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Nevin Manimala Statistics

Efficacy and Safety of Lorundrostat in Uncontrolled Hypertension: A Systematic Review and Meta-Analysis

J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70155. doi: 10.1111/jch.70155.

ABSTRACT

This systematic review and meta-analysis evaluated the efficacy and safety of lorundrostat in adults with uncontrolled hypertension. Following PRISMA guidelines and PROSPERO registration (CRD420251088503), five databases were systematically searched through July 2025 for randomized controlled trials comparing lorundrostat with placebo in this population. The primary outcome was change in systolic blood pressure (SBP), while secondary outcomes included diastolic blood pressure, severe BP events, and adverse effects. Three RCTs comprising 1568 participants across 10 study arms were included. Lorundrostat significantly reduced 24-h ambulatory SBP (mean difference [MD]: -7.45 mmHg; 95% CI: -12.54 to -2.36; p = 0.0041; p2 = 0%) and diastolic BP (MD: -3.49 mmHg; 95% CI: -5.56 to -1.41; p = 0.0010; I2 = 0%). While office SBP showed a non-significant reduction in the primary analysis (MD: -13.55 mmHg; p = 0.077; I2 = 94%), it became statistically significant in a sensitivity analysis (MD: -9.08 mmHg; p < 0.0001). Lorundrostat also significantly lowered the risk of severely elevated BP events (odds ratio [OR]: 0.37; 95% CI: 0.17-0.81; p = 0.028). Adverse effects included an increased risk of hyperkalemia (OR: 3.22; p < 0.001) and hyponatremia (OR: 2.16; p = 0.037), with no significant difference in serious adverse events between groups. In conclusion, lorundrostat demonstrates significant reductions in both ambulatory and diastolic BP in patients with uncontrolled hypertension, with a generally tolerable safety profile. Hyperkalemia and hyponatremia remain notable risks. Further long-term trials are warranted to validate its sustained efficacy and safety.

PMID:40991241 | DOI:10.1111/jch.70155

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Improvements in Blood Pressure Control and the Hypertension Care Continuum Over 2 Years in Urban Haiti Amidst Civil Unrest

J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70153. doi: 10.1111/jch.70153.

ABSTRACT

Hypertension (HTN) is the leading cause of death worldwide, yet only 8% of individuals have controlled blood pressure (BP) in low- and middle-income countries, with particular challenges in humanitarian crisis settings including Haiti. The Haiti Cardiovascular Disease Cohort, an observational population-based cohort in Port-au-Prince, offers a unique opportunity to evaluate the HTN Care Continuum in a setting of extreme poverty and civil unrest. From 2019 to 2021, 3005 adults were enrolled, with BP measured every 6 months and free clinical care provided. HTN was defined as SBP ≥ 140, DBP ≥ 90, or antihypertensive medication use. We assessed screening, awareness, treatment, and BP control (BP < 140/90 on antihypertensives) at enrollment and 24 months. Multivariable Poisson regression identified sociodemographic factors associated with BP control. Of 3005 adults, 878 had HTN at enrollment (median age 57; 62% female; 71% earned < $1/day). Among 568 hypertensive participants with 24-month follow-up, awareness increased from 67% to 95%, treatment from 40% to 71%, and BP control from 11% to 32%. Median BP decreased from 150/91 to 138/82 mmHg. Across visits, 67% had ≥ 1 controlled BP and 35% had control at more than half of visits. Younger age (18-39 vs. ≥60 years) was associated with lower BP control (PR: 0.40, 95% CI: 0.18-0.77). Substantial improvements in HTN care, including a threefold rise in BP control and a mean SBP decrease of 12 mmHg, are achievable even in settings of extreme adversity and humanitarian crises. Trial Registration: ClinicalTrials.gov identifier: NCT03892265.

