Comparative efficacy and safety of alpha-blockers as monotherapy for benign prostatic hyperplasia: a systematic review and network meta-analysis.

Despite the availability of various drugs for benign prostatic hyperplasia (BPH), alpha(α)-blockers are the preferred first-line treatment. However, there remains a scarcity of direct comparisons among various α-blockers. Therefore, this network meta-analysis (NMA) of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of α-blockers in the management of BPH. A comprehensive electronic search covered PubMed, Embase, Ovid MEDLINE, and Cochrane Library until August 2023. The primary endpoints comprised international prostate symptom score (IPSS), maximum flow rate (Qmax), quality of life (QoL), and post-void residual volume (PVR), while treatment-emergent adverse events (TEAEs) were considered as secondary endpoints. This NMA synthesized evidence from 22 studies covering 3371 patients with six kinds of α-blockers with 12 dose categories. IPSS has been considerably improved by tamsulosin 0.4 mg, naftopidil 50 mg and silodosin 8 mg as compared to the placebo. Based on the p-score, tamsulosin 0.4 mg had the highest probability of ranking for IPSS, PVR, and Qmax, whereas doxazosin 8 mg had the highest probability of improving QoL. A total of 297 adverse events were reported among all the α-blockers, silodosin has reported a notable number of TEAEs. Current evidence supports α-blockers are effective in IPSS reduction and are considered safer. Larger sample size with long-term studies are needed to refine estimates of IPSS, QoL, PVR, and Qmax outcomes in α-blocker users.

Normative data for insulin-like growth factor-1 (IGF-1) in healthy children and adolescents from India.

BACKGROUND: Serum IGF-1 is an important biochemical tool to diagnose and monitor GH-related disorders. However, ethnic-specific Indian data following consensus criteria for the establishment of normative data, are not available. Our objective was to generate chronological age (CA)-, bone age (BA)- and Tanner stage-specific normative data for IGF-1 in healthy Indian children and adolescents. METHODS: A cross-sectional epidemiological study was conducted in schools and the community, which enrolled apparently healthy children and adolescents with robust exclusion criteria. The outcome measure was serum IGF-1 assessed using an electro-chemiluminescence immunoassay (ECLIA). The 2.5th, 5th, 10th, 25th, 50th (median), 75th, 90th, 95th, and 97.5th centiles for IGF-1 were estimated using generalized additive models. RESULTS: We recruited 2226 apparently healthy participants and following exclusion, 1948 (1006 boys, 942 girls) were included in the final analysis. Girls had median IGF-1 peak at CA of 13 years (321.7 ng/mL), BA of 14 years (350.2 ng/mL) and Tanner stage IV (345 ng/mL), while boys had median IGF-1 peak at CA of 15 years (318.9 ng/mL) BA of 15 years (340.6 ng/mL) and Tanner stage III (304.8 ng/mL). Girls had earlier rise, peak and higher IGF-1 values. The reference interval (2.5th-97.5th percentile) was broader during peri-pubertal ages, indicating a higher physiological variability. CONCLUSION: This study provides ethnicity-specific normative data on serum IGF-1 and will improve the diagnostic utility of IGF-1 in the evaluation and management of growth disorders in Indian children and adolescents.

Comprehensive safety profile of dipeptidyl peptidase-4 inhibitors: a post-marketing study based on FAERS database using signal detection algorithms.

BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports. The disproportionality analysis was performed using signal detection algorithms (SDAs) incorporating frequentist-based data mining approach such as relative reporting ratio (RRR), reporting odds ratio (ROR) and proportional reporting ratio (PRR) with 95% confidence interval (CI). RESULTS: A total of 14,573 adverse event reports were reported in the FAERS public dashboard associated with all the included DPP-4 inhibitors. The computed PRR, ROR, and RRR indicated positive signals for DPP-4 inhibitors with cardiac failure, pancreatitis, pemphigoid, hypoglycemia, acute kidney injury and lactic acidosis. Saxagliptin showed a higher signal score for cardiac failure, while sitagliptin was more associated with pancreatitis. Moreover, alogliptin exhibited an elevated signal score associated with pancreatic carcinoma. CONCLUSION: Several significant disproportionality signals were observed with DPP-4 inhibitors. However, clinicians have to consider the comorbidities and concomitant drugs while prescribing these drugs.

Mobile health applications for epilepsy in Indian app stores: A systematic review and content analysis using the mobile app rating scale.

