研究目的：雖然糖尿病新藥DPP-4抑制劑(Sitagliptin)的治療，可以改善血糖之控制，但其長期心血管疾病之預後仍然未知。因此本cohort研究，期盼可以分析出糖尿病族群接受DPP-4抑制劑(Sitagliptin)的治療，是否可降低罹患心血管疾病之風險。 研究方法及資料：本研究是收集台灣在近幾年內的健保資料庫數據(2003/03/01~2011/12/31)，收錄總共104,756位新診斷出的糖尿病族群，加以分析其各類降血糖藥物的使用。其中有接受Sitagliptin治療者為暴露組，再依性別年齡等配對找出四倍人數的對照組，分析其後續罹患心血管疾病之事件與死亡率。統計方法採用邏輯式回歸模組，計算其hazard ratio[HR]與95%信賴區間[CI]，分析出糖尿病族群接受Sitagliptin的治療，與後續罹患心血管疾病之相關性。 研究結果：經過平均約14個月的治療，接受Sitagliptin之暴露組，與對照組相比，顯然有較低之心血管疾病事件(3.41 vs 5.17 每千人-月,p<0.001)。多項變因校正後，暴露組與對照組相比，罹患冠狀動脈心臟病之HR: 0.59; 95% CI: 0.48~0.72。而罹患缺血性中風之HR: 0.75; 95% CI: 0.59~0.96，週邊血管阻塞疾病之HR: 0.86; 95% CI: 0.45~1.65，總死亡率之HR: 0.56; 95% CI: 0.41~0.74。 結論與建議：本研究發現糖尿病患者接受DPP-4抑制劑(Sitagliptin)的治療，對於各種心血管疾病，有良好之預後。
Purpose Although dipeptidyl peptidase 4 (DPP-4) inhibitor improves glycemic control, the actual cardiovascular outcomes remain unclear. The objective of this cohort study was to thus evaluate the cardiovascular outcome in diabetic patients who received DPP-4 inhibitors (Sitagliptin). Methods A total of 104,756 new diabetic patients were identified from the Taiwan National Health Insurance Research Database (NHIRD) during the period from March 1, 2003, to December 31, 2011. Patients who received Sitagliptin therapy were included as exposures and up to four age- and sex-matched controls were selected by risk-set sampling. Outcomes as major adverse cardiovascular diseases (CVD) and deaths were assessed. Logistic regression models were applied to estimate the hazard ratios (HRs) and 95% CIs between DPP-4 inhibitor use and cardiovascular outcome. Results Over a mean of 14 months, the rates of total CVD per 1,000 person-months were significantly lower in Sitagliptin users (3.41 vs 5.17, p<0.001), whereas other different CVDs (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.48 to 0.72 for coronary heart disease; HR: 0.75; 95% CI: 0.59 to 0.96 for ischemic stroke; HR: 0.86; 95% CI: 0.45 to 1.65 for peripheral artery occlusive disease) and all cause mortality (HR: 0.56; 95% CI: 0.41 to 0.74]) were also fewer after adjustment for covariates. Conclusion The results showed a favorable outcome of Sitagliptin as a class on lowering CVD incidence in patients with type 2 diabetes.