PMID:40991240 | DOI:10.1111/jch.70153

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Changes of chicken liver-enriched antimicrobial peptide 2 across feeding states and body weight and its regulatory role in feed intake

Br Poult Sci. 2025 Sep 24:1-8. doi: 10.1080/00071668.2025.2527227. Online ahead of print.

ABSTRACT

1. Liver-enriched antimicrobial peptide 2 (LEAP2), ghrelin and growth hormone secretagogue receptor (GHSR) are critical components of the appetite regulation system. This study analysed changes in LEAP2-ghrelin-GHSR expression across diverse feeding conditions and body weights in adult broilers and investigated the effects of intraperitoneally injected LEAP2 and ghrelin peptides on the feed intake of chicks.2. In adult broilers, the expression of LEAP2 in the liver and intestine exhibited significant variations under different feeding conditions (fed, fasting and refeeding), with a notable reduction observed during fasting. Compared to the fed group, proventriculus ghrelin and hypothalamus GHSR gene expression doubled, but was not statistically significant. Serum analyses revealed that fasting significantly decreased LEAP2 levels relative to the fed state and a significant negative correlation was identified between LEAP2 levels and body weight in fasting chickens. Conversely, ghrelin levels remained stable irrespective of feeding states and showed no correlation with body weight.3. Intraperitoneal injection of LEAP2 mature peptide, comprising the N-terminal 14 amino acids significantly reduced feed intake of chicks within the initial 4 h. In contrast, ghrelin injection resulted in a decrease in feed intake during the first 30 min. However, prior administration of ghrelin followed by LEAP2 mitigated the suppressive effect of ghrelin on feed intake within this timeframe.4. This study demonstrated that chicken LEAP2 gives a more sensitive feedback factor than ghrelin under different feeding conditions in adult broilers. It revealed that LEAP2 in a chick model modulated feed intake. These findings provide a theoretical basis for exploring the underlying mechanisms of LEAP2-mediated feed intake regulation in poultry.

PMID:40991231 | DOI:10.1080/00071668.2025.2527227

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Development & validation of a format for reporting endoscopic colonic biopsies

Indian J Med Res. 2025 Jul;162(1):111-116. doi: 10.25259/IJMR_355_2025.

ABSTRACT

Background & objectives Non-neoplastic diseases make a considerable part of daily workload of gastroenterologist and an endoscopist. As there are only a few endoscopic findings in literature to suggest a large era of colonic diseases, endoscopic biopsy is a must, to reach a definitive diagnosis. This needs a checklist or a similar format that contains all the important histological features to be seen in a colonic biopsy which is currently lacking in published literature. Hence, this study aimed to develop a format for reporting endoscopic colonic biopsies a first of a kind as per our knowledge particularly for non-neoplastic colonic diseases using modified kappa statistics. Methods Seventy one questions were included in this format after searching in various search engines using various phrases. These questions were reviewed by experts and changes were done accordingly. The finalized questionnaire was further shared with 20 subject matter experts. Their feedback was utilized to determine the Content Validity Index (CVI), calculated at both the item level (I-CVI) and the overall scale level (S-CVI), along with the modified kappa coefficient. For studies involving more than six experts, an I-CVI of 0.78 and an S-CVI/average of 0.9 were considered acceptable benchmarks. Results Fourteen out of 20 experts responded. Mean I-CVI for relevance across all items was 0.933, S-CVI/Average (based on proportion data) across all experts was 0.94 and Mean I-CVI was well above 0.78 (0.928). Interpretation & conclusions The scores indicated a strong agreement among experts on various histological features to be seen in an endoscopic colonic biopsy. These findings clearly indicates that the format met the content validity criteria and hence histological sections of endoscopic colonic biopsies can be read using this format.

PMID:40991214 | DOI:10.25259/IJMR_355_2025

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Efficacy of structured exercise & relaxation techniques in managing post-COVID paraspinal myalgia in manual labourers of Belagavi, Karnataka: A quasi-experimental study

Indian J Med Res. 2025 Jul;162(1):117-123. doi: 10.25259/IJMR_827_2024.

ABSTRACT

Background & objectives This study compared the effectiveness of Progressive Muscle relaxation technique (PMRT) and Spinal Muscle Training (SMT) against Standard Neurosurgical Care (SNC) for the management of post-acute-COVID-19 syndrome (PACS)-associated paraspinal myalgia (PM), via changes in serum interleukin (IL)-17 and functional independence measured by Katz index of activities of daily living (ADL). Methods Male manual labourers aged 40-50 yr with PACS-associated PM were enrolled and allocated to the experimental group receiving PMRT and SMT and the control group receiving SNC delivered via telerehabilitation over 12 wk. IL-17 and ADL were measured pre- and post-intervention. Data analysis involved paired and unpaired t-tests, with a P value < 0.05 being statistically significant. Results There was a notable decrease in IL-17 in the experimental and control groups, from (31.13±3.68 pg/mL) to (18.96±2.56 pg/mL) and (31.05±4.24 pg/mL) to (28.89±4.58 pg/mL), respectively. The experimental group’s ADL scores increased from 2.93±0.94 to 5.03±0.85, while the control improved from 2.5±1.13 to 3.53±1.04. The experimental intervention was supported by large effect sizes and statistically significant differences in IL-17 reduction and ADL improvement on inter-group comparisons. Interpretation & conclusions The combination of PMRT and SMT was significantly efficacious than SNC at lowering systemic inflammation and improving functional independence in PACS patients with PM. This study also highlighted the role of telerehabilitation in intervention delivery to socio-demographically limited populations. Future studies should investigate long-term effects and generalizability to larger populations.

PMID:40991213 | DOI:10.25259/IJMR_827_2024

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Pharmacological therapies for alcohol use disorder reduce hepatic decompensation & mortality in alcohol-related liver disease: A GRADE evaluation through a meta-analysis

Indian J Med Res. 2025 Jul;162(1):66-73. doi: 10.25259/IJMR_2086_2024.

ABSTRACT

Background & objectives The role of behavioural therapies for alcohol use disorder (AUD) has been reported in patients with alcohol-related liver disease (ALD); however, that of pharmacological treatments is yet to be established. We conducted a systematic review and meta-analysis to study the use of these pharmacological interventions in ALD for liver-related and patient-important outcomes, including abstinence. Methods We conducted a systematic search of four major databases. Title and abstract screening, full-text review, risk of bias assessment, and data extraction were performed independently by two reviewers. Random-effects meta-analysis was used to calculate pooled effect estimates with 95 per cent confidence intervals (CI). The certainty of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool and categorised as high, moderate, low, or very low. Results Altogether, eleven studies (1 RCT and 10 cohort studies) were included in the systematic review and eight studies in the meta-analyses. Meta-analysis of two cohort studies (44813 participants) showed significantly lower odds of all-cause mortality with the use of AUD pharmacotherapy with acceptable statistical heterogeneity [Odds Ratio (OR) 0.86; 95% CI 0.79-0.93; I2 = 0%]. Meta-analysis of one RCT and three cohort studies (303 participants) for the outcome of abstinence revealed a pooled proportion of 47.5 per cent (95% CI, 42.1-52.9; I2 = 11.7%). The certainty in estimates was very low. Interpretation & conclusions The present systematic review and meta-analysis suggest that pharmacological therapies in ALD may reduce overall mortality and the incidence of hepatic decompensation. However, given the very low certainty of evidence, these findings should be interpreted with caution and underscore the need for well-designed trials.

PMID:40991211 | DOI:10.25259/IJMR_2086_2024

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Hope, Mindfulness, and Anxiety in the Context of Racial Discrimination Among Black Young Adults

J Racial Ethn Health Disparities. 2025 Sep 24. doi: 10.1007/s40615-025-02655-8. Online ahead of print.

