Emcure Pharmaceuticals Ltd.

Background Trelagliptin and vildagliptin are oral dipeptidyl peptidase-4 (DPP-4) inhibitors used in the treatment of type 2 diabetes mellitus. The administration of vildagliptin is twice daily, whereas trelagliptin provides the convenience of once-weekly dosing, which may enhance patient adherence. A phase 3 clinical trial was conducted to assess the non-inferiority of trelagliptin compared to vildagliptin. Methods This multicenter, randomized, open-label, parallel-group, active-controlled non-inferiority clinical trial was conducted at 10 geographically distinct sites across India. A total of 240 treatment-naive patients with type 2 diabetes mellitus were randomized in a 1:1 ratio to receive either trelagliptin (100 mg once weekly) or vildagliptin (50 mg twice daily) for 16 weeks. The primary endpoint was non-inferiority of trelagliptin to vildagliptin in reducing glycated hemoglobin (HbA1c) levels from baseline to week 16. Secondary efficacy measures included changes in fasting and postprandial blood glucose, fasting insulin, glucagon, C-peptide, and glucagon-like peptide-1 (GLP-1) levels. Safety was assessed based on the incidence of adverse events. Results At week 16, the mean HbA1c levels were 7.18 ± 1.47% and 7.21 ± 1.49% in trelagliptin and vildagliptin groups, respectively (Δ -0.89% vs. Δ -1.00%, p < 0.0001). The difference between groups was 0.11% (95% CI: -0.28 to 0.50; p = 0.5899), showing non-inferiority of trelagliptin. A total of 48.57% of patients in the trelagliptin group and 47.57% in the vildagliptin group achieved the target HbA1c level of <7% (p = 0.8850). No statistically significant differences were observed between the groups for glycemic parameters, including fasting blood glucose (Δ 1.11; 95% CI: -16.79 to 19.02; p = 0.9025), 2-hr postprandial glucose (Δ 3.33; 95% CI: -30.55 to 23.88; p = 0.8093), fasting serum insulin (Δ 5.22; 95% CI: -15.01 to 25.45; p = 0.6113), fasting glucagon (Δ 0.72; 95% CI: -96.34 to 94.90; p = 0.9882), C-peptide (Δ 0.36; 95% CI: -0.31 to 1.03; p = 0.2912), and GLP-1 levels (Δ -0.02; 95% CI: -0.06 to 0.02; p = 0.3995). All reported adverse events were mild in nature and resolved without any lasting effects. Adverse events occurred in 6.67% (8/120) of patients in the trelagliptin group and 9.17% (11/120) in the vildagliptin group. Conclusions Trelagliptin showed a significant reduction in HbA1c, fasting, and postprandial glucose levels, indicating effective glycemic control in patients with type 2 diabetes mellitus. The study drug exhibited a favorable safety profile, with no major adverse events reported. Overall, trelagliptin proved to be both efficacious and well-tolerated, demonstrating non-inferiority to vildagliptin.

Menopause affects 1.5 million women annually, with perimenopause lasting 2-8 years and causing symptoms like hot flashes, sleep disturbances, mood changes, and joint pain. While hormone replacement therapy (HRT) is effective, safety concerns limit its use, leading many women to seek nonhormonal alternatives. Nutraceuticals such as ashwagandha, vitex, and black cohosh offer potential benefits, with 80% of women using supplements. This study evaluates the efficacy and safety of Arth perimenopause multisymptom capsules, providing evidence for nutraceuticals as an alternative to HRT.

The Effectiveness of Multisymptom Support for Better Relief and Alleviation of Common Effects in Perimenopause (EMBRACE PERIMENOPAUSE) study was a prospective, observational trial conducted at Redkar Hospital and Research Center, Goa. Thirty perimenopausal women aged 40-48 years with irregular menstrual cycles and at least two menopausal symptoms received one Arth capsule daily for 60 days. Using standardized case report forms, data were collected at screening, baseline, and days 7, 15, 30, and 60. Primary outcomes included changes in menopausal symptoms (Menopause Rating Scale (MRS)), reduction in daily hot flashes, and improvement in breast tenderness. Secondary outcomes assessed the quality of life (QoL), changes in hair and skin texture, patient and physician global assessments, and intervention tolerability. Statistical analyses included Chi-square tests and analysis of variance (ANOVA) (p < 0.05).

At baseline, 100% of patients reported hot flashes, followed by irritability (90%) and night sweating (83%). The mean MRS score decreased from 39 at baseline to 2.74 by day 60 (-92.97%, p < 0.01). By day 60, 93% of patients achieved complete resolution of hot flashes, 88% for sweating, 91% for anxiety, and 90% for depressive mood (p < 0.05). Overall, treatment significantly improved menopausal symptoms, QoL, and patient satisfaction.

Arth Perimenopause Multisymptom Support capsules demonstrated significant efficacy in alleviating perimenopausal symptoms while improving QoL. This nonhormonal, well-tolerated nutraceutical represents a promising alternative for managing perimenopause-related discomfort.

Background Wound healing following tissue injury is a precisely programmed biological process, typically occurring in a proper sequence and timeframe. While healing is perceived as inevitable, it heavily depends on tissue perfusion, which ensures oxygen and nutrient delivery, removal of waste, and promotion of cellular repair mechanisms. However, complications such as vascular occlusion due to fibrin or cellular debris, microbial contamination leading to infection, ischemic tissue necrosis, and dysregulated inflammation can impair healing. Proper care and repair are crucial to maintaining tissue perfusion and supporting the normal wound healing phases: reaction, regeneration, and remodeling. The use of oral enzymatic agents like trypsin, bromelain, and rutin offers a faster and more reliable method to support wound healing by reducing inflammation and enhancing tissue regeneration. This study was designed to assess the safety and effectiveness of treatment with Tibrolin^® (a fixed-dose combination of trypsin 48 mg, bromelain 90 mg, and rutoside 100 mg tablet) in improving wound healing and alleviating acute pain in patients following uncontaminated surgeries. Methods A phase-IV, open-label, prospective, multi-center clinical study was conducted on 200 patients after elective, clean, uncontaminated surgery. Patients were randomized (1:1) to receive either Tibrolin^® or Chymoral Forte^® (trypsin-chymotrypsin) tablets, administered as two tablets to be taken orally thrice a day for seven days postoperatively. The primary outcome measure was the percentage of patients reporting incidences of adverse events, while secondary outcome measures were the mean change in the individual and total score of surgical wounds and the Numerical Pain Rating Scale (NPRS) score from baseline (day 0) to day 7. Results Tibrolin^® was well-tolerated in the study, with no observed adverse or treatment-related adverse events. At the end of the treatment regimen, all wound healing parameters, including erythema, edema, discharge, induration, local irritation, and tenderness, showed a highly significant improvement (p < 0.001) in both treatment groups. Additionally, there was more than an 85% reduction in NPRS scores reported in both groups. A non-significant difference between groups in pain reduction (p = 0.737) and wound healing symptoms (p = 0.554) confirms that Tibrolin^® is as efficacious as trypsin-chymotrypsin when evaluated on days 3, 5, and 7 of treatment. Tibrolin^® tablets were regarded as good to excellent for treating wound symptoms by 87% of patients and 94% of investigators. Conclusion Our results suggest that Tibrolin^® administration favors wound healing and improves wound symptoms, such as edema, inflammation, and pain in the management of elective clean, uncontaminated surgical wounds.