Han, Seung Hwan; Oh, Gyu Chul; Kwon, Hyuck Moon; Park, Chang Gyu; Kim, In Jai; Hwang, Gyo-Seung; Yoo, Byung Su; Park, Seong Hoon; Lee, Kwang Je; Kim, Hyo-Soo
Drug design, development and therapy
2018NA ; 12 ( 12 ) :4217-4229.
PMID : 30587918
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Han, Seung Hwan - Division of Cardiology, Department of Internal Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.
Oh, Gyu Chul - Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, hyosoo@snu.ac.kr.
Kwon, Hyuck Moon - Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Park, Chang Gyu - Division of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea.
Kim, In Jai - Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
Hwang, Gyo-Seung - Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
Yoo, Byung Su - Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
Park, Seong Hoon - Division of Cardiology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
Lee, Kwang Je - Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea.
Kim, Hyo-Soo - Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, hyosoo@snu.ac.kr.
ABSTRACT
PURPOSE: This study aimed to compare the efficacy and safety of generic and branded irbesartan for 8 weeks in patients with mild-to-moderate essential hypertension. PATIENTS AND
METHODS: We screened 221 patients with mild-to-moderate hypertension. After exclusion per study criteria, 177 subjects were randomized to receive 150 mg generic irbesartan (n=91) or branded irbesartan (n=86) as the intention to treat set. The primary efficacy endpoint of this study was the change in mean sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks between the generic and branded irbesartan groups. The secondary efficacy endpoints were the change in mean SiDBP at Week 4 from baseline and the change in mean sitting systolic blood pressure (SiSBP) at Weeks 4 and 8 from baseline in both groups. All safety issues were evaluated.
RESULTS: At Week 8, the generic and branded irbesartan groups showed significantly reduced SiDBP (-10.3±8.0, -10.7±7.7 mmHg, all P<0.0001) compared with baseline values, and the mean between-group difference in SiDBP change after 8 weeks of treatment was -0.4±1.2 mmHg, showing the non-inferiority of generic irbesartan vs branded irbesartan. Furthermore, secondary efficacy, which was the mean change of SiDBP from baseline at 4 weeks, was comparable between the two groups (-9.4±8.1 vs -9.9±7.4 mmHg, P=0.69). There were no between-group differences in mean changes of SiSBP after 4 or 8 weeks of treatment (P=0.78, P=0.97, respectively), or in the incidence of adverse effects (16.7 vs 24.4%, P=0.20). CONCLUSION: Generic irbesartan treatment in patients with mild-to-moderate essential hypertension has shown effective antihypertensive effects comparable with the branded irbesartan treatment, with similar incidence of adverse effects.
keyword
anti-hypertensive; generic medicine; hypertension; irbesartan
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