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Findings of the naftidrofuryl in quality of life (NIQOL) european study program

(2002) INTERNATIONAL ANGIOLOGY. 21(1). p.20-27
Author
Organization
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'', ing'', ''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.
Keywords
quality of life, questionnaires, vasoactive agents, arterial occlusive diseases, drug therapy, intermittent claudication, TRIAL, IMPACT, OUTCOMES, EXERCISE REHABILITATION, OF-LIFE, INTERMITTENT CLAUDICATION, LOWER-LIMB ISCHEMIA, ARTERIAL OCCLUSIVE DISEASE, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY

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Chicago
Spengel, F, Denis Clement, H Boccalon, F Liard, T Brown, and P Lehert. 2002. “Findings of the Naftidrofuryl in Quality of Life (NIQOL) European Study Program.” International Angiology 21 (1): 20–27.
APA
Spengel, F., Clement, D., Boccalon, H., Liard, F., Brown, T., & Lehert, P. (2002). Findings of the naftidrofuryl in quality of life (NIQOL) european study program. INTERNATIONAL ANGIOLOGY, 21(1), 20–27.
Vancouver
1.
Spengel F, Clement D, Boccalon H, Liard F, Brown T, Lehert P. Findings of the naftidrofuryl in quality of life (NIQOL) european study program. INTERNATIONAL ANGIOLOGY. 2002;21(1):20–7.
MLA
Spengel, F, Denis Clement, H Boccalon, et al. “Findings of the Naftidrofuryl in Quality of Life (NIQOL) European Study Program.” INTERNATIONAL ANGIOLOGY 21.1 (2002): 20–27. Print.
@article{165014,
  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'', ing'', ''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{\textlangle}0.001). A separate covariance analysis for the 5 dimensions showed highly significant differences for ''daily living'', ''pain'', ''social life'' and ''mood'' (all p{\textlangle}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.},
  author       = {Spengel, F and Clement, Denis and Boccalon, H and Liard, F and Brown, T and Lehert, P},
  issn         = {0392-9590},
  journal      = {INTERNATIONAL ANGIOLOGY},
  keyword      = {quality of life,questionnaires,vasoactive agents,arterial occlusive diseases,drug therapy,intermittent claudication,TRIAL,IMPACT,OUTCOMES,EXERCISE REHABILITATION,OF-LIFE,INTERMITTENT CLAUDICATION,LOWER-LIMB ISCHEMIA,ARTERIAL OCCLUSIVE DISEASE,PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY},
  language     = {eng},
  number       = {1},
  pages        = {20--27},
  title        = {Findings of the naftidrofuryl in quality of life (NIQOL) european study program},
  volume       = {21},
  year         = {2002},
}

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