Safety and Efficacy of Nimesulide/Paracetamol Fixed-dose Combination in Acute Pain (SAFE Study)

Background: Nimesulide shows preferential inhibition for the cyclooxygenase-2 (COX-2) enzyme, which blocks the formation of prostaglandins critical in pain and inflammatory pathways. Few studies in the past have reported rare and unpredictable hepatic effects with nimesulide. The present study aimed to evaluate the efficacy and safety of nimesulide/paracetamol (100 mg + 325 mg) fixed-dose combination twice a day for 2 weeks in the management of acute pain in Indian population. Materials and methods: This was a multicenter study, performed on 500 patients, by 24 experienced physicians across India. The primary outcome assessed clinical safety at 2 weeks for mild/serious adverse effects (AEs), change in liver function tests (LFTs), serum bilirubin and alkaline phosphatase levels. The secondary outcomes assessed the clinical effectiveness in reduction of pain at rest and at movement. Results: Analysis of LFT at 2 weeks showed a slight increase (mean change) in the aspartate transaminase {-0.73 [95% confidence interval (CI) -1.54, 0.09; p = 0.081]}, alanine transaminase [-1.73 (95% CI -2.82, -0.64; p = 0.002)], serum bilirubin [-0.02 (95% CI -0.04, -0.001; p = 0.018)] and alkaline phosphatase levels [-1.92 (95% CI -5.84, 2; p = 0.336), not exceeding the normal range. Only one in 500 patients reported AEs. The numerical rating scale (NRS) scores for intensity of pain at rest and at movement at 2 weeks, ≤7 days and >7 days were 68.38%, 68.44% and 68.39%; and 65.43%, 64.60% and 66.02%, respectively. An improvement of 96.6% was observed in patient global assessment scale (GAS) and 97.2% in physician GAS. Conclusion: Nimesulide/paracetamol combination was safe, effective and well-tolerated in acute pain conditions and did not lead to clinically significant changes in liver parameters indicating hepatic safety

Osmotic controlled drug delivery system (OSMO technology) and its impact on diabetes care

Recently, focus on the development of controlled release drug delivery system has increased, as existing drugs exhibit certain pharmacokinetic limitations. The major goal of designing sustained release formulations is to improve the drug performance by prolonged duration of drug action, decreased frequency of dosing and reduced side effects by using smallest quantity of drug administered by the most suitable route. Osmotic-controlled release oral delivery system (OSMO technology) is the most promising strategy based system for sustained delivery of drug. Drug can be delivered in a controlled manner over a long period of time by the process of osmosis. Osmotic drug delivery system appears to be a promising solution for the limitations of conventional extended release formulations by virtue of their distinguished technological features. The present review describes briefly about various controlled drug delivery systems with special focus on advantages of osmotic-controlled release oral delivery system related to diabetes therapy and improved compliance

Hypertension clinical care in the era of coronavirus disease 2019: Practical insights from India

Objective: The objective of this study was to seek the opinion of Indian health-care professionals (HCPs) about hypertension (HTN) care during coronavirus disease 2019 (COVID-19) era. Methods: HCPs' opinions (n = 2832) were recorded based on survey and round table meetings. Standard questionnaire consisting of nine questions pertaining to HTN care in COVID-19 was prepared, discussed, and evaluated by experts who treat patients with HTN during COVID-19 era. Results: Smoking/tobacco use, obesity, and comorbidities (diabetes/dyslipidemia) were ranked as the top three modifiable risk factors. A total of 37% and 33% of HCPs reported an increase in blood pressure (BP) during the lockdown period in 10%–20% and 20%–40% of hypertensive patients, respectively, who were on monotherapy. Around 35% of HCPs reported that 20%–30% of their patients with HTN showed uncontrolled BP (>150/100 mmHg). Dual-drug therapy in patients with uncontrolled BP was preferred by 56% of HCPs. Nearly 71% preferred dual combination for HTN management. In dual combination, 27% preferred angiotensin receptor blockers (ARBs) + diuretic, 26% preferred ARB + calcium channel blockers, and 18% preferred ARB + beta-blockers. The majority of HCPs (44%) consider that <30% of their patients with HTN check BP at home. A total of 47% of HCPs reported acute coronary syndrome as the most common HTN-related complication. The majority of HCPs (57%) considered that avoiding contamination during BP measurement is the challenging parameter. Around 32% considered self-BP monitoring (SBPM) as the best method to improve medication adherence. Conclusion: SBPM, combination therapies, and digital connect with patients are critical aspects of HTN management during COVID-19 pandemic

Quantifying Remission Probability in Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a chronic progressive disorder and is associated with significant morbidity and mortality. The concept of T2DM remission and the reversal of diabetic parameters to normal levels has been gaining momentum over the past years. T2DM remission is increasingly being recognized by various global guidelines. Multiple models have been developed and validated for quantifying the extent of remission achieved. Based on favorable clinical evidence, T2DM remission can be considered as the therapeutic goal in diabetes management and, in select cases, as an alternative to expensive treatment options, which can be burdensome as T2DM progresses. This narrative review discusses the available strategies, such as lifestyle interventions, physical activity, bariatric surgery, medical nutrition therapy, and non-insulin glucose-lowering medications, for achieving T2DM remission. Although the concept of T2DM remission has emerged as a real-world option, effective implementation in routine clinical practice may not be feasible until long-term studies prove the efficacy of different approaches in this regard

Intermittent Use of Continuous Glucose Monitoring: A New Paradigm in Treatment of Type 2 Diabetes

Objectives: To suggest how continuous glucose monitoring (CGM) may be used intermittently in individuals with type 2 diabetes (T2D). Materials and methods: The use of CGM is largely in those with type 1 diabetes (T1D), in whom it makes sense to use CGM continuously as CGM provides a valuable tool to not only adjust their insulin doses but also to match it with their diet, physical activity, and other lifestyle modifications. In the case of T2D, however, especially for those not on insulin, the use of CGM may not be needed on a continuous basis. The use of CGM on an intermittent basis is rarely discussed in the literature. This article tries to provide clinical situations where CGM can be used intermittently. Results: Intermittent use of CGM defined as the “use of CGM once in 2 or 3 months or a fixed frequency,” and may be useful in several situations in those with T2D. We suggest the following indications for the intermittent use of CGM in T2D—newly diagnosed patients where treatment is being started, uncontrolled diabetes where treatment is being altered, starting intensive lifestyle modification, during infections, during preoperative control, in children and adolescents with T2D, as a motivational tool to improve behavioral modification, after metabolic surgery, and in patients on steroids, apart from other indications. Conclusion: Intermittent use of CGM in T2D can be useful in special situations and can also be cost saving particularly in resource-constrained regions of the world.</p

Diagnosis and Management of Hypothyroidism: Addressing the Knowledge-Action Gaps

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