Amlodipine 5mg / Valsartan 160mg tablets

Background: Amlodipine has recently been incidentally reported with angioedema and is frequently prescribed with renin-angiotensin-aldosterone system inhibitors (RAAS-i) for hypertension management. While RAAS-i drugs are known to cause angioedema, the risk associated with amlodipine alone or in combination with RAAS-i drugs remains unclear. This study aimed to evaluate the association between amlodipine use and angioedema using pharmacovigilance data. Methods: We analyzed adverse event reports from the US FDA Adverse Event Reporting System using both frequentist and Bayesian approaches. Drug-drug interactions were assessed using multiplicative models. Additionally, we conducted a systematic review of published case reports of amlodipine-associated angioedema. Results: Among 29,661,136 reports, 2076 cases of angioedema were identified (1067 with amlodipine alone, 1009 with amlodipine-RAAS-i combinations). Significant safety signals were detected for amlodipine alone and in combination with aliskiren, specific ACE inhibitors (quinapril, benazepril, trandolapril, fosinopril, perindopril), and certain ARBs (candesartan, losartan). No significant interactions were observed between amlodipine and RAAS-i drugs except for the amlodipine-trandolapril combination. A review of published cases demonstrated definite causality in two cases and possible association in others, with most patients presenting with oropharyngeal/facial edema and achieving complete recovery following drug discontinuation and standard therapy. Conclusions: Our findings suggest a potentially increased risk of angioedema with amlodipine, both as monotherapy and in specific RAAS-i combinations. While these results should not discourage appropriate clinical use, they emphasize the importance of monitoring for angioedema, particularly during therapy initiation. The findings from this study need to be validated in prospective studies for further elucidation of the underlying mechanisms.

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ObjectiveTo systematically evaluate the relative efficacy and impact on cardiac function of sacubitril/valsartan (Sac/Val) vs. active antihypertensive comparators represented in the eligible evidence base for reversing left ventricular hypertrophy (LVH) in patients with hypertension using network meta-analysis.MethodsPubMed, Embase, The Cochrane Library, CNKI, Wanfang Data, and SinoMed databases were searched from inception to December 2025 for randomized controlled trials (RCTs) evaluating sacubitril/valsartan vs. active antihypertensive comparators in patients with essential hypertension and cardiovascular remodeling. The primary outcome was the change in left ventricular mass index (LVMI). Network meta-analysis was performed using STATA 18.0 software based on the frequentist framework. Given the clinical heterogeneity in imaging assessment modalities, a random-effects model was employed to calculate the weighted mean difference (MD) and 95% confidence intervals (CI). The surface under the cumulative ranking curve (SUCRA) was used as a supportive ranking metric, whereas comparative interpretation primarily relied on effect estimates and their confidence intervals.ResultsEleven RCTs involving 851 patients were included. The network meta-analysis showed that Sac/Val achieved greater LVMI regression than Amlodipine (MD = -22.54 g/m2, 95% CI: -40.23, -4.86) and Valsartan (MD = -11.34 g/m2, 95% CI: -21.45, -1.23) in reversing LVMI. Compared with Enalapril and Olmesartan, Sac/Val also showed numerically greater LVMI regression, but these differences were not statistically significant. Sac/Val had the highest SUCRA value (96.4%); however, rankings were interpreted descriptively only, while comparative interpretation was primarily based on effect sizes and confidence intervals. Secondary outcome analysis indicated that while Sac/Val effectively reduced systolic and diastolic blood pressure, it had no significant impact on left ventricular ejection fraction (LVEF) (P > 0.05).ConclusionIn hypertensive patients with cardiovascular remodeling, sacubitril/valsartan was associated with greater LVMI regression than amlodipine and valsartan within the current network, whereas comparisons with enalapril and olmesartan remained inconclusive. Given the substantial heterogeneity, evidence of network incoherence, and low-to-very-low certainty of the main comparisons, these results should be regarded as tentative rather than definitive.Systematic review registrationPROSPERO CRD420261281426.

