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Antiretroviral Therapy and the Prevalence and Incidence of Diabetes Mellitus in the Multicenter AIDS Cohort Study

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Antiretroviral Therapy and the Prevalence and Incidence of Diabetes Mellitus in the Multicenter AIDS Cohort Study ORIGINAL INVESTIGATION Antiretroviral Therapy and the Prevalence and Incidence of Diabetes Mellitus in the Multicenter AIDS Cohort Study Todd T. Brown, MD; Stephen R. Cole, PhD; Xiuhong Li, MAS; Lawrence A. Kingsley, DrPH; Frank J. Palella, MD; Sharon A. Riddler, MD, MPH; Barbara R. Visscher, MD, DrPH; Joseph B. Margolick, MD, PhD; Adrian S. Dobs, MD, MHS Background: The risk of diabetes mellitus (DM) in hu- Results: Fifty-seven (14%) of the 411 HIV-infected men man immunodeficiency virus (HIV)–infected patients re- using HAART at the baseline visit had prevalent DM com- ceiving highly active antiretroviral therapy (HAART) has pared with 33 (5%) of the 711 HIV-seronegative men not been well defined. (prevalence ratio=4.6; 95% confidence interval, 3.0- 7.1, adjusted for age and body mass index[calculated as weight in kilograms divided by the square of height in Methods: We conducted an analysis in the Multicenter meters]). The rate of incident DM was 4.7 cases per 100 AIDS Cohort Study to determine the prevalence and person-years among HIV-infected men using HAART incidence of DM in this cohort of HIV-infected and HIV- compared with 1.4 cases per 100 person-years among HIV- seronegative men. Prevalence analysis included 1278 seronegative men (rate ratio=4.11; 95% confidence in- men (710 HIV seronegative and 568 HIV infected, 411 terval, 1.85-9.16, adjusted for age and body mass in- receiving HAART) with fasting glucose concentration dex), during the 4-year observation period, based on a determinations at baseline. Incidence analysis included median follow-up of 2.3 years. 680 of these 1278 men who at the baseline visit had a fasting glucose concentration of 98 mg/dL (5.4 mmol/L) Conclusion: The incidence of DM in HIV-infected men or less, no self-reported history of DM, and no self- with HAART exposure was greater than 4 times that of reported use of antidiabetic medication. Diabetes melli- HIV-seronegative men, representing a risk that is higher tus was defined as a fasting glucose concentration of 126 than previous estimates. mg/dL (7 mmol/L) or higher, self-reported diagnosis of DM, or self-reported use of antidiabetic medication. Arch Intern Med. 2005;165:1179-1184 INCE THE ADVENT OF HIGHLY ascertainment was determined by self- active antiretroviral therapy reports at semiannual visits. Without the use (HAART) in the mid-1990s, of fasting glucose (FG) concentration de- abnormalities in glucose ho- terminations, however, the true incidence meostasis have been reported of DM is likely to be underestimated. Swith increasing frequency in persons in- Estimates of the incidence of DM and fected with human immunodeficiency vi- fasting hyperglycemia based on active sur- rus (HIV).1-4 Insulin resistance has been veillance using recommended diagnostic described in 41 (61%) of 67 protease in- techniques are needed. In this prospec- hibitor (PI)–treated, HIV-infected pa- tive study, we sought to determine the tients,5 and impaired glucose tolerance was prevalence and incidence of DM in a well- observed in 25 (35%) of 71 HIV-infected characterized cohort of HIV-seronega- patients using HAART.6 Prevalence esti- tive and HIV-infected men with heterog- mates of diabetes mellitus (DM) are lower. eneous exposure to antiretroviral therapies. In a cross-sectional study, 28 (6%) of 493 7 HIV-infected patients had DM. METHODS Prospective data estimating the inci- dence of DM are beginning to emerge.2,3 In Author Affiliations are listed at STUDY PARTICIPANTS the Women’s Interagency HIV Study, 20 the end of this article. Group Information: A listing of (3% or 2.8 cases per 100 person-years) of The Multicenter AIDS Cohort Study (MACS) en- the members of the Multicenter the 609 HIV-infected women receiving a PI- rolled 5622 homosexual and bisexual men be- AIDS Cohort Study appears in containing HAART regimen were diag- tween 1984 and 1991. These men have been seen the box on page 1184. nosed as having DM during 2.9-year me- at semiannual study visits at sites located in Pitts- Financial Disclosure: None. dian follow-up period.8 In that study, case burgh, Pa; Baltimore, Md; Chicago, Ill; and Los (REPRINTED) ARCH INTERN MED/ VOL 165, MAY 23, 2005 WWW.ARCHINTERNMED.COM 1179 ©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 Angeles, Calif.9 Institutional review boards at each site ap- bined end point was the first of incident DM or incident hy- proved the MACS protocol and forms, and each participant gave perglycemia. This combined end point, which included both written informed consent. The semiannual study visits consist clinically significant hyperglycemia and DM,10 was con- of a detailed interview, physical examination, and collection of structed to improve the precision of these analyses