Study shows the SGLT-2 inhibitor can lower HbA1c, BP, and weight in T2DM patients.
The purpose of the study was to assess the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, in patients with type 2 diabetes enrolled in the CANagliflozin cardioVascular Assessment Study (CANVAS) who were on an incretin mimetic [dipeptidyl peptidase-4 (DPP-4) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist]. CANVAS is a double-blind, placebo-controlled study that randomized participants to canagliflozin 100 or 300 mg or placebo added to routine therapy. The present post hoc analysis assessed the efficacy and safety of canagliflozin 100 and 300 mg compared with placebo in subsets of patients from CANVAS who were taking background DPP-4 inhibitors or GLP-1 receptor agonists with or without other antihyperglycemic agents at week 18.
The results of the study showed that, of the 4,330 patients in CANVAS, 316 were taking DPP-4 inhibitors and 95 were taking GLP-1 receptor agonists. At 18 weeks, canagliflozin 100 and 300 mg provided larger placebo-subtracted reductions in glycated hemoglobin (HbA1c) in patients taking DPP-4 inhibitors [−0.56% (95% confidence interval [CI]: −0.77, −0.35), and −0.75% (95% CI: −0.95, −0.54), respectively] and GLP-1 receptor agonists [−1.00% (95% CI: −1.35, −0.65), and −1.06% (95% CI: −1.43, −0.69), respectively]. Body weight and blood pressure (BP) reductions were seen with canagliflozin versus placebo in both subsets. Higher incidences of genital mycotic infections and osmotic diuresis–related adverse events (AEs) were seen with canagliflozin compared with placebo. The incidence of hypoglycemia was numerically higher with canagliflozin versus placebo, all the hypoglycemic events in patients on background insulin or insulin secretagogues.
Another retrospective, observational study used electronic health record (EHR) data to examine Invokana’s (canagliflozen’s) efficacy. The study’s aim was defined as: “[D]escribing the clinical characteristics and glycemic control of a sample of patients with [type 2 diabetes] following approval of [canagliflozin] in a real-world setting.”
Patrick Lefebvre, MA, vice president of Groupe d’analyse in Montreal, and colleagues examined data for adults diagnosed with type 2 diabetes and at least 12 months of clinical activity before the first canagliflozin prescription, identified in the IMS Health Real-World Data Electronic Medical Records – US database. Patient quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected goals were HbA1c <7% (<53 mmol/mol), <8% (<64 mmol/mol), and >9% (>75 mmol/mol, poor control), BP <140/90 mmHg, and weight loss ≥5%.
In total, 16,163 patients were identified (mean age = 58.5 years; 47.9% female; 75.8% white). At baseline, 90.4% of patients used at least one anti-hyperglycemic agent. Among patients with baseline HbA1c at or above 7%, 21.2%, 59.5%, and 17.6% had an HbA1c <7%, <8%, and >9% after 3 months, respectively; these proportions remained stable through 12 months.
Among patients with baseline BP at or above 140/90, 60.0% and 75.6% attained systolic BP <140 mmHg and diastolic BP <90 mmHg after 3 months, respectively; proportions remained stable through 12 months. Weight loss ≥5% was observed in 13.3% of patients at 3 months and the proportion increased to 25.8% at 12 months.
“In the U.S. healthcare system, where achievement of quality measures in patients with [type 2 diabetes] impacts provider reimbursement, therapy with [canagliflozin] may be an effective therapeutic option for improving such measurements,” the researchers wrote.
The end result was that, In patients on background incretin mimetics, canagliflozin improved HbA1c, body weight and BP, with an increased incidence of AEs related to SGLT2 inhibition.
- The efficacy and safety of canagliflozin 100 and 300 mg was compared with placebo in 16,`63 patients.
- SGLT-2 inhibitor was found to lower HbA1c, BP, and weight in T2DM patients.
- 75.6% attained systolic BP <140 mmHg and diastolic BP <90 mmHg after 3 months, respectively; proportions remained stable through 12 months.
Patrick Lefebvrea*, Dominic Pilona “Real-world glycemic, blood pressure, and weight control in patients with type 2 diabetes mellitus treated with canagliflozin—an electronic health-record-based study,” Current Medical Research and Opinion Volume 32, Issue 6, 2016 DOI:10.1080/03007995.2016.1183604 Published online: 11 May 2016