Perindopril erbumine 4mg / Indapamide 1.25mg tablets

Background: Uncontrolled blood pressure is a major risk factor for cardiovascular diseases. Fixed-dose combination (FDC) therapy offers a promising approach to addressing this challenge by providing a convenient single-tablet solution that enhances the effectiveness of blood pressure control. In our systematic review, we assess the effectiveness of perindopril/amlodipine FDC in managing blood pressure. Methods: We conducted a comprehensive search across four primary electronic databases, namely, PubMed, Virtual Health Library (VHL), Global Health Library (GHL), and Google Scholar, as of 8 February 2022. Additionally, we performed a manual search to find relevant articles. The quality of the selected articles was evaluated using the Study Quality Assessment Tools (SQAT) checklist from the National Institute of Health and the ROB2 tool from Cochrane. Results: Our systematic review included 17 eligible articles. The findings show that the use of perindopril/amlodipine FDC significantly lowers blood pressure and enhances the quality of blood pressure control. Compared to the comparison group, the perindopril/amlodipine combination tablet resulted in a higher rate of blood pressure response and normalization. Importantly, perindopril/amlodipine FDC contributes to improved patient adherence with minimal side effects. However, studies conducted to date have not provided assessments of the cost-effectiveness of perindopril/amlodipine FDC. Conclusion: In summary, our analysis confirms the effectiveness of perindopril/amlodipine FDC in lowering blood pressure, with combination therapy outperforming monotherapy and placebo. Although mild adverse reactions were observed in a small subset of participants, cost-effectiveness assessments for this treatment remain lacking in the literature.

Abstract licence: CC BY

Abstract Background Perindopril erbumine is a specific inhibitor of angiotensin-converting enzyme, indapamide is the one providing thiazide diuretic effect, and amlodipine besylate is a calcium antagonist which belongs to the dihydropyridines which helps to maintain the pressure of the blood in the patient having arterial hypertension. The literature survey discloses that only one method is available for the estimation of the combination in the quantitative analytical liquid chromatographic method. Moreover to this, the literature review also reveals that HPTLC, UV spectroscopy, and HPLC methods are available for the analysis of either of the two in combination. Hence, our area of interest is to develop and validate the RP-HPLC in order to quantify perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and formulation. Result Sensitive and accurate RP-HPLC method was developed for the simultaneous estimation of indapamide, perindopril erbumine, and amlodipine besylate in bulk and available as triplixam-marketed tablet dosage form which is a combination of these drugs. The Phenomenex C-18 column (250 mm × 4.6 mm, 5 μm) was used as a stationary phase, and acetonitrile: methanol: water (30:20:50, v/v/v) was found to be optimized mobile phase which was further adjusted to pH 3.0 by utilizing 1.0% orthophosphoric acid; the flow rate kept was 1 ml/min and experiments were performed using PDA detector. The common detection wavelength for all the three APIs was found to be 215.0 nm. The method was validated as per ICH Q2 (R1). The linearity range for amlodipine besylate was found to be 0.500–9.500 μg/ml; for perindopril erbumine was found to be 0.400–7.600 μg/ml, and for indapamide was found to be 0.125–2.375 μg/ml. The correlation coefficient was found to be more than 0.9975 for all three of them, whereas the mean percentage recovery was found to be 99.52–100.71%, 99.49–100.89%, and 99.90–100.78%, respectively. Conclusion The proposed RP-HPLC method is found to be accurate and robust enough to estimate the perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and available tablet dosage form of combination.

Abstract licence: CC BY

A sensitive, accurate, robust, and precise analytical quality by design (AQbD)-based RP-HPLC (reverse-phase high-performance liquid chromatography) method has been developed for the simultaneous estimation of perindopril erbumine and moxonidine hydrochloride, both used in hypertension treatment. Initially, a three-level factorial design screened various parameters impacting chromatographic responses, followed by Central Composite Design (CCD) for optimizing the critical parameters. This cost-effective isocratic method employed a Shimpack ODS C-18 column (250 mm × 4.6 mm, 5 μm) as the stationary phase. The method, developed and validated in line with ICH Q2 (R1) guidelines, utilized a mobile phase comprising methanol: acetonitrile: phosphate buffer (34:30:36 v/v/v) adjusted to pH 3.5 with 1% ortho phosphoric acid, at a flow rate of 1.0 mL/min, a column temperature of 40 ºC, and UV detection at 214 nm, achieving efficient separation of both drugs. Linearity ranges were 25–125 μg/mL for perindopril erbumine (r2 = 0.9996) and 1–5 μg/mL for moxonidine hydrochloride (r2 = 0.9993). This newly developed RP-HPLC method effectively enables routine quantitative and simultaneous qualitative analysis of these compounds in bulk and synthetic mixtures. Additionally, the method’s greenness and environmental safety were evaluated using eco-analytical metrics (eco analytical scale, NEMI, GAPI, and AGREE), confirming its ecological capability.

