Irbesartan 150mg / Hydrochlorothiazide 12.5mg tablets

This study aimed to evaluate the efficacy of single-pill combination (SPC) antihypertensive drugs in patients with uncontrolled essential hypertension. Through Searching Pubmed, EMBASE, the Cochrane Library, and Web of Science collected only randomized controlled trials on the efficacy of single-pill combination antihypertensive drugs in people with uncontrolled essential hypertension. The search period is from the establishment of the database to July 2022. The methodological quality of the included studies was assessed using the Cochrane Risk of Bias Assessment, and statistical analyses were performed using Review Manage 5.3 and Stata 15.1 software. This review ultimately included 32 references involving 16 273 patients with uncontrolled essential hypertension. The results of the network meta-analysis showed that a total of 11 single-pill combination antihypertensive drugs were included, namely: Amlodipine/valsartan, Telmisartan/amlodipine, Losartan/HCTZ, Candesartan/HCTZ, Amlodipine/benazepril, Telmisartan/HCTZ, Valsartan/HCTZ, Irbesartan/amlodipine, Amlodipine/losartan, Irbesartan/HCTZ, and Perindopril/amlodipine. According to SUCRA, Irbesartan/amlodipine may rank first in reducing systolic blood pressure (SUCRA: 92.2%); Amlodipine/losartan may rank first in reducing diastolic blood pressure (SUCRA: 95.1%); Telmisartan/amlodipine may rank first in blood pressure control rates (SUCRA: 83.5%); Amlodipine/losartan probably ranks first in diastolic response rate (SUCRA: 84.5%). Based on Ranking Plot of the Network, we can conclude that single-pill combination antihypertensive drugs are superior to monotherapy, and ARB/CCB combination has better advantages than other SPC in terms of systolic blood pressure, diastolic blood pressure, blood pressure control rate, and diastolic response rate. However, due to the small number of some drug studies, the lack of relevant studies has led to not being included in this study, which may impact the results, and readers should interpret the results with caution.

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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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BackgroundFemale sexual dysfunction (FSD) among females with hypertension (HTN) is frequently overlooked, with a reported prevalence of 42.1%.ObjectivesWe aimed to determine the impact of beta-blockers (BBs), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs), and thiazides on sexual function in hypertensive females.MethodsA prospective randomized controlled trial enrolled 125 female participants. Group (1) included 25 normotensive females serving as the controls. Groups (2) and (3) consisted of 50 controlled and uncontrolled hypertensive patients who received BBs, respectively. Groups (4) and (5) consisted of 50 patients with controlled and uncontrolled HTN who received ACIs/ARBs, respectively. Each group consisted of patients who received one tablet daily of ramipril 2.5 mg for one month, while the other half received one tablet daily of valsartan (VAL) 80 mg for the same duration. After one month, the subjects were transitioned to a daily regimen of one tablet of ramipril 2.5 mg combined with hydrochlorothiazide 12.5 mg, as well as one tablet of VAL 80 mg with hydrochlorothiazide 12.5 mg for two months, respectively.ResultsControlled and uncontrolled hypertensive patients receiving ACEIs/ARBs, as well as controlled hypertensive patients receiving BBs, demonstrated a significant decrease in serum total testosterone and free testosterone levels, accompanied by a significant increase in estradiol after 3 months. Furthermore, controlled and uncontrolled hypertensive patients receiving ACEI/ARBs showed significant increases in all female sexual function (FSF) domains and total FSF scores after 3 months. Consistently, controlled hypertensive patients receiving BBs showed significant improvements across all domains of the validated Arabic version of the female sexual function index (ArFSFI) and the total score, comparable to the ACEI/ARB groups, except for pain. Conversely, uncontrolled hypertensive patients receiving BBs demonstrated significant increases in scores for desire and arousal and orgasm and satisfaction after 3 months. After three months, there was a significant reduction in the GAD-7 scores among all hypertensive patients.ConclusionACEIs/ARBs demonstrated a favorable effect on FSF. Future large-scale cohort studies are warranted to validate these findings as this study was a single center and of small sample size.

