title: Effects of Beraprost sodium on subjective symptoms in diabetic patients with peripheral arterial disease.
abstract: BACKGROUND
  This study evaluated the effects of Beraprost sodium (Berasil) on subjective leg symptoms in patients with peripheral arterial disease caused by diabetes mellitus.
  
  
  METHODS
  Ninety-four diabetic patients with peripheral arterial disease were treated with Beraprost in a fixed-dose, prospective, multicenter, cohort study. Beraprost (40 µg) was administered orally 3 times daily (120 µg/day) for 12 weeks. We developed a new disease-specific symptom questionnaire, which evaluated the effect of peripheral arterial disease on leg discomfort in daily life and assessed therapeutic responses to treatment. Patients were asked for their subjective assessment of symptoms on a written questionnaire before treatment and after 12 weeks of therapy.
  
  
  RESULTS
  There was significant improvement in all estimated subjective symptoms (burning, coldness, edema, exertional pain, stabbing, and paresthesias) in the lower extremities at 12 weeks (p < 0.001). There were 18 patients with neuropathy in whom significant improvement was noted for 6 subjective symptoms at 12 weeks (p < 0.05). Adverse events considered to be drug-related were observed in 4 patients (4.3%), all of which were mild and resolved with discontinuation of the medication.
  
  
  CONCLUSIONS
  Beraprost is effective as a treatment for improving various subjective symptoms in the lower extremities, such as burning, coldness, edema, exertional pain, stabbing, and paresthesias, in diabetic patients with peripheral arterial disease.
authors.affiliation: Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hang Seob
authors.initials: HS
authors.lastname: Yoon
authors.forename: Woo Jin
authors.initials: WJ
authors.lastname: Choi
authors.forename: Il Hoon
authors.initials: IH
authors.lastname: Sung
authors.forename: Ho Seong
authors.initials: HS
authors.lastname: Lee
authors.forename: Hyung Jin
authors.initials: HJ
authors.lastname: Chung
authors.forename: Jin Woo
authors.initials: JW
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D048909:Diabetes Complications / Q000188:drug therapy* / Q000503:physiopathology; D011464:Epoprostenol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000150:complications / Q000188:drug therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D018709:Statistics, Nonparametric
chemical_list: D010975:Platelet Aggregation Inhibitors; C048081:beraprost; D011464:Epoprostenol
keywords: Beraprost sodium; Diabetes mellitus; Intermittent claudication; Peripheral arterial disease; Prostaglandin I2