Document Detail


Perindopril arginine: benefits of a new salt of the ACE inhibitor perindopril.
MedLine Citation:
PMID:  17519062     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The efficacy of the angiotensin-converting enzyme (ACE) inhibitor perindopril in the treatment of hypertension, stable coronary artery disease, and heart failure is well established. The reduced stability of the current salt, perindopril-tert-butylamine, in extreme climatic conditions has prompted research into more stable compounds. This article presents stability and bioequivalence results for a new L-arginine salt of perindopril. METHODS: Drug stability studies were performed on nonsalified perindopril, perindopril-tert-butylamine, and perindopril arginine in closed and open containers. The bioequivalence of perindopril arginine was tested in 36 healthy male volunteers in an open-label, randomized, two-period, crossover pharmacokinetic study. A consumer study was carried out in 120 patients to assess preference for a simplified packaging using a high-density polyethylene canister designed for distribution to all climatic zones. RESULTS AND DISCUSSION: Perindopril arginine is 50% more stable than perindopril-tert-butylamine, which increases the shelf life from 2 to 3 years. At the revised dosage (perindopril arginine 5-10 mg/day corresponds to perindopril-tert-butylamine 4-8 mg/day), the new salt is equivalent in terms of pharmacokinetics, efficacy, safety, and acceptability. The consumer studies indicate a preference for the new packaging, with 62% of patients nominating the canister as better than the blister packs. CONCLUSION: The new perindopril arginine salt is equivalent to perindopril-tert-butylamine and more stable, and can be distributed to climatic zones III and IV without the need for specific packaging. The patient preference for the new packaging could have positive implications for compliance.
Authors:
Elwira Telejko
Publication Detail:
Type:  Comparative Study; Journal Article; Review    
Journal Detail:
Title:  Current medical research and opinion     Volume:  23     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-05-23     Completed Date:  2007-07-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  953-60     Citation Subset:  IM    
Affiliation:
Studium Kształcenia Podyplomowego, Białystok, Poland. ztpl@amb.edu.pl
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MeSH Terms
Descriptor/Qualifier:
Angiotensin-Converting Enzyme Inhibitors / adverse effects,  chemistry,  pharmacokinetics,  therapeutic use*
Climate
Drug Evaluation
Drug Packaging
Drug Stability
Geography
Humans
Models, Biological
Patient Acceptance of Health Care
Perindopril / adverse effects,  chemistry,  pharmacokinetics,  therapeutic use*
Risk Assessment
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 82834-16-0/Perindopril

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


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