title: Evaluation of safety and efficacy of rosiglitazone in the treatment of HIV-associated lipodystrophy syndrome.
abstract: BACKGROUND
  HIV-associated lipodystrophy syndrome (LDS) as a long-term side effect of HAART is becoming increasingly important and negatively affects adherence to medication. Currently, an effective therapy is not available. There is some evidence that the drug class of thiazolidindiones might be effective in the treatment of LDS.
  
  
  METHODS
  Prospective open-label study with 20 HIV-infected patients suffering from severe LDS. Patients received 4 mg rosiglitazone once daily for a 24-week study period. Efficacy was assessed by measurement of metabolic and anthropometric parameters, total body DXA scan, CT scan of the abdomen, photo documentation and self-assessment.
  
  
  RESULTS
  Rosiglitazone treatment was well tolerated. DXA scans demonstrated a highly significant increase in adipose tissue of the limbs (2644 +/- 1334 g vs 3380 +/- 1614 g, p < or = 0.001) without any change in total fat mass. Abdominal CT-scans revealed a significant increase in subcutaneous adipose tissue (113.7 +/- 82.4 cm(2) vs 125.3 +/- 83.7 cm(2), p = 0.04). Abdominal circumference decreased significantly (94.7 +/- 8.7 cm vs 92.2 +/- 8.45 cm, p = 0.03) without any relevant change of body weight or BMI. We observed an increase in serum cholesterol (248 vs 281 mg/dl, p = 0.006) and serum triglycerides (301 vs 351 mg/dl, p = 0.1). Furthermore, no side effects of clinical relevance were observed. The insulin sensitivity index improved without reaching statistical significance. Thirteen patients (65%) reported general improvement of LDS symptoms. Evaluation of photo documentation by five HIV-experts revealed poor concordance and no relevant change of LDS.
  
  
  CONCLUSIONS
  The results of this study suggest that rosiglitazone is safe in the treatment of HAART-associated lipodystrophy and has moderate clinical efficacy. We found a trend towards improved insulin sensitivity and as a possible limiting factor an unfavorable increase in serum cholesterol and triglycerides.
authors.affiliation: Clinic of Gastroenterology, Hepatology, and Infectious Diseases, Heinrich-Heine University, Moorenstr. 5, 40225 Düsseldorf, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Feldt
authors.forename: M
authors.initials: M
authors.lastname: Oette
authors.forename: A
authors.initials: A
authors.lastname: Kroidl
authors.forename: K
authors.initials: K
authors.lastname: Goebels
authors.forename: R
authors.initials: R
authors.lastname: Fritzen
authors.forename: J
authors.initials: J
authors.lastname: Kambergs
authors.forename: G
authors.initials: G
authors.lastname: Kappert
authors.forename: C
authors.initials: C
authors.lastname: Vogt
authors.forename: M
authors.initials: M
authors.lastname: Wettstein
authors.forename: D
authors.initials: D
authors.lastname: Häussinger
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D001823:Body Composition / Q000187:drug effects; D005260:Female; D005951:Glucose Tolerance Test; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone