Komamine Maki, Kajiyama Kazuhiro, Ishiguro Chieko, Uyama Yoshiaki
Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1166-1174. doi: 10.1002/pds.4847. Epub 2019 Jul 23.
We evaluated the cardiovascular risk associated with dipeptidyl peptidase-4 inhibitors (DPP-4Is) as monotherapy compared with other antidiabetic drugs in Japan.
We conducted a nationwide cohort study involving 2 716 000 diabetes patients in Japan. New users of any antidiabetic drug as monotherapy between 1 April 2010 and 31 October 2014 were identified. Occurrences of myocardial infarction (MI), heart failure (HF), and stroke requiring hospitalization associated with DPP-4Is were compared with those associated with biguanides (BGs), sulfonylureas (SUs), or α-glucosidase inhibitors (α-GIs). Adjusted hazard ratios (aHRs) for these outcomes were estimated by Cox proportional hazards model. Propensity score standardization was used to control for confounding.
We identified 1 105 103 patients using DPP-4Is, 278 280 patients using BGs, 273 449 patients using SUs, and 217 026 patients using α-GIs. The risks of MI and HF for DPP-4I users were significantly higher than those for BG users (MI: aHR, 1.48 [95%CI, 1.20-1.82], HF: aHR, 1.46 [95%CI, 1.31-1.62]), while significantly lower than those for SU users (MI: aHR, 0.84 [95%CI, 0.72-0.98], HF: aHR, 0.86 [95%CI, 0.81-0.92]). The risk of MI for DPP-4I users was similar to that for α-GI users, while the risk of HF for DPP-4I users was slightly higher than for α-GI users (MI: aHR, 0.98 [95%CI, 0.82-1.17], HF: aHR, 1.12[95%CI, 1.04-1.21]).
Risk of MI and HF requiring hospitalization associated with DPP-4Is as monotherapy was significantly higher than BGs, significantly lower than SUs, and similar to α-GIs.
我们评估了在日本，与其他抗糖尿病药物相比，二肽基肽酶-4抑制剂（DPP-4Is）作为单一疗法时的心血管风险。
我们在日本开展了一项全国性队列研究，纳入了2716000名糖尿病患者。确定了2010年4月1日至2014年10月31日期间开始单一使用任何抗糖尿病药物的新使用者。将与DPP-4Is相关的心肌梗死（MI）、心力衰竭（HF）以及需住院治疗的中风的发生率，与与双胍类（BGs）、磺脲类（SUs）或α-葡萄糖苷酶抑制剂（α-GIs）相关的发生率进行比较。通过Cox比例风险模型估计这些结局的调整后风险比（aHRs）。采用倾向评分标准化来控制混杂因素。
我们确定了1105103名使用DPP-4Is的患者、278280名使用BGs的患者、273449名使用SUs的患者以及217026名使用α-GIs的患者。DPP-4I使用者发生MI和HF的风险显著高于BG使用者（MI：aHR，1.48[95%CI，1.20 - 1.82]，HF：aHR，1.46[95%CI，1.31 - 1.62]），而显著低于SU使用者（MI：aHR，0.84[95%CI，0.72 - 0.98]，HF：aHR，0.86[95%CI，0.81 - 0.92]）。DPP-4I使用者发生MI的风险与α-GI使用者相似，而DPP-4I使用者发生HF的风险略高于α-GI使用者（MI：aHR，0.98[95%CI，0.82 - 1.17]，HF：aHR，1.12[95%CI，1.04 - 1.21]）。
DPP-4Is作为单一疗法时，需住院治疗的MI和HF风险显著高于BGs，显著低于SUs，且与α-GIs相似。
