Diabetes, obesity & metabolism · 2025
Safety and clinical effectiveness of iGlarLixi in people with type 2 diabetes mellitus in Mexico.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Rosas-Guzman Juan, Navarro-Lara Alberto, Sañudo-Maury Maria Elena, Anguiano Luis, Sauque-Reyna Leobardo
Аннотация
AIMS: To evaluate the safety and effectiveness of iGlarLixi in people with type 2 diabetes mellitus (T2DM) in clinical practice in Mexico.
MATERIALS AND METHODS: This was a prospective, observational, multicentre study in adults with T2DM who were prescribed iGlarLixi in routine clinical practice in Mexico. The participants were followed for 24 ± 1 months. The primary endpoint included the incidence proportion, incidence rate of adverse drug reactions (ADRs), serious ADRs and the severity of suspected ADRs possibly related to iGlarLixi throughout the study.
RESULTS: The study included 330 participants (mean ± SD age: 57.8 ± 11.9 years, weight: 77.1 ± 17.7 kg, duration of diabetes: 14.1 ± 9.9 years, and female: 55.5%). During the 24-month study, 59 participants (17.9%; 95% confidence interval [CI]: 13.9-22.4) reported 95 ADRs, with a mean of 0.164 events per participant-year. The most commonly reported ADRs were gastrointestinal disorders (11.2%), with nausea being the most frequent (7.3%). HbA1c decreased from 9.5% at baseline to 7.3% at the end of the study. Additionally, 51.7%, 64.6% and 86.3% of participants achieved the glycaemic target of HbA1c < 7%, FPG < 110 mg/dL and PPG < 180 mg/dL, respectively, at the end of the study. A significant decrease (p < 0.0001) in 7-point self-monitoring plasma or capillary blood glucose was observed from baseline to 3, 6, 12 and 24 months post iGlarLixi initiation.
CONCLUSIONS: iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets.
MATERIALS AND METHODS: This was a prospective, observational, multicentre study in adults with T2DM who were prescribed iGlarLixi in routine clinical practice in Mexico. The participants were followed for 24 ± 1 months. The primary endpoint included the incidence proportion, incidence rate of adverse drug reactions (ADRs), serious ADRs and the severity of suspected ADRs possibly related to iGlarLixi throughout the study.
RESULTS: The study included 330 participants (mean ± SD age: 57.8 ± 11.9 years, weight: 77.1 ± 17.7 kg, duration of diabetes: 14.1 ± 9.9 years, and female: 55.5%). During the 24-month study, 59 participants (17.9%; 95% confidence interval [CI]: 13.9-22.4) reported 95 ADRs, with a mean of 0.164 events per participant-year. The most commonly reported ADRs were gastrointestinal disorders (11.2%), with nausea being the most frequent (7.3%). HbA1c decreased from 9.5% at baseline to 7.3% at the end of the study. Additionally, 51.7%, 64.6% and 86.3% of participants achieved the glycaemic target of HbA1c < 7%, FPG < 110 mg/dL and PPG < 180 mg/dL, respectively, at the end of the study. A significant decrease (p < 0.0001) in 7-point self-monitoring plasma or capillary blood glucose was observed from baseline to 3, 6, 12 and 24 months post iGlarLixi initiation.
CONCLUSIONS: iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets.