A review of long-term safety data with buflomedil.
Tolerance of long-term buflomedil was assessed by compiling safety data (adverse effects, vital signs and clinical laboratory results) from three multicentre clinical trials in patients with intermittent claudication or Alzheimer's disease-type senile dementia. The three studies were similar in design: open placebo lead-in; double-blind, placebo-controlled treatment; and open long-term treatment. Patients were randomly assigned to receive 600 mg/day buflomedil given orally for 3 or 6 months (n = 297) or placebo (n = 298). Buflomedil was continued for a further 6-12 months in 193 patients and for 12 months or more in 99 patients. Side-effects occurred in 20.5% and 18.1% of buflomedil- and placebo-treated patients, respectively, with discontinuation in 14.5% and 13.1%, respectively. In the open phase, 10.9% experienced side-effects, with 1.5% of patients discontinuing treatment. Mean changes in vital signs and laboratory tests were occasionally statistically, but not clinically, significant. Overall long-term tolerance was excellent.
Abbott International, North Chicago, Illinois.
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D000544:Alzheimer Disease / Q000188:drug therapy*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000209:etiology; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000627:therapeutic use*
D011759:Pyrrolidines; D014665:Vasodilator Agents; C010651:buflomedil