Effectiveness and Tolerability of Vildagliptin in Indian Patients with Type 2 Diabetes Mellitus: Results From Edge−A Real-World Observational Study.

Objective: To assess the effectiveness and tolerability of vildagliptin in combination with another oral antidiabetic drug (OAD) versus any other two-agent OAD combinations in Indian patients with type 2 diabetes mellitus (T2DM) in a real-world setting. Study design: This was a post hoc analysis of a multicenter, prospective, 1-year, observational EDGE study for patients enrolled in India. The primary efficacy endpoint of the study was proportion of patients achieving glycosylated hemoglobin (HbA1C) reduction of >0.3% without peripheral edema, hypoglycemic event, discontinuation due to a gastrointestinal event or weight gain. One of the secondary efficacy endpoints was proportion of patients achieving HbA1C <7% without hypoglycemia and weight gain. Results: The mean age, body mass index, HbA1C and duration of T2DM were 51.8 years, 26.6 kg/m2, 8.6% and 4.3 years, respectively. The proportion of patients achieving the efficacy endpoints was significantly higher in the vildagliptin cohort compared with the comparator cohort (p < 0.0001). The vildagliptin cohort showed a numerically greater reduction in HbA1C than the comparator cohort (1.4 vs 1.1%; analysis not pre-specified). Adverse events were comparable in both groups (4.2% vs 4.9%). Conclusion: In India, in a real-world setting, vildagliptin showed better overall clinical benefits compared with comparator OADs in patients with T2DM.

Efficacy, Safety and Tolerability of Trioptal®d: (Oxcarbazepine) in Children and Adolescents with Newly Diagnosed Partial Seizures or Generalized Tonic-Clonic Seizures: Results of a 6 Months, Prospective, Open-Label, Multicentre, Non-Comparative, Observational Post-Marketing Surveillance Study.

Objective: The current study was designed to analyze the extended efficacy and safety of Trioptal® (Oxcarbazepine) in treatment of children and adolescents with newly diagnosed partial seizures or generalized tonicclonic seizures in Indian population. Methods: This was an open-label non-randomized multi-centric observational prospective study (PMS study) across 54 centers in India. Treatment with Trioptal® (Oxcarbazepine) was initiated with a clinically effective dose (8-10 mg/kg/day in children) given in two divided doses as per the prescribing information. The dose was increased depending on the clinical response of the patient. In children, if clinically indicated, the dose was increased by a maximum of 10 mg/kg/day increments at approximately weekly intervals from the starting dose, to a maximum daily dose of 60 mg/kg/day. The efficacy of Trioptal® was assessed primarily by the percentage of seizure-free patients at 24 weeks. Secondary efficacy of the treatment was assessed through: reduction in seizure frequency at 24 weeks and the Global assessment of efficacy by the investigator at 24 weeks. Results: A total of 485 subjects were enrolled in the study. Majority of the subjects (52%) were stabilized at 8-15 mg/kg/day dose of Trioptal® and mean effective dose was 16.1 mg/kg/day (± 7.02). Approximately 70 % of the subjects were seizures free after 24 weeks of Trioptal® treatment and around 88% of the subjects reported the reduction in seizure of more than 50 %. The mean reduction in seizure frequency after 24 weeks of treatment was 82.3%. The overall efficacy with the Trioptal® treatment for 24 weeks was ‘good’ to ‘excellent’ in more than 97% of the subjects as per the assessment by the physician. A total of 59 adverse events were observed in 43 (8.9%) subjects. Headache was the most common adverse event being recorded in 8 subjects, followed by somnolence, nausea, vomiting, skin rash and weight gain. The overall tolerability of Trioptal® as per assessment by the patients was ‘good’ to ‘excellent’ in more than 98% of the subjects. Conclusion: Trioptal® (Oxcarbazepine) treatment is effective, safe and well tolerable in children and adolescents with newly diagnosed partial seizures or generalized tonic-clonic seizures.

Efficacy and Tolerability of GenTeal® Gel in Post-menopausal Women with Moderate to Severe Dry Eye: Results of a Post Marketing Observational Study.

Purpose: To assess the effectiveness and tolerability of GenTeal® gel in post-menopausal patients with moderate to severe dry eye. Methods: This was an open label, multicenter, non-comparative, non-interventional, observational study in post-menopausal women patients of age 39-82 years with moderate to severe dry eye. The patients were treated with GenTeal® gel for 20 weeks and assessed for effectiveness at baseline, 10-12 weeks and at 20 weeks. The primary effectiveness outcomes were changes in ocular symptoms (foreign body sensation, itching, burning, watering, photophobia, feeling of dryness in the eye), tear break up time (TBUT), Schirmer, fluorescein corneal staining score and global assessment for efficacy on dry eye condition. The secondary objective of the study was to evaluate ocular tolerance and systemic safety of the product. Results: A total of 169 out of 170 enrolled patients completed the study. At 20 weeks of treatment, the median composite ocular symptoms scores was reduced by 78% from baseline (median; 2.0 vs 9.0 of baseline, p<0.0001). All ocular symptoms except photophobia were significantly reduced (p<0.05) at 20 weeks of treatment. At 20 weeks, TBUT and schirmer scores were significantly increased by 39.9% and 48.6% respectively (p < 0.0001); while fluorescein staining cumulative score was significantly decreased (100.0%, p < 0.0001) from their baseline. The overall efficacy and ocular tolerability of GenTeal® gel, was ‘good’ to ‘excellent’ for >98.0% of the subjects. Adverse events of mild dyspepsia and frequent micturition of moderate intensity were reported by a subject. Conclusions: The findings of the present study indicate that GenTeal® gel treatment is an effective and tolerable treatment for dry eye in post-menopausal women patients in Indian clinical practice.