Real world evidence is important as it complements data from randomised controlled trials (RCTs). Both have limitations in design, interpretation, and extrapolatability. It is imperative one designs real world studies in the right way, else it can be misleading. An RCT is always considered higher in the evidence ladder and when there is discordance between a real world study and an RCT, it is the latter which is always considered pristine because of the way it is conducted, e.g., randomization, prospective, double-blind, etc. A real world study can also be done prospectively, and propensity score matching can be used to construct comparable cohorts but may not be able to account for certain biases or confounding factors the way an RCT can do. Nevertheless, comparative effectiveness research in the real world is being resorted to, especially for efficiency studies or pharmacoeconomic analyses, and with the advent of machine learning, the electronic healthcare database mining can result in algorithms that help doctors identify clinical characteristics that correlate with optimal response of a patient to a drug/regimen, thus helping him/her select the right patient for the right drug.

Overall, the financial burden associated with medical care for patients with stroke with atrial fibrillation along with rehabilitation and long-term care costs places a significant demand on health services in India.

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Public expenditure on healthcare in India is low by international comparison, and access to essential treatment pushes many uninsured citizens below the poverty line. In many countries, policymakers utilize health technology assessment (HTA) methodologies to direct investments in healthcare, to obtain the maximum benefit for the population as a whole. With rising incomes and a commitment from the Government of India to increase the proportion of gross domestic product spent on health, this is an opportune moment to consider how HTA might help to allocate healthcare spending in India, in an equitable and efficient manner. Despite the predominance of out-of-pocket payments in the Indian healthcare sector, payers of all types are increasingly demanding value for money from expenditure on healthcare. In this review we demonstrate how HTA can be used to inform several aspects of healthcare provision. Areas in which HTA could be applied in the Indian context include, drug pricing, development of clinical practice guidelines, and prioritizing interventions that represent the greatest value within a limited budget. To illustrate the potential benefits of using the HTA approach, we present an example from a mature HTA market (Canada) that demonstrates how a new treatment for patients with atrial fibrillation — although more expensive than the current standard of care — improves clinical outcomes and represents a cost-effective use of public health resources. If aligned with the prevailing cultural and ethical considerations, and with the necessary investment in expert staff and resources, HTA promises to be a valuable tool for development of the Indian healthcare sector.

Background and Objectives:Empagliflozin, a sodium glucose cotransporter-2 inhibitor, was recently evaluated in a randomized, controlled trial (RCT) in drug-naïve Type 2 diabetes mellitus (T2DM) patients managed on diet and exercise therapy. Efficacy and safety of empagliflozin in Indian subgroup of patients from a 76-week extension study of the initial multicentric RCT are reported in this article.Materials and Methods:In this study, patients were randomized to empagliflozin 10 mg (E10, n = 24), empagliflozin 25 mg (E25, n = 29), placebo (n = 28) and sitagliptin 100 mg (S100, n = 27). Exploratory efficacy endpoints were changed from baseline to week 76 in glycosylated hemoglobin (HbA1c, %) and fasting blood glucose (mg/dL) along with body weight (kg) and blood pressure (BP) (mmHg) reduction. Safety analysis included clinically relevant adverse events (AEs).Results:In 108 randomized patients, adjusted mean reduction in HbA1c compared to placebo was significant with E10 (−0.81, 95% confidence interval (CI) −1.33, −0.28; P = 0.0029) and E25 (−1.11, 95% CI − 1.60, −0.61; P < 0.0001). HbA1c below 7% at week 76 was achieved in significantly higher number of patients with E10 (20.8%, P < 0.0001) and E25 (28.0%, P < 0.0001). There was significant reduction in adjusted mean weight as compared to placebo with E10 (−1.41, 95% CI − 2.51, −0.31; P = 0.0125) and E25 (−1.50, 95% CI − 2.54, −0.46; P = 0.0051) but nonsignificant with S100 (−0.75 95% CI − 1.86, −0.36; P = 0.1842). BP reduction was numerically higher with empagliflozin compared to placebo. AEs were similar in all treatment groups except for genital infections which were more common in E10 (20.8%) but not in E25 (3.4%) as compared to placebo (3.6%). All treatments were well tolerated with no severe AEs.Conclusion:Treatment with empagliflozin was well tolerated and resulted in sustained glycemic efficacy over long-term (76 weeks) in drug-naïve Indian T2DM patients.