Cilostazol 경구제 (품명: 프레탈정 등)

기준 내용

허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정함.

가. 간헐성 파행을 동반한 만성동맥폐색증(버거씨병, 폐색성 동맥경화증, 당뇨병성 말초혈관병증 등)

나. 뇌경색(심인성뇌색전증 제외) 발증 후 재발억제 및 간헐성 파행을 동반하지 않은 만성동맥폐색증은 [일반원칙] 경구용 항혈전제(항혈소판제 및 Heparinoid 제제) “세부사항” 범위 내에서 투여

* 시행일: 2014.12.1.

* 신설사유: 항혈소판 작용과 혈관이완 작용을 동시에 가지고 있으나, [일반원칙] 경구용 항혈전제 급여기준에 따라 말초동맥성질환에 투여시 제한이 있는 점 고려하여 단독투여 및 타 경구용 항혈전제와 병용이 가능하도록 개별 고시로서 급여 인정함.

* 관련근거:

· Harrison's Principles of Internal Medicine, 18e. Chapter 249 Vascular Diseases of the Extremities

· Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e

· Goldman's Cecil Medicine , 24th Edition. Chapter 79 Atherosclerotic Peripheral Arterial Disease

· Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 9th ed. Chapter 61 Peripheral Arterial Diseases

· Management of Patients With Peripheral Artery Disease (Compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations), 2013.

· Antithrombotic Therapy in Peripheral Artery Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed, 2012.

· Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). 2007.

· Stevens JW et al. Systematic review of the efficacy of cilostazol, naftidrofuryl oxalate and pentoxifylline for the treatment of intermittent claudication. Br J Surg. 2012 Dec;99(12):1630-8.

· Squires H et al. A systematic review and economic evaluation of cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease. Health Technol Assess. 2011 Dec;15(40):1-210.

· Pande RL et al. A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication. Vasc Med. 2010 Jun;15(3):181-8.

· Robless P et al. Cilostazol for peripheral arterial disease. Cochrane Database Syst Rev. 2008 Jan 23;(1)

· Hashiguchi M et al. Studies on the effectiveness and safety of cilostazol, beraprost sodium, prostaglandin E1 for the treatment of intermittent claudication. Yakugaku Zasshi. 2004 Jun;124(6):321-32.

· Hiatt WR et al. Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: A Study in Long-term Effects). J Vasc Surg. 2008 Feb;47(2):330-336.