Dapagliflozin could be used effectively in patients with type 2 diabetes, CVD, and hypertension, according to a new study….
Dapagliflozin is a selective sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes. Not many studies have been conducted on the efficacy of this medication on patients with high risk for cardiovascular disease (CVD). In a new study, researchers assessed the efficacy and safety of dapagliflozin compared to placebo in type 2 diabetic patients with pre-existing CVD and a history of hypertension.
In this multicenter, randomized, double-blind placebo-controlled, international, phase 3 study, a total of 922 type 2 diabetic patients with preexisting CVD and a history of treated hypertension were enrolled and randomly assigned 1:1 to 2 groups, either once-daily 10 mg dapagliflozin group (n=455) or matched placebo group (n=459) for 24 weeks duration as well as a 28-week extension period. For patients who were being treated with insulin, the insulin dose was reduced by 25% at randomization. Multiple factors were used to stratify patients; those included age ( 65 years), insulin use at randomization (no or yes), and time from the most recent qualifying cardiovascular (CV) event (>1 or ≤1 year). More than 40% of the patients in both groups were more than 65 years of age. Primary endpoints included absolute decrease from baseline HbA1c level, proportion of patients with combined reduction in HbA1c of 0.5% or more (5.5 mmol/mol), patients with body weight (BW) of 3% or more, and systolic blood pressure (SBP) of 3 mmHg or more. ANCOVA model and the Cochran-Mentel-Haenszel method were used for statistical analyses.
At 24 weeks, compared to placebo which had a slight increase from baseline of 8.08% (0.08% [2.8 mmol/mol], dapagliflozin reduced HbA1c level (-0.38% [-4.8 mmol/mol]) from baseline (8.18%). More patients in the dapagliflozin group met the three endpoints compared to placebo (11.7% vs. 0.9%, respectively). Changes persisted over 52 weeks. Similar results were seen in both age-stratified groups. Similar rates of serious adverse events, hypoglycemia, urinary tract infection, and cardiac disorders were seen in both groups. However, adverse events such as hypotension, dehydration, hypovolemia, genital infection, and renal failure/impairment were seen more in dapagliflozin group.
In conclusion, compared to placebo, dapagliflozin significantly reduced HbA1c, body weight, and systolic blood pressure without affecting cardiovascular safety. “Given the paucity of available data, the current study assists clinicians when determining appropriate regimens for patients with type 2 diabetes who are at high risk for CVD,” the group of researchers mentioned. They also concluded, “As such, dapagliflozin, when added to usual care in a population with a high CVD risk, was superior to placebo in reducing HbA1c levels, as well as demonstrating combined efficacy for the lowering of HbA1c levels, [body weight] reduction and [systolic] BP reduction, in a year-long study. These data indicate that the safety profile of dapagliflozin makes it appropriate for use in a population of patients with advanced type 2 diabetes, CVD, and hypertension, and, as such, provides significantly new clinical information.”
- Compared to placebo, dapagliflozin significantly reduced HbA1c, body weight, and systolic blood pressure without affecting cardiovascular safety.
- Dapagliflozin may be used in patients with type 2 diabetes, CVD, and hypertension.
- Adverse events such as hypotension, dehydration, hypovolemia, genital infection, and renal failure/impairment may be seen.
Cefalu WT et al. “Dapagliflozin’s Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension.” Diabetes Care. 2015 Apr 7.