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Almost a third of the population of the Republic of Belarus suffers from elevated blood pressure which results in a high risk of cardiovascular disease developing. Despite the availability of numerous antihypertensive drugs, more than 40% of patients receiving antihypertensive therapy do not achieve target blood pressure levels and continue to be at an increased risk of cardiovascular events. A fixed combination drug irbesartan/hydrochlorothiazide, which includes two active ingredients in one dosage form of a tablet, is an anti-hypertensive combination balanced on the basis of clinical and pharmacological properties, which is approved by the Ministry of Health of the Republic of Belarus for use in patients when indicated in case of essential arterial hypertension. This fixed-dose combination is intended for adult patients whose blood pressure is not adequately controlled by irbesartan or hydrochlorothiazide monotherapy. The clinical efficacy and safety of this combination was demonstrated in randomized clinical trials, including patients with a combination of hypertension and type 2 diabetes, metabolic syndrome, and obesity. The use of the fixed-dose combination of irbesartan/hydrochlorothiazide leads to a more rapid decrease in blood pressure compared to irbesartan monotherapy, allows the majority of patients with severe hypertension to achieve the target blood pressure, and increases drug compliance. Thus, the irbesartan/hydrochlorothiazide combinationis a valuable addition to clinicians’ armamentarium for the treatment of hypertension.

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Urinary bladder ulceration and perforation are serious conditions that may develop due to various causes, most commonly trauma or complications from medical procedures. In rare instances, these conditions can occur without an identifiable cause. Bladder perforation can lead to peritonitis, a life-threatening complication with a reported mortality rate approaching 50%, primarily due to systemic inflammatory responses and multi-organ failure. Although spontaneous bladder rupture is uncommon, it has been associated with underlying conditions such as bladder outlet obstruction (BOO), malignancy, and chronic infections, or it may occur without a clearly identifiable cause (idiopathic). Prompt recognition and intervention are essential to improving patient outcomes. We present the case of a 69-year-old woman with a medical history of diabetes mellitus, arterial hypertension, and knee osteoarthritis, for which she was receiving insulin, irbesartan, and hydrochlorothiazide. Additionally, approximately three years prior to her death, she was diagnosed with a urinary bladder neoplasm and underwent transurethral resection of the bladder tumor (TURBT), followed by intravesical therapy. Postmortem examination (PME) revealed evidence of peritonitis. Histopathological examination confirmed the diagnosis of peritonitis, along with bladder ulceration and perforation. The cause of death (COD) was determined to be peritonitis secondary to bladder perforation.

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In this randomized, double-blind, controlled, parallel group study (ZENITH), 434 essential hypertensives with additional cardiovascular risk factors, uncontrolled by a previous monotherapy, were treated for 18 weeks with zofenopril 30 or 60 mg plus hydrochlorothiazide (HCTZ) 12.5 mg or irbesartan 150 or 300 mg plus HCTZ. Rate of office blood pressure (BP) response (zofenopril: 68% versus irbesartan: 70%;p=0.778) and 24-hour BP response (zofenopril: 85% versus irbesartan: 84%;p=0.781) was similar between the two treatment groups. Cardiac and renal damage was equally reduced by both treatments, whereas the rate of carotid plaque regression was significantly larger with zofenopril. In conclusion, uncontrolled monotherapy treated hypertensives effectively respond to a combination of zofenopril or irbesartan plus a thiazide diuretic, in terms of either BP response or target organ damage progression.

