Mahatma Gandhi Memorial Hospital

Background:Type 2 diabetes mellitus (T2DM) is the most common non-communicable disease affecting over 89.8 million adults in India. Evidence suggests long-acting glucagon-like peptide-1 (GLP-1) receptor agonist improves glycaemic control in the patients with T2DM. This phase 3 trial compared a novel semaglutide injection developed by Zydus Lifesciences Ltd. with the reference biologic in Indian adults with T2DM inadequately controlled on metformin. Methods:In this multicentre, randomised study, 314 patients aged 18-65 years with HbA1c 7.0-10.5 % were randomised 1:1 to once-weekly semaglutide injection (test) or reference semaglutide for 24 weeks. Doses were titrated according to glycaemic targets. The primary endpoint was change in HbA1c at 24 weeks (pre-specified non-inferiority margin of 0.4 percentage points). Secondary endpoints included changes in fasting and post-prandial glucose, body weight, BMI, lipid profile, blood pressure, rescue medication use, safety profile and anti-drug antibody formation. Analyses were conducted on the modified intent-to-treat (mITT) population. Results:Of 314 randomised participants, 274 completed the trial (133 in the test arm and 141 in the comparator arm). HbA1c decreased from 8.36 % to 6.81 % in the test group and from 8.36 % to 6.79 % in the comparator, with a least-squares mean difference of -0.0038 % (95 % CI -0.20 to 0.19), meeting the pre-specified non-inferiority margin. Reductions in body weight (-4.59 vs -4.42 kg), BMI (-1.76 vs -1.68 kg/m2), fasting plasma glucose (-37.5 vs -39.0 mg/dL) and post-prandial plasma glucose (-54.5 vs -55.7 mg/dL) at week 24 were comparable between the groups. Treatment-emergent adverse events (TEAEs) were reported in 58.6 % of patients in the test group and 61.8 % of patients in the comparator group, respectively. Most events were mild and no serious adverse events occurred. Hypoglycaemia was infrequent and mild (1.9 % vs 0 %). Anti-drug antibodies were detected in 2.23 % of samples and had no impact on efficacy. Conclusions:This novel formulation of once-weekly semaglutide injection demonstrated non-inferior glycaemic efficacy, safety & immunogenicity to the reference product in Indian adults with type 2 diabetes. Trial registration:Clinical Trials Registry-India (CTRI/2025/03/082615).

Abstract Background and aims Sovateltide, an endothelin-B receptor agonist, has shown favorable functional outcomes in acute ischemic stroke (AIS) and is approved in India as a first-in-class therapy for AIS. A phase 4 study (NCT05955326) is currently recruiting patients in India (target N=160) to further assess safety and effectiveness. This report presents the results of a prespecified interim analysis conducted after enrollment of 80 patients. Methods Eligible participants were adults aged 18 to 78 years with radiologically confirmed AIS and an NIHSS score of 6 or higher, presenting within 24 hours of symptom onset. Exclusion criteria included intracranial hemorrhage and receipt of endovascular therapy. Participants were randomized to receive either normal saline or sovateltide (0.3 μg/kg), administered intravenously in three doses at 3±1 hour intervals on days 1, 3, and 6. Analyses were conducted in the intention-to-treat population, with missing endpoints imputed using MICE. Results Patient age and body weight, sex distribution, NIHSS score (p=0.5216), comorbidities, and the median time from symptom onset to first dose (16–18 hours) were comparable between groups. At 90 days, the sovateltide group (92.3%) of patients with mRS 0-2, showed greater improvement (OR 8.50, 95% CI 2.44-29.01; p=0.0005) than the control group (58.5%). Sovateltide group had more patients (84.62%) with improvement of ≥2 mRS points from baseline (Odds 5.24, 95% CI 1.85-15.50; p=0.0014) than control (51.22%). Ordinal shift analysis of mRS also favored sovateltide by 33% compared to control. Conclusions Sovateltide was associated with significantly improved 90-day functional outcomes, consistent with results from previous AIS efficacy trials. Conflict of interest

