title: Abacavir use and cardiovascular disease events:  a meta-analysis of published and unpublished data.
abstract: BACKGROUND
  The use of abacavir (ABC) has been associated with an increased risk of cardiovascular disease in some cohort studies. However, no excess risk of myocardial infarction (MI) with ABC therapy has been observed in individual randomized clinical trials (RCTs) and in the aggregated clinical trials database maintained by the manufacturer of ABC.
  
  
  OBJECTIVE
  To combine all the evidence from RCTs by means of meta-analysis to estimate the effect of combined antiretroviral therapy (cART) containing ABC on MI and overall major cardiovascular events (CVEs).
  
  
  METHODS
  Primary outcomes included MI, CVE, adverse events requiring discontinuation of treatment, and overall mortality. We used a conventional Mantel-Haenszel method, with risk ratio and 95% confidence intervals (CIs) or, in the presence of heterogeneity, a random-effect model.
  
  
  RESULTS
  Data were from 28 primary RCTs (9233 participants) comparing ABC-containing cART (4376 participants) to other regimens not containing ABC (4857 controls). MI data were available from 18 trials (31 episodes in 7054 patients) and CVE data from 20 trials (79 episodes in 7899 patients). Compared to the controls, ABC use did not increase significantly the occurrence of MI (risk ratio 0.73, 95% CI 0.39-1.35; P = 0.31), CVE (risk ratio 0.95, 95% CI 0.62-1.44; P = 0.80), overall mortality (risk ratio 1.20, 95% CI 0.63-2.27; P = 0.58), and adverse events requiring discontinuation of treatment (risk ratio 0.82, 95% CI 0.67-1.00; P = 0.05).
  
  
  CONCLUSIONS
  This meta-analysis of RCTs does not support the hypothesis that ABC-containing cART regimens carry a greater risk of MI or major cardiovascular events relative to comparator cART.
authors.affiliation: Centre of Community Medicine & HIV Outpatient Clinic, Verona, Italy. crucianimario@virgilio.it
authors.forename: Mario
authors.initials: M
authors.lastname: Cruciani
authors.forename: Veronica
authors.initials: V
authors.lastname: Zanichelli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Serpelloni
authors.forename: Oliviero
authors.initials: O
authors.lastname: Bosco
authors.forename: Marina
authors.initials: M
authors.lastname: Malena
authors.forename: Romualdo
authors.initials: R
authors.lastname: Mazzi
authors.forename: Carlo
authors.initials: C
authors.lastname: Mengoli
authors.forename: Saverio G
authors.initials: SG
authors.lastname: Parisi
authors.forename: Graeme
authors.initials: G
authors.lastname: Moyle
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000401:mortality; D015224:Dideoxynucleosides / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000139:chemically induced / Q000401:mortality; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D000099227:Abacavir