Ihm, Sang-Hyun; Jeon, Hui-Kyung; Cha, Tae-Joon; Hong, Taek-Jong; Kim, Sang-Hyun; Lee, Nae-Hee; Yoon, Jung Han; Yoon, Namsik; Hwang, Kyung-Kuk; Jo, Sang-Ho; Youn, Ho-Joong
Drug design, development and therapy
2016NA ; 10 ( 22 ) :3817-3826.
PMID : 27920497
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Ihm, Sang-Hyun -
Jeon, Hui-Kyung -
Cha, Tae-Joon -
Hong, Taek-Jong -
Kim, Sang-Hyun -
Lee, Nae-Hee -
Yoon, Jung Han -
Yoon, Namsik -
Hwang, Kyung-Kuk -
Jo, Sang-Ho -
Youn, Ho-Joong -
ABSTRACT
PURPOSE: To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy. PATIENTS AND
METHODS: Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ??0 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.
RESULTS: After the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (P<0.0001/P<0.0001), CKD-828 2.5/80 mg (P<0.0001/P<0.0001), and S-amlodipine 2.5 mg (P<0.0001/P=0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: P=0.0002/P<0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: P=0.0001/P<0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg (P<0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: P=0.0028/P=0.0001 and P<0.0001/P=0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, P=0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828. CONCLUSION: CKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.
angiotensin receptor blocker; antihypertensive; blood pressure; calcium channel blocker; efficacy; safety
MESH
Aged, Amlodipine/adverse effects/*therapeutic use, Angiotensin II Type 1 Receptor Blockers/adverse effects/*therapeutic use, Antihypertensive Agents/adverse effects/*therapeutic use, Benzimidazoles/adverse effects/*therapeutic use, Benzoates/adverse effects/*therapeutic use, Blood Pressure/*drug effects, Calcium Channel Blockers/adverse effects/*therapeutic use, Double-Blind Method, Drug Combinations, Female, Humans, Hypertension/diagnosis/*drug therapy/physiopathology, Male, Middle Aged, Republic of Korea, Time Factors, Treatment Outcome
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