Liraglutide efficacy in Japanese patients “easy” to predict

By Sally Robertson, B.Sc.Jun 29 2012

Liraglutide therapy is an effective alternative to basal-supported oral therapy (BOT) for some Japanese patients with diabetes, while it is completely ineffective for others, report researchers.

However, whether or not patients respond well to liraglutide can "easily be predicted" in clinical practice, they say.

"It is likely that baseline insulin dosage and post-breakfast glycemia with BOT are clinically useful indicators for the efficacy of liraglutide therapy," report Hideaki Kaneto (Osaka University Graduate School of Medicine, Japan) and team.

Recently, the Liraglutide Effect and Action in Diabetes 5 (LEAD-5) trial showed that liraglutide in combination with oral hypoglycemic agents produced greater glycemic improvement than long-acting insulin, note Kaneto et al.

However, anxieties have arisen about the use of such regimens in Japanese patients, who have been reported to suffer from severe hypoglycemia after combined incretin-based and sulfonylurea therapy.

"These observations have never been reported in Caucasians, and it might be that some Japanese patients have an ethnical manifestation of potentially extreme sensitivity to incretin-based therapy with the administration of sulfonylureas," suggest the researchers.

In a retrospective analysis of 37 Japanese diabetes patients who were insufficiently controlled with BOT (long-acting insulin plus glimepiride), the team found that 37% of patients achieved their glycemic target after switching to liragultide therapy, whereas 12% had somewhat deteriorated glycemic control.

As reported in the Journal of Diabetes Investigation, the frequency of hypoglycemia was as low as 0.04 and 0.08 episodes per person per week, with no significant difference between the two regimens. And no hypoglycemic event requiring assistance from another person was recorded.

Cox proportional hazard modeling revealed that larger insulin doses and higher glycemia 2 hours after breakfast with BOT, had significant inverse associations with the achievement of glycemic control with liraglutide therapy. For each 1-standard deviation increment in insulin (1 unit) and 2-hr post-breakfast glycemia (1 mmol/L), the likelihood of achieving glycemic control with liraglutide reduced by 76% and 73%, respectively.

"These two variables at baseline are easy to check in clinical practice and therefore would be useful in the predictive assessment for the potential effectiveness of liraglutide therapy," suggests the team.

Over a 12-week period, the patients were administered 0.3-0.9 mg liraglutide per day, with the addition of 0.5-1.0 mg glimepiride per day when required. The glycemic target was pre- and postprandial glycemia levels of less than 7.2 mmol/L and less than 10.0 mmol/L, respectively.

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