title: Therapeutic Differences in 24-h Ambulatory Blood Pressures in Patients Switched Between Bioequivalent Nifedipine Osmotic Systems With Differing Delivery Technologies.
abstract: Comparing modified-release formulations can be difficult using current bioequivalence criteria. Two 60-mg-once-daily nifedipine formulations are deemed bioequivalent in Canada. This study examined the validity of the assumption that these interchangeable, but different, delivery technologies are therapeutically equivalent in maintaining systolic blood pressure (SBP) control throughout the entire dosing interval. We used 24-h Ambulatory Blood Pressure Monitoring to objectively examine whether formulation switches changed population SBP >2 mmHg (reflecting 6% increased stroke mortality) and in what proportion of patients SBP changed ≥6 mmHg (risking unnecessary therapeutic alterations). When 20 patients, previously receiving 60-mg-once-daily Nifedipine-GITS, were switched to Mylan-Nifedipine-XL, population-mean ± SE 24-h SBP increased 3 ± 1.1 mmHg (P = 0.0173) and 8-h nocturnal SBP increased 4 ± 1.6 mmHg (P = 0.0098). Thus, interchange of nifedipine formulations can affect therapeutic consistency. These data support existing calls to improve criteria for establishing bioequivalence between formulations employing differing modified-release technologies.
authors.affiliation: University of Calgary, Calgary, Alberta, Canada.
authors.forename: P T
authors.initials: PT
authors.lastname: Pollak
authors.affiliation: University of Calgary, Calgary, Alberta, Canada.
authors.forename: R J
authors.initials: RJ
authors.lastname: Herman
authors.affiliation: Memorial University, St John's, Newfoundland & Labrador, Canada.
authors.forename: R D
authors.initials: RD
authors.lastname: Feldman
mesh_terms: D000368:Aged; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D003710:Demography; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D009995:Osmosis; D013599:Systole / Q000187:drug effects; D013810:Therapeutic Equivalency
chemical_list: D009543:Nifedipine