Long-term effect of the perindopril/indapamide/amlodipine single-pill combination on left ventricular hypertrophy in outpatient hypertensive subjects

Mazza, Alberto; Townsend, Danyelle M.; Schiavon, Laura; Torin, Gioia; Lenti, Salvatore; Rossetti, Ciro; Rigatelli, Gianluca; Rubello, Domenico

doi:10.1016/j.biopha.2019.109539

Cited by 11 publications

(12 citation statements)

References 37 publications

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“…This can translate into clinical benefits resulting from improved patient satisfaction and compliance with FDC therapy, leading to improved glycemic control and an increased likelihood of achieving glycemic targets [19][20][21]. FDCs are increasingly used in clinical practice for a range of chronic disorders that require the use of multiple treatments, such as chronic obstructive pulmonary disease [22], hypertension [23,24], hepatitis C [25,26], and HIV infection [27,28], with the aim of simplifying treatment regimens and improving clinical outcomes. Similarly, in the field of T2D management, the use of FDCs of effective and well-tolerated therapies can offer a useful treatment option to help optimize therapy for individual patients, and several FDC therapies for T2D are available for clinical use [29].…”

Section: Introductionmentioning

confidence: 99%

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Lingvay

Beetz

Sennewald

et al. 2020

Postgraduate Medicine

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Objectives: Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations. Methods: Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (C max) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and C max for each component within 80.00-125.00%. Results: Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported. Conclusion: The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D. PLAIN LANGUAGE SUMMARY: Study supports the convenience of empagliflozin, linagliptin, and metformin XR in 1 tablet as new treatment for type 2 diabetes What is the purpose of this summary? • This summary is to help you understand findings from recent research. • This summary is about 2 studies that are part of a larger group of studies with these medications. Researchers look at many studies to understand whether a medication works, how it works, and whether it is safe to prescribe to patients. What is known? • People with type 2 diabetes often need several medicines to control their blood sugar. • Some people find it difficult to take a lot of different tablets, and some people may not want to. This can lead to difficulties with managing type 2 diabetes. • Combining medicines into 1 tablet may help make it easier to take the treatment and to manage type 2 diabetes, wh...

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Section: Introductionmentioning

confidence: 99%

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Lingvay

Beetz

Sennewald

et al. 2020

Postgraduate Medicine

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“…Furthermore, BP variability was significantly lower with the SPC than with the free combination [ 42 ]. At 14 months, 77.1% and 72.4% of patients in the SPC and free combination arms achieved target office BP [ 48 ].…”

Section: What Is the Efficacy Of Per/ind/aml In Clinical Studies?mentioning

confidence: 99%

“…Patients with left ventricular hypertrophy at baseline who did not achieve a reduction in LVMI during antihypertensive therapy are at an increased risk for cardiovascular events [ 4 , 48 ]. PER/IND/AML reduced LVMI in patients with hypertension [ 37 , 40 , 48 ]. In a randomized trial (Sect.…”

Section: What Are the Other Benefits Of Per/ind/aml?mentioning

confidence: 99%

Perindopril/Indapamide/Amlodipine in Hypertension: A Profile of Its Use

Syed

2022

Am J Cardiovasc Drugs

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The single-pill combination (SPC) of perindopril (PER)/indapamide (IND)/amlodipine (AML) is a valuable and convenient treatment option for patients with hypertension controlled with two-drug SPC of PER/IND + AML given as two separate pills at the same dose level. PER [an angiotensin-converting enzyme (ACE) inhibitor], IND (a thiazide-like diuretic) and AML (a calcium channel blocker) are well established antihypertensive agents, which have been available for a long time as monotherapies and dual SPCs and have complementary mechanisms of action. Once-daily PER/IND/AML provided effective BP control, with good tolerability, in patients with uncontrolled hypertension in clinical trials and in large observational prospective studies. The efficacy and tolerability of PER/IND/AML was similar to that of PER/IND + AML in a randomized clinical trial. The therapeutic effect of PER/IND/AML was associated with improved health-related quality of life. Thus, switching from the two-pill PER/IND + AML regimen to single-pill PER/IND/AML reduces pill burden and simplifies drug administration, which may improve adherence to treatment, leading to better BP control and clinical outcomes. Supplementary Information The online version contains supplementary material available at 10.1007/s40256-022-00521-0.

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“…In this context, only three studies have investigated this aspect using ABPM [46][47][48]. At the same time, only few studies with small samples focused on patients taking a triple antihypertensive therapy using ABPM, but they found favorable effects of a triple fixed-dose combination versus triple free combination therapies in terms of both ambulatory BP parameters and cardiac organ damage [49,50].…”

Section: Discussionmentioning

confidence: 99%

The Number of Pills, Rather Than the Type of Renin–Angiotensin System Inhibitor, Predicts Ambulatory Blood Pressure Control in Essential Hypertensives on Triple Therapy: A Real-Life Cross-Sectional Study

et al. 2021

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Introduction: We evaluated the prevalence and predictors of ambulatory blood pressure (BP) control in patients taking a triple antihypertensive therapy (renin-angiotensin system inhibitor ? calcium channel blocker ? thiazide/thiazide-like diuretic, in either free or fixed-dose combinations) containing an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB). Methods: We performed an observational cross-sectional study on 520 consecutive patients with essential hypertension taking a stable triple therapy in whom 24-h ambulatory BP was evaluated. Both number of pills and antihypertensive treatment intensity (ATI), as possible pharmacological predictors of ambulatory BP control, were taken into account. Results: A total of 189 (36.3%) patients were taking triple therapy with ACEi and 331 (63.7%) patients were taking triple therapy with ARB. Mean age was 62.7 ± 12.2 years. Patients on triple therapy with ACEi had a significantly lower ATI and took fewer antihypertensive pills than patients on triple therapy with ARB (22.2% of patients took a single-pill triple fixed-dose combination). Patients taking triple therapy with ACEi had higher prevalence of both 24-h (54.8% vs 44.0%; p = 0.019) and daytime BP control (61.8% vs 49.2%; p = 0.006) than patients taking triple therapy with ARB, even after adjusting for age, sex, body mass index, smoking habit, type 2 diabetes mellitus, estimated glomerular filtration rate, and ATI [OR 1.5 (95% CI 1.1-2.2) and OR 1.6 (95% CI 1.1-2.4), respectively]. However, these independent associations with ambulatory BP control were lost when the number of antihypertensive pills was included in the model. Conclusion:The higher prevalence of ambulatory BP control found in patients taking a triple therapy with ACEi was affected by the lower number of antihypertensive pills taken, which was also the key predictor of ambulatory BP control in our study. This confirms the importance of fixed-dose combinations in the management of essential hypertension.

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Long-term effect of the perindopril/indapamide/amlodipine single-pill combination on left ventricular hypertrophy in outpatient hypertensive subjects

Cited by 11 publications

References 37 publications

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Perindopril/Indapamide/Amlodipine in Hypertension: A Profile of Its Use

The Number of Pills, Rather Than the Type of Renin–Angiotensin System Inhibitor, Predicts Ambulatory Blood Pressure Control in Essential Hypertensives on Triple Therapy: A Real-Life Cross-Sectional Study

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