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

Abstract

BackgroundTo investigate the clinical results of sitagliptin (SITA) and the characteristics of the treatment failure group or of low responders to SITA.MethodsA 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 (ΔHbA1c) in treatment maintenance group were subanalyzed.ResultsThe HbA1c level was significantly reduced in four groups, including initial coadministration of SITA with metformin (ΔHbA1c=-1.1%, P<0.001), add-on to MET (ΔHbA1c=-0.6%, P=0.017), add-on to sulfonylurea (ΔHbA1c=-0.5%, P<0.001), and switching from thiazolidinedione (ΔHbA1c=-0.3%, P=0.013). SITA was noninferior to sulfonlyurea (ΔHbA1c=-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 ΔHbA1c showed that low-response to SITA (tertile 1) was associated with a longer diabetes duration (P=0.009) and lower HbA1c (P<0.001).ConclusionSITA 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.

Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients: the COSMETIC study

“…However, the response to DPP‐4 inhibitors and metformin combination therapy may be different in individuals according to their pancreatic function and insulin resistance status. In fact, previous studies with DPP‐4 inhibitors showed different potency in glycaemic controls depending on various patient characteristics including the severity of diabetes and the use of other antidiabetic drug 1,3,10,12–14 . Consequently, it would be clinically important to identify the most appropriate candidate for this combination therapy.…”

“…In fact, previous studies with DPP-4 inhibitors showed different potency in glycaemic controls depending on various patient characteristics including the severity of diabetes and the use of other antidiabetic drug. 1,3,10,[12][13][14] Consequently, it would be clinically important to identify the most appropriate candidate for this combination therapy. However, there has been little knowledge about the predictive factors for therapeutic efficacy of initial combination therapy with DPP-4 inhibitors and metformin.…”

Optimal Candidates for the Switch from Glimepiride to Sitagliptin to Reduce Hypoglycemia in Patients with Type 2 Diabetes Mellitus

“…We evaluated the switch from a sulfonylurea to a DPP-4 inhibitor in an actual clinical setting, particularly in patients with frequent hypoglycemia. Kim et al [ 21 ] showed that switching from a low dose sulfonylurea (average dose of 1.8 mg glimepiride and 30 mg gliclazide modified release) did not change the HbA1c or FPG levels. Chung and Lee [ 22 ] reported similar results in 45 patients who switched from glimepiride (average dose, 3.44 mg/day) to sitagliptin.…”

“…We also identified good candidates for the switch from a sulfonylurea to sitagliptin. In previous clinical studies, high baseline HbA1c [ 25 , 26 ], low insulinogenic index [ 26 ], short duration of diabetes [ 21 , 26 ], and high BMI [ 27 ] were predictors of sitagliptin efficacy. However, our study was different in that we did not use add-on therapy at the time of the sulfonylurea-to-sitagliptin switch.…”

Clinical Characteristics of the Responders to Dipeptidyl Peptidase-4 Inhibitors in Korean Subjects with Type 2 Diabetes

“…Efficacy and safety of DPP4i have been demonstrated comparable in Asians to those in Caucasians (8), but some researchers suggested more prominent HbA1c reduction with DPP4i in Japanese than in Caucasian (9). There are a few reports on the clinical factors contributing to the efficacy of Sitagliptin, one of DPP4i, in Asian (10-14), but most of the studies are small-sized and retrospective ones, and some results are conflicting. Furthermore, there was no sufficient evaluation about insulin secretory capacity.…”