Postregistration Study of Comparative Assessment Efficacy of the Use of Fixed Combination of Nebivolol and Amlodipine for the Treatment of Patients With Moderate and High Degree of Arterial Hypertension

Печерина, Т. Б.; Vedernikova, A G; Evdokimov, Dmitrii; Klimenkova, A V; Барбараш, О. Л.

doi:10.18565/cardio.2014.6.21-28

Cited by 3 publications

(7 citation statements)

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“…All studies were randomized. One trial used a parallel group design, [17] one used a randomized, controlled, within-patient study design, [27] and the remaining 5 trials used a cross-over design. [21, 22, 28–30].…”

Section: Resultsmentioning

confidence: 99%

“…The main analysis included three trials, [27, 29, 30] but excluded four trials for the following reasons: three trials (Jaatela 1978, Solomon 1980, and Pecherina 2014) [17, 21, 22] did not report standard deviation, while the fourth trial (Asplund 1984)[28] reported mean change in systolic BP.…”

Section: Resultsmentioning

confidence: 99%

“…We included in this analysis three trials (Nissinen 1980, Solomon 1980, Olvera 1991)[22, 27, 29] that reported on the numbers of patients achieving BP target at the conclusion of the trial. We excluded one trial (Pecherina 2014)[17], that did not report on the exact numbers. In that trial, the authors implied a possible advantage of the fixed combination regarding this outcome, since addition of a thiazide diuretic was necessary to achieve BP target in 1.6% of patients in the intervention group versus 2.3% in the control group.…”

Section: Resultsmentioning

confidence: 99%

“…Three of the included trials, did not report standard deviations in the assessment of the primary outcome mean systolic BP. [17, 21, 22] We tried to contact the authors for any unpublished missing data that could assist us in calculating the missing standard deviations values, however we were not able to obtain this data. To account for the missing standard deviation we used the median standard deviation from the three included trials that reported mean systolic BP and standard deviations as described elsewhere.…”

Section: Methodsmentioning

confidence: 99%

“…[16] Since the publication of these two systematic reviews, at least one potentially eligible randomized clinical trial has been published. [17] Furthermore, there is a need to summarize and evaluate evidence from studies having the least risk of bias, i.e., randomized trials.…”

Section: Introductionmentioning

confidence: 99%

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Free versus Fixed Combination Antihypertensive Therapy for Essential Arterial Hypertension: A Systematic Review and Meta-Analysis

et al. 2016

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BackgroundIn a free drug combination, each Blood pressure (BP)-lowering drug is administered as a separate pill, while in a fixed drug combination several BP-lowering agents are combined in a single pill. Using a single pill may enhance compliance and simplify treatment, which would translate into better clinical outcomes. The objective of this meta-analysis is to compare the effects of using a fixed combination versus free combination of BP-lowering agents in the management of patients with essential hypertension.MethodsWe searched Cochrane CENTRAL, MEDLINE, and EMBASE for randomized clinical trials (RCTs) addressing the objective of the review and assessing at least one of the following outcomes: BP-lowering efficacy, rapidity in achieving BP target, compliance, incidence of side effects, mortality, and morbidity. Two review authors independently selected eligible studies, abstracted data, and assessed risk of bias of included trials. The primary meta-analyses used a random-effects model.ResultsWe identified seven RCTs with a total of 397 participants. Meta-analysis of efficacy in controlling BP showed a non-significant reduction of mean systolic BP of 0.81 mmHg (95% CI -3.25, 1.64) favoring the fixed combination group. As for adverse events, results showed a non-significant 13% risk reduction favoring the free combination (risk ratio 1.13, 95% CI 0.85, 1.5). Low quality of evidence was noted for both outcomes. Rapidity in achieving BP target was assessed in only one trial, and the results favored the fixed combination. Adherence to treatment was assessed in three trials, no pooled analysis was possible for this outcome. None of the included trials assessed mortality and morbidity.ConclusionThe available low quality evidence does not confirm or rule out a substantive difference between fixed combination and free combination therapy in the management of HTN. Well designed RCTs with a long duration of follow-up and assessment of morbidity and mortality outcomes are needed.

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