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BackgroundSome clinical guidelines recommend initiating combination antihypertensive therapy as first-line treatment rather than monotherapy. Evidence indicates that a substantial proportion of patients with hypertension require more than one antihypertensive agent to achieve recommended blood pressure targets. However, it remains unclear whether the benefits of initiating combination therapy outweigh the potential risks compared with antihypertensive monotherapy.ObjectiveThis systematic review and meta-analysis was conducted to assess the efficacy of blood pressure control and the risk of drug-related adverse events associated with amlodipine monotherapy compared against first-line combination therapy of amlodipine and an angiotensin receptor blocker (ARB) in patients with primary hypertension.MethodsA systematic literature search was conducted in PubMed, PubMed Central, and the Cochrane Library up to 15 November 2025, using the following search terms: "amlodipine" AND "angiotensin receptor blocker" AND "primary hypertension" AND "randomized controlled trial." Only randomized controlled trials comparing amlodipine monotherapy with first-line combination therapy of amlodipine and an ARB, administered for at least 8 weeks, were included. The primary outcomes were blood pressure control and drug-related adverse events. Meta-analysis was performed using Review Manager (RevMan), version 5.4.ResultsBased on six included studies, the analytical results showed that combination therapy with Calcium Channel Blocker (CCB) and an ARB was associated with 2.25 (odds ratio = 2.25: 95% CI: 1.78-2.83) times odds ratio with statistically significant overall effect (P P = 0.24) compared with CCB (amlodipine 5 mg) monotherapy.ConclusionsThe results of this study indicate that combination therapy with CCB and an ARB is associated with a 2.25-fold higher likelihood of achieving blood pressure control, with a significant correlation, and a lower risk of drug-related adverse events, without a significant correlation, compared with CCB monotherapy.

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ObjectiveThis study aimed to compare and rank antihypertensive agents based on their urate-lowering effects in patients with hypertension and hyperuricemia.MethodsWe systematically searched PubMed, Embase, the Cochrane Library, the Chinese National Knowledge Infrastructure, and the Wanfang databases for eligible trials published up to September 2023. Randomized controlled trials that directly compared different antihypertensive agents in hypertensive patients with hyperuricemia were included. Pairwise and network meta-analyses were conducted using odds ratios and weighted mean differences with 95% confidence intervals. The surface under the cumulative ranking area (SUCRA) was used to rank the efficacy of the antihypertensive treatments.ResultsA total of 172 trials involving 16,226 hypertensive patients with hyperuricemia were included in the final analysis. According to SUCRA values, losartan plus amlodipine (SUCRA: 96%), valsartan plus amlodipine (SUCRA: 90%), and allisartan (SUCRA: 90%) showed relatively superior effects in reducing serum uric acid levels. Additionally, irbesartan plus amlodipine (SUCRA: 94%), losartan plus amlodipine (SUCRA: 92%), and losartan (SUCRA: 84%) were associated with higher effective rates.ConclusionBased on the only available eligible evidence, the combination of losartan and amlodipine was the optimal dual therapy for Chinese patients with hypertension and hyperuricemia, while allisartan and losartan were the most effective monotherapies for lowering serum uric acid. These findings are not generalizable to non-Chinese populations, reflecting a gap in global evidence rather than intentional study scope restriction.

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BackgroundHypertension (HTN) and dyslipidemia are major risk factors for cardiovascular diseases. Recently, researchers have investigated the potential benefits of combining multiple medications in one bill to improve their metabolic and cardiovascular efficacy.ObjectivesWe investigated a treatment approach that combines two antihypertensive medications with one statin. We aim to assess the safety and effectiveness of a triple therapy regimen consisting of angiotensin receptor blockers (ARBs) combined with amlodipine/rosuvastatin. We compared this triple therapy to dual therapy involving either ARBs/amlodipine or ARBs/rosuvastatin in patients with HTN and dyslipidemia.MethodsWe conducted systematic search in the following databases: Medline, Web of Science, Scopus, and Cochrane Library until August 2024. The main outcomes assessed were the variations in mean systolic blood pressure (mSBP), mean diastolic blood pressure (mDBP), and the percentage changes in LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C) following an eight-week treatment period.ResultsOur analysis included seven randomized controlled trials (RCTs) which enrolled 1074 patients. Triple therapy revealed a significant reduction in mSBP (mean difference (MD): -4.06, 95% C.I. [-7.97: -0.15], p-value = 0.04), mDBP (MD: -5.45, 95% C.I. [-7.96: -2.93], p-value = ConclusionTriple therapy has greater effectiveness in decreasing blood pressure in hypertensive patients with dyslipidemia compared to treatments involving ARBs combined with amlodipine or ARBs with rosuvastatin. Additionally, Triple therapy significantly improved lipid profiles compared to the ARB/amlodipine group. Our study lays the groundwork for developing a single-pill, triple-combination therapy. Further RCTs are necessary to confirm our findings.

