Multicenter study on the quality of life after i.v. Prostavasin (R) therapy in stage IVPAOD

Background: The healing of trophic lesions, and the amelioration of pain by treatment with intravenous prostaglandin E-1 (Prostavasin(R)) in patients with stage IV PAOD are clinically well documented. In the absence of diseas e-specific questionnaires, the question as to whether successful treatment is accompanied by an improvement in quality of life has so far not been inv estigated. The aint of the present study was, therefore, to establish wheth er the recently developed disease-specific questionnaire PAVK-86 could be u sed to investigate the question whether a 4-week treatment with intravenous prostaglandin E-1 results in an improvement in the quality of life in stag e IV patients as well as in clinical improvements. Patients and Methods: 90 inpatients (median age 75 years) in stage IV PAOD with ankle arterial pressures of 34.1 +/- 24.8 mmHg (without diabetes melli tus) and 59.4 +/- 51.5 mmHg (with diabetes mellitus) were submitted to a 4- week regimen consisting of a once-daily intravenous infusion of 60 mu g pro staglandin E-1 (3 ampoules of Prostavasin(R)). This,was followed by a treat ment-free follow-up period of 3 months. Recording of trophic lesions and re st pain (visual analog scale) together with a patient interview using the d isease-specific questionnaire PAVK-86 and the generic questionnaire SF-36, were effected prior to the study, on termination of the 4-week treatment pe riod, and again at the end of follow-up. Results: Quality of life as measured with the PAVK-86 was significantly imp roved in all subscales (pain, functional status, anxiety, and mood) both at the end of treatment and following the 3-month follow-up period. Among the diabetic patients, the improvement in the quality of life was clearly hare pronounced than in the non-diabetics. Concomitantly with this improvement, rest pain and ulcer size were significantly reduced (p < 0.001). Similar r esults were also shown bit the genetic questionnaire SF-36. Conclusions: This pilot study has shown for the first time that treatment w ith intravenous Prostavasin(R) of stage IV PAOD leads not only to a decreas e in rest pain and ulcer size, brit also to a significant, clinically relev ant improvement in quality of life.