Prospective, Systematic Observational Study on the Daily Use of Cilostazol (Pletal) in Clinical Vascular Surgical Practice - Significant Improvement of Walking Distance and Quality of Life for Patients with PAOD, Stage II b

Abstract

Through a defined time period, all consecutive vascular surgical patients with indicated and initiated medication with cilostazol (PAOD, stage II b) were registered and controlled clinically within 3-month time intervals to investigate the therapeutic effect in a representative, specifically vascular surgical group of patients using a systematic prospective, unicentre clinical observational study. In particular, maximum walking distance, subjective (semiquantitative) assessment of the quality of life, impact of accompanying diseases as well as the occurrence of adverse effects and their impact onto the treatment were studied. Out of the 146 registered patients with initiated medication of cilostazol, 93 subjects were finally evaluated. Three months after initiation of cilostazol medication, maximum walking distance increased by 108 m (159.7 %) based on the initial 181 m. After 6 and 9 months, walking distance increased by 181 m (200 %) and 168 m (192.8 %), respectively. After 12 months, there was no further increase of the walking distance by 126 m (169.6 %) compared with months 6 and 9 but still with a significant difference to the initial distance. There was a trend of an improved walking distance from the 3rd to the 6th month (p = 0.1055) and a significant difference between the 3rd and the 9th month (p = 0.0094; no further significant differences between the time points 3rd/12th, 6th/9th, 6th/12th and 9th/12th month). While an improved quality of life was reported in 80.7 % of patients after 3 months, the rate varied between 82.6, 72.9 and 80.9 % at 6, 9 and 12 months, respectively, i.e., always in the majority of cases. There were no hints for safety concerns with regard to severe adverse effects, in particular, bleeding episodes. Subgroup analyses on accompanying diseases such as diabetes, hyperlipidemia or nicotine abuse did not reveal any impact on the improved walking distance (ABI - no feasible parameter). Medication with cilostazol led to a significant increase of the maximum walking distance (p < 0.0001) compared to the initial distance, which was further increased through one year (however, the effect became weaker) accompanied by a dominating improvement of the quality of life. The effects can be observed longer than 3-6 months.