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ObjectivesThis study investigated the safety of azilsartan and amlodipine combination therapy versus other angiotensin receptor blockers (ARBs) and amlodipine in patients with hypertension.MethodsWe conducted a cohort study utilizing healthcare databases from Korea and Taiwan. Patients aged between 18 years and 75 years who were newly prescribed both an ARB and amlodipine within 6 months of hypertension diagnosis were included. Safety outcomes assessed were hypotension, angioedema, acute pancreatitis, hyperkalemia, hypokalemia, toxic liver disease, hepatic failure, nausea and vomiting, and fall-related injury. Hazard ratios (HRs) with 95% confidence intervals (CIs) for each safety outcome associated with azilsartan medoxomil and amlodipine versus other ARBs combined with amlodipine were calculated within a 1:1 propensity score (PS)-matched cohort. Summary HRs across databases were computed using random-effects meta-analysis.ResultsWe identified 2,472 eligible patients (1,521 from Korea, 951 from Taiwan) initiating treatment with azilsartan medoxomil and amlodipine, and 671,468 patients (312,322 from Korea, 355,409 from Taiwan) initiating other ARBs with amlodipine. After PS matching, baseline characteristics were well-balanced between treatment groups. During the 180-day follow-up, most adverse outcomes did not occur even once in either group, thus precluding the calculation of HRs. The risk of acute pancreatitis was not significantly different between the azilsartan medoxomil and amlodipine group and the other ARB and amlodipine groups (summary HR, 0.86; 95% CI, 0.14 to 5.37).ConclusionsIn this population-based cohort study, azilsartan medoxomil combined with amlodipine was not associated with an increased risk of adverse outcomes compared to other ARBs combined with amlodipine.

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BackgroundCombination therapy is often required for treating hypertension,but the comparative efficacy and safety of triple versus dual antihypertensive regimens remain to be clarified by the latest evidence-based medical data. This meta-analysis aims to compare the efficacy and safety of dual versus triple antihypertensive drug therapy for adult primary hypertension, providing updated evidence to support clinical decision-making.MethodsA systematic search was conducted across four databases-PubMed, Embase, Cochrane, and Web of Science-up to July 2025 to identify randomized controlled trials comparing dual antihypertensive therapy with triple antihypertensive therapy for treating adult primary hypertension. The primary outcome was mean seated blood pressure; secondary outcomes included blood pressure control rates and adverse events. Screening, data extraction, and quality assessment were performed by two independent researchers.The Cochrane Risk of Bias Assessment Tool was used to evaluate study quality; data analysis was conducted using Stata 15.1 software.ResultsA total of 21 studies involving 17,669 patients were ultimately included. Of these, 6,918 patients received triple therapy and 10,751 patients received dual therapy. Triple therapy reduced systolic blood pressure [WMD: -5.98 mmHg, (95% CI: -7.04, -4.92)] and diastolic blood pressure [WMD: -3.34 mmHg, (95% CI: -4.03, -2.65)]. In the ARB subgroup, valsartan-based triple therapy demonstrated significant blood pressure-lowering effects on systolic blood pressure [WMD = -7.41 mmHg, (95% CI: -8.91 to -5.91)] and diastolic blood pressure [WMD = -4.57 mmHg, (95% CI: -5.65 to -3.49)]. An evaluation of 14 adverse reaction symptoms revealed that triple therapy improved patient fatigue [RR: 0.80, (95% CI: 0.67, 0.96)]. Triple therapy increased the rate of blood pressure control [RR: 1.31, (95% CI: 1.23, 1.39)].ConclusionCompared with the dual-drug regimen, the triple-drug antihypertensive regimen may be more effective for short-term blood pressure control, and its overall safety profile is acceptable. However, the subgroup analyses in this study represent exploratory findings only and cannot be directly used to guide clinical drug selection. Given that, although the evidence for the primary efficacy outcome is of moderate certainty, significant heterogeneity remains, the results should be interpreted with caution.

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