Objective:To assess the association between protease inhibitor (PI) use and the incidence of diabetes mellitus (DM) among participants in the Women's Interagency HIV Study.
Design:Prospective multicenter cohort study. The diagnosis of DM was based on self-report at semiannual interviews conducted from 1994 to 1998.
Setting:Six inner-city clinical sites in the United States (Brooklyn, NY; Bronx, NY; Washington, DC; Chicago, IL; San Francisco, CA; and Los Angeles, CA).
Participants:A total of 1785 nonpregnant women who had no history of prior DM. The women made up four groups: 1) PI users (n = 609, person-years [PY] at risk = 707); 2) reverse transcriptase inhibitor (RTI)-only users (n = 932, PY = 1486); 3) HIV-infected women reporting no antiretroviral therapy (ART) ever (n = 816, PY = 1480): and 4) HIV-uninfected women (n = 350, PY = 905).
Main Outcomes:Incidence of DM and median body mass index (BMI) from 1995 to 1998 were compared among the four groups.
Results:Sixty-nine incident cases of DM occurred among 1785 women (1.5 cases per 100 PY; 95% CI: 1.2-1.9). The incidence of DM among PI users was 2.8 cases per 100 PY (2.8%) versus 1.2% among both RTI users and women on no ART (95% CI: 1.6-4.1 [PI]; 0.7-1.8 [RTI and no ART]; P = 0.01 for comparison of the PI group with the RTI group) and 1.4% among HIV-uninfected women (95% CI: 0.7-2.2, P = 0.06 for comparison with PI group). Weight gain was not associated with either PI or RTI use. Multivariate models identified PI use (hazard ratio [HR] = 2.90 [95% CI: 1.50-5.60]; P = 0.002), age (HR = 1.75 per 10 years [95% CI: 1.31-2.34]; P = 0.0002) and BMI as independent risk factors for DM.
Conclusions:PI use was associated with a threefold increase in the risk of reporting incident DM. Routine screening for diabetes, particularly among older and heavier patients using PI therapy, is advisable.
The WIHS is funded by the National Institute of Allergy and Infectious Diseases, with supplemental funding from the National Cancer Institute, National Institute of Child Health and Human Development. National Institute on Drug Abuse, National Institute of Dental Research, Agency for Health Care Policy and Research, and Centers for Disease Control and Prevention (U01-AI-35004, U01-AI-31834, U01-AI-34994, AI-34989, U01-HD-32632 [NICHD], U01-AI-34993, U01-AI-42590).
Address correspondence and reprint requests to Jessica E. Justman, Bronx-Lebanon Hospital Center, 1650 Grand Concourse. 8th Floor. Bronx. NY 10457, U.S.A.; e-mail: email@example.com.
Data in this manuscript were collected by the Women's Interagency HIV Study (WIHS) Collaborative Study Group with centers (Principal Investigators) at New York City/Bronx Consortium (Kathryn Anastos); Brooklyn. NY (Howard Minkoff); Washington DC Metropolitan Consortium (Mary Young); The Connie Wofsy Study Consortium of Northern California (Ruth Greenblatt. Herminia Palacio); Los Angeles County/Southern California Consortium (Alexandra Levine); Chicago Consortium (Mardge Cohen); and Data Coordinating Center (Alvaro Muñoz, Stephen J. Gange).
Manuscript received May 2, 2002; accepted November 13, 2002.
© 2003 Lippincott Williams & Wilkins, Inc.