RESUMO
BACKGROUND: The multinational EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed the effectiveness and tolerability of vildagliptin versus other oral antihyperglycemic drugs (OAD) when added to monotherapy in patients in the real-world setting. METHODS: Prospective, real-world observational study. The primary endpoint (PEP) was the proportion of patients achieving a reduction in HbA1c > 0.3% without peripheral edema, hypoglycemia, discontinuation, dueto gastrointestinal event, or weight gain > 5%. The secondary endpoint (SEP) was the proportion of patient achieving HbA1c < 7% (at month 12), without proven hypoglycemia or weight gain (≥ 3%). RESULTS: Of the 3,523 patients enrolled in Mexico, 2,847 were in the vildagliptin and 676 in the comparator cohort. The PEP was reached in 61.8 and 53.2% in the vildagliptin and comparator cohorts, respectively. The unadjusted odds ratio was 1.42 (95% CI: 1.19-1.68) in favor of vildagliptin. A similar advantage for vildagliptin-based therapies was seen for the SEP. The percentage was lower in the vildagliptin (n = 145; 5.0%) than in the comparator group (n = 95; 14.0%). CONCLUSION: Vildagliptin, added to a first-line OAD monotherapy, allows patients to reach target HbA1c without experiencing significant adverse events.
Assuntos
Adamantano/análogos & derivados , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Nitrilas/uso terapêutico , Pirrolidinas/uso terapêutico , Adamantano/efeitos adversos , Adamantano/uso terapêutico , Administração Oral , Adulto , Idoso , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Masculino , México , Pessoa de Meia-Idade , Nitrilas/efeitos adversos , Estudos Prospectivos , Pirrolidinas/efeitos adversos , Resultado do Tratamento , VildagliptinaRESUMO
A review is carried out to examine the risk of patients suffering from diabetes mellitus in the context of general morbidity and mortality and related to infection by SARS-CoV-2. Likewise, the general recommendations for food and the prevention of comorbidities that most these patients suffer most frequently are also studied. Finally, a review of the pharmacological recommendations on both oral and parenteral treatment in the outpatient, in hospitalization and in critical states infected with SARS-CoV-2 is made.
Se realiza una revisión sobre el riesgo de los pacientes que padecen diabetes mellitus en el contexto de morbimortalidad general y relacionada a infección por el coronavirus 2 del síndrome respiratorio agudo grave (SARS-CoV-2). Así mismo se repasan las recomendaciones generales, de alimentación y de la prevención de las comorbilidades que más frecuentemente padecen dichos enfermos. Finalmente se hace una revisión de las recomendaciones farmacológicas sobre el tratamiento tanto oral como parenteral en el paciente ambulatorio, en la hospitalización y en estados críticos infectados por el SARS-CoV-2.
Assuntos
Doenças Cardiovasculares/terapia , Infecções por Coronavirus/epidemiologia , Diabetes Mellitus/terapia , Pneumonia Viral/epidemiologia , Assistência Ambulatorial/métodos , Betacoronavirus , COVID-19 , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/virologia , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/terapia , Estado Terminal , Diabetes Mellitus/mortalidade , Diabetes Mellitus/virologia , Hospitalização , Humanos , Pandemias , Pneumonia Viral/mortalidade , Pneumonia Viral/terapia , Fatores de Risco , SARS-CoV-2RESUMO
Resumen Se realiza una revisión sobre el riesgo de los pacientes que padecen diabetes mellitus en el contexto de morbimortalidad general y relacionada a infección por el coronavirus 2 del síndrome respiratorio agudo grave (SARS-CoV-2). Así mismo se repasan las recomendaciones generales, de alimentación y de la prevención de las comorbilidades que más frecuentemente padecen dichos enfermos. Finalmente se hace una revisión de las recomendaciones farmacológicas sobre el tratamiento tanto oral como parenteral en el paciente ambulatorio, en la hospitalización y en estados críticos infectados por el SARS-CoV-2.
