Doxazosin 3mg/5ml oral solution

PurposeAlpha-blockers and 5-alpha reductase inhibitors (5ARIs) are well-established treatments for symptoms of benign prostatic hyperplasia (BPH). Despite their therapeutic benefits, concerns have been raised regarding a potential association between these medications and an increased risk of dementia. However, current evidence remains inconsistent, highlighting the need for further evaluation. This study aims to assess the potential dementia risk among patients receiving alpha-blockers and 5ARIs.MethodsFollowing PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines (PROSPERO CRD42025643431), 7 databases were systematically searched through December 2024 for studies examining the association between alpha-blockers or 5ARIs and dementia risk in patients with BPH. Risk of bias was assessed using the ROBINS-I (Risk of Bias in Non-randomized Studies of Interventions) tool. A Bayesian network meta-analysis was performed to estimate risk ratios with 95% credible intervals and to generate surface under the cumulative ranking curve (SUCRA) values.ResultsFive multicenter studies involving 3,650,434 patients (mean age, 71.1 years) and demonstrating an overall low risk of bias were included. The network analysis indicated that neither alpha-blockers nor 5ARIs were significantly associated with an increased risk of dementia compared with no treatment. However, SUCRA values suggested a relatively higher probability of dementia risk for 5ARIs (finasteride and dutasteride), followed by tamsulosin, doxazosin, terazosin, and alfuzosin.ConclusionThis study found no significant association between the use of alpha-blockers or 5ARIs and increased dementia risk. These findings may assist clinicians in making more informed prescribing decisions, particularly for older male patients with BPH. Further large-scale research with extended follow-up periods is needed to strengthen the evidence across all BPH medications.

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Background: Doxazosin, an α1-adrenergic antagonist, is commonly used in the management of hypertension and benign prostatic hyperplasia (BPH). Pharmacokinetic (PK) variability across populations may affect drug exposure and clinical response. This systematic review and meta-analysis aimed to summarize PK differences and generate pooled estimates of key parameters, including area under the curve (AUC) and maximum plasma concentration (Cmax). Methods: A systematic search of Google Scholar, PubMed, ScienceDirect, and the Cochrane Library identified 25 eligible studies reporting doxazosin PK data. All extracted AUC and Cmax values were dose-normalized prior to synthesis to ensure comparability across different doses and formulations. A random-effects meta-analysis was performed using the metafor package in R to estimate pooled dose-normalized AUC and Cmax while accounting for between-study variability. Heterogeneity was assessed using the I2 statistic. Sensitivity analyses-including leave-one-out diagnostics and Baujat plots-were used to identify influential studies. Publication bias and small-study effects were evaluated through funnel plots, trim-and-fill procedures, and Egger's regression test. Meta-regression analyses examined the influence of age and body weight on PK parameters. Results: The meta-analysis produced pooled dose-normalized estimates for AUC and Cmax, with high heterogeneity across studies (I2 ≈ 90%). Leave-one-out analyses demonstrated stable pooled estimates; for dose-normalized AUC, exclusion of three influential studies reduced heterogeneity to 82% with only a modest decrease in the pooled mean. Baujat plots identified a small number of studies as key contributors to heterogeneity, while most exerted minimal influence. Funnel plots showed notable asymmetry for both AUC and Cmax, and trim-and-fill analyses suggested possible small-study effects; however, adjusted pooled estimates remained consistent. Egger's regression confirmed significant asymmetry for dose-normalized AUC (t = 4.41, p = 0.0003) and Cmax (t = 4.35, p = 0.0001). Meta-regression revealed that body weight significantly reduced Cmax, whereas age had no significant effect on either AUC or Cmax. Conclusions: This systematic review and meta-analysis provide a comprehensive evaluation of doxazosin PK across diverse populations. Despite normalization, substantial variability remained in AUC and Cmax, related in part to ethnicity, hepatic impairment, dosage formulation, and body weight. While pooled estimates offer valuable summary reference points, the high heterogeneity and evidence of small-study effects highlight the need for more standardized PK trials and patient-level analyses to better support individualized dosing strategies.

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Doxazosin, a selective α1-receptor antagonist, is widely used to treat lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). However, its cardiovascular effects remain clinically relevant, particularly in older patients. This systematic review and meta-analysis evaluated blood pressure, heart rate, headache and vertigo during doxazosin treatment. PubMed/MEDLINE, the Cochrane Library, CNKI, Wanfang Data, Google Scholar and ScienceDirect were searched using Chinese and English terms related to doxazosin, BPH, prostate and cardiovascular outcomes. Sixteen evidence reports were included: 12 primary studies, 2 pooled analyses and 2 secondary review sources that supplied aggregate trial data. The pooled analyses showed no statistically significant difference in systolic blood pressure (MD 1.44, 95% CI -4.17 to 7.06; p=0.61), diastolic blood pressure (MD -0.33, 95% CI -3.68 to 3.03; p=0.85), headache (OR 0.99, 95% CI 0.73-1.34; p=0.95) or heart rate (MD 0.98, 95% CI -0.89 to 2.84; p=0.30). Vertigo was more frequent with doxazosin than with control treatment (OR 1.93, 95% CI 1.50-2.49; p<0.00001). Risk-of-bias assessment identified 2 reports at low risk, 10 with some concerns, 1 at high risk, 1 observational study of moderate quality, and 2 secondary reviews for which Cochrane Risk of Bias 2 and the Newcastle-Ottawa Scale were not applicable. Doxazosin was not associated with statistically significant average changes in blood pressure or heart rate, but the increased occurrence of vertigo warrants counselling and monitoring, particularly in older patients at risk of falls.

Abstract licence: CC BY-NC-ND

PURPOSE: Doxazosin and tamsulosin are the most frequently used α1-blockers for the treatment of male lower urinary tract symptoms. Clinical practice guidelines state that all α1-blockers have a similar clinical efficacy but differ in tolerability when used in appropriate doses. We compared the efficacy and tolerability of different doses/formulations of doxazosin (immediate release 2, 4 or 8mg; gastrointestinal therapeutic system [GITS] 4 or 8mg) versus tamsulosin (modified release 0.2, 0.4 or 0.8mg; oral controlled absorption system [OCAS] 0.4mg). METHODS: PubMed, EMBASE and Cochrane databases were systematically searched until December 2024 to identify RCTs with doxazosin and/or tamsulosin. Bayesian random-effects models estimated efficacy and tolerability outcomes, including all International Prostate Symptom Score (IPSS) variations, QoL, overall adverse events (AE) and discontinuation. Tests for heterogeneity, similarity, and consistency ensured robust estimates. RESULTS: In total, 1,866 abstracts were identified, of which we included 40 publications with 12,201 participants. Doxazosin GITS 4mg had the largest mean (95% credible interval) improvement from baseline in total IPSS (-10.07 [-11.96, -8.25]), IPSS-QoL (-1.82 [-2.07, -1.60]) and IPSS storage-subscore (-4.26 [-4.29, -3.40]), and was statistically superior compared to most tamsulosin doses. No significant differences between different doses or formulations for the two drugs were seen for the IPSS voiding-subscore, maximum urine flow or post-void residuals. Only doxazosin GITS 4mg had significantly lower odds of discontinuation due to AE compared to tamsulosin OCAS 0.4mg. CONCLUSIONS: This network meta-analysis found a statistically significantly greater clinical efficacy (IPSS-T, IPSS-S, QoL improvement) for doxazosin GITS 4mg versus most tamsulosin formulations and a similar overall tolerability profile.

Abstract licence: CC BY-NC-ND