Single-Pill Combination of Telmisartan/Amlodipine Versus Amlodipine Monotherapy in Diabetic Hypertensive Patients: An 8-Week Randomized, Parallel-Group, Double-Blind Trial

Sharma, Arya M.; Bakris, George L.; Neutel, Joel M.; Littlejohn, Thomas; Kobe, Maureen; Ting, Naitee; Ley, Ludwin

doi:10.1016/j.clinthera.2012.02.004

Cited by 18 publications

(27 citation statements)

References 45 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In patients with stage 1 or 2 hypertension and diabetes uncontrolled on amlodipine monotherapy, 8 weeks of treatment with the T/A SPC resulted in a significantly higher reduction in SBP and in more patients achieving their BP goal. The results were similar in the subpopulation of obese patients 52. In a post hoc analysis of data from patients stratified into subpopulations based on age, race, coexisting diabetes, obesity, metabolic syndrome, renal impairment, and elevated baseline SBP, it was seen that BP reductions, goal-attainment rate, and response rate obtained with T80/A10 in these added-risk patients were similar to those observed in the overall population 53.…”

Section: Which Combination For Which Patient?supporting

confidence: 62%

A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

Segura

Ruilope²

2013

VHRM

View full text Add to dashboard Cite

This review discusses the rationale for earlier use of single-pill combinations (SPCs) of antihypertensive drugs, with a focus on telmisartan/amlodipine (T/A) and telmisartan/hydrochlorothiazide (T/H) SPCs. Compared with the respective monotherapies, the once-daily T/A and T/H SPCs have been shown to result in significantly higher blood pressure (BP) reductions, BP goal rates, and response rates in patients at all stages of hypertension. As expected, BP reductions are highest with the highest dose (T80/A10 and T80/H25) SPCs. Subgroup analyses of the telmisartan trials have reported the efficacy of both SPCs to be consistent, regardless of the patients’ age, race, and coexisting diabetes, obesity, or renal impairment. In patients with mild-to-moderate hypertension, the T/A combination provides superior 24-hour BP-lowering efficacy compared with either treatment administered as monotherapy. Similarly, the T/H SPC treatment provides superior 24-hour BP-lowering efficacy, especially in the last 6 hours relative to other renin–angiotensin system inhibitor-based SPCs. The T/A SPC is associated with a lower incidence of edema than amlodipine monotherapy, and the T/H SPC with a lower incidence of hypokalemia than hydrochlorothiazide monotherapy. Existing evidence supports the use of the T/A SPC for the treatment of hypertensive patients with prediabetes, diabetes, or metabolic syndrome, due to the metabolic neutrality of both component drugs, and the use of the T/H SPC for those patients with edema or in need of volume reduction.

show abstract

Section: Which Combination For Which Patient?supporting

confidence: 62%

A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

Segura

Ruilope²

2013

VHRM

View full text Add to dashboard Cite

show abstract

“…Amlodipine (Pfizer Inc., New York, NY, USA) is a well-established, long-acting CCB for the treatment of hypertension, including patients with diabetes 20–22. Studies in hypertensive patients have highlighted the additional benefit of titrating amlodipine from 5 mg to 10 mg once daily with regard to lowering BP,23–27 including Asian patients 26.…”

Section: Introductionmentioning

confidence: 99%

Uptitrating amlodipine significantly reduces blood pressure in diabetic patients with hypertension: a retrospective, pooled analysis

Jeffers

Bhambri

Robbins

2014

VHRM

View full text Add to dashboard Cite

Diabetic patients with hypertension are approximately twice as likely to develop cardiovascular disease as non-diabetic patients with hypertension. Given that hypertension affects ∼60% of patients with diabetes, effective blood pressure (BP) management is important in this high-risk population. This post-hoc analysis pooled data from six clinical studies to quantify additional BP efficacy achieved when titrating hypertensive diabetic patients from amlodipine 5 mg to 10 mg. Approximately half of the diabetic patients were male (44/98; 44.9%) with a mean (standard deviation [SD]) age of 60.6 (9.6) years and a baseline mean (standard error [SE]) systolic blood pressure/diastolic blood pressure (SBP/DBP) of 150.8 (1.30)/87.5 (0.94) mmHg while on amlodipine 5 mg (159.1 [1.40]/92.6 [0.94] mmHg prior to treatment). In comparison, 350/610 (57.4%) non-diabetic patients were male with a mean (SD) age of 58.7 (11.1) years and baseline mean (SE) SBP/DBP of 150.3 (0.62)/90.9 (0.41) mmHg while on amlodipine 5 mg (160.0 [0.67]/96.2 [0.45] mmHg prior to treatment). Increasing amlodipine from 5 mg to 10 mg lowered sitting SBP by −12.5 mmHg (95% confidence interval (CI): −15.5, −9.5; P<0.0001) and DBP by −6.0 mmHg (−7.4, −4.6; P<0.0001) in diabetic patients; and SBP by −12.4 mmHg (−13.5, −11.3; P<0.0001) and DBP by −7.3 mmHg (−8.0, −6.7; P<0.0001) in non-diabetic patients. In total, 12.0% (95% CI: 6.4, 20.0) of diabetic patients achieved their BP goal versus 46.4% (42.4, 50.4) of non-diabetic patients after titration to amlodipine 10 mg. Overall, 22.0% of diabetic patients experienced 31 adverse events (AEs) and 28.9% of non-diabetic patients experienced 282 AEs. Serious AEs were reported by one (1.0%) diabetic and five (0.8%) non-diabetic patients. In this analysis, increasing amlodipine from 5 mg to 10 mg produced a clinically significant reduction in the BP of diabetic hypertensive patients, similar to non-diabetic patients, highlighting the importance of optimizing amlodipine titration in this high-risk population.

show abstract

“…Although numerous studies have shown similar adverse event incidences between a fixed-dose combination containing amlodipine/telmisartan and amlodipine monotherapy,15,16,18,19 this clinical trial showed a significantly lower adverse event incidence in the CKD-828 2.5/40 mg group than there was in the S-amlodipine 2.5 mg group. The differences of adverse event incidence between two groups in this clinical study may be due to the differences in the incidences of respiratory disorders.…”

Section: Discussionmentioning

confidence: 51%

“…Headache, one of the most common adverse events associated with amlodipine and telmisartan, was reported in one and three subjects (1.59% and 4.92%) in the CKD-828 2.5/80 mg and S-amlodipine 2.5 mg groups, respectively. Previous studies comparing a fixed-dose combination of amlodipine and telmisartan with amlodipine monotherapy reported that the incidence of headache was 2%–5.7% for the combination and 2.5%–6% for amlodipine monotherapy 15,16,19. Although the incidence of headache reported in the S-amlodipine 2.5 mg group in the present study was similar to those of the previous studies; it was lower in the CKD-828 2.5/80 mg group with no incidences in the CKD-828 2.5/40 mg group.…”

Section: Discussionmentioning

confidence: 99%

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

Ihm¹,

Jeon²,

Joon³

et al. 2016

DDDT

View full text Add to dashboard Cite

PurposeTo 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 methodsEligible 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.ResultsAfter 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.ConclusionCKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.

show abstract

Single-Pill Combination of Telmisartan/Amlodipine Versus Amlodipine Monotherapy in Diabetic Hypertensive Patients: An 8-Week Randomized, Parallel-Group, Double-Blind Trial

Cited by 18 publications

References 45 publications

A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

Uptitrating amlodipine significantly reduces blood pressure in diabetic patients with hypertension: a retrospective, pooled analysis

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

Contact Info

Product

Resources

About