Evaluation of efficacy and safety of manidipine hydrochloride among essential hypertensive patients - Substitution from branded product (Calslot®) to generic product (Manidip®)

Hiroko Kobayashi, Taku Obara, Norio Takahashi, Takeshi Takahashi, Yukie Igari, Takuya Oikawa, Shinichiro Saito, Takayoshi Ohkubo, Yutaka Imai, Masanobu Takahashi

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Calcium channel blockers are most commonly used in hypertensive patients in Japan. However, information on the efficacy and safety of generic calcium channel blockers is insufficient. The objective of the present study was to retrospectively evaluate the efficacy 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 significantly different 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 different between before and after substitution (from 94.0 ± 8.8% to 93.1 ± 9.6%, p=0.72). There were 8 cases of adverse effects before substitution and 4 after substitution. No patient stopped taking the generic drug due to an adverse effect. In conclusion, significant differences in the efficacy, 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.

Original languageEnglish
Pages (from-to)2045-2050
Number of pages6
JournalYakugaku Zasshi
Volume127
Issue number12
DOIs
Publication statusPublished - 2007 Dec 1

Keywords

  • Drug compliance
  • Efficacy
  • Generic product
  • Manidipine hydrochloride
  • Retrospective study
  • Safety

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

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