Improvement in the quality of life after i.v. PGE1 therapy for intermittent claudication.

Background: Increasingly and justifiably, clinical studies are now being expected to investigate the influence of therapeutic measures also on the quality of life of the patient. Patients and Methods: Since no data on the variability of changes in the quality of life of the patient following PGE 1 treatment are so far available, the initial investigation was designed as an uncontrolled pilot study. 104 patients (median age 64.5 years) with a maximum walking distance on the treadmill (3 km/12%) of 50-250 m were included and given a daily intravenous infusion of 60 μg PGE 1 (Prostavasin®) over a period of 4 weeks excluding weekends. This was followed by treatment-free follow-up period of months. Changes in the quality of life were recorded with both the newly developed disease-specific questionnaire PAVK-86, and the generic questionnaire SF 36; in addition, the pain-free and maximun walking distance on the treadmill were also established prior to and immediately following treatment as also at the end of the follow-up period. Results: The quality of life was significantly improved in all dimensions (functional status, complaints pain, mood, anxiety, social life, treatment expectations) in addition to a marked increase in the median pain-free walking distance from 77 to 108 m, (p < 0.001) and the maximum walking distance from 118 to 171 m (p < 0.001). At the end of the 3-month observation period, the improvement was essentially still demonstrable. Conclusion: The study has shown for the first time that treatment with intravenous PGE 1 brings about not only the already known increase in the walking distance but also a clinically relevant and significant improvement in the patient's quality of life.