Document Detail


Hemolysis on intravenous administration of a new calcium antagonist.
MedLine Citation:
PMID:  7564328     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Hemolysis-inducing properties of the new calcium antagonist Ro 40-5967 administered intravenously to 39 healthy male subjects were investigated in a placebo-controlled study. The volunteers were randomized into five parallel groups of 9 subjects each: three groups, receiving infusions of 40 mg Ro 40-5967 in 60, 30, and 15 min, respectively; one group receiving 80 mg Ro 40-5967 in 30 min as two simultaneous doses of 40 mg in the cubital veins of both arms; and one group receiving 80 mg Ro 40-5967 in 30 min in one arm. Within each group, 3 subjects received placebo under randomized double-blind conditions. Plasma haptoglobin decreased by 67% after 3.5 h in 2 subjects who received 80 mg Ro 40-5967 in one arm (treatment schedule thereupon discontinued). Serum bilirubin levels also increased in a dose-dependent manner in all groups as compared with placebo. Other parameters of hemolysis remained unchanged; no hemoglobinuria was observed. The intravascular hemolysis observed on infusion limits the therapeutic application of Ro 40-5967 to oral use only.
Authors:
C H Kleinbloesem; M Siepmann; W Kirch
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of cardiovascular pharmacology     Volume:  25     ISSN:  0160-2446     ISO Abbreviation:  J. Cardiovasc. Pharmacol.     Publication Date:  1995 Jun 
Date Detail:
Created Date:  1995-11-07     Completed Date:  1995-11-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7902492     Medline TA:  J Cardiovasc Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  855-8     Citation Subset:  IM    
Affiliation:
Clin-Pharma Research AG, Center for Clinical Pharmacology, Basel, Switzerland.
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MeSH Terms
Descriptor/Qualifier:
Adult
Benzimidazoles / administration & dosage,  adverse effects*,  therapeutic use
Bilirubin / blood
Blood Proteins / analysis,  metabolism
Calcium Channel Blockers / administration & dosage,  adverse effects*
Dose-Response Relationship, Drug
Double-Blind Method
Haptoglobins / metabolism
Hemoglobinuria / metabolism
Hemolysis / drug effects*
Humans
Infusions, Intravenous
Male
Mibefradil
Tetrahydronaphthalenes / administration & dosage,  adverse effects*,  therapeutic use
Chemical
Reg. No./Substance:
0/Benzimidazoles; 0/Blood Proteins; 0/Calcium Channel Blockers; 0/Haptoglobins; 0/Tetrahydronaphthalenes; 116644-53-2/Mibefradil; 635-65-4/Bilirubin

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


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