A review of long-term safety data with buflomedil.

Abstract

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.

• Authors: R T Bachand, A Y Dubourg
• Journal: The Journal of international medical research (J Int Med Res) 1990 May-Jun Vol. 18 Issue 3 Pg. 245-52 ISSN: 0300-0605 [Print] England
• PMID: 2193838 (Publication Type: Clinical Trial, Comparative Study, Journal Article)

Chemical References

• Pyrrolidines
• Vasodilator Agents
• buflomedil

Topics

• Alzheimer Disease (drug therapy)
• Arterial Occlusive Diseases (complications, drug therapy)
• Clinical Trials as Topic
• Double-Blind Method
• Follow-Up Studies
• Humans
• Intermittent Claudication (drug therapy, etiology)
• Pyrrolidines (adverse effects, therapeutic use)
• Vasodilator Agents (therapeutic use)