Dr. Solomon has received salary support from research grants (more than $10,000 each) to Brigham and Women's Hospital from Amgen, Lilly, Pfizer, and the Consortium of Rheumatology Researchers of North America, has served in unpaid roles on studies sponsored by Pfizer, Novartis, Lilly, and Bristol Myers Squibb, and has received royalties from UpToDate.
Effect of Hydroxychloroquine on Insulin Sensitivity and Lipid Parameters in Rheumatoid Arthritis Patients Without Diabetes Mellitus: A Randomized, Blinded Crossover Trial†
Article first published online: 28 JUL 2014
Copyright © 2014 by the American College of Rheumatology
Arthritis Care & Research
Volume 66, Issue 8, pages 1246–1251, August 2014
How to Cite
Solomon, D. H., Garg, R., Lu, B., Todd, D. J., Mercer, E., Norton, T. and Massarotti, E. (2014), Effect of Hydroxychloroquine on Insulin Sensitivity and Lipid Parameters in Rheumatoid Arthritis Patients Without Diabetes Mellitus: A Randomized, Blinded Crossover Trial. Arthritis Care Res, 66: 1246–1251. doi: 10.1002/acr.22285
ClinicalTrials.gov identifier: NCT01132118.
- Issue published online: 28 JUL 2014
- Article first published online: 28 JUL 2014
- Accepted manuscript online: 27 JAN 2014 01:51PM EST
- Manuscript Accepted: 14 JAN 2014
- Manuscript Received: 24 MAY 2013
- NIH/National Institute of Musculoskeletal and Arthritis and Skin Diseases. Grant Number: R21-AR-057924
Observational studies suggest that hydroxychloroquine (HCQ) may reduce the risk of developing diabetes mellitus in patients with rheumatoid arthritis (RA). We examined the effect of HCQ on insulin resistance in subjects without diabetes mellitus with stable RA.
Twenty-three RA subjects not currently using HCQ completed a 16-week, double-blind crossover study. Subjects were randomly allocated to receive HCQ (6.5 mg/kg/day) or placebo for the first 8 weeks, followed by crossover to the other arm for the final 8 weeks. Subjects underwent oral glucose tolerance testing and fasting lipid measurements at baseline, 8 weeks, and 16 weeks. The change ± SD from baseline in insulin sensitivity index (ISI), homeostatic model assessment for insulin resistance (HOMA-IR), and lipid parameters were compared between placebo and HCQ using linear regression.
The mean patient age was 56 years, with 96% women, and the median body mass index was 26.0 kg/m2. After 8 weeks of HCQ, the mean ± SD ISI increase was 0.4 ± 2.9 compared with a small increase during placebo of 0.14 ± 3.1 (adjusted P = 0.785), and the mean ± SD HOMA-IR decrease was 0.3 ± 1.5 during HCQ versus a decrease of 0.42 ± 1.4 during placebo (adjusted P = 0.308). Small decreases in total cholesterol (12.7 mg/dl) and low-density lipoprotein (LDL) cholesterol (12.4 mg/dl) were observed during the HCQ treatment periods (both adjusted P < 0.05 compared to placebo).
HCQ use for 8 weeks in patients without diabetes mellitus with stable RA produced no significant change in insulin resistance. We observed small and statistically significant improvements in total and LDL cholesterol during HCQ treatment.