Real-world safety assessment of SGLT2 inhibitors: an observational study in diverse patient population

Objectives of the study:

·       To evaluate serious and non-serious adverse effects of SGLT2 inhibitors in diabetic and non-diabetic population.

·       To analyze the usage of SGLT2 inhibitors as per prescription in diabetic and non-diabetic population.

This is a Prospective longitudinal study that has been obtained approval from the Institutional Ethics Committee(IEC) and study will commence after clearance from the Clinical Trials Registry of India (CTRI). The inclusion criteria includes patients initiating medication with Sodium-Glucose Co-Transporter-2 inhibitors (SGLT2i). Both inpatients and outpatients from Cardiology and Endocrinology departments will be recruited after obtaining a written informed consent and observed for a minimum of 6 months if any potential adverse drug reactions occurs based on the proforma and assessment scales such as Naranjo’s scale, Hartwig’s severity assessment scale and Modified Schumock & Thornton scale within a diverse and comprehensive patient population on SGLT2 inhibitors.

The Naranjo Adverse Drug Reaction Probability Scale is a tool used to assess the likelihood that a particular adverse reaction in a patient is actually caused by a medication they are taking. Each question is scored, and the total score is used to categorize the likelihood of the adverse reaction being caused by the medication as definite, probable, possible, or doubtful.

Hartwig’s severity assessment scale will be used to assess severity of ADRs. It classifies ADRs into mild, moderate & severe groups.

The Schumock and Thornton Scale, also known as the Preventability Scale, is a tool used to assess the preventability of adverse drug events (ADEs).

These scales will be administered if the patient developed any ADRs.

Permission to usage of these scales has been obtained.