Esteves Beatriz, Monteiro Cristina, Duarte Ana Paula Coelho
Health Science Faculty, University of Beira Interior, 6201-001 Covilhã, Portugal.
UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 6201-001 Covilhã, Portugal.
Healthcare (Basel). 2023 Aug 3;11(15):2197. doi: 10.3390/healthcare11152197.
The first line medication for the treatment of type 2 diabetes is metformin. This study aims to investigate the safety profile of metformin and metformin combination medications in older adults using pharmacovigilance data. A literature search was used to identify published clinical studies reporting safety of metformin in older patients (age ≥ 65 years old), which were then thoroughly evaluated. Additionally, a deep analysis was performed, taking into account suspected adverse drug reaction (ADR) reports submitted to the Portuguese Pharmacovigilance System involving patients with 65 years old or older, with metformin or metformin combination as the suspected drug. The results suggest that metformin is safer when used in combination with other antidiabetics than when used in monotherapy. Metformin prolonged-release tablets have a lower incidence of adverse effects compared to treatment with immediate-release metformin tablets. The analysis of the reports showed that "gastrointestinal disorders" was one of the most common classes reported, and metformin alone was the drug most commonly associated with serious gastrointestinal reactions that resulted in hospitalization. In addition, it was the drug most commonly associated with the lactic acidosis ADR. Even though most ADRs in the reports were serious, the majority progressed to cure. According to the analysis performed, the results suggest that the patient's renal function should be considered in order to prevent ADRs associated with metformin, such as lactic acidosis. Therefore, monitoring the safety profile of metformin remains essential to prevent serious ADRs.
2型糖尿病治疗的一线药物是二甲双胍。本研究旨在利用药物警戒数据调查二甲双胍及二甲双胍联合用药在老年人中的安全性。通过文献检索来识别已发表的报告二甲双胍在老年患者（年龄≥65岁）中安全性的临床研究，然后对这些研究进行全面评估。此外，还进行了深入分析，考虑了提交给葡萄牙药物警戒系统的涉及65岁及以上患者、以二甲双胍或二甲双胍联合用药为可疑药物的疑似药品不良反应（ADR）报告。结果表明，与单药治疗相比，二甲双胍与其他抗糖尿病药物联合使用时更安全。与速释二甲双胍片治疗相比，二甲双胍缓释片的不良反应发生率更低。对报告的分析表明，“胃肠道疾病”是报告最多的常见类别之一，单独使用二甲双胍是最常与导致住院的严重胃肠道反应相关的药物。此外，它是最常与乳酸酸中毒ADR相关的药物。尽管报告中的大多数ADR都很严重，但大多数都好转治愈了。根据所进行的分析，结果表明应考虑患者的肾功能，以预防与二甲双胍相关的ADR，如乳酸酸中毒。因此，监测二甲双胍的安全性对于预防严重ADR仍然至关重要。
