Phase IV Studies: What Clinicians Need to Know!

Phase IV trials, also known as postmarketing safety and efficacy studies and postmarketing surveillance (PMS) studies, occur after a drug or medical device has received regulatory approval and is available in the market. These trials are designed to collect additional information regarding the product's safety, efficacy, and prolonged effects in a larger and more diverse patient population. The foremost goal of phase IV trials is to detect any rare or long-term adverse effects that may not have been identified during the prior phases of clinical development.

Naftifine: A Topical Allylamine for Superficial Dermatophytosis.

Dermatophytosis is a very common public health problem with high prevalence. Dermatophytes are a highly specialized set of filamentous fungi, which are adapted to keratinized tissues of humans and animals. Dermatophytosis is the most common fungal infection worldwide, affecting approximately 20-25% of the world's population.

Current Role of Dapagliflozin in Clinical Practice.

Dapagliflozin is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors which was approved by USFDA in management of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise to improve glycemic control in adults initially, followed by to reduce the risk of hospitalization for heart failure (HHF) in adults with T2DM and established cardiovascular disease or multiple cardiovascular risk factors. Most recently, it is approved to reduce the risk of cardiovascular death and in adults with heart failure (HF) with reduced ejection fraction (NYHA class II-IV). Dapagliflozin has been studied in a wide range of patients with diabetes and plethora of evidence has confirmed its efficacy as a monotherapy as well as an add-on to the oral therapies and insulin, when compared to placebo.

Clinical Evidence of Evogliptin plus Metformin in Management of Type 2 Diabetes mellitus.

Achieving adequate glycemic control in type 2 diabetes mellitus (T2DM) remains a difficult but achievable goal. Oral agents (OADs) are important option for management of T2DM. Most T2DM patients require more than one medication for adequate glycemic control.

Arbekacin - A Novel Antibiotic for Critical Infections.

Antibiotic resistance is one of the biggest menace to global health. Deaths from Drug-resistant infections is set to escalate exponentially. Pipeline for new antibacterials is almost empty.

Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin: A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study.

Aim: This study aimed to assess efficacy and safety of evogliptin versus sitagliptin, when added to background metformin therapy in Indian patients with uncontrolled type 2 diabetes.

Method: Overall, 184 patients with uncontrolled type 2 diabetes (7% ≤ HbA < 10%) receiving ≥8 weeks of stable metformin monotherapy (≥1 g/day), were randomized to receive add-on treatment (evogliptin 5 mg or sitagliptin 100 mg) for 24 weeks. Primary endpoint was change in HbA from baseline to 12 weeks (non-inferiority margin: <0.

Dabigatran - the First Approved DTI for SPAF.

Atrial fibrillation (AF) is commonly occurring arrhythmia in clinical practice. AF is easy to recognize but difficult to treat. Stroke is the most devastating complication of AF and is associated with a huge disease burden on the society.

A Study of salt and fat Consumption pattern in Regional Indian diet among hypertensive and dyslipidemic PaTients - SCRIPT study.

Background: Cardiovascular diseases are leading cause of mortality and morbidity. There is an increasing prevalence of hypertension and dyslipidemia due to globalization and adoption of westernized dietary habits in India. These transitions are manifest in dietary patterns and health outcomes.

Management Practices in Indian Patients with Uncontrolled Hypertension.

Introduction: Hypertension (HTN), being a major risk factor for cardiovascular diseases (CVDs), is an important issue of medical and public health. High blood pressure (BP) is ranked as the third most important risk factor for attributable burden of disease in south Asia (2010). Hypertension (HTN) exerts a substantial public health burden on cardiovascular health status and healthcare systems in India.

DemographIc Assessment and EValuation of DEgree of Lipid Control in High Risk Indian DySlipidemia PatiEnts (DIVERSE Study).

Background: Cardiovascular diseases (CVD's) are the major cause of morbidity and mortality in both developed and developing countries. Many clinical trials have demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, reduces the incidence of coronary and cerebrovascular events across a broad spectrum of patients at risk. Guidelines for the management of patients at risk have been established in Europe and North America.

Acenocoumarol: A Review of Anticoagulant Efficacy and Safety.

Anticoagulant treatment is required for the treatment and prevention of thromboembolic disorders. Vitamin K antagonists are commonly used oral anticoagulants worldwide. Acenocoumarol is mono-coumarin derivative with racemic mixture of R (+) and S (-) enantiomers.

Fondaparinux in Acute Coronary Syndromes.

Anticoagulant therapy is a major component in the management of acute coronary syndromes (ACS). Anticoagulant-associated adverse events like heparin-induced thrombocytopenia, bleeding complications and need of close monitoring of anticoagulation led to focus on developing agents causing anticoagulation without affecting primary haemostasis. Fondaparinux, a new-age synthetic anticoagulant, acts by inhibiting factor Xa.