Therapeutic Evaluation of Antidiabetic and Antihypertensive Therapy versus Antidiabetic, Antihypertensive and Statins Therapy in the Management of Type 2 Diabetes Mellitus Patients with Hypertension: A Pragmatic Clinical Trial

Introduction: India is grappling with a growing occurrence of Type 2 Diabetes Mellitus (T2DM) and its related conditions, including hypertension and dyslipidaemia, with Cardiovascular Diseases (CVD) being the primary cause of morbidity and mortality. Statins, primarily used for hypercholesterolaemia and CVD prevention, have demonstrated potential in lowering Blood Pressure (BP) through mechanisms that are independent of cholesterol reduction. Need of the study: Most evidence regarding the effect of statins on BP comes from controlled trial settings, which may not fully reflect real-world scenarios. Additionally, many clinical studies do not compare different therapeutic approaches to evaluate their impact on patients with T2DM and hypertension. This study aims to address this gap by assessing and comparing the effects of different therapies in a more realistic clinical context. Aim: To assess the real-world effectiveness of adding a statin to an antihypertensive drug compared to an antihypertensive drug alone in patients with T2DM and hypertension. Materials and Methods: This pragmatic clinical trial will be conducted across three centres from August 2024 to August 2025 in Maharashtra: one tertiary care hospital and two multispecialty private hospitals, namely Shalinitai Meghe Hospital and Research Centre, Nagpur; Hrudaya Cardiac and Vascular Care Centre, Nagpur; and Shri Sai Multispeciality Hospital, Amravati, Maharashtra, India. The study will enroll a minimum of 300 patients who are newly diagnosed with T2DM and hypertension. Patients will be divided into two groups based on the prescriptions given by physicians: Group 1: Antidiabetic drug + Antihypertensive drug + Statins; Group 2: Antidiabetic drug + Antihypertensive drug. Their effects will be assessed on BP, blood sugar and lipid level parameters. Statistical analyses will include linear regression, multiple regression and quantile regression to evaluate the significance of statin therapy on BP control. A p-value <0.05 will be considered statistically significant.