Similar effectiveness of dapagliflozin and GLP‐1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Abstract

Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were collected at baseline and at the first follow‐up visit after 3 to 12 months. The primary endpoint was the proportion of patients achieving a simultaneous reduction in HbA1c, body weight and systolic blood pressure. To reduce confounding, we used multivariable adjustment (MVA) or propensity score matching (PSM). Results Totals of 473 patients initiating dapagliflozin and 336 patients initiating GLP‐1RA were included. The two groups differed in age, diabetes duration, HbA1c, weight and concomitant medications. The median follow‐up was 6 months in both groups. Using MVA or PSM, the primary endpoint was observed in 30% to 32% of patients, with no difference between groups. Simultaneous reduction of HbA1c, BP and SBP by specific threshold, as well as achievement of final goals, did not differ between groups. GLP‐1RA reduced HbA1c by 0.3% more than the reduction achieved with dapagliflozin. Conclusion In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP‐1RA for attainment of combined risk factor goals.

A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe

“…The study comprised 17,285 patients initiating dapagliflozin or comparator glucose-lowering medications, and showed that those initiating dapagliflozin were younger, with longer disease duration and higher HbA 1c , suggesting that dapagliflozin was initially channelled to difficult-to-treat patients. In line with other trials, dapagliflozin reduced HbA 1c by 0.7%, body weight by 2.7 kg, systolic blood pressure by 3.0 mmHg and improved albuminuria [24].…”

Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon‐like peptide‐1 receptor agonists

“…Observational studies, although unable to substitute for CVOTs, complement CVOT findings and can provide an estimate of true effectiveness in real‐world patients often not represented in CVOTs. Real‐world studies on the glycaemic and extra‐glycaemic effectiveness of GLP‐1RAs have confirmed findings from phase III RCTs, but there is still a paucity of cardiovascular real‐world studies . In a small study from the UK, the intensification of oral therapy by adding GLP‐1RAs was associated with a lower cardiovascular events rate than the intensification with insulin .…”

Fixed versus flexible combination of GLP‐1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study

“…A dedicated software was developed to extract all relevant anonymized patient information for placement into a clinical research form without manual intervention. Suitability of this data collection approach for performing real‐world comparative effectiveness studies has been demonstrated extensively …”

“…Suitability of this data collection approach for performing real-world comparative effectiveness studies has been demonstrated extensively. [19][20][21][22] The study was promoted by the University Hospital of Padova and approved by the respective ethical committees of each participating centre. As data were anonymized at time of automatic extraction, making patient re-identification impossible, no informed consent was required according to national regulations concerning retrospective studies.…”