IMPROVEMENT IN THE QUALITY-OF-LIFE AFTER IV PGE(1) THERAPY FOR INTERMITTENT CLAUDICATION

Background: Increasingly and justifiably, clinical studies are now bei ng 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 patie nt following PGE(1) treatment are so far available, the initial invest igation was designed as an uncontrolled pilot study. 104 patients (med ian 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 infus ion of 60 mu g PGE(1) (Prostavasin(R)) over a period of 4 weeks exclud ing weekends. This was followed by a treatment-free follow-up period o f 3 months. Changes in the quality of life were recorded with both the newly developed disease-specific questionnaire PAVK-86, and the gener ic questionnaire SF 36; in addition, the pain-free and maximum walking distances on the treadmill were also established prior to and immedia tely following treatment, as also at the end of the follow-up period. Results: The quality of life was significantly improved in all dimensi ons (functional status, complaints, pain, mood anxiety, social life, t reatment expectations) in addition to a marked increase in the median pain-free walking distance from 77 to 108 m (p < 0.001) and the maximu m walking distance from 118 to 171 m (p < 0.001). At the end of the 3- month observation period, the improvement was essentially still demons trable. Conclusion. The study has shown for the first time that treatm ent with intravenous PGE(1) brings about not only the already known in crease in the walking distance, but also a clinically relevant and sig nificant improvement in the patient's quality of life.