Effects of randomized rosuvastatin compared with placebo on bone and body composition among HIV-infected adults.
BACKGROUND
Statins have a beneficial effect on bone mineral density (BMD) and lean mass in some studies of HIV-uninfected adults; however, this has never been investigated in the setting of HIV infection.


METHODS
HIV-infected individuals on stable antiretroviral therapy with a low-density lipoprotein cholesterol level of 130 mg/dl or less and evidence of heightened immune activation or inflammation were randomized to rosuvastatin 10 mg daily or placebo for 96 weeks.


METHODS
This was a prespecified interim analysis at 48 weeks. Between-group and within-group differences were compared; multivariable regression models were constructed.


RESULTS
Seventy-two individuals were randomized to statin therapy and 75 to placebo. Modest 48-week relative increases in trochanter BMD [0.9%; 95% confidence interval (95% CI) -0.9 to 0.6] and total hip BMD (0.6%; 95% CI 0.0-1.1) in the statin arm were significantly greater than placebo (P < 0.05). The relationship between statin use and total hip BMD change was robust to adjustment of age, sex, race and smoking status (P = 0.02) and strengthened by inclusion of baseline (P = 0.01) and week 48 change in soluble tumour necrosis factor-α receptor (sTNFR)-1 (P = 0.009). Relative increases in total body, trunk and limb fat were similar between statin and placebo arms (P ≥ 0.58). Although a significant gain in leg lean mass was seen in the statin arm, this was not significantly different compared with placebo (P = 0.36).


CONCLUSIONS
The improvements seen in total hip BMD after 48 weeks of rosuvastatin therapy support further potential benefits of statin therapy in HIV, beyond a reduction of cardiovascular risk.
aDepartment of Medicine, Divisions of Infectious Diseases and Geriatric Medicine, University of Colorado, Aurora, Colorado bDepartment of Biostatistics cDepartment of Medicine and Pediatrics, Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.
Kristine M
KM
Erlandson
Ying
Y
Jiang
Sara M
SM
Debanne
Grace A
GA
McComsey
D015502:Absorptiometry, Photon; D000328:Adult; D015415:Biomarkers; D001823:Body Composition / Q000187:drug effects*; D015519:Bone Density / Q000187:drug effects*; D002318:Cardiovascular Diseases / Q000517:prevention & control; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000517:prevention & control; D011743:Pyrimidines / Q000627:therapeutic use*; D047888:Receptors, Tumor Necrosis Factor, Type I / Q000378:metabolism; D012044:Regression Analysis; D012307:Risk Factors; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*
D015415:Biomarkers; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008077:Lipoproteins, LDL; D011743:Pyrimidines; D047888:Receptors, Tumor Necrosis Factor, Type I; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium