Cilostazol therapy effectively improves the walking distance of the patients, independently of diabetes status and smoking habit – results of a national non-interventional study
█ Original article
Járai Zoltán1, 2, Farkas Katalin2,3, Takács Johanna4, Kolossváry Endre2, 3
1Szt. Imre Egyetemi Oktatókórház, Kardiológiai Profil, Budapest
2Semmelweis Egyetem, Általános Orvostudományi Kar, Angiológia Tanszéki Csoport, Budapest
3Szt. Imre Egyetemi Oktatókórház, Angiológiai Profil, Budapest
4Semmelweis Egyetem, Egészségtudományi Kar, Budapest
Intermittent claudication is the symptomatic clinical form of lower extremity arterial disease, which deteriorates quality of life and increases the risk of mortality. Cilostazol is a phosphodiesterase-3 inhibitor for the management of symptomatic treatment of intermittent claudication.
Goals: To prove the effectivity and safety of cilostazol treatment for claudicant patients in the Hungarian clinical practice. We also aimed to assess the association of effectiveness of cilostazol with smoking habit and diabetes status.
Results: To this non-interventional trial altogether 761 patients were included in 30 centers, from them due to missing data 661 patients’ data has been evaluated (mean age: 66.45±9.33 year, 62% male). Among comorbidities the most frequent were hypertension (84%), hyperlipidemia (69%), diabetes (42%) and coronary heart disease (37%). 37.7% of the patients (n=246) were non-smokers, 35.5% (n=234) active smokers, while 27.3% (n=180) were the ex-smokers. The ankle-brachial index (0.70±0.17 vs. 0.78±0.16), the pain-free walking distance (176.08±120.47 vs. 285.21±191.96 meter), the maximal walking distance (275.32±205.31 vs. 431.97±251.33 meter) and the 6-minute walking distance (258.56±175.07 vs. 366.39±238.16 meter) increased significantly (p<0.001) during the 6-month treatment. The changes in ankle-brachial index and in walking tests were independent of smoking habits and diabetes status. Side effects were recorded in 7.2% of the patients. The rate of side effects was low (headache: 2.4%, palpitation: 2.0%, dyspnoe: 0.9%, diarrhea: 0.9%, other gastrointestinal symptoms: 0.5%, vertigo: 0.4%).
Conclusion: During 6 months of cilostazol treatment the functional state of the included patients improved, walking distance measured by objective tools increased, while no major side effects have been recorded.