A randomized controlled trial on the blood pressure–lowering effect of amlodipine and nifedipine‐GITS in sustained hypertension

Huang, Qi‐Fang; Sheng, Chang‐Sheng; Li, Yan; Dou, Yu; Zheng, Mingqi; Zhu, Zhiming; Wang, Ji‐Guang

doi:10.1111/jch.13543

Cited by 12 publications

(14 citation statements)

References 26 publications

(29 reference statements)

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“…14 Huang et al assessed the efficacy of amlodipine and nifedipine-GITS by comparing the reduction of SBP and DBP means with the univariate approach and found similar reduction which might be different if correlation accounted. 15 The correlation among the variables plays a major role in decision making; in this analysis at 84th month of follow-up, both SBP and DBP means were statistically similar in univariate and bivariate approaches with observed correlation among them (r = 0.514). But a little shift of correlation from 0.514 to 0.571, the decision of bivariate approach changed in contrast to univariate, suggesting decisions are sensitive towards correlation.…”

Section: Discussionmentioning

confidence: 53%

“…14 The effectiveness of amlodipine against the nifedipine in lowering ambulatory BP in sustained hypertension was investigated and compared between the groups at the base, 4-week, and 8-week using unpaired t-test. 15 Similarly Chen et al in one randomized trial of 8 weeks investigated efficacy and tolerability of initial high (5.0 mg/d) vs. low (2.5 mg/d) doses of S-(− )amlodipine in hypertension. The univariate unpaired t-test was applied to compare the mean change of clinic as well as ambulatory BP between the two groups.…”

Section: Introductionmentioning

confidence: 99%

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Multivariate approach in analyzing medical data with correlated multiple outcomes: An exploration using ACCORD trial data

Mishra

Harichandrakumar

Binu

et al. 2021

Clinical Epidemiology and Global Health

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Background: In clinical setting, to answer a research question, very often more than one outcome variables are used which are statistically correlated. Univariate analysis approach, which is commonly used in such context, violates the assumption of independence for correlated variables, while multivariate approach could give more robust and precise clinical decision by accounting this correlation. This paper is a demonstration of the change in statistical decision in multivariate approach compared to univariate approach in analysing medical data with multiple correlated outcome variables. Method: ology: The data used in this paper was the ACCORD trial data and the variables were Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) which are correlated. The condition of bivariate normality was checked after removing the outliers. We compared the differences in means of SBP and DBP separately between the groups at different follow up time points by univariate approach using unpaired 't' test and thereafter together by bivariate approach using Hotelling 'T 2' . Further the role of varied levels of correlation between SBP and DBP coupled with the variations in sample size in changing the statistical inference has been investigated. Robustness of these results were demonstrated through 1000 samples of simulated data from Accord trial data. Results: The statistical decision regarding difference in means of either SBP or DBP between the two groups at baseline, 12th, 36th and 84th month in both univariate and bivariate approaches were similar. At baseline and 84th month the hypotheses were accepted and at 12th and 36th month the hypotheses were rejected with both the approaches. However at 60th and 72nd month the univariate and multivariate approach results contradicted each other which reflect the significance of correlation in modifying the inference. The analysis results further indicated that varied levels of correlation and sample size too modify the inference in bivariate approach and contradict univariate results. Conclusion: Studies with multiple correlated outcomes, the multivariate approach which accounts this statistical correlation has potential to change statistical decisions and provide more precise results. Hence multivariate approach is recommended in such situations.

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Section: Discussionmentioning

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Multivariate approach in analyzing medical data with correlated multiple outcomes: An exploration using ACCORD trial data

Mishra

Harichandrakumar

Binu

et al. 2021

Clinical Epidemiology and Global Health

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“…Furthermore, the incidence of adverse events was similar between the two groups. However, after missing a dose of medication, greater reduction in 24‐hour DBP (nifedipine GITS vs amlodipine = ‐4.3 vs ‐5.5 mmHg, P = .04) and daytime DBP (nifedipine GITS vs amlodipine = ‐4.5 mmHg vs. ‐6.0 mmHg, P = .02) was observed in the amlodipine group, indicating that when a dose is delayed for hours on monotherapy, the efficacy of nifedipine GITS might be reduced markedly 13 …”

Section: Discussionmentioning

confidence: 92%

“…Fiscal outcomes compared with both the gastrointestinal therapeutic system (GITS) and the osmotic‐controlled release oral delivery system (OROS) of nifedipine use osmotic pressure as the driving force to deliver drugs through laser‐drilled holes, providing stable drug concentrations, uniform drug effect, and reduced dosing frequency 11,12 . Furthermore, with regard to clinical efficacy, application of extended‐release formulations of nifedipine demonstrated similar blood pressure (BP)‐lowering effects as long‐acting amlodipine 13,14 …”

