Comparison of Clinical Efficacy and Safety of Generic Pravastatin Sodium with Those of Branded Product

Calcium channel blockers are most commonly used in hypertensive patients in Japan. However, information on the e‹cacy and safety of generic calcium channel blockers is insu‹cient. The objective of the present study was to retrospectively evaluate the e‹cacy and safety of manidipine hydrochloride in 21 essential hypertensive patients (mean age; 70.6 ±10.6 years, male/female; 14/7) in Sendai Postal Services Agency Hospital who were switched (substituted) from a brand product (Calslot ) to a generic product (Manidip ). For this retrospective study, we used data from patient medical records and drug prescription information. Data from patients who were taking both types of manidipine hydrochloride, whose regimen were not changed for ＞ 6 months before and after switching, and who provided informed consent were included in the analysis. Control values of blood pressure were not signiˆcantly diŠerent between before and after substitution (systolic/diastolic; from 137.9±9.1/78.7±5.4 mmHg to 137.3±9.1/77.8±6.3 mmHg, p ＝0.73/p＝0.36). The level of patient compliance for the antihypertensive drugs was also not diŠerent between before and after substitution (from 94.0±8.8％ to 93.1±9.6％, p＝0.72). There were 8 cases of adverse eŠects before substitution and 4 after substitution. No patient stopped taking the generic drug due to an adverse eŠect. In conclusion, signiˆcant diŠerences in the e‹cacy, safety, and patient compliance were not observed between the brand product and generic product among patients who were switched from the brand product to the generic product.

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Evaluation of Efficacy and Safety of Manidipine Hydrochloride among Essential Hypertensive Patients-Substitution from Branded Product (Calslot) to Generic Product (Manidip)-

Kobayashi¹,

Obara

Takahashi

et al. 2007

YAKUGAKU ZASSHI

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Assessment of Therapeutic Equivalence of Original and Generic Preparations of Pravastatin Sodium (Mevalotin vs. Mevan): A Retrospective Study

公一¹,

都子²,

友明³

et al. 2008

Jpn. J. Pharm. Health Care Sci.

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Comparison of Clinical Efficacy and Safety of Generic Pravastatin Sodium with Those of Branded Product

Cited by 2 publications

References 8 publications

Evaluation of Efficacy and Safety of Manidipine Hydrochloride among Essential Hypertensive Patients-Substitution from Branded Product (Calslot) to Generic Product (Manidip)-

Evaluation of Efficacy and Safety of Manidipine Hydrochloride among Essential Hypertensive Patients-Substitution from Branded Product (Calslot) to Generic Product (Manidip)-

Assessment of Therapeutic Equivalence of Original and Generic Preparations of Pravastatin Sodium (Mevalotin vs. Mevan): A Retrospective Study

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