Document Detail


A review of long-term safety data with buflomedil.
MedLine Citation:
PMID:  2193838     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article    
Journal Detail:
Title:  The Journal of international medical research     Volume:  18     ISSN:  0300-0605     ISO Abbreviation:  J. Int. Med. Res.     Publication Date:    1990 May-Jun
Date Detail:
Created Date:  1990-08-08     Completed Date:  1990-08-08     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0346411     Medline TA:  J Int Med Res     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  245-52     Citation Subset:  IM    
Affiliation:
Abbott International, North Chicago, Illinois.
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MeSH Terms
Descriptor/Qualifier:
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*
Chemical
Reg. No./Substance:
0/Pyrrolidines; 0/Vasodilator Agents; 55837-25-7/buflomedil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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