Section: Introductionmentioning

confidence: 99%

Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan

Lee

Huang

Leu

et al. 2022

J of Clinical Hypertension

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The control rate of hypertension remains concerning, indicating the requirement for better management strategies. The calcium channel blockers brand-name amlodipine and nifedipine with extended-release formulations demonstrate similar clinical efficacy. However, the efficacy of generic nifedipine remains obscure. We compared the efficacy of generic nifedipine and brand-name amlodipine in terms of cardiovascular (CV) outcomes. Patients prescribed generic nifedipine (SRFC CYH) or brand-name amlodipine besylate (Norvasc, Pfizer) between August 1, 2017, and July 31, 2018, were enrolled; patients with CV events within 3 months were excluded. CV outcomes included CV death, nonfatal myocardial infarction (MI), nonfatal ischemic stroke, hospitalization for heart failure, and composite endpoints of 3P-and 4P-major adverse cardiac events (MACE). A total of 1625 patients treated with nifedipine (SRFC CYH) and 16 587 patients treated with Norvasc were included. After propensity score matching, there were 995 and 4975 patients in the nifedipine CYH and Norvasc groups, respectively. At a mean follow-up period of 30.3 ± 6.4 months, nifedipine CYH was comparable to Norvasc in terms of CV death (P = .107), nonfatal MI (P = .121), nonfatal ischemic stroke (P = .453), hospitalization for heart failure (P = .330), 3P-MACE (P = .584), and 4P-MACE (P = .274). Cox regression analysis revealed that nifedipine CYH and Norvasc had similar efficacy in terms of 3P-MACE (hazard ratio, 0.970; 95% confidence interval, 0.601-1.565, P = .900) and 4P-MACE (hazard ratio, 0.880; 95% confidence interval, 0.628-1.233, P = .459). In conclusion, Nifedipine SRFC CYH and Norvasc have comparable clinical efficacy for hypertension management.

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“…38 Huang et al reported that amlodipine was more efficacious (2–3 mm Hg) than nifedipine in reducing the 24-hour BP when the dose of medication got missed. 39 A phase IV study investigated the effect of amlodipine/valsartan on the mean 24-hour ambulatory BP when given in the morning (6–10 am ) and evening (6–10 pm ). Following 4 weeks of treatment, the patients who took dose in morning, and evening showed a mean reduction of −12.16 (0.88)/− 11.17 (0.90) mm Hg in SBP, respectively while the reduction of DBP in morning, and evening was −7.71 (0.59) and −7.01 (0.60) mm Hg, respectively.…”

Section: Amlodipine: Blocks All Types Of Calcium Channelsmentioning

confidence: 99%

24-Hour Blood Pressure Control with Amlodipine: A Review of the Current Scenario

Nair

Kumar

Unni

et al. 2022

Journal of Cardiac Critical Care TSS

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Introduction Hypertension is the leading cause of cardiovascular diseases and premature death worldwide. Antihypertensive therapy using calcium channel blockers (CCBs) is one of the preferred choices to treat blood pressure (BP) and control blood pressure variability (BPV). In contrast to clinic BP, 24-hour ambulatory BP monitoring (ABPM) has evolved into an accurate and reproducible tool for the assessment and management of hypertension. Amlodipine, a longer acting dihydropyridine CCB is effective for 24 hours BP control and also minimizing BPV. The present article is the comprehensive review highlighting the efficacy of amlodipine in controlling 24-hour BP and minimizing BPV from the review of recent studies. Materials and Methods The literature search was done using PubMed, Google Scholar, and MEDLINE databases. The studies to be included for review, were identified through the keywords: “amlodipine,” “ambulatory BP monitoring (ABPM),”“blood pressure variability (BPV),” “CCBs,” and filtering articles published in English language only. Results Pharmacological evidence suggests that amlodipine has the ability to block all the subtypes of CCBs such as L-, N-, P-, Q-, R-, and T-type. Various clinical studies reported that amlodipine is a powerful, well-tolerated, and safe antihypertensive agent which is widely used either alone or as a key component of combination therapy for control of 24 hours BP. Conclusion Overall, amlodipine is a proven and effective antihypertensive drug and helpful in controlling 24-hour BP, minimizing BP variability and hence reducing the risk of cardiovascular complications.

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A randomized controlled trial on the blood pressure–lowering effect of amlodipine and nifedipine‐GITS in sustained hypertension

Cited by 12 publications

References 26 publications

Multivariate approach in analyzing medical data with correlated multiple outcomes: An exploration using ACCORD trial data

Multivariate approach in analyzing medical data with correlated multiple outcomes: An exploration using ACCORD trial data

Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan

24-Hour Blood Pressure Control with Amlodipine: A Review of the Current Scenario

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