Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis.

IF 3.8 3区医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-09 DOI:10.1007/s13300-024-01642-2

Mohamed Hassanein, Rachid Malek, Saud Al Sifri, Rakesh Kumar Sahay, Mehmet Akif Buyukbese, Khier Djaballah, Lydie Melas-Melt, Inass Shaltout

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Abstract

Introduction: The aim of this work was to assess the safety and effectiveness of concomitant iGlarLixi and sodium-glucose co-transporter-2 inhibitors (SGLT-2i) use in adults with type 2 diabetes (T2D) who fasted during Ramadan.

Methods: Of the 420 eligible participants from the SoliRam study, 174 were using SGLT-2i in addition to iGlarLixi and 246 were not using SGLT-2i, referred to as SGLT-2i user and non-user, respectively. The primary endpoint was the proportion of participants experiencing ≥ 1 severe and/or symptomatic documented (< 70 mg/dl [< 3.9 mmol/l]) hypoglycemia.

Results: More than 50% of participants in both groups were male. The mean weight, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG) were similar in both groups. Approximately half of participants in the SGLT-2i-user group and ~ 25% participants in the SGLT-2i-non-user group were on two oral anti-hyperglycemic drugs (OADs), whereas ~ 20% in the SGLT-2i-user group and ~ 1% of participants in the SGLT-2i-non-user group were on three OADs in addition to iGlarLixi. Around 35% and 55% of participants in the SGLT-2i-user and SGLT-2i-non-user groups, respectively, were taking concurrent sulphonylureas. About 97% of participants in both groups were able to fast for ≥ 25 days. The incidence of primary endpoint was low in both groups; SGLT-2i user: 0.6%, 4.2%, and 0.6% and SGLT-2i-non-user: 1.3%, 0.9% and 0% during pre-Ramadan, Ramadan, and post-Ramadan period, respectively. The incidence of severe and/or symptomatic documented (< 54 mg/dl [< 3.0 mmol/l]) hypoglycemia events was also low throughout the study, including during Ramadan. No severe hypoglycemia occurred during Ramadan in either group. Improvements in HbA1c and FPG, with a small reduction in weight, were observed from pre- to post-Ramadan in both groups. No serious adverse event was reported in either group.

Conclusions: Concomitant iGlarLixi and SGLT-2i therapy with or without other OADs was demonstrated to be safe in adults with T2D during Ramadan fast, with a low risk of hypoglycemia and improvements in glycemic outcomes.

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斋月禁食期间 T2D 患者同时服用 iGlarLixi 和 SGLT-2i 的安全性和有效性：SoliRam研究子分析。

简介这项研究旨在评估在斋月期间禁食的2型糖尿病（T2D）成人患者同时使用iGlarLixi和钠-葡萄糖协同转运体-2抑制剂（SGLT-2i）的安全性和有效性：在 SoliRam 研究的 420 名合格参与者中，174 人在使用 iGlarLixi 的同时使用 SGLT-2i，246 人未使用 SGLT-2i，分别称为 SGLT-2i 使用者和非使用者。主要终点是出现≥1次严重和/或症状记录的参与者比例（结果：两组中均有 50%以上的参与者为男性。两组的平均体重、糖化血红蛋白（HbA1c）和空腹血浆葡萄糖（FPG）相似。SGLT-2i用户组和SGLT-2i非用户组分别约有一半和约25%的参与者服用两种口服降糖药（OAD），而SGLT-2i用户组和SGLT-2i非用户组分别约有20%和约1%的参与者除服用iGlarLixi外还服用三种OAD。SGLT-2i使用者组和SGLT-2i非使用者组中分别约有35%和55%的参与者同时服用磺脲类药物。两组中约 97% 的参与者禁食时间≥ 25 天。两组主要终点的发生率都很低；使用 SGLT-2i 的组别为 0.6%，使用 SGLT-2i 的组别为 4.2%：SGLT-2i使用者：0.6%、4.2%和0.6%，SGLT-2i非使用者：1.3%、0.9%和0.6%：在斋月前、斋月期间和斋月后，SGLT-2i 使用者分别为 0.6%、4.2% 和 0.6%，SGLT-2i 非使用者分别为 1.3%、0.9% 和 0%。严重和/或有症状记录的发生率（结论：在斋月前、斋月中和斋月后分别为 1.3%、0.9% 和 0%）：在斋月禁食期间，iGlarLixi和SGLT-2i与其他OADs或不与其他OADs同时治疗被证明对患有T2D的成人是安全的，低血糖风险较低，血糖结果也有所改善。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.