Hassanein Mohamed, Malek Rachid, Shaltout Inass, Sahay Rakesh Kumar, Buyukbese Mehmet Akif, Djaballah Khier, Pilorget Valerie, Coudert Mathieu, Al Sifri Saud
Dubai Hospital, Al Khaleej Street, Al Baraha, Dubai, United Arab Emirates.
CHU Mohamed Saadna Abdennour, Sétif, Algeria.
Diabetes Metab Syndr. 2023 Feb;17(2):102707. doi: 10.1016/j.dsx.2023.102707. Epub 2023 Jan 11.
To evaluate the safety and effectiveness of iGlarLixi in adults with type 2 diabetes (T2D) fasting during Ramadan.
SoliRam was a multinational, prospective, single-arm, real-world observational study conducted during Ramadan 2020 and 2021 in adults with T2D treated with iGlarLixi ≥3 months at study entry. The primary endpoint was the percentage of participants experiencing ≥1 episode of severe and/or symptomatic documented hypoglycemia (<70 mg/dL [<3.9 mmol/L]).
Among the 409 eligible participants followed during Ramadan, 96.8% fasted for ≥25 days and 92.4% did not break fasting during Ramadan. Four participants broke their fast due to hypoglycemia. Minimal adjustments were seen in antihyperglycemic therapies from pre to during Ramadan. Documented symptomatic hypoglycemia was experienced by 1.0%, 2.3%, and 0.3% of participants, respectively, during the last month of pre-Ramadan, Ramadan, and first month post-Ramadan. Mean change in HbA from pre-to post-Ramadan periods was -0.75% (-8.2 mmol/mol), and participants with HbA <7% (<53 mmol/mol) increased from 7.9% pre-Ramadan to 28.6% post-Ramadan.
iGlarLixi is an effective and well-tolerated therapy for people with T2D, including those who intend to fast during Ramadan, and is associated with a low risk of hypoglycemia; benefits were observed both during and after Ramadan.
评估在斋月期间禁食的2型糖尿病（T2D）成年患者中，甘精胰岛素利司那肽（iGlarLixi）的安全性和有效性。
SoliRam是一项跨国、前瞻性、单臂、真实世界观察性研究，于2020年和2021年斋月期间开展，研究对象为入组时接受iGlarLixi治疗≥3个月的T2D成年患者。主要终点是经历≥1次严重和/或有症状记录的低血糖发作（<70mg/dL [<3.9mmol/L]）的参与者百分比。
在斋月期间随访的409名符合条件的参与者中，96.8%禁食≥25天，92.4%在斋月期间未中断禁食。4名参与者因低血糖而中断禁食。从斋月前到斋月期间，降糖治疗的调整极小。在斋月前最后一个月、斋月期间和斋月后第一个月，分别有1.0%、2.3%和0.3%的参与者经历了有症状记录的低血糖。从斋月前到斋月后，糖化血红蛋白（HbA）的平均变化为-0.75%（-8.2mmol/mol），HbA<7%（<53mmol/mol）的参与者从斋月前的7.9%增加到斋月后的28.6%。
甘精胰岛素利司那肽对T2D患者，包括那些打算在斋月期间禁食的患者，是一种有效且耐受性良好的治疗方法，且低血糖风险较低；在斋月期间及之后均观察到了益处。