ABSTRACT

OBJECTIVES: Anxiety disorders have a chronic, more severe course among Black individuals. Racial and ethnic discrimination exacerbates anxiety among Black adults. Hope and mindfulness are positive resilience traits that correlate with lower anxiety levels. Protective factors against anxiety must be examined in culturally informed contexts. This study evaluates the unique associations of hope, mindfulness, discrimination, anxiety, and social anxiety among Black adults.

METHODS: Participants were 635 (133 men, 502 women) adults from a large southwestern United States university who identified as African American or Black. Ages ranged from 18 to 52 (Mage = 21.66 years). Participants completed a battery of self-report questionnaires on hope, mindfulness, anxiety, social anxiety, and discrimination.

RESULTS: Structural equation modeling analyses demonstrated that hope is associated with lower social fear when accounting for mindfulness and discrimination (β = – 0.14, C.I = – 0.24: – 0.03). Mindfulness is associated with lower anxiety (β = – 0.31, C.I = – 0.41: – 0.21), social fear (β = – 0.18, C.I = – 0.29: – 0.07), and social avoidance (β = – 0.22, C.I = – 0.34: – 0.10) when accounting for hope and discrimination. Discrimination is associated with higher anxiety (β = 0.28, C.I = 0.20:0.36), social fear (β = 0.31, C.I = 0.22:0.39), and social avoidance (β = 0.29, C.I = 0.20:0.37) when accounting for mindfulness and hope.

CONCLUSIONS: Mindfulness had more robust protective qualities in the context of discrimination for anxiety and social anxiety than hope. The maladaptive relationships between discrimination and anxiety remained despite the presence of hope and mindfulness. Additional research is needed to identify strength-based approaches to protecting against and healing from experiences with discrimination among Black adults.

PMID:40991199 | DOI:10.1007/s40615-025-02655-8

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Impact of continuous positive airway pressure therapy on metabolic and renal parameters in patients with obstructive sleep apnea, type 2 diabetes mellitus, and chronic kidney disease: a prospective cohort study

Int Urol Nephrol. 2025 Sep 24. doi: 10.1007/s11255-025-04777-8. Online ahead of print.

ABSTRACT

BACKGROUND: Continuous positive airway pressure (CPAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), but its impact on type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), remains unclear. This study aimed to evaluate the effects of CPAP therapy on metabolic and renal parameters in patients with OSA, T2DM, and CKD for over 18 months.

MATERIAL AND METHODS: This prospective, non-randomized, single-centre cohort study enrolled 60 patients with moderate-to-severe OSA (AHI > 15 episodes/hour), CKD (eGFR 15-60 mL/min/1.73m2), and T2DM. The patients were divided into a CPAP therapy group (n = 30) and a usual care group (n = 30). CPAP adherence was defined as ≥ 4 h/night for at least 70% of monitored nights. The primary outcomes included changes in the urinary albumin-to-creatinine ratio (UACR) Secondary outcomes included changes in serum creatinine, estimated glomerular filtration rate (eGFR), HbA1c, homeostasis model assessment of insulin resistance (HOMA-IR), apnea-hypopnea index (AHI), and oxygen desaturation index (ODI). Statistical analyses included independent test, repeated measures of analysis of variance, and analysis of covariance (ANCOVA).

RESULTS: 8 (13%) patients were lost to follow-up, and therefore 52 patients (27 patients in CPAP group and 25 patients in usual care group) were included in per-protocol analysis. After 18 months, CPAP therapy significantly improved AHI (mean change: 8.96 ± 4.94, p = 0.001), HbA1c (mean change: 1.44 ± 0.46, p = 0.001), HOMA-IR (mean change: 1.85 ± 0.14, p = 0.001), UACR (mean change: 139.08 ± 85.27 mg/g, p = 0.015), and serum creatinine (mean change: 1.02 ± 0.34 mg/dL, p = 0.011). No significant changes were observed in eGFR (p = 0.513) levels.

