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      Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study

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          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] ≥90 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.

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          Most cited references 16

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          Fixed-dose combinations improve medication compliance: a meta-analysis.

          Compliance with treatment is a sine qua non for successful treatment of chronic conditions like hypertension. Fixed-dose combinations are designed to simplify the medication regimen and potentially improve compliance. However the data on comparison of fixed-dose combination with free-drug regimen to improve patient's medication compliance is limited. We conducted a MEDLINE search of studies using the words fixed-dose combinations, compliance and/or adherence. The inclusion criteria were studies which involved fixed-dose combination versus free-drug components of the regimen given separately. Only studies which reported patient's compliance were included. Of the 68 studies on fixed-dose combinations, only 9 studies fulfilled the inclusion criteria. Two studies were in patients with tuberculosis, 4 in the hypertensive population, 1 in patients with human immunodeficiency virus (HIV) disease and 2 in the diabetic population. A total of 11,925 patients on fixed-dose combination were compared against 8317 patients on free-drug component regimen. Fixed-dose combination resulted in a 26% decrease in the risk of non-compliance compared with free-drug component regimen (pooled relative risk [RR] 0.74; 95% confidence interval [CI], 0.69-0.80; P <.0001). There was no evidence of heterogeneity in this analysis (chi(2)=14.49, df=8; P=.07). A subgroup analysis of the 4 studies on hypertension showed that fixed-dose combination (pooled RR 0.76; 95% CI, 0.71-0.81; P <.0001) decreased the risk of medication non-compliance by 24% compared with free-drug combination regimen. Fixed-dose combination decreases the risk of medication non-compliance and should be considered in patients with chronic conditions like hypertension for improving medication compliance which can translate into better clinical outcomes.
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            2013 Korean Society of Hypertension guidelines for the management of hypertension. Part II—treatments of hypertension

            Treatment strategies are provided in accordance with the level of global cardiovascular risk, from lifestyle modification in the lower risk group to more comprehensive treatment in the higher risk group. Considering the common trend of combination drug regimen, the choice of the first drug is suggested more liberally according to the physician’s discretion.
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              Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.

              Telmisartan belongs to a class of orally active angiotensin II receptor blockers (ARBs), and S-amlodipine is an enantiomer of amlodipine. Amlodipine is a racemic mixture and the calcium channel blocking (CCB) effect is confined to S-amlodipine, whereas R-amlodipine has a 1000-fold lower activity and no racemization occurs in vivo in human plasma. Combination therapy of ARBs with CCBs provides advantages for blood pressure control and vascular protection over monotherapy.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2016
                23 November 2016
                : 10
                : 3817-3826
                Affiliations
                [1 ]Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Seoul
                [2 ]Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine
                [3 ]Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan
                [4 ]Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul
                [5 ]Department of Cardiology, Soonchunhyang University Hospital, Bucheon
                [6 ]Division of Cardiology, Wonju College of Medicine, Yonsei University, Wonju
                [7 ]Department of Cardiology, Chonnam National University Hospital, Gwangju
                [8 ]Department of Internal Medicine, Chungbuk National University, College of Medicine, Cheongju
                [9 ]Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, South Korea
                Author notes
                Correspondence: Ho-Joong Youn, Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, 505 Banpo-dong, Seocho-gu, Seoul 137-701, South Korea, Tel +82 2 2258 6029, Fax +82 2 591 1506, Email younhj@ 123456catholic.ac.kr
                Article
                dddt-10-3817
                10.2147/DDDT.S116847
                5125808
                © 2016 Ihm et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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