title: Cilostazol Can Increase Skin Oxygen Supply Assessed by Transcutaneous Oxygen Pressure Measurement in Type 2 Diabetes With Lower Limb Ischemic Disease: A Randomized Trial.
abstract: OBJECTIVE
  The purpose of this study was to compare the efficacy and safety of cilostazol versus acetylsalicylic acid (ASA) for amelioration of lower limb ischemia in type 2 diabetes.
  
  
  METHODS
  Prospective, randomized positive-controlled open clinical trial.
  
  
  METHODS
  Eighty-nine patients with type 2 diabetes mellitus and symptoms of lower limb ischemia (perceptions of coldness of the lower limbs, numbness, intermittent claudication, or pain at rest) present for 6 months or more that had not significantly changed within the past 3 months participated in the study. All subjects had an initial transcutaneous oxygen pressure (TcpO2) of less than 40 mm Hg in the foot when measured in the supine position. Subjects included 46 males and 43 females; their ages ranged from 35 to 80 years.
  
  
  METHODS
  Participants were randomly allocated to 2 groups, one was treated with cilostazol 100 mg taken twice daily (n = 48), and a second group took 100 mg of ASA daily (n = 41) for 8 weeks. Clinical assessment included measurement of transcutaneous oxygenation, and symptoms associated with lower limb ischemia. Blood analyses included a full blood panel, coagulation screen, renal function tests, hepatic function tests, and lipid profiles. All tests were performed at baseline and repeated at 8 weeks.
  
  
  RESULTS
  Age, duration of diabetes, diabetic complications, lower limb ischemic symptoms, TcpO2, and smoking status did not differ between the 2 groups. In contrast, TcpO2 significantly improved from 37.1 ± 11.9 mm Hg to 42.0 ± 9.7 mm Hg in the cilostazol-treated group (P < .05), whereas no significant change was observed in the ASA-treated group (P > .05). Ischemic symptoms such as intermittent claudication (P = .009), perception of limb coldness (P = .008), and pain at rest (P = .017) showed greater improvement in the cilostazol-treated group when compared to subjects treated with ASA. Approximately 10% of patients treated with cilostazol experienced adverse side effects (palpitations, headache, diarrhea). Cilostazol was not found to have significant detrimental effects in hematologic or biochemical indices, including renal, hepatic, and blood coagulant function tests.
  
  
  CONCLUSIONS
  We found that 8 weeks of treatment with cilostazol 100 mg daily was safe and well tolerated for the treatment of type 2 diabetes with lower limb ischemic disease.
authors.affiliation: Jinglu Zhang, PhD, Institution of Endocrinology and Metabolism, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Zidong Xiao, MD, Department of Endocrinology of First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China. Lihong Chen, PhD, Institution of Endocrinology and Metabolism, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Li Li, MD, Emergency Department, the Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Haiyun Yang, MD, Department of Ultrasonic of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Baoming Luo, MD, Department of Ultrasonic of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Lifang Mai, MD, Institution of Endocrinology and Metabolism, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Li Yan, MD, Institution of Endocrinology and Metabolism, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Chuan Yang, PhD, Institution of Endocrinology and Metabolism, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
authors.forename: Jinglu
authors.initials: J
authors.lastname: Zhang
authors.forename: Zidong
authors.initials: Z
authors.lastname: Xiao
authors.forename: Lihong
authors.initials: L
authors.lastname: Chen
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Haiyun
authors.initials: H
authors.lastname: Yang
authors.forename: Baoming
authors.initials: B
authors.lastname: Luo
authors.forename: Lifang
authors.initials: L
authors.lastname: Mai
authors.forename: Li
authors.initials: L
authors.lastname: Yan
authors.forename: Chuan
authors.initials: C
authors.lastname: Yang
mesh_terms: D000368:Aged; D001785:Blood Gas Monitoring, Transcutaneous / Q000379:methods; D000077407:Cilostazol; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy; D005260:Female; D006801:Humans; D000860:Hypoxia / Q000517:prevention & control*; D007511:Ischemia / Q000175:diagnosis* / Q000628:therapy; D035002:Lower Extremity / Q000098:blood supply / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012867:Skin / Q000098:blood supply*; D013777:Tetrazoles / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D013777:Tetrazoles; D000077407:Cilostazol