OBJECTIVE: The growing prevalence of smartphones may prompt individuals with epilepsy to pursue unfulfilled healthcare requirements through mobile health (mHealth) apps, but the content and quality of these mHealth apps are rarely analysed. Hence, this study aimed to identify and assess the quality of epilepsy apps for patients with epilepsy (PWE), their caregivers, and healthcare practitioners (HCPs) available in the Play Store and App Store of India. METHODS: We performed a systematic search on the Google Play Store and Apple App Store of India to identify the mHealth apps for epilepsy which were released and updated till May 2023. The identified applications were downloaded and the quality was assessed using a Mobile app rating scale (MARS) for the overall quality, Aesthetics, Engagement, Functionality, and Information by three independent reviewers. The intraclass correlation coefficient (ICC) was calculated to assess the interrater reliability between the reviewers. An unpaired t-test was calculated to analyse the difference in mean scores for Android and iOS applications. RESULTS: The systematic search yielded a total of 2518 apps, out of which 26 were selected for inclusion in the study. Among these, 9 apps were compatible with Android, 11 with iOS, and 6 on both platforms. The mean (SD) MARS score of the apps was 3.5 (0.6) and the ICC for the overall app quality was 0.90 (95% CI: 0.82-0.96). Overall, apps scored highest in functionality (3.9), followed by aesthetics (3.6), information (3.3), and engagement (3.2). Among the included apps, the overall quality score was found to be higher for iOS apps than Android (MD = 0.54; 95% CI: 0.02 - 1.07; p-value: 0.042). CONCLUSION: Our study identified twenty-six mHealth applications for epilepsy that integrated various aspects of epilepsy self-management. The results of this study emphasize the importance of ensuring that current and future applications offer evidence-based information, integrate features that align with patient preferences, and generate evidence regarding the effectiveness of application usage.

Estimating the active and lifetime prevalence and incidence of epilepsy in Asian Countries: A systematic review and meta-analysis.

OBJECTIVE: In the current era of the World Health Organization's Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022-2031 (IGAP), precise and updated estimates of epilepsy burden are vital in formulating policies to improve the care of persons with epilepsy, especially in Asian countries with significant treatment gap. Hence, we aimed to consolidate the available data and quantify epilepsy prevalence and incidence estimates in Asian countries. METHODS: We systematically searched PubMed, Embase, Ovid, and Scopus databases from inception until March 2023 for studies reporting epilepsy prevalence and incidence in Asian countries. We applied random effects meta-analysis to generate the pooled prevalence and incidence using the Meta package in R. Additionally, we performed a subgroup meta-analysis to explore the potential sources of heterogeneity. A meta-regression analysis was conducted to examine the trend of epilepsy over time. RESULTS: A total of 99 studies with 100,654,124 participants were included in the meta-analysis. The pooled prevalence was 5.6 per 1000 (95 % confidence interval (CI) 4.4-6.8) for active epilepsy and 6.7 per 1000 (95 % CI 5.7-7.9) for lifetime epilepsy. The pooled incidence rate of epilepsy was 52.5 per 100,000 person-years (95 % CI 42.7-79.4). The subgroup analysis revealed a higher prevalence of active epilepsy (6.7/1000) and lifetime epilepsy (8.6/1000) in West Asia than in other regions. The funnel plot and Egger's test (p-value =<0.0001) revealed publication bias for active epilepsy. CONCLUSION: Our findings highlight a high prevalence of active and lifetime epilepsy in West Asia and emphasize the necessity of implementing and formulating specific strategies to tackle the epilepsy burden in this region. Furthermore, high-quality epidemiological studies incorporating economic burdens and comorbidities associated with epilepsy in Asia are still needed.

Venetoclax adverse event monitoring: a safety meta-analysis of randomized controlled trials and a retrospective evaluation of the FAERS.