Abstract A review is carried out to examine the risk of patients suffering from diabetes mellitus in the context of general morbidity and mortality and related to infection by SARS-CoV-2. Likewise, the general recommendations for food and the prevention of comorbidities that most these patients suffer most frequently are also studied. Finally, a review of the pharmacological recommendations on both oral and parenteral treatment in the outpatient, in hospitalization and in critical states infected with SARS-CoV-2 is made.
Assuntos
Humanos , Pneumonia Viral/epidemiologia , Doenças Cardiovasculares/terapia , Infecções por Coronavirus/epidemiologia , Diabetes Mellitus/terapia , Doenças Cardiovasculares/mortalidade , Fatores de Risco , Estado Terminal , Diabetes Mellitus/mortalidade , Pandemias , Assistência Ambulatorial/métodos , Betacoronavirus , SARS-CoV-2 , COVID-19 , HospitalizaçãoRESUMO
OBJECTIVE: To assess the proportion of patients on vildagliptin add-on dual therapy who respond to treatment over a 12 month follow-up, relative to comparator oral anti-diabetes dual therapy, in a usual care setting. RESEARCH DESIGN AND METHODS: Participants were patients with type 2 diabetes (T2DM) aged 18 years and older from 311 centers in Argentina, Colombia, Ecuador, Mexico and Venezuela. Patients were taking monotherapy with an oral anti-diabetes drug (OAD), and were prescribed a new add-on OAD based on the judgment of their personal physician. According to this choice, patients were assigned to one of the two cohorts: vildagliptin or comparator OADs. MAIN OUTCOME MEASURES: The primary endpoint was the proportion of patients achieving an A1c drop >0.3% without edema, hypoglycemia, weight gain or discontinuation due to gastrointestinal (GI) events. The secondary endpoint was the proportion of patients with baseline A1c ≥7% who reached the goal of an A1c <7% without hypoglycemia or weight gain. RESULTS: The per-protocol population (a subset of the intention-to-treat population that excluded patients with pre-specified protocol deviations) comprised 3773 patients, 3002 in the vildagliptin cohort and 771 in the comparator cohort. The proportion of patients reaching the primary endpoint was higher in the vildagliptin cohort (60.3%) than the comparator cohort (50.7%), OR 1.48 (95% CI: 1.25-1.73). The same was observed for the secondary endpoint (44.8 versus 33.1%) OR 1.64 (95% CI: 1.37-1.98). The incidence of adverse events was low and similar between treatment cohorts. CONCLUSION: In a usual care setting, patients treated with a vildagliptin combination succeeded in lowering A1c to <7%, without weight gain, hypoglycemia or peripheral edema more often than patients treated with comparator combinations, without increased risk of adverse events. Key limitations are the observational nature of the study and its relatively limited 12 month timeframe.
Assuntos
Adamantano/análogos & derivados , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Nitrilas/uso terapêutico , Pirrolidinas/uso terapêutico , Adamantano/uso terapêutico , Administração Oral , Adulto , Idoso , Biomarcadores/sangue , Pesquisa Comparativa da Efetividade , Diabetes Mellitus Tipo 2/sangue , Quimioterapia Combinada , Feminino , Seguimentos , Hemoglobinas Glicadas/metabolismo , Humanos , América Latina , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , VildagliptinaRESUMO
Resumen Tres enfermedades con alta prevalencia en la población adulta, especialmente en México, son la diabetes mellitus tipo 2, la hipertensión arterial y la hiperuricemia-gota; entre ellas comparten características fisiopatológicas que favorecen su aparición como Aceptado: 11 de junio 2019 un conjunto en los pacientes y cuyos tratamientos van frecuentemente de la mano, lo que ha permitido que en las siguientes líneas puedan describirse tales enfermedades Correspondencia como los tres desafortunados enemigos de la salud de la población. Manuel González Ortiz.
Abstract Three diseases with a high prevalence in the adult population, especially in Mexico, are type 2 diabetes mellitus, arterial hypertension and hyperuricemia-gout; they share among them pathophysiological characteristics that favor their appearance as a group in the patients and whose treatments are frequently in the same way, the above-mentioned has allowed that in the following lines can be described such diseases as the three to;35(4):596-608. unfortunate enemies of the health of the population.