麻豆传媒

ORLANDO -- Patients with type 2 diabetes saw a greater reduction in their HbA1c levels with canagliflozin (Invokana) plus metformin versus glimepiride (Amaryl), according to a post-hoc analysis, though the same number of patients in each group hit their glycemic goals.

Researchers analyzed data from nearly 1,500 patients on background metformin in the year-long trial and found that 100 mg of canagliflozin was non-inferior in lowering HbA1c levels to glimepiride (-0.82% versus -0.81%). But 300 mg of the drug showed superiority to glimepiride, with mean changes of -0.93%, according to , with Janssen Pharmaceuticals in New York City, and colleagues. Janssen markets Invokana.

The proportion of patients who achieved an HbA1c level of <7.0% after 52 weeks was similar across all three groups, with 53.6% in the 100-mg group, 60.1% in the 300-mg group, and 55.8% in the glimepiride group, they reported in a poster at the American Association of Clinical Endocrinologists annual meeting.

For a target of <6.5%, 25.5% in the 100-mg group, 30.6% in the 300-mg group, and 30.7% in the glimepiride group hit the goal, the authors stated.

But canagliflozin appeared to be much safer in getting patients to their goal. When Davies and colleagues considered only patients who did not have an incident of hypoglycemia and who achieved an A1c of <7.0%, significantly more patients in the treatment groups hit the goal (49.8%, 56.5%, and 32.8%, respectively), yielding an odds ratio of 2.1 (95% CI 0.9-1.8) and 2.9 (95% CI 2.2-3.8) in the 100-mg and 300-mg groups, respectively.

Canagliflozin -- a sodium-glucose transport 2 (SGLT-2) inhibitor -- was the first drug in its class to be approved for treating type 2 diabetes. Data from the phase III trial that Davies and colleagues analyzed were reported in in 2013; in that study, the drug was found to be associated with a reduced body weight and fewer hypoglycemia events than glimepiride.

There were 1,450 patients in the initial trial with a mean age of 56 and mean A1c levels of 7.8%. Mean body mass index was 31 kg/m², according to Davies and colleagues.

The overall incidence of adverse events were similar in both groups, but incidence of genital mycotic infections and osmotic diuresis-related adverse events in both men and women were higher in the canagliflozin group. This was "consistent with other phase III studies of canagliflozin," the authors noted.

The incidence of hypoglycemia was significantly lower in the canagliflozin groups (5.6% in the 100-mg group; 4.9% in the 300-mg group) than in the glimepiride group (34.2%; P<0.001). A greater proportion off patients without an incidence of hypoglycemia achieved <6.5% A1c (23.0%, 28.5%, and 18.4%, respectively). The OR of achieving that goal in the 100-mg group was 1.3 (95% CI 0.9-1.8) and 1.8 (95% CI 1.3-2.5) in the 300-mg group.

Comment