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Clinical Trial
. 2018 Dec 19:12:4217-4229.
doi: 10.2147/DDDT.S172046. eCollection 2018.

Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study

Seung Hwan Han  1 , Gyu Chul Oh  2 , Hyuck Moon Kwon  3 , Chang Gyu Park  4 , In Jai Kim  5 , Gyo-Seung Hwang  6 , Byung Su Yoo  7 , Seong Hoon Park  8 , Kwang Je Lee  9 , Hyo-Soo Kim  2
Affiliations
Clinical Trial

Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study

Seung Hwan Han et al. Drug Des Devel Ther. .

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.

Keywords: anti-hypertensive; generic medicine; hypertension; irbesartan.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Study flow.
Figure 3
Figure 3
Change in SiDBP at Week 8 from baseline after irbesartan (whole study group as well as generic and branded irbesartan groups) treatment among subgroups of baseline characteristics (full analysis set). Note: Bars indicate mean, and lines indicate standard error of mean. *Statistically significant. Abbreviations: BMI, body mass index; DM, diabetes mellitus; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; Prev. Tx, previous treatment history of antihypertensive agent; SiDBP, sitting diastolic blood pressure; TG, triglyceride.
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References

    1. Matchar DB, Mccrory DC, Orlando LA, et al. Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension. Ann Intern Med. 2008;148(1):16–29. - PubMed
    1. Waeber B. A review of irbesartan in antihypertensive therapy: comparison with other antihypertensive agents. Current Therapeutic Research. 2001;62(7):505–523.
    1. Park S, Chung N, Kwon J, et al. Results of a multicenter, 8-week, parallel-group, randomized, double-blind, double-dummy, Phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension. Clin Ther. 2005;27(4):441–450. - PubMed
    1. Kim MS, Jeong MH, Lee MG, et al. The Phase 4 Randomized, Public, Parallel, Comparative, Clinical Trial to Compare Efficacy and Safety of S-(−)-Amlodipine Nicotinate with Ramipril in Hypertensive Patients. J Korean Soc Hypertens. 2011;17(3):103–113.
    1. James PA, Oparil S, Carter BL. Evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8) JAMAa. 2014;2014(311):507–520. - PubMed

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