Document Detail


Therapeutically relevant blood pressure differences with two nifedipine (60 mg) osmotic delivery systems of differing design: three case reports.
MedLine Citation:
PMID:  20497748     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
During the introduction of a new once-daily nifedipine 60 mg osmotic delivery tablet to Canada in 2009, several patients previously maintained at target blood pressure on regimens that included nifedipine 60 mg daily were observed to have > 10 mmHg rises in their systolic pressure during follow-up. The only difference noted in their medication and clinical status was a substitution with the new 60 mg nifedipine formulation by their pharmacists. Three patients agreed to report home blood pressure for N of 1 studies in which all clinical parameters remained the same, but their nifedipine was repeatedly switched between the original and alternate formulations each week. Of 14 recorded switches, systolic pressure was higher on the alternate formulation 13 times. In at least some patients, the alternate pump technology appears less effective. This highlights the need for better bioequivalence criteria for comparing differing delivery technologies that artificially retard absorption of the drug.
Authors:
P T Pollak
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Publication Detail:
Type:  Case Reports; Comparative Study; Journal Article    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  48     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-25     Completed Date:  2010-07-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  400-4     Citation Subset:  IM    
Affiliation:
Departments of Medicine, Cardiac Sciences, and Physiology & Pharmacology, University of Calgary, Calgary, Canada. amiokinetics@hotmail.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Atrial Fibrillation / drug therapy,  etiology
Blood Pressure / drug effects*
Calcium Channel Blockers / administration & dosage,  pharmacokinetics,  pharmacology*
Delayed-Action Preparations
Female
Humans
Hypertension / complications,  drug therapy
Male
Nifedipine / administration & dosage,  pharmacokinetics,  pharmacology*
Osmosis
Tablets
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Calcium Channel Blockers; 0/Delayed-Action Preparations; 0/Tablets; 21829-25-4/Nifedipine

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


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