by increas- biological specimens, including serologic HIV antibody tests on ing the number of events. HIV-seronegative men. Beginning in April 1, 1999, the biologi- cal specimens obtained included a fasting serum sample. ASSESSMENT OF EXPOSURE Of the 5622 men enrolled in MACS, 1857 HIV-seroneg- ative men were administratively censored in 1996, and 1750 TO ANTIRETROVIRAL THERAPY had died by April 1, 1999, leaving 2015 men. Of these 1773 (88%) were observed between April 1, 1999, and March 31, The detailed interview given at each semiannual study visit in- 2003, and 1627 had at least 1 blood specimen drawn includ- cludes extensive questions about the use of specific antiretro- ing 1278 fasting (Ն8 hours) serum samples on which the glu- viral therapies. The definition of HAART followed the Depart- ment of Health and Human Services/Kaiser Panel guidelines13 cose concentration was determined. The visit at which a par- 14 ticipant had an initial FG concentration determination was and has been previously described. Adherence to antiretro- defined as the index visit. At the index visit, the prevalence of viral therapy was assessed by response to interviewer query, DM was determined, defined as an FG concentration of 126 “On average, how often did you take your medication as pre- mg/dL (7 mmol/L) or higher, self-reported DM, or self- scribed?” recorded in categories of 100%, 95% to 99%, 75% to reported use of an antidiabetic medication (ie, insulin, sulfo- 94%, or less than 75%, and stratified herein as 95% or higher nylureas, thiazolidinediones, biguanides, meglitinides, or ␣-glu- or less than 95%. cosidase inhibitors). Age, body mass index (BMI) (calculated The primary exposures of interest were HIV infection and as weight in kilograms divided by the square of height in me- antiretroviral therapy use. We classified men into the follow- ters), waist-hip ratio, educational attainment, and total cho- ing 3 groups: (1) HIV seronegative, (2) HIV infected not using lesterol level, all measured at the index visit, and race (ie, white HAART, and (3) HIV infected using HAART. We combined HIV- vs nonwhite) were ascertained for all participants. infected men not using HAART (ie, 103 who were antiretro- The study population for incident analysis was composed viral free, 5 using monotherapy, and 49 using combination of 680 of 1278 men. Of the 1278 men, 970 had an FG concen- therapy at the index visit) because of the small number of men tration of 98 mg/dL (5.4 mmol/L) or less at the index visit. Of and similar event rates. To create time-varying exposure cat- these 970, seven hundred five had follow-up data. The exclu- egories, men were classified at each semiannual visit accord- sion of those with self-reported DM (n=22) or self-reported use ing to HIV serostatus and self-reported use of antiretroviral therapy in the prior 6 months. of an antidiabetic medication at the index visit (n=3) yielded 5,8 the 680 men used in the analysis. The FG concentration cutoff Based on the results of prior studies, we explored the effect point of 98 mg/dL (which is the lower boundary of the defini- of the individual PIs most frequently used at the index visit on tion of fasting hyperglycemia [ie, 100 mg/dL]10 minus about 1 the rate of the combined end point by stratifying the HIV- SD for the glucose assay [ie,1.8 mg/dL {0.09 mmol/L}]) was infected HAART group by exposure to ritonavir, nelfinavir me- chosen to ensure that the incident study population excluded sylate, saquinavir mesylate, and indinavir sulfate. Self- men with prevalent hyperglycemia. reported exposure to PIs was classified as time varying (ie, updated at each semiannual visit). To explore the effect of dis- ease severity on the rate of the combined end point among men END POINT ASCERTAINMENT exposed to HAART at the index visit, we compared men with a nadir CD4 cell count greater than 300 cells/mm3 to men with nadir CD4 cell counts of 300 cells/mm3or less. Nadir CD4 cell Two end points were examined in the incident study popula- counts greater than 300 cells/mm3 represented approximately tion. First, the date of incident DM was defined as the mid- the upper quartile of values. This cutoff point was chosen af- point between the date of the last visit seen free of DM and the ter noting similar rates of the combined end point in the low- date of the first visit seen with DM. Incident DM was defined est 3 nadir CD4 count quartiles. as an FG concentration of 126 mg/dL (7 mmol/L) or higher, self-reported DM, or current self-reported use of antidiabetic medication, each of which was ascertained at each semiannual STATISTICAL ANALYSIS study visit beyond the index visit. All FG concentrations were measured by the combined hexokinase/glucose-6-phosphate de- The Fisher exact and Wilcoxon nonparametric tests, as appro- hydrogenase method11 using serum samples that had been stored priate, were used to test differences in proportions and distri- at −80°C and shipped to a central laboratory (Heinz Labora- butions between groups.
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