Effectiveness of Oral Cephalexin-Clavulanic Acid, Cefuroxime, and Amoxicillin-Clavulanic Acid in the Management of Dental Infections: A Real-World, Retrospective, Electronic Medical Record-Based Study in India.

Background: Despite multiple antibiotics being available to manage dental infections (DI), there is lack of data comparing commonly prescribed antibiotics in India.

Objectives: The aim of this study was to evaluate the real-world effectiveness and tolerability of cephalexin-clavulanic acid fixed-dose combination (cephalexin CV FDC) in contrast with amoxicillin-clavulanic acid (co-amoxiclav FDC) and cefuroxime among patients with dental infections (odontogenic) in India.

Methods: This retrospective, multi-centric, observational, real-world electronic medical record (EMR)-based study was conducted between January 2022 and December 2022.

Fixed-Dose Combination of Dapagliflozin + Sitagliptin + Metformin in Patients with Type 2 Diabetes Poorly Controlled with Metformin: Phase 3, Randomized Comparison with Dual Combinations.

Introduction: This study compared efficacy and safety of triple drug fixed-dose combination (FDC) of dapagliflozin (DAPA) + sitagliptin (SITA) + metformin (MET) extended release (ER) with SITA + MET sustained release (SR) and DAPA + MET ER in patients with type 2 diabetes poorly controlled with metformin.

Methods: This phase 3, randomized, open-label, active-controlled study included adult patients with glycated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) and ≤ 11% (97 mmol/mol), randomized in 1:1:1 ratio to receive either FDC of DAPA + SITA + MET ER (10 mg + 100 mg + 1000 mg) tablets once daily (n = 137) or co-administration of SITA + MET SR (100 mg + 1000 mg) tablets once daily (n = 139) or FDC of DAPA + MET ER (10 mg + 1000 mg) tablets once daily (n = 139). Primary endpoint was mean change in HbA1c from baseline to week 16.

Efficacy and Safety of Pregabalin Prolonged Release-Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase 3, Randomized Study.

Introduction: Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg-etoricoxib 60 mg to address both pain components.

Methods: This randomized phase 3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP.

Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study.

Introduction: Partial meal replacement (PMR) offers potential glycemic and weight control benefits in type 2 diabetes mellitus (T2DM) patients. We evaluated the clinical impact of PMR (diabetes-specific nutritional supplement [DSNS]) in overweight/obese Indian patients with T2DM.

Methods: PRIDE, a 12-week, phase IV, open-label, multicenter study randomized (1:1) newly diagnosed T2DM patients (≤ 1 year) to either DSNS plus standard of care (SOC; diabetes treatment with dietary counseling) group (PMR) or SOC alone group (SOC).

Clinical safety and pharmacokinetic evaluation of aqueous extract of an anti-viral phytopharmacetical drug as a potential for the treatment of dengue and COVID-19.

Background And Aim: Dengue a worldwide concern for public health has no effective vaccine or drug available for its prevention or treatment. There are billions of people who are at risk of contracting the dengue virus (DENV) infections with only anti-mosquito strategies to combat this disease. Based on the reports, particularly in vitro studies and small animal studies showing anti-viral activity of aqueous extract of (AQCH), studies were conducted on AQCH tablets as a potential for the treatment of dengue and COVID-19 infections.

Efficacy and Safety of a Phytopharmaceutical Drug Derived from Cocculus hirsutus in Adults with Moderate COVID-19: a Phase 2, Open-label, Multicenter, Randomized Controlled Trial.

Introduction: There is an urgent need for an effective, oral therapy for COVID-19. Purified aqueous extract of Cocculus hirsutus (AQCH) has shown robust antiviral activity in in vitro studies. We aimed to evaluate the efficacy and safety of AQCH plus standard of care in hospitalized patients with moderate COVID-19.

Arrive: A retrospective registry of Indian patients with venous thromboembolism.

Background And Aim: There is lack of substantial Indian data on venous thromboembolism (VTE). The aim of this study was to provide real-world information on patient characteristics, management strategies, clinical outcomes, and temporal trends in VTE.

Subjects And Methods: Multicentre retrospective registry involving 549 medical records of patients with confirmed diagnosis of VTE (deep vein thrombosis [DVT] confirmed by Doppler ultrasonography; pulmonary embolism [PE] by computed tomography, pulmonary angiography and/or V/Q scan) from 2006 to 2010 at three Indian tertiary care hospitals.

A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis.

Introduction: Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis.

A Questionnaire-Based Survey of Indian ENT Surgeons to Estimate Clinic Prevalence of Acute Otitis Media, Diagnostic Practices, and Management Strategies.

Acute otitis media (AOM) is common in Indian children, but there is limited published information on its clinic prevalence, clinicians' diagnostic practices, and their management strategies. We approached 649 ear-nose-throat (ENT) surgeons to assess these aspects of AOM. We conducted the survey between May 2010 and February 2011 with the same set of ENT surgeons practising across India, once each during summer, monsoon and winter, using a validated 36-item questionnaire to record their reflective recall.

Rationalizing antibiotic use to limit antibiotic resistance in India.

Antibiotic resistance, a global concern, is particularly pressing in developing nations, including India, where the burden of infectious disease is high and healthcare spending is low. The Global Antibiotic Resistance Partnership (GARP) was established to develop actionable policy recommendations specifically relevant to low- and middle-income countries where suboptimal access to antibiotics - not a major concern in high-income countries - is possibly as severe a problem as is the spread of resistant organisms. This report summarizes the situation as it is known regarding antibiotic use and growing resistance in India and recommends short and long term actions.