Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (the world’s first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO). Methods: The data on patients with RVO who had received ≥3 injections of Razumab® between January and August 2016 were analyzed. Endpoints were: improvement in best corrected visual acuity (BCVA), and a decrease in central macular thickness (CMT), intraretinal fluid (IRF), and subretinal fluid (SRF) from baseline at weeks 4, 8, and 12. Results: Of 160 patients, the majority (61.87%) were men. The mean (±SE) BCVA improved from baseline (0.76 ± 0.04) to week 4 (0.73 ± 0.03; p = 0.0656), which attained significance at week 8 (0.55 ± 0.02; p < 0.0001) and week 12 (0.47 ± 0.02; p < 0.0001). The mean (±SE) CMT significantly decreased from baseline (447.60 ± 10.91 μm) to week 4 (431.84 ± 10.92 μm; p = 0.0028), week 8 (339.28 ± 8.12 μm; p < 0.0001), and week 12 (298.23 ± 6.68 μm; p < 0.0001). The proportion of patients with IRF and SRF significantly (p < 0.0001) decreased from baseline to weeks 4, 8, and 12 (IRF: from 70.63 to 45.63, 39.38, and 30.00%, respectively; SRF: from 65.63 to 37.50, 28.13, and 24.38%, respectively). A subgroup analysis of branch RVO and central RVO showed similar results. No new safety concerns were observed. Conclusion: Razumab® (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns.

Introduction: The REal life assessmENt of safety And effeCTiveness of Razumab (RE-ENACT) and long-term RE-ENACT 2 retrospective studies have evaluated the use of Razumab TM (world's first biosimilar ranibizumab) in retinal disorders in Indian patients. This report presents the subgroup analysis from the RE-ENACT 2 study in patients with wet age-related macular degeneration (wet AMD). Methods: Medical charts of patients administered biosimilar ranibizumab injections as PRN treatment regimen between September 2015 and June 2018, at 17 centers across India, were reviewed. Changes from baseline in best-corrected visual acuity (BCVA, based on Snellen's or logMAR chart), central subfield thickness (CSFT), intraocular pressure (IOP), and

A strong inverse relationship existed between gestational age of 30 weeks or younger and birth weight of 1,500 g or less and LOS. Resuscitation and indwelling intravenous catheters were also risk factors.

The results document significant taste losses in HIV-infected subjects, and HAART contributes considerably to such taste perversion.

Purpose The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO). Methods Data of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen’s/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48. Results Of 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1–5) injections (53.5%). Significant improvements ( P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 ( n = 94); week 48, 0.41 ± 0.08 ( n = 14)] and CSFT [baseline, 527.58 ± 19.9 ( n = 85); week 48, 307.47 ± 16.4 ( n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 ( n = 94); week 48, 13.94 ± 0.6 ( n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% ( n = 84) vs week 48, 0% ( n = 15)] and SRF [baseline, 52.5% ( n = 83) vs week 48, 0% ( n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns. Conclusions Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns. Electronic supplementary material The online version of this article (10.1007/s40123-020-00277-3) contains supplementary material, which is available to authorized users.

Objectives:Squamous cell carcinoma is the most common oral cancer. Radiotherapy with concomitant chemotherapy is an ideal treatment modality largely used for oral cancers, which precipitates many side effects, of which the most challenging and debilitating side effect is xerostomia. This study aimed to evaluate the efficacy of bethanechol in patients with xerostomia following chemoradiation therapy for oral cancer.Materials and Methods:Fifty patients with xerostomia postchemoradiation therapy, aged between 30 and 65 years, were selected based on selection criteria. Thirty patients in the study group were administered 25 mg bethanechol three times daily (TDS) and 20 patients in the control group with placebo capsules. The subjective symptoms of oral dryness were periodically evaluated at baseline, at the end of 1st, 2nd and 3rd weeks using a self-reported questionnaire. Salivary analysis such as whole resting saliva and whole stimulated saliva (WSS) volumes, amylase, pH and sodium potassium ratio were evaluated before and 3 weeks after bethanechol and placebo therapy.Results:Twenty-four (80%) patients in bethanechol group and only 2 (10%) patients in control group showed subjective improvement in oral dryness at the end of 3rd week. A significant difference was found between two groups in whole resting and stimulated saliva volume, pH and amylase. However, there was no statistically significant difference in sodium potassium ratio with insignificant adverse effects after 3 weeks of bethanechol therapy.Conclusions:25 mg bethanechol (TDS) has shown subjective improvement in oral dryness in 24 (80%) patients with significant improvement in whole resting and WSS volumes, pH and salivary amylase with insignificant adverse effects.

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Objective Antihyperglycemic activity of Thymoquinone (TQ) was evaluated in diabetic mouse model and patients. Methods TQ (50 mg/kg) was orally administered daily for 21 days in combination with metformin in diabetic mice and a reduction on blood glucose level was monitored. In human, a 90-day randomized study was carried out in 60 Type 2 Diabetes mellitus patients to evaluate safety and efficacy of TQ administration with metformin in a 3-arm study. Patients in arm 1 (T1) received 1 tablet of metformin SR 1000 mg and 1 tablet of TQ 50 mg once daily. The second arm (T2) patients received 1 tablet of metformin SR 1000 mg and 2 tablets of TQ 50 mg once daily. Patients in arm 3 (R) received 1 tablet of metformin SR 1000 mg only. Results The diabetic mice treated with combination of TQ and metformin showed significant decrease in blood sugar compared to those treated with only metformin. In patients who completed the study, the glycated hemoglobin (HbA1c) values in T1, T2 and R decreased after 3 months from 7.2, 7.2 and 7.3 to 6.7, 6.8, and 7.1, respectively. A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R. Conclusion At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.