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ObjectiveHypertension is a leading global risk factor for disability and death. Irbesartan, a potent angiotensin II receptor blocker, requires continuous safety monitoring. We conducted a disproportionality analysis of irbesartan-related adverse drug events (ADEs) using the FDA's FAERS and Japan's JADER databases.MethodsWe extracted irbesartan-related ADE reports from FAERS (Q1 2004 to Q1 2024) and JADER (Q2 2008 to Q4 2023). We used Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) for signal detection. Sensitivity analyses were conducted to exclude comorbid medications, and subgroup analyses by age and gender were performed to explore ADE occurrence in specific populations. Th time to onset (TTO) of ADEs was assessed using Weibull distribution test and Kaplan-Meier curves.ResultsA total of 5,816 (FAERS) and 366 (JADER) reports were analyzed, with irbesartan-related preferred terms (PTs) involving 27 System Organ Classes (SOCs) in FAERS and 22 in JADER. Three SOCs met detection thresholds in both databases: "metabolism and nutrition disorders," "cardiac disorders," and "renal and urinary disorders." We identified 219 positive signals in FAERS and 20 in JADER, including known signals like hyperkalemia, hypotension, and acute kidney injury. Notably, newly identified signals such as acute pancreatitis (n = 50, ROR: 7.76 [5.88-10.25]) and rhabdomyolysis (n = 50, ROR: 7.76 [5.88-10.25]) in FAERS and respiratory failure (n = 7, ROR: 6.76 [3.20-14.26]) in JADER could have significant clinical implications, as they may lead to severe outcomes if not recognized and managed promptly. Subgroup analyses revealed both similarities and differences in signal detection across gender and age groups. Sensitivity analyses, excluding concomitant medications, confirmed the persistence of key positive signals, including hyperkalemia, angioedema, acute pancreatitis, and agranulocytosis. ADEs mainly occurred within 1 month (34.14%) and after 1 year (32.32%) after dosing, with a median onset of 107 days.ConclusionThis study provides valuable real-world evidence on the safety profile of irbesartan. The identification of new safety signals underscores the necessity of updating drug labels, particularly for assessing and managing high-risk patients. Additionally, the TTO analysis emphasizes the importance of sustained vigilance for adverse events over time. In conclusion, our findings contribute to a more comprehensive understanding of irbesartan's safety, aiding healthcare professionals in optimizing its use in clinical practice.

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BackgroundArterial hypertension is the most common cardiovascular comorbidity in atrial fibrillation (AF). Few studies investigated management strategies of hypertension in AF.Materials and methodsWe included 5769 AF patients on oral anticoagulants from the nationwide ongoing Italian START registry. We investigated the prescription of antihypertensive drugs and mortality risk. Subgroup analyses according to sex and major cardiovascular comorbidities were performed.ResultsMean age was 80.8 years, 46.1% were women; 80.3% of patients were hypertensive. Furosemide (30.1%) was the most frequent diuretic followed by hydrochlorothiazide (15.4%) and potassium canrenoate (7.9%). 61.1% received β-blockers: 34.2% bisoprolol, 6.2% atenolol. Additionally, 36.9% were on angiotensin converting enzyme inhibitors (ACE-I): ramipril (20.9%), enalapril (5.3%) and perindopril (2.8%); 31.7% were on angiotensin receptors blockers (ARBs): valsartan (7.6%) and irbesartan (6.4%). Amlodipine and lercanidipine were prescribed in 14.0% and 2.3%, respectively. ACE-I (p ConclusionA lower mortality risk was found in AF patients on ACE-I/ARBs. Different prescription patterns of antihypertensive drugs between men and women do exist.

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IntroductionHyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.ObjectiveThe main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).MethodA disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).ResultsSix hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.ConclusionThere are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disproportionate reporting, diuretics leads the list, followed by antiepileptics as oxcarbazepine and eslicarbazepine. Safety signals were found for several drugs, more plausibly for pregabalin and paliperidone, thus a possible association between these drugs and hyponatraemia/SIAD is identified. This signal must be further studied. Meanwhile healthcare professionals should pay attention to this possibility. The reporting of suspected ADRs is essential to understand the risks associated with medicines once they are on the market.

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