Long-term efficacy and safety of early sitagliptin initiation in individuals with type 2 diabetes: an extension of the SPIKE study.

IF 1.3 Q4 ENDOCRINOLOGY & METABOLISM

Diabetology International Pub Date : 2025-01-12 eCollection Date: 2025-04-01 DOI:10.1007/s13340-024-00786-7

Tomoya Mita, Naoto Katakami, Hidenori Yoshii, Tomio Onuma, Hideaki Kaneto, Takeshi Osonoi, Toshihiko Shiraiwa, Tetsuyuki Yasuda, Yutaka Umayahara, Tsunehiko Yamamoto, Hiroki Yokoyama, Nobuichi Kuribayashi, Kazunari Matsumoto, Masahiko Gosho, Iichiro Shimomura, Hirotaka Watada

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引用次数: 0

Abstract

Aims/instruction: We previously demonstrated that sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, slowed down the progression of carotid atherosclerosis in type 2 diabetes participants who were treated with insulin and had no history of cardiovascular disease in the Sitagliptin Preventive study of Intima-Media Thickness Evaluation (SPIKE) trial. This was an extension of the SPIKE trial that examined if early sitagliptin initiation improved long-term cardiovascular outcomes.

Materials and methods: In the SPIKE trial, 282 participants were randomized to either sitagliptin or conventional treatment to examine the effects of sitagliptin on carotid atherosclerosis. All participants who completed the SPIKE trial were recruited to this prospective, observational, cohort study and followed for up to 520 weeks. The primary endpoint was the first occurrence of a major cardiovascular event, which included acute myocardial infarction, stroke, or total mortality.

Results: Events of composite primary outcome occurred in only a few participants in each group (15 [12.6%] in the sitagliptin group and eight in the conventional treatment group [6.7%]). The incidence rate of the primary outcome did not differ significantly between two groups. In post hoc Poisson regression analysis, there were no significant between-group differences in the incidence rates of composite recurrence events for the same outcomes as the primary endpoint.

Conclusions: Early initiation of sitagliptin as add-on therapy to insulin was not linked to reduced risk of composite cardiovascular disease. This may be due to low event numbers in both groups and/or relatively lower continuation rates of DPP-4 inhibitors in the sitagliptin group during the follow-up period.

Supplementary information: The online version contains supplementary material available at 10.1007/s13340-024-00786-7.

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目的/说明：我们曾在西他列汀内膜厚度评估预防性研究（Sitagliptin Preventive study of Intima-Media Thickness Evaluation，SPIKE）试验中证实，二肽基肽酶-4（DPP-4）抑制剂西他列汀可减缓接受胰岛素治疗且无心血管疾病史的2型糖尿病患者颈动脉粥样硬化的进展。这是SPIKE试验的延伸，目的是研究早期服用西格列汀是否能改善长期心血管预后：在 SPIKE 试验中，282 名参与者被随机分配到西他列汀或常规治疗中，以研究西他列汀对颈动脉粥样硬化的影响。所有完成 SPIKE 试验的参与者都被纳入了这项前瞻性、观察性、队列研究，并接受了长达 520 周的随访。主要终点是首次发生重大心血管事件，包括急性心肌梗死、中风或总死亡率：每组仅有少数参与者发生复合主要结局事件（西他列汀组 15 例 [12.6%]，常规治疗组 8 例 [6.7%]）。两组的主要结果发生率没有显著差异。在事后泊松回归分析中，与主要终点相同结果的复合复发事件发生率在组间无显著差异：结论：尽早开始使用西格列汀作为胰岛素的附加疗法与降低心血管疾病的综合风险无关。结论：西他列汀作为胰岛素附加疗法的早期启动与复合心血管疾病风险的降低无关，这可能是由于两组中的事件发生率较低，以及/或者西他列汀组在随访期间继续使用DPP-4抑制剂的比例相对较低：在线版本包含补充材料，可在10.1007/s13340-024-00786-7网站上查阅。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetology International ENDOCRINOLOGY & METABOLISM-

CiteScore

3.90

自引率

4.50%

发文量

期刊介绍： Diabetology International, the official journal of the Japan Diabetes Society, publishes original research articles about experimental research and clinical studies in diabetes and related areas. The journal also presents editorials, reviews, commentaries, reports of expert committees, and case reports on any aspect of diabetes. Diabetology International welcomes submissions from researchers, clinicians, and health professionals throughout the world who are interested in research, treatment, and care of patients with diabetes. All manuscripts are peer-reviewed to assure that high-quality information in the field of diabetes is made available to readers. Manuscripts are reviewed with due respect for the author''s confidentiality. At the same time, reviewers also have rights to confidentiality, which are respected by the editors. The journal follows a single-blind review procedure, where the reviewers are aware of the names and affiliations of the authors, but the reviewer reports provided to authors are anonymous. Single-blind peer review is the traditional model of peer review that many reviewers are comfortable with, and it facilitates a dispassionate critique of a manuscript.