Diabetes Metab J.  2011 Jun;35(3):290-297. 10.4093/dmj.2011.35.3.290.

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

• Kim WJ
• Park CY
• Jeong EH
• Seo JY
• Seol JS
• Park SE
• Rhee EJ
• Lee WY
• Oh KW
• Park SW
• Kim SW

• KMID: 2175440
• DOI: http://doi.org/10.4093/dmj.2011.35.3.290

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.

Keyword

Diabetes mellitus, type 2; Sitagliptin; Treatment outcome

MeSH Terms

Diabetes Mellitus, Type 2
Fasting
Glucose
Humans
Metformin
Plasma
Prescriptions
Pyrazines
Retrospective Studies
Thiazolidinediones
Treatment Failure
Treatment Outcome
Triazoles
Sitagliptin Phosphate
Glucose
Metformin
Pyrazines
Thiazolidinediones
Triazoles

Figure

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  Fig. 1 HbA1c change over time. MET, metformin; SU, Sulfonylurea; TZD, thiazolidinedione. aDenotes significant reduction by according to the Wilcoxon Signed Rank test.

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  Fig. 2 Fasting plasma glucose change over time. MET, metformin; SU, Sulfonylurea; TZD, thiazolidinedione. aDenotes significant reduction by according to the Wilcoxon Signed Rank test.

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