Background At the peak of the coronavirus disease 2019 (COVID-19) pandemic, the need for an orally administered agent to prevent the progression of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection became increasingly evident, which was the impetus behind our investigations with molnupiravir. Molnupiravir has been shown to be effective in preventing hospitalizations and/or clinical complications in patients with mild-to-moderate COVID-19. In this study, we evaluate the efficacy and safety of molnupiravir in Indian patients with mild SARS-CoV-2 infection and at least one risk factor for disease progression (CTRI/2021/05/033739).
View Article and Find Full Text PDFBackground: Acotiamide is a novel prokinetic drug that acts by enhancing the release of acetylcholine and is used in the treatment of functional dyspepsia-postprandial distress syndrome (FD-PDS). Mosapride is indicated to FD-PDS as per the Rome III treatment guidelines. Mosapride 5 mg three times daily (TID) is approved by the Drugs Controller General of India (DCGI) for the treatment of FD-PDS.
View Article and Find Full Text PDFBackground Depression is a leading cause of psychiatric morbidity in the modern world, and the introduction of selective serotonin reuptake inhibitors (SSRIs) is a revolution in the treatment of depression. Vilazodone, a novel SSRI and 5-HT1A partial agonist, received FDA approval in 2011 to treat the major depressive disorder (MDD) in adults. This study conducted in India aimed to evaluate the efficacy and safety of vilazodone when compared to escitalopram or placebo in patients with MDD.
View Article and Find Full Text PDFBackground This post-marketing surveillance (PMS), observational, prospective, safety study evaluated the safety, tolerability, and long-term immunogenicity of prescribed usage of Darbepoetin alfa (DA-α, manufactured by Hetero Biopharma, Hyderabad, India) in Indian patients having chronic kidney disease (CKD) with anemia. Methods All patients having chronic kidney disease with anemia and prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients.
View Article and Find Full Text PDFCureus
April 2021
Background: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS.
Methods: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks.
Background: Globally, women and men over the age of 25 years suffer from hypertension, the need for new treatment strategies to treat hypertension is due to the multi-faceted nature of the disease. Lack of optimal blood pressure control can lead to multiple complications. Therefore, this phase 3 study was conducted to assess the efficacy, safety and tolerability of potential product azilsartan hydrochloride for reduction in blood pressure in Indian patients with essential hypertension.
View Article and Find Full Text PDFBMC Rheumatol
June 2020
Following publication of the original article [1], the authors reported errors in the presentation of Tables 2, 4 and 5.
View Article and Find Full Text PDFJ Assoc Physicians India
June 2018
Objective: :To compare efficacy and safety of a biosimilar, Bevacizumab (Hetero) vs reference medicinal product (Bevacizumab, Roche) as first line therapy in patients with metastatic colorectal cancer (mCRC) in combination with chemotherapy.
Methods: Patients of aged 18 to 65 with histologically pre-confirmed mCRC and treatment naïve with unresectable metastatic disease or distant metastases were enrolled and randomized to receive either Hetero-Bevacizumab or RMPBevacizumab along with chemotherapy (XELOX or FOLFOX-4) regimen over a period of 24 weeks (up to 8 cycles of Hetero-Bevacizumab/RMP-Bevacizumab+ XELOX regimen (each cycle of 3 weeks) or up to 12 cycles of Hetero-Bevacizumab/ RMP-Bevacizumab + FOLFOX-4 regimen (each cycle of 2 weeks). Bevacizumab was administered at 7.
Background: Darbepoetin alfa (DA-α) is a long-acting erythropoiesis-stimulating glycoprotein which has half-life three-fold longer than that of Erythropoietin alfa (EPO). The objective of this study was to compare the efficacy and safety of DA-α injection versus EPO for treating renal anemia amongst Indian patients with end-stage renal disease (ESRD) undergoing dialysis.
Methods: Patients of either gender (aged 18-65 years) with ESRD undergoing dialysis who had hemoglobin (Hb) levels < 10 g/dL after receiving EPO were switched to DA-α (0.