Therapeutic Differences in 24‐h Ambulatory Blood Pressures in Patients Switched Between Bioequivalent Nifedipine Osmotic Systems With Differing Delivery Technologies

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 the...

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Bibliographic Details
Published in:Clinical and translational science 2017-05, Vol.10 (3), p.217-224
Main Authors: Pollak, PT, Herman, RJ, Feldman, RD
Format: Article
Language:English
Subjects:
Aged
Blood pressure
Blood Pressure - drug effects
Blood Pressure Monitoring, Ambulatory
Demography
Drug Delivery Systems
Drug dosages
Drug stores
Female
Formulations
Humans
Male
Middle Aged
Nifedipine
Nifedipine - administration & dosage
Nifedipine - pharmacokinetics
Nifedipine - pharmacology
Nifedipine - therapeutic use
Osmosis
Patients
Pharmaceuticals
Pharmacy
Regulatory approval
Systole - drug effects
Therapeutic Equivalency
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Summary: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.
ISSN:1752-8054
1752-8062
DOI:10.1111/cts.12442