title: Findings of the Naftidrofuryl in Quality of Life (NIQOL) European study program.
abstract: BACKGROUND
  We report in this paper the findings of a pooled analysis of 3 previously published studies undertaken in Germany, France and Belgium to assess the effects of naftidrofuryl on the quality of life of patients with intermittent claudication.
  
  
  METHODS
  A total of 754 patients were randomised in the 3 studies, 709 of whom (358 naftidrofuryl, 351 placebo) were available for the primary intention-to-treat analysis. The primary outcome variable was the change in the disease-related limitation of the quality of life as measured by the CLAU-S questionnaire. This instrument which has been validated in an international study, comprises 47 questions covering 5 dimensions: "daily living", "pain", "social life", "disease specific anxiety" and "mood".
  
  
  RESULTS
  A multivariate analysis of covariance adjusted for baseline values, study effect and first order study treatment interaction, demonstrated the global superiority of naftidrofuryl over placebo (p<0.001). A separate covariance analysis for the 5 dimensions showed highly significant differences for "daily living", "pain", "social life" and "mood" (all p<0.01).
  
  
  CONCLUSIONS
  In conclusion, this pooled analysis has shown that naftidrofuryl can significantly improve the quality of life of patients with intermittent claudication. These findings, taken together with evidence from previous studies that it improves treadmill walking distances, suggest that naftidrofuryl can play a useful role in the treatment of this condition.
authors.affiliation: Klinik Feldafing, Feldafing, Germany. florentin.spengel@i-dial.de
authors.forename: F
authors.initials: F
authors.lastname: Spengel
authors.forename: D
authors.initials: D
authors.lastname: Clément
authors.forename: H
authors.initials: H
authors.lastname: Boccalon
authors.forename: F
authors.initials: F
authors.lastname: Liard
authors.forename: T
authors.initials: T
authors.lastname: Brown
authors.forename: P
authors.initials: P
authors.lastname: Lehert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009257:Nafronyl / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010349:Patient Compliance; D011446:Prospective Studies; D011788:Quality of Life; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D012702:Serotonin Antagonists; D009257:Nafronyl