Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial
Il Suk Sohn, Chong-Jin Kim, Byung-Hee Oh, Taek-Jong Hong, Chang-Gyu Park, Byung-Soo Kim, Woo-Baek Chung, Investigators, Chang-Wook Nam, Cheol-Ho Kim, Dong-Ju Choi, Sang-Hong Baek, Baek Chung, Woo-Shik Kim, Tae-Hoon Ahn, Jang-Hyun Cho, Hweung-Kon Hwang, Eun-Seok Shin, Joon-Han Shin, Myung-Ho Jeong, Jin- Ok Jeong, Chong-Jin Kim, Il Suk Sohn, Jang-Ho Bae, Hwan Lee, Se-Joong Rim, Jay-Young Rhew, Dae-Kyeong Kim, Soon-Kil Kim, Hye-Sun Seo, Duk-Hyun Kang, Young-Dae Kim, Dong-Woon Kim, Taek-Jong Hong, Jong-Won Ha, Woo-Jung Park, Tae Ho Kim, Kee-Sik Kim, Seung-Woo Park, Wan-Joo Shim, Joo- Young Yang, Jae- Woong Choi, Sun-Hwa Lee, Jeong-Cheon Ahn, Keun Lee, Byung-Soo Kim, Il Suk Sohn, Chong-Jin Kim, Byung-Hee Oh, Taek-Jong Hong, Chang-Gyu Park, Byung-Soo Kim, Woo-Baek Chung, Investigators, Chang-Wook Nam, Cheol-Ho Kim, Dong-Ju Choi, Sang-Hong Baek, Baek Chung, Woo-Shik Kim, Tae-Hoon Ahn, Jang-Hyun Cho, Hweung-Kon Hwang, Eun-Seok Shin, Joon-Han Shin, Myung-Ho Jeong, Jin- Ok Jeong, Chong-Jin Kim, Il Suk Sohn, Jang-Ho Bae, Hwan Lee, Se-Joong Rim, Jay-Young Rhew, Dae-Kyeong Kim, Soon-Kil Kim, Hye-Sun Seo, Duk-Hyun Kang, Young-Dae Kim, Dong-Woon Kim, Taek-Jong Hong, Jong-Won Ha, Woo-Jung Park, Tae Ho Kim, Kee-Sik Kim, Seung-Woo Park, Wan-Joo Shim, Joo- Young Yang, Jae- Woong Choi, Sun-Hwa Lee, Jeong-Cheon Ahn, Keun Lee, Byung-Soo Kim
Abstract
Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5).
Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period.
Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated.
Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).
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Source: PubMed