Olmesartan medoxomil 40mg / Amlodipine 5mg 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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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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BackgroundInsulin autoimmune syndrome (IAS) is a rare immune-mediated hypoglycemic disorder predominantly triggered by pharmacological agents. Despite the established links to thiol-containing drugs, emerging non-thiol triggers and significant geographical reporting biases limit comprehensive risk profiling. This study integrated pharmacovigilance data and published evidence to establish the first systematic epidemiological and pharmacological profile of drug-induced IAS.MethodsWe analysed 228 IAS cases from the FDA AE Reporting System (FAERS; 2004-Q2 2024) and a systematic review of 263 published cases (1980-2024). Multimodal disproportionality analysis-including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN)-identified drug-induced adverse event signals. Associations were stratified into a three-tier evidence framework (Levels 1-3) based on methodological concordance, case counts, and strength of the supporting literature.ResultsFifty-eight agents showed potential IAS associations, including 12 novel pharmacovigilance signals (e.g., bevacizumab, sitagliptin, amlodipine, and olmesartan). Thiol-containing drugs exhibit the strongest signals (PRR > 200; e.g., captopril, methimazole, and clopidogrel). Level 1 evidence (highest confidence) implicated the use of clopidogrel, captopril, omeprazole, and methimazole. IAS was predominantly affected in older patients (median age, 66 years; IQR, 58-77 years), with a male predominance (59.21%), reflecting sex-specific prescription patterns. Geographical disparities persisted, with 85.17% of the cases reported in the literature in Asia. Reports of hypoglycemia exceeded IAS cases for most agents, suggesting an underdiagnosis.ConclusionsThis study established the first evidence-based hierarchy for drug-induced IAS, identifying 58 agents warranting clinical vigilance. Thiol-containing drugs dominate the high-risk profile; however, novel associations (e.g., proton pump inhibitors (PPIs), dipeptidyl peptidase-4 (DPP-4) inhibitors) reveal broader immunological mechanisms. Clinicians should prioritize IAS in older patients with unexplained hypoglycemia exposed to antiplatelet agents or PPIs. Standardized diagnostic criteria and pharmacogenetic profiling (e.g., human leukocyte antigen DRB1 (HLA-DRB1) *04:06) are urgently required to improve detection.

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Cardiovascular conditions disrupt the normal functioning of the heart and blood vessels, often due to underlying conditions like atherosclerosis or hypertension. Antihypertensive medications are essential in cardiovascular disease management, encompassing several major drug classes with distinct mechanisms of action. Hence, this review evaluated the impact of various antihypertensive treatments on cardiovascular event reduction in asymptomatic carotid artery stenosis (CAS) patients. A comprehensive literature search was conducted from inception to 2024 on various databases by using specific keywords, and based on the eligibility criteria, three observational cohort studies and six randomized controlled trials (RCTs) of the 540 records retrieved were incorporated in this systematic review. The Newcastle-Ottawa scale was used to assess the methodological quality of the cohort studies, and the risk of bias visualization tool was used for RCTs. Data were then systematically extracted and analyzed. The results reported that enalapril and fosinopril demonstrated dual benefits in blood pressure (BP) reduction and vascular remodeling, though meta-analysis showed statistically insignificant improvements in regional cerebral blood flow (CI: -0.84, 6.08, P = 0.14, I2= 94%). Similarly, isradipine, lacidipine, and amlodipine improved carotid hemodynamics and cerebral perfusion, with meta-analysis favoring calcium channel blocker intervention for blood pressure management (CI: -3.25 to 7.64, P = 0.43). On the other hand, thiazide diuretics effectively reduced BP but showed limited efficacy in preventing atherosclerosis progression. In addition, angiotensin II receptor blockers (ARBs) significantly reduced 5-year stroke rates from 11% to 3.5%. Moreover, beta-blockers showed specific benefits, with metoprolol improving plaque echogenicity (57.3 ± 16.8 vs. 51.8 ± 20.0, p = 0.006) and reducing cardiovascular events (17% vs. 37% placebo, p = 0.011), while labetalol effectively managed post-endarterectomy hypertension. In conclusion, antihypertensive treatments showed varying effectiveness in cardiovascular event reduction and improvements in vessel measures.

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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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IntroductionA systematic literature review and network meta-analysis was conducted on azilsartan medoxomil (AZL-M) versus other antihypertensive drugs' efficacy in hypertensive patients.MethodsThe search utilized English platforms, from January 2000 until December 2023, resulting in 10,380 articles being screened. Screening criteria included hypertension (mild or moderate); first-line treatment and washout periods; studies (monotherapy) with AZL-M, angiotensin type II receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor neprilysin inhibitor (ARNIs), beta-blockers, calcium channel blockers (CCBs), and diuretics, either as intervention or comparator; and antihypertension efficacy as an outcome measure. Study design was randomized clinical trials. Efficacy variables included absolute office systolic and diastolic blood pressure (BP) reductions. A total of 21 publications provided adequate data for analysis, of which 20 studies reported both systolic and diastolic BP and one study reported only the diastolic BP.ResultsIn 21 studies on systolic BP, against the common comparator placebo, the differences in systolic BP were significantly in favor of AZL-M, amlodipine, candesartan, irbesartan, nebivolol, nifedipine, olmesartan, sacubitril valsartan, telmisartan, and valsartan. The surface under the cumulative ranking curve (SUCRA) ranking shows that AZL-M 80 mg had the highest ranking, with a possibility of 93% being the best in all other included treatments. In 20 studies on diastolic BP, against the common comparator placebo, the differences in diastolic BP were significantly in favor of AZL-M, amlodipine, bisoprolol, nebivolol, olmesartan, sacubitril valsartan, telmisartan, and valsartan. The SUCRA ranking shows that AZL-M 80 mg had the highest ranking, with a possibility of 90% being the best in all other included treatments.ConclusionAZL-M at 40 mg and 80 mg shows favorable efficacy compared to other anti-hypertensives, and the 80 mg dosage seemed to be the most efficacious of all the included treatments in reducing both office systolic and diastolic BP in patients with mild-to-moderate hypertension.

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