Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials.
Expert Opin Drug Saf
; 19(9): 1193-1202, 2020 Sep.
Article
em En
| MEDLINE
| ID: mdl-32552153
ABSTRACT
OBJECTIVES:
The fixed-dose combination of empagliflozin and linagliptin, two glucose-lowering drugs prescribed for type 2 diabetes mellitus, has demonstrated good tolerability in phase III clinical trials. To further evaluate the safety profile of this combination, the data from these trials were pooled and analyzed.METHODS:
This was a post-hoc pooled analysis of five randomized, double-blind, clinical trials of the empagliflozin/linagliptin fixed-dose combination. Data for adverse events and laboratory parameters were evaluated.RESULTS:
The analysis included 2895 patients 1410, 1015, and 470 receiving the empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy, respectively. Overall, the incidence of adverse events with the empagliflozin/linagliptin combination was similar to that with empagliflozin or linagliptin alone. Fewer than 2% of patients experienced hypoglycemia, and its incidence was similar across treatment groups. Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%). No cases of Fournier's gangrene, diabetic ketoacidosis, or pemphigoid occurred, and no clinically relevant mean changes in laboratory parameters were noted.CONCLUSION:
The safety profile of the fixed-dose combination of empagliflozin and linagliptin was similar to the individual monotherapies. No new safety signals were identified.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Compostos Benzidrílicos
/
Diabetes Mellitus Tipo 2
/
Linagliptina
/
Glucosídeos
Tipo de estudo:
Clinical_trials
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
Expert Opin Drug Saf
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Japão