Concerns persist about venetoclax's long-term safety in larger populations, with limited evidence of infrequent and delayed adverse events (AEs). The study integrated safety data on venetoclax in leukemia patients from randomized controlled trials (RCTs) and FDA adverse event monitoring system (FAERS). We systematically reviewed RCTs reporting safety outcomes of venetoclax in adult leukemia patients of any gender, either monotherapy or in combination, applying advanced search on databases like PubMed, EMBASE, and ClinicalTrial.gov. The quality assessment was done using the Cochrane Risk of Bias Tool. We utilized a random effect meta-analysis to calculate risk ratio (RR) with 95% confidence intervals (CI). The Open Vigil 2.1 MedDRAv24 was used to search the FAERS database, with data available until September 2023. The disproportionality was calculated using the proportional reporting ratio and the reporting odds ratio. The study protocol for meta-analysis was registered with PROSPERO; CRD42022378006. For the safety meta-analysis, seven RCTs with available AEs were examined. A total of 942 AEs were found associated with the venetoclax group; 79% of them were in grade three or above. Venetoclax significantly increased the risk of neutropenia grade three or above (RR = 1.34, 95% CI: 1.10-1.64, p: 0.0033) compared with the control group. In FAERS, 26,436 patients were reported with AEs associated with venetoclax. Significant signal scores were observed in hematological, cardiac, vascular, and gastrointestinal disorders. 11 out of 30 generated signals, failed to meet the signal criteria upon refinement. The current study updated and improved the safety profile of venetoclax in the post-marketing period, assisting in risk evaluation and mitigation for the best possible patient health care.

Trends estimation of obesity prevalence among South Asian young population: a systematic review and meta-analysis.

The premise for effective prevention and treatment of obesity is the availability of accurate prevalence figures. However, the prevalence of pediatric obesity and overweight in South Asian countries has seldom been analyzed. This article provides a comprehensive review and meta-analysis of studies on overweight and obesity to provide a more precise prevalence estimate. The study protocol was registered on PROSPERO (CRD42022320625). PubMed and Embase databases were comprehensively searched from inception till September 2023. The random-effects model was utilized to derive the pooled prevalence of obesity and overweight. Subgroup meta-analysis was used to assess variations in prevalence estimates across subgroups. A meta-regression analysis was also performed to assess the trend of overweight and obesity over the years. 152 studies were included with 489,525 participants. The pooled prevalence was 12.4 (95% CI 11.1-13.6) for overweight, 6.6% (95% CI 5.6-7.8) for obesity, and 19.3% (95% CI 17.1-21.7) for obesity and overweight. In subgroup analysis, Bangladesh reported a higher prevalence for both obesity (8.9%; 95% CI 4.9-13.9) and overweight (13.6%; 95% CI 9.2-18.8). Meta-regression analysis found a significant association between obesity prevalence and the publication year (ß = 0.004; p = 0.03; R2 = 2.74%). The results of this study indicate a relatively higher prevalence of childhood obesity in South Asia, emphasizing the necessity for large-scale awareness efforts and context-specific preventative methods.

Societal costs of illness for infantile epileptic spasms syndrome and evolutionary cost prediction in the era of WHO's IGAP.

BACKGROUND: To achieve the goal of improving the quality of life for persons with epilepsy within the framework of the WHO's Intersectoral Global Action Plan (IGAP), our study aimed to assess the societal financial burden linked to infantile epileptic spasms syndrome (IESS), ensuring that children afflicted with IESS receive high-quality healthcare without enduring substantial financial constraints. METHODS: Between August 2022 and March 2023, 92 children with IESS (male: female: 2:1), recently diagnosed or previously followed-up, were recruited. We gathered costs for drugs, tests, and medical services, along with legal guardians' monthly income. Total expenditure was determined by multiplying unit costs by the yearly service usage commencing from the onset. Time series analysis was utilised to forecast the financial burden from 2022 to 2032. RESULTS: Clinicians' first choice of treatment was ACTH (n = 60, 65·2%), prednisolone (n = 25, 27·2%), and vigabatrin (n = 7, 7·6%) and the median cost of treatment during the initial year was INR 39,010 [USD 479·2]. The median direct medical, direct non-medical, and indirect cost were INR 31,650 [USD 388·4], INR 6581 [USD 80·8], and INR 10,100 [USD 124·07], respectively. Families lost a median of 12 days of work annually. Drug costs and loss of wages were the key factors in the financial burden. The projected and adjusted figures exhibited an incremental growth rate of 2·6% tri-annually. INTERPRETATION: This pioneering study in developing countries, the first of its kind, evaluates the societal cost, financial hardship, and trajectory of incremental cost in IESS. The primary drivers of the financial burden were pharmacological treatment and family work adjustments. The government shoulders 62% of the financial burden, and projected a triannual growth of 2·6% from 2022 to 2032. Our results rationalize policymakers' focus on incorporating IESS into social security programs, particularly in developing countries.