Background: Metformin is the first-line therapy for the treatment of Type 2 diabetes mellitus (T2DM) . However, the use of metformin may lead to neuropathy by affecting the absorption of vitamin B12. Our objective was to explore the association between the application of metformin and diabetic peripheral neuropathy (DPN) . Methods: The multicenter randomized cross-sectional study was conducted in 13 hospitals in Beijing from October 2015 to April 2016. T2DM Patients were divided into confirmed DPN group, suspected DPN group and non-DPN group by the five physical examinations (Ankle reflex, acupuncture pain, temperature, vibration, and pressure) . Non-parametric Mann-Whitney test was used for the comparison between non-normally distributed variables between two groups. Chi-square test was used for the comparison of categorical variables. The risk factors of DPN in T2DM Patients were assessed using logistic regression. Results: Compared with patients without metformin, patients taking metformin were more likely to suffer from DPN and suspected DPN (P < 0.0for both) . Similar results were obtained after stratifying the data based on age, BMI, and HbA1c. It was shown that the application of metformin was a risk factor for DPN (OR = 5.06, 95%Cl: 3.90-6.56; P < 0.001) and suspected DPN (OR = 3.58, 95%Cl: 2.78-4.62; P < 0.001) in T2DM patients after the adjustment for age, BMI and HbA1c. In addition, prolonged application of metformin, increased cumulative and single doses would also be associated with the risk of DPN (P < 0.0for all) . Conclusion: The application of metformin was observed relate to DPN in T2DM patients. The vitamin B12 concentration and peripheral nerve function of T2DM patients with the application of metformin should be monitored. Disclosure Q.Pan: None. J.Luo: None. L.Guo: None. Funding National Key R&D Program of China (2020YFC2009006)
Background: Dapagliflozin is effective and well-tolerated in type 2 diabetes mellitus (T2DM) patients and is often combined with metformin in clinical practice, with or without other antidiabetic agents. Yet, real-world data on the safety of the combined use of dapagliflozin and metformin are limited. Methods: The DONATE study assessed the safety of dapagliflozin in 2,990 Chinese T2DM patients who received ≥1 dose of dapagliflozin. This post-hoc analysis assessed the incidences of adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) during the 24-week follow-up in patients receiving both dapagliflozin and metformin, with or without other antidiabetic agents. Results: In total, 2,165 patients (72.4%) from the DONATE study received both dapagliflozin and metformin. Comparable with that observed in the overall population, of these patients, 780 (36.0%) had ≥1 AE: 197 (9.1%) were drug-related as judged by the investigator, 129 (6.0%) were serious, and 96 (4.4%) resulted in treatment discontinuation. Urinary tract infections (UTIs), genital tract infections (GTIs) and hypoglycaemia developed in 50 (2.3%), 32 (1.5%), and 23 (1.1%) patients, respectively. In patients receiving dapagliflozin and metformin without other antidiabetic agent (n=322), 86 (26.7%) had ≥1 AE: 12 (3.7%) were drug-related as judged by the investigator, 8 (2.5%) were serious, and 6 (1.9%) resulted in treatment discontinuation. UTIs, GTIs, and hypoglycaemia developed in 4 (1.2%), 2 (0.6%), and 1 (0.3%) patient, respectively. The incidences of AEs, SAEs, and AESIs were also low when dapagliflozin and metformin were used together with dipeptidyl peptidase-4 inhibitor (DPP-4i, 37.5%, 3.1%, and 6.9%) or insulin (36.5%, 7.1%, and 5.0%). Conclusion: The combined use of dapagliflozin and metformin, with or without other antidiabetic agents such as DDP-4i or insulin, showed a good safety profile in Chinese T2DM patients in the real world. Disclosure L. Guo: None. J. Wang: None. L. Li: None. L. Yuan: None. S. Chen: None. H. Wang: None. T. Li: None. L. Qi: None. H. Yang: None.
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