Abstract
HIV patients on antiretroviral therapy (ART) have a unique dyslipidemia [elevated triglycerides and non-high-density lipoprotein-cholesterol (HDL-C), low HDL-C] with insulin resistance (characterized by hypoadiponectinemia). The aim was to test a targeted, comprehensive, additive approach to treating the dyslipidemia. We conducted a randomized, double-blind, placebo-controlled, 24-wk trial of lifestyle modification, fenofibrate, and niacin in multiethnic HIV clinics at an academic center. Hypertriglyceridemic adult patients were stratified on three combinations of ART classes. Subjects retained at the first measurement (2 wk) after entry were included in the analysis (n = 191). Subjects were randomized into five treatment groups: usual care (group 1); low-saturated-fat diet and exercise (D/E; group 2); D/E + fenofibrate (group 3); D/E + niacin (group 4); or D/E + fenofibrate + niacin (group 5). We measured changes in fasting triglycerides, HDL-C, and non-HDL-C (primary), and in insulin sensitivity, glycemia, adiponectin, C-reactive protein, energy expenditure, and body composition (secondary). Data were analyzed as a factorial set of treatment combinations using a mixed repeated measures model, last observation carried forward, and complete case approaches (groups 2-5), and as an unstructured set of treatments (groups 1-5). Fenofibrate improved triglycerides (P = 0.002), total cholesterol (P = 0.02), and non-HDL-C (P = 0.003), whereas niacin improved HDL-C (P = 0.03), and both drugs decreased the total cholesterol-to-HDL-C ratio (P = 0.005-0.01). The combination of D/E, fenofibrate, and niacin provided maximal benefit, markedly reducing triglycerides (-52% compared to usual care; P = 0.003), increasing HDL-C (+12%; P < 0.001), and decreasing non-HDL-C (-18.5%; P = 0.003) and total cholesterol-to-HDL-C ratio (-24.5%; P < 0.001). Niacin doubled adiponectin levels. A combination of fenofibrate and niacin with low-saturated-fat D/E is effective and safe in increasing HDL-C, decreasing non-HDL-C and hypertriglyceridemia, and ameliorating hypoadiponectinemia in patients with HIV/ART-associated dyslipidemia.
Highlights
MethodsSubjects Subjects were recruited mainly from the Legacy CommunityHealth Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics
Participants: Hypertriglyceridemic adult patients were stratified on three combinations of antiretroviral therapy (ART) classes
The combination of diet and exercise (D/E), fenofibrate, and niacin provided maximal benefit, markedly reducing triglycerides (Ϫ52% compared to usual care; P ϭ 0.003), increasing high-density lipoprotein (HDL)-C (ϩ12%; P Ͻ 0.001), and decreasing non-HDL-C (Ϫ18.5%; P ϭ 0.003) and total cholesterol-to-HDL-C ratio (Ϫ24.5%; P Ͻ 0.001)
Summary
Subjects Subjects were recruited mainly from the Legacy CommunityHealth Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics. Subjects were randomized in blocks of 10 to five study groups: 1) usual care with two placebos; 2) intensive D/E with two placebos; 3) D/E with active fenofibrate and niacin placebo; 4) D/E with active niacin and fenofibrate placebo; and 5) D/E with active fenofibrate and active niacin. They were separately randomized for each of the following strata defined by three commonly used combinations of ART classes: 1) a protease inhibitor-containing regime; 2) a nonnucleoside reverse transcriptase inhibitor-containing regime; and 3) three nucleoside reverse transcriptase inhibitors.
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: The Journal of Clinical Endocrinology & Metabolism
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
