Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.
Adv Ther
; 37(8): 3463-3484, 2020 08.
Article
en En
| MEDLINE
| ID: mdl-32372290
Empagliflozin is approved to treat adults with type 2 diabetes mellitus (T2DM) insufficiently controlled by diet and exercise. It lowers blood glucose levels by inhibiting sodium-glucose co-transporter-2 (SGLT2), a protein involved in glucose reabsorption by the kidneys. By blocking SGLT2, glucose is removed in urine instead of being reabsorbed into the bloodstream. Numerous clinical studies have shown the effectiveness and safety of empagliflozin, but recent reports of two types of serious side effects [fractures and lower limb amputations (LLAs)] associated with another drug in the class, canagliflozin, has triggered a review of the risk associated with taking SGLT2 inhibitors. To examine the safety and tolerability of empagliflozin we pooled data from 20 clinical trials involving over 15,000 patients with T2DM who received either empagliflozin or placebo (control). We found that the risk of side effects was similar whether patients received empagliflozin or placebo. This included side effects that led to treatment being stopped as well as severe and serious side effects, including fractures and LLAs. Empagliflozin was not associated with a higher rate of hypoglycemia (low blood sugar) versus placebo, except in patients also treated with insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The risk of urinary tract infections was also similar for empagliflozin versus placebo (9.27 vs. 9.70/100 patient-years, respectively). However, genital infections, as anticipated, occurred more frequently in patients treated with empagliflozin than placebo (3.54 vs. 0.95/100 patient-years, respectively). Overall, this analysis confirms the results of previous studies showing that empagliflozin is well tolerated in patients with T2DM.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Compuestos de Bencidrilo
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Diabetes Mellitus Tipo 2
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
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Inhibidores del Cotransportador de Sodio-Glucosa 2
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Glucósidos
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Hipoglucemiantes
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Adv Ther
Asunto de la revista:
TERAPEUTICA
Año:
2020
Tipo del documento:
Article
País de afiliación:
Alemania