI, 1-4.4). The adjusted HR for PI use was 2 (95% CI,1.0-4.1, p = 0.06). When only CAD events (AMI, Angina, coronary heart disease, PTCA/CABG) were modeled, the event rates for PI and non-PI use were 1.31% and 0.39%, respectively; unadjusted HR was 2.3 (95% CI, 1-5); and adjusted HR for PI exposure was 2.1 (95% CI, 1-5, p = 0.08).

CONCLUSIONS: PI exposure was consistently found to double the risk of developing both CVD and CHD events in this analysis. Longer term follow-up data will be needed to confirm these findings. Use of HAART regimens which minimize this risk should be considered by physicians.

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Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.