Retrospective Analysis on the Efficacy, Safety and Treatment Failure Group of Sitagliptin for Mean 10-Month Duration

ABSTRACT

BACKGROUND: To investigate the clinical results of sitagliptin (SITA) and the characteristics of the treatment failure group or of low responders to SITA. METHODS: A retrospective study of type 2 diabetic patients reviewed 99 cases, including 12 treatment failure cases, who stopped SITA because of worsening patients' condition, and 87 cases, who continued treatment over five visits (total 9.9+/-10.1 months) after receiving the prescription of SITA from December 2008 to June 2009. Subjects were classified as five groups administered SITA as an initial combination with metformin (MET), add-on to metformin or sulfonylurea, and switching from sulfonylurea or thiazolidinedione. The changes in HbA1c level from the first to last visit (DeltaHbA1c) in treatment maintenance group were subanalyzed. RESULTS: The HbA1c level was significantly reduced in four groups, including initial coadministration of SITA with metformin (DeltaHbA1c=-1.1%, P<0.001), add-on to MET (DeltaHbA1c=-0.6%, P=0.017), add-on to sulfonylurea (DeltaHbA1c=-0.5%, P<0.001), and switching from thiazolidinedione (DeltaHbA1c=-0.3%, P=0.013). SITA was noninferior to sulfonlyurea (DeltaHbA1c=-0.2%, P=0.63). There was no significant adverse effect. The treatment failure group had a longer diabeties duration (P=0.008), higher HbA1c (P=0.001) and fasting plasma glucose (P=0.003) compared to the maintenance group. Subanalysis on the tertiles of DeltaHbA1c showed that low-response to SITA (tertile 1) was associated with a longer diabetes duration (P=0.009) and lower HbA1c (P<0.001). CONCLUSION: SITA was effective and safe for use in Korean type 2 diabetic patients. However, its clinical responses and long-term benefit-harm profile is yet to be established.