title: Diarrhea associated with lopinavir/ritonavir-based therapy: results of a meta-analysis of 1469 HIV-1-infected participants.
abstract: BACKGROUND
  Antiretroviral therapy is associated with adverse events (AEs). The most frequently reported AE associated with lopinavir/ritonavir (LPV/r) containing regimens is diarrhea. The objective of this meta-analysis is to describe the incidence, prevalence, and duration of diarrhea in individuals taking LPV/r.
  
  
  METHODS
  This is a meta-analysis of Abbott-conducted clinical trials. Inclusion criteria included prospective randomized clinical trials with the LPV/r tablet formulation and had AE data (moderate/severe diarrhea) available through 48 weeks of treatment.
  
  
  RESULTS
  Three trials (total 1469 participants) met the inclusion criteria. In all, 11.2% of participants reported moderate/severe diarrhea by week 8, with median time to resolution of 7.4 weeks. The overall 48-week incidence of moderate/severe diarrhea was 15.5%. The discontinuation rate due to moderate/severe diarrhea was 1.3%.
  
  
  CONCLUSIONS
  Moderate/severe diarrhea occurred in less than 1 in 6 participants taking LPV/r, typically started in the first 8 weeks of treatment and infrequently resulted in premature discontinuation.
authors.affiliation: 1Abbott, Abbott Park, IL, USA.
authors.forename: Colleen M
authors.initials: CM
authors.lastname: Wegzyn
authors.forename: Linda M
authors.initials: LM
authors.lastname: Fredrick
authors.forename: Roxann O
authors.initials: RO
authors.lastname: Stubbs
authors.forename: William C
authors.initials: WC
authors.lastname: Woodward
authors.forename: Michael
authors.initials: M
authors.lastname: Norton
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects*; D000930:Antidiarrheals / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced* / Q000188:drug therapy / Q000453:epidemiology*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D006801:Humans; D015994:Incidence; D061466:Lopinavir / Q000009:adverse effects*; D015995:Prevalence; D012307:Risk Factors; D019438:Ritonavir / Q000009:adverse effects*
chemical_list: D019380:Anti-HIV Agents; D000930:Antidiarrheals; D004338:Drug Combinations; D061466:Lopinavir; D019438:Ritonavir