Background: Evenamide, a glutamate modulator, is currently in phase 3 of development as add-on treatment to antipsychotics in patients with inadequate response or treatment-resistant schizophrenia. This study was designed to determine if patients with chronic schizophrenia inadequately responding to a second-generation antipsychotic would benefit from add-on treatment with evenamide at a dose of 30 mg bid.
Methods: Study 008A was a prospective, 4-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of oral doses of evenamide of 30 mg bid in patients with chronic schizophrenia treated at stable therapeutic doses of a second-generation antipsychotic.
The results from a pilot, 1-year, randomized, open-label, add-on treatment study in treatment-resistant schizophrenia (TRS) with evenamide, a glutamate modulator, were not associated with any safety abnormalities at all doses (7.5-30 mg bid), with a high retention rate even at 6-month (~85%), and 1-year (~75%), and the absence of psychotic relapses during the 1-year treatment period. Overall, treatment with evenamide showed a gradual, sustained, and clinically important improvement up to 1 year in all efficacy measures (eg, PANSS mean change ~ -20%; CGI-S mean change ~ -1.
View Article and Find Full Text PDFIn the last two decades, air pollution has increased throughout India resulting in the deterioration of air quality. This paper estimates the prevalence of self-reported asthma in women aged 15-49 years and examines the link between outdoor air pollution and disease prevalence in India by combining satellite data on particulate matter (PM2.5) and the National Family Health Survey (NFHS-4), 2015-16.
View Article and Find Full Text PDFResults from a pilot, 6-week, randomized, open-label, rater-blinded study, with 46-week extension, indicate very good tolerability with exceptional, clinically important, increasing efficacy of evenamide (7.5, 15, and 30 mg bid), a glutamate modulator, as add-on treatment to antipsychotics in 161 treatment-resistant, schizophrenia patients. Ninety-five percent of patients completed 6 weeks (1 discontinued for adverse event), and 89% continued in the extension.
View Article and Find Full Text PDFThe submental artery island flap has been used for reconstruction of mild to moderate size oral defects after resection despite its controversy of oncological safety.Our study aims to assess the efficiency and oncological safety of submental artery flap in oral reconstruction.Twenty-three oral cancer patients who underwent resection and reconstruction using the submental artery island flap at State Cancer Institute, Guwahati, India, between February 2021 and February 2022 were retrospectively studied for the flap viability, complications, and function and locoregional recurrence.
View Article and Find Full Text PDFBackground & Objectives: In India, the burden of Plasmodium vivax malaria has been projected to be highest in some areas. This study investigated the efficacy and safety of fixed dose combination (FDC) of arterolane maleate (AM) 37.5 mg and piperaquine phosphate 187.
View Article and Find Full Text PDFAims: The aim of this study was to evaluate the accuracy of minimum lumen area (MLA) by coronary computed tomography angiography (cCTA) and its impact on fractional flow reserve (FFRCT).
Methods And Results: Fifty-seven patients (118 lesions, 72 vessels) who underwent cCTA and optical coherence tomography (OCT) were enrolled. OCT and cCTA were co-registered and MLAs were measured with both modalities.
Appl Health Econ Health Policy
June 2018
Background: The burden from non-communicable diseases and injuries (NCDI) in India is increasing rapidly. With low public sector investment in the health sector generally, and a high financial burden on households for treatment, it is important that economic evidence is used to set priorities in the context of NCDI.
Objective: Our objective was to understand the extent to which economic analysis has been used in India to (1) analyze the impact of NCDI and (2) evaluate prevention and treatment interventions.
Background: Administration of artemisinin-based combination therapy (ACT) to infant and young children can be challenging. A formulation with accurate dose and ease of administration will improve adherence and compliance in children. The fixed-dose combination dispersible tablet of arterolane maleate (AM) 37.
View Article and Find Full Text PDFMalar J
January 2016
Background: Chloroquine has been the treatment of choice for acute vivax malaria for more than 60 years. Malaria caused by Plasmodium vivax has recently shown resistance to chloroquine in some places. This study compared the efficacy and safety of fixed dose combination (FDC) of arterolane maleate and piperaquine phosphate (PQP) with chloroquine in the treatment of uncomplicated vivax malaria.
View Article and Find Full Text PDFBackground: The World Health Organization (WHO) recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated Plasmodium falciparum malaria. The present study investigated the efficacy and safety of fixed dose combination (FDC) of arterolane maleate 37.5 mg and piperaquine phosphate (PQP) 187.
View Article and Find Full Text PDFBackground: Artemisinin-based combination therapy is the first-line treatment for uncomplicated falciparum malaria. This study assessed the antimalarial efficacy and safety of a combination of 150 mg of arterolane maleate and 750 mg of piperaquine phosphate (AM-PQP) in comparison to Coartem (artemether and lumefantrine) in patients with acute uncomplicated P. falciparum malaria.
View Article and Find Full Text PDFArterolane (RBx 11160) maleate is a novel, rapidly acting synthetic trioxolane antimalarial compound being developed by Ranbaxy Research Laboratories (Haryana, India). It is presently under phase III in combination with piperaquine phosphate. The present work reports the relationship between pharmacokinetic (PK) parameter (AUC(0-8h) on day 0/day 6) and indices of pharmacodynamic (PD) response (50% parasite clearance [PC(50)], 90% parasite clearance [PC(90)], parasite clearance time [PCT], recrudescence) from a phase II, double-blind, multicenter, randomized, parallel-group, dose-ranging trial.
View Article and Find Full Text PDFClin Infect Dis
September 2010
Background: Drug-resistant Plasmodium falciparum malaria necessitates development of novel drugs for treatment.The present study assessed the efficacy and safety of 3 dose levels of arterolane (RBx 11160), a synthetic trioxolane, for treatment of acute uncomplicated falciparum malaria.
Methods: In this randomized, double-blind, multicenter, parallel-group, dose-finding, phase II trial, 230 patients from 4 centers in Thailand, India, and Tanzania (mainland and Zanzibar) received either 50 mg (n=78), 100mg (n=76), or 200 mg (n=76) of arterolane once daily for 7 days.
Background: Uncomplicated skin and skin structure infections (uSSSI) are commonly encountered community-acquired infections and are typically confined to the superficial layers of the skin. Hence, they seldom lead to the destruction of skin structures.
Aims: To evaluate the efficacy and tolerability of cefditoren pivoxil in uSSSI in Indian patients.