Dipeptidyl peptidase-4 inhibitors and heart failure: Analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System.
Nutr Metab Cardiovasc Dis
; 26(5): 380-6, 2016 05.
Article
en En
| MEDLINE
| ID: mdl-27067162
ABSTRACT
BACKGROUND AND AIMS:
We tested the possible association between dipeptidyl peptidase-4 inhibitors (DPP-4-I) use and heart failure (HF) occurrence by assessing the publicly available US-FDA Adverse Event Reporting System (FAERS).METHODS:
FAERS data reporting HF and DPP-4-Is use in the period from the fourth quarter of 2006 through 2013 were extracted, using the Standardized MedDRA Query "Cardiac failure". Disproportionality (case/non-case method) was implemented by calculating Reporting Odds Ratios (RORs) with 95% Confidence Interval (CI) (1) exploratory analysis on the entire FAERS (using rosiglitazone as positive control); (2) consolidated analyses by therapeutic area (within antidiabetics), correcting for event- and drug-related competition bias and adjusting for co-reported drugs as confounders.RESULTS:
HF during DPP4-I use was recorded in 390 reports (4.4% of total reports). In exploratory analysis, statistically significant ROR emerged for DPP-4-I as a class (ROR = 1.17; 95% CI = 1.05-1.29), saxagliptin (1.68; 1.29-2.17), vildagliptin (2.39; 1.38-4.14), and rosiglitazone (13.98; 13.30-14.70). In consolidated analyses, the ROR for saxagliptin (2.60; 1.92-3.50) and vildagliptin (4.07; 2.28-7.27) increased, and became also significant for sitagliptin (1.61; 1.40-1.86). Concomitant drugs were reported in more than 50% of cases; the adjusted RORs of saxagliptin (2.30; 1.70-3.10), vildagliptin (3.15; 1.76-5.63), and sitagliptin (1.48; 1.28-1.71) were nonetheless significant.CONCLUSION:
FAERS data are consistent with clinical studies on a possible association between saxagliptin and HF. The disproportionate reporting of HF with sitagliptin, conflicting with a recent phase IV trial, suggests that cardiovascular safety requires close post-marketing vigilance by clinicians of individual DPP-4-I in the community until the issue of class effect is solved.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
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Glucemia
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Adamantano
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Sistemas de Registro de Reacción Adversa a Medicamentos
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Dipeptidil Peptidasa 4
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Diabetes Mellitus Tipo 2
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Dipéptidos
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Inhibidores de la Dipeptidil-Peptidasa IV
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Fosfato de Sitagliptina
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Insuficiencia Cardíaca
Tipo de estudio:
Diagnostic_studies
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
America do norte
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Asia
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Europa
Idioma:
En
Revista:
Nutr Metab Cardiovasc Dis
Asunto de la revista:
ANGIOLOGIA
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CARDIOLOGIA
/
CIENCIAS DA NUTRICAO
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METABOLISMO
Año:
2016
Tipo del documento:
Article
País de afiliación:
Italia