Abstract Introduction: Anterior shoulder instability is common among young, active individuals, with Bankart lesions present in the majority of cases. While arthroscopic Bankart repair is the current standard of care, the optimal number of suture anchors remains debated. This prospective study evaluated whether anchor number influences functional outcomes and recurrence rates over 2 years. Methods: A total of 100 consecutive patients undergoing arthroscopic Bankart repair for magnetic resonance imaging-confirmed Bankart lesions between December 2019 and December 2022 were included. Exclusion criteria were significant bone loss, multidirectional instability, rotator cuff tears, and connective tissue disorders. Repairs were performed by a single surgeon using two or more anchors, with remplissage added for engaging Hill–Sachs lesions. Functional scores (American Shoulder and Elbow Surgeons [ASES], Quick Disabilities of the Arm, Shoulder, and Hand [DASH], and ROWE), range of motion, and pain (visual analog scale [VAS]) were recorded preoperatively and at 1, 3, 6, 12, and 24 months. Outcomes were compared between patients receiving two anchors versus ≥3 anchors. Results: Mean age was 25.2 ± 7.1 years; 91% were male. Two anchors were used in 77% of cases. Remplissage was performed in 26%. At 2 years, mean VAS decreased from 5.0 to 0.8, ASES improved from 48.2 to 88.1, Quick DASH from 42.0 to 9.6, and ROWE from 50.9 to 92.4 ( P < 0.001). Range of motion improved significantly without clinically relevant external rotation loss. No recurrences or anchor-related complications occurred. Functional outcomes were equivalent between anchor groups and remplissage status. Conclusion: Our findings suggest that, in carefully selected patients without major bone loss, arthroscopic Bankart repair provides excellent early to midterm functional outcomes and stability, and that outcomes are not significantly influenced by the absolute number of suture anchors used.

Background and Aims: Lateral extra-articular tenodesis (LET) is increasingly used as an adjunct to anterior cruciate ligament reconstruction (ACLR) to reduce graft failure, particularly in high-risk patients. Multiple femoral fixation techniques for LET have been described; however, their relative effectiveness in improving graft survivorship and associated complications remains unclear. Materials and Methods: A systematic review and meta-analysis were performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Electronic databases were searched for studies comparing ACLR with and without LET using the modified Lemaire technique. Subgroup analyses were conducted based on femoral fixation method, graft type, reconstruction setting (primary vs. revision), and level of evidence. The primary outcome was anterior cruciate ligament (ACL) graft failure. Pooled odd ratios (ORs) were calculated using a random-effects model. Results: Eleven studies encompassing 2208 knees were included. Overall, ACLR augmented with LET significantly reduced graft failure compared with isolated ACLR (OR, 0.45; 95% confidence interval [CI], 0.30–0.68; p = 0.0002). Subgroup analysis demonstrated a significant reduction in failure rates with anchor fixation (OR, 0.31; 95% CI, 0.13–0.75) and staple fixation (OR, 0.43; 95% CI, 0.23–0.79). Screw, button, and suture fixation did not demonstrate statistically significant reductions in graft failure. No significant heterogeneity was observed across analyses. Conclusion: LET augmentation significantly improves ACL graft survivorship compared with ACLR alone. Anchor and staple femoral fixation methods demonstrate the greatest clinical benefit; however, overlapping confidence intervals preclude definitive superiority of one technique.

Background and Aims: Anterior cruciate ligament reconstruction (ACLR) is commonly performed using autografts. Hamstring tendon (HT) grafts are traditionally favored, and in recent times, quadriceps tendon (QT) grafts are gaining popularity. This systematic review and meta-analysis aimed to compare patient-reported outcomes, graft failure rates, adverse events, and donor site morbidity between QT and HT autografts in primary ACLR. Materials and Methods: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Multiple databases were searched to identify randomized controlled trials (RCTs) comparing QT and HT autografts in primary ACLR. Outcomes included International Knee Documentation Committee (IKDC) scores, Lysholm Knee Questionnaire, Tegner Activity Scale, graft failure rates, adverse events, and donor site morbidity. Meta-analysis was performed using standardized mean differences and odds ratios with assessment of heterogeneity. The quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation framework. Results: Six RCTs comprising 426 patients were included. Meta-analysis demonstrated no significant differences between QT and HT autografts in IKDC scores, Lysholm scores, or Tegner activity levels at final follow-up. Graft failure rates and overall adverse event rates were also comparable between groups. However, QT autografts were associated with significantly lower donor site morbidity scores at 24 months. The overall quality of evidence ranged from low to moderate, with generally low heterogeneity across pooled outcomes. Conclusion: QT autografts provide clinical outcomes, graft survival, and safety profiles comparable to HT autografts in primary ACLR, with the added advantage of reduced donor site morbidity. These findings support that QT autografts are a safe and effective alternative to HT autografts.