CONCLUSION: CPAP therapy significantly improved metabolic and renal parameters, particularly albuminuria and insulin resistance, in patients with OSA, T2DM, and CKD. However, it did not significantly impact the eGFR over 18 months.

PMID:40991192 | DOI:10.1007/s11255-025-04777-8

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The mediating role of pain in the relationship between sleep and recovery

Ir J Med Sci. 2025 Sep 24. doi: 10.1007/s11845-025-04097-x. Online ahead of print.

ABSTRACT

BACKGRAUND: Sleep disturbances and pain are common in the early postoperative period and can significantly impact recovery. Poor sleep quality may increase pain perception, while unmanaged pain can further disrupt sleep, creating a negative cycle that impairs healing. Understanding how these factors interact is essential to improving postoperative outcomes.

AIM: This study aims to examine the mediating role of pain in the relationship between sleep quality on the first postoperative night and the level of recovery.

METHODS: This descriptive and cross-sectional study was conducted with 250 patients who underwent laparoscopic cholecystectomy in the general surgery clinic of a university hospital. Data were collected using the Patient Information Form, the Richards-Campbell Sleep Questionnaire, the Quality of Recovery-40 Questionnaire, and the Visual Analogue Scale. For statistical analysis, Pearson correlation, regression, hierarchical regression, and bootstrap mediation analysis were performed.

RESULTS: Sleep quality was found to be a significant and positive predictor of recovery (β = 0.415, p < .001). However, when pain was included in the model, the effect of sleep quality decreased but remained significant (β = 0.130, p = .035). The results of the bootstrap mediation analysis confirmed that pain was a significant mediator in this relationship.

CONCLUSION: Sleep quality influences postoperative recovery both directly and indirectly through pain levels. The findings suggest that holistic approaches to sleep and pain management in postoperative care processes may optimise recovery.

PMID:40991188 | DOI:10.1007/s11845-025-04097-x

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Estimating QALYs in adults with cerebral palsy: mapping the San Martin scale to the EQ-5D-5L for economic evaluation

Eur J Health Econ. 2025 Sep 24. doi: 10.1007/s10198-025-01831-1. Online ahead of print.

ABSTRACT

BACKGROUND: Responses on health-related quality of life measured by disease-specific instruments can be mapped onto the EQ-5D to estimate utility values for economic evaluation. San Martin´s Quality of Life Scale (St. MQoL-S) is a preferred measure to obtain health outcomes in adults with cerebral palsy. Nevertheless, it lacks a preference-based health utility score for estimating quality-adjusted life years (QALYs).

OBJECTIVE: To develop algorithms for mapping from the St. MQoL-S to allow future prediction of the EQ-5D-5L, in adults with cerebral palsy, when utility data have not been collected.

METHODS: Direct mapping models were developed using ordinary least squares, a generalized linear model, and Tobit regression analysis to estimate EQ-5D-5L utilities, with St. MQoL-S total and domain scores as explanatory variables, in a cross-sectional study of adults with cerebral palsy in Spain. Goodness-of-fit was assessed using mean absolute error (MAE) and root mean square error (RMSE). Repeated k-fold cross-validation was employed to select the optimal mapping model demonstrating superior predictive performance.

RESULTS: The best-performing model for predicting EQ-5D-5L utilities, includes the St. MQoL-S total scores, age, gender, and types of cerebral palsy as explanatory variables in a stepwise ordinary least squares regression, making it the most robust model for use as a mapping algorithm with external data.

CONCLUSION: This is the first study to present mapping algorithms between the St. MQoL-S and EQ-5D-5L. The mapping functions preferred in this study seem adequate for estimating the utilities of the EQ-5D-5L for economic evaluation and to obtain QALYs in adults with cerebral palsy.

PMID:40991164 | DOI:10.1007/s10198-025-01831-1