title: Study of the gastrointestinal tolerance of a new tablet formulation of the lopinavir/ritonavir antiretroviral in HIV-infected patients.
abstract: BACKGROUND
  Preliminary studies suggest that the new film-coated tablet formulation of lopinavir/ritonavir (LPV/r-fct) could cut down the rate of adverse gastrointestinal symptoms of the conventional lopinavir/ritonavir soft gelatine capsules (LPV/r-sgc).
  
  
  OBJECTIVE
  To ascertain the difference in the rate of adverse gastrointestinal symptoms in patients who switch from LPV/r-sgc to LPV/r-fct.
  
  
  METHODS
  An uncontrolled, open, prospective study including a pre/post comparison using the Gastrointestinal Symptom Rating Scale (GSRS) modified to the characteristics of the protease inhibitors.
  
  
  RESULTS
  Seventy patients were included, with a mean time of treatment, with the new formulation of 77 days [confidence interval (CI) 95%: 70 to 84]. The total GSRS score was 26.96 (CI 95%: 25.02 to 28.89) in the prechange survey and 26.27 (CI 95%: 24.08 to 28.47) in the postchange survey, with a mean difference of 0.69 points (CI 95%: -1.18 to 2.55, P = 0.47). None of the questions obtained the objective of a difference of at least 2 points, previously set as a clinically significant difference. Only 1 patient dropped the study due to gastrointestinal toxicity.
  
  
  CONCLUSIONS
  Our study has unearthed no clinically significant differences in the gastrointestinal tolerance profile of (LPV/r-sgc) and (LPV/r-fct), measuring this tolerance level by application of the GSRS scale.
authors.affiliation: Pharmacy Service, Internal Medicine Service, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Sáez de la Fuente
authors.forename: Virginia
authors.initials: V
authors.lastname: Granja
authors.forename: Ismael
authors.initials: I
authors.lastname: Escobar
authors.forename: Elena
authors.initials: E
authors.lastname: Collada de la Fuente
authors.forename: Victor
authors.initials: V
authors.lastname: Moreno
authors.forename: Rafael
authors.initials: R
authors.lastname: Rubio
mesh_terms: D000328:Adult; D000368:Aged; D004338:Drug Combinations; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects*; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects*; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D061466:Lopinavir; D019438:Ritonavir