Abstract licence: CC BY-NC-ND

Single-pill combination therapy for hypertension is recognized to improve adherence to treatment. However, less is known about the benefits of triple single-pill combinations. This retrospective observational analysis aimed to assess changes in adherence when treatment was switched from perindopril (PER)/indapamide (IND) + amlodipine (AML) to PER/IND/AML single-pill combination, in Italian clinical practice. This analysis used data extracted from administrative databases of Italian healthcare entities. Adult patients receiving PER/IND/AML were selected, and the prescription date was considered as the index date. Among them, those who had a prescription for PER/IND + AML during the 12 months before the index date and a prescription of PER/IND/AML during 6 months of follow-up were included. Adherence was calculated as the proportion of days covered (PDC: PDC < 40%, non-adherent; PDC = 40–79%, partially adherent; PDC ≥ 80%, adherent). Among the identified patients, 158 were exposed users and were included in the analysis. When patients were compared before and after switch to triple single-pill combination, the proportion of adherent patients was significantly higher with PER/IND/AML single-pill combination (75.3%) than with PER/IND + AML combination (44.3%) (P < 0.05). Conversely, the proportion of non-adherent patients was lower with the PER/IND/AML single-pill combination (14.6%) vs PER/IND + AML (17.7%) (P < 0.001). This real-world analysis showed that switching to a triple single-pill combination could offer an opportunity to improve adherence to antihypertensive treatment in real-life clinical practice. Medication adherence is defined by the World Health Organization as the “extent to which a person’s behavior (in taking medication) corresponds with agreed recommendations from a healthcare provider”. Low levels of medication adherence in hypertension have been linked with increased disease burden and with higher costs for patients. Patients with hypertension whose blood pressure is poorly controlled often need to receive more than one pill. Nevertheless, having to take many pills may result in poor adherence, i.e., patients not taking their treatment as prescribed. Combining multiple drugs into a single pill for the management of hypertension is known to improve adherence; however, limited evidence exists about the benefits of triple single-pill combinations compared with equivalent free combinations in real clinical practice. This analysis evaluated changes in adherence before and after patients switched from a three-drug therapy of perindopril/indapamide single-pill + amlodipine (PER/IND + AML) to perindopril/indapamide/amlodipine (PER/IND/AML) taken as a single pill. In this analysis, real-world data from Italian administrative databases covering around 11% of the Italian population were used. Overall, 158 patients were included. More patients were found to be adherent after switch to PER/IND/AML single pill (75.3% vs 44.3% of PER/IND + AML combination). Partially adherent and poorly adherent patients were fewer with PER/IND/AML single-pill combination (10.1% and 14.6%, respectively) compared to PER/IND + AML combination (38.0% and 17.7%, respectively). These findings indicate that switching to a simplified therapy in which all three drugs are taken in one pill may offer an opportunity for increasing the number of patients that are adherent to their medication.

Abstract licence: CC BY-NC

OBJECTIVES: This analysis compared adherence, cardiovascular (CV) events and all-cause mortality incidence, and healthcare costs among hypertensive patients treated with perindopril (PER)/indapamide (IND)/amlodipine (AML) in single-pill combination (SPC) vs. multiple-pill combination, in a real-world setting in Italy. METHODS: In this observational retrospective analysis of Italian administrative databases, adult patients treated with PER/IND/AML between 2010 and 2020 were divided into two cohorts: single-pill vs. multiple-pill. Patient data were available for at least one year before and after index date. Propensity score matching (PSM) was applied to reduce selection bias. Adherence was defined as proportion of days covered: non-adherence, <40%; partial adherence, 40-79%, and adherence ≥80%. Mortality incidence and CV events as single, or composite, endpoints were evaluated after first year of follow-up. Healthcare cost analyses were performed from the perspective of the Italian National Health Service. RESULTS: Following PSM, the single-pill cohort included 12 150 patients, and the multiple-pill cohort, 6105. The SPC cohort had a significantly higher percentage of adherent patients vs. the multiple-pill cohort (59.9% vs. 26.9%, P < 0.001). Following the first year of follow-up, incidence of all-cause mortality, and combined endpoint of all-cause mortality and CV events were lower in the SPC cohort compared with multiple-pill cohort. Average annual direct healthcare costs were lower in the single-pill cohort (€2970) vs. multiple-pill cohort (€3642); cost of all drugs and all-cause hospitalizations were major contributors. CONCLUSION: The SPC of PER/IND/AML, compared with multiple-pill combination, is associated with higher adherence to medication, lower incidence of CV events and mortality, and reduced healthcare costs.

Abstract licence: CC BY-NC-ND

Abstract Simple, diverse univariate spectrophotometric methods were developed and validated for the determination of amlodipine besylate (AM), perindopril arginine (PE), and indapamide (ID). The first method involved direct measurement of AM absorbance at 365 nm within a concentration range of 2.00–40.00 µg/mL, where PE and ID exhibited no spectral interference. To eliminate the contribution of AM from the ternary mixture, its spectrum was divided by a reference spectrum of AM (12 µg/mL), followed by mathematical subtraction of the resulting constant. The spectrum was then multiplied by the AM divisor to yield a corrected spectrum of the PE and ID binary mixture, allowing their quantification. Various approaches were used to quantify both drugs, including measurement of their second (2DD) and first derivative (1DD) spectra at 231.30 nm and 251.00 nm, respectively. Additionally, the ratio difference (RD) technique and dual wavelength (DW) method were employed. The concentration ranges for PE and ID were 5.00–100.00 µg/mL and 1.00–20.00 µg/mL, respectively. Among these methods, the DW technique was the simplest, so it was chosen for dissolution monitoring of PE and ID. These methods were successfully applied to determine AM, PE, and ID in bulk powder, as well as in Triplixam ® tablets, without interference from excipients and in different used dissolution media. The whiteness of the method was evaluated, demonstrating its excellent environmental, analytical and practical efficiency.

Abstract licence: CC BY