RESUMO
We compared the efficacy of twice-daily doses of remogliflozin etabonate (RE) and once-daily pioglitazone with placebo for reduction in glycated haemoglobin (HbA1c) concentration. In this 12-week, double-blind, randomized, active- and placebo-controlled trial, 336 treatment-naïve subjects with type 2 diabetes and an HbA1c of 7.0-9.5% (53-80 mmol/mol) were randomized to RE (50, 100, 250, 500 or 1000 mg twice daily), matching placebo or 30 mg pioglitazone once daily. The primary endpoint was change in HbA1c from baseline. Other endpoints included changes in body weight, lipid levels, safety and tolerability. RE produced a decreasing dose response in HbA1c at week 12 (p < 0.001), with reductions in HbA1c versus placebo ranging from 0.64 to 1.07% (p < 0.001). Statistically significant reductions in body weight for RE compared with placebo were also observed. Twice-daily RE resulted in a dose-ordered improvement in glycaemic control and was generally well tolerated.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucosídeos/administração & dosagem , Hiperglicemia/prevenção & controle , Hipoglicemiantes/administração & dosagem , Moduladores de Transporte de Membrana/administração & dosagem , Pró-Fármacos/administração & dosagem , Pirazóis/administração & dosagem , Inibidores do Transportador 2 de Sódio-Glicose , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Seguimentos , Glucosídeos/efeitos adversos , Glucosídeos/uso terapêutico , Hemoglobinas Glicadas/análise , Humanos , Hipertrigliceridemia/complicações , Hipertrigliceridemia/prevenção & controle , Hipoglicemia/prevenção & controle , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Análise de Intenção de Tratamento , Moduladores de Transporte de Membrana/efeitos adversos , Moduladores de Transporte de Membrana/uso terapêutico , Pessoa de Meia-Idade , Pacientes Desistentes do Tratamento , Pioglitazona , Pró-Fármacos/efeitos adversos , Pró-Fármacos/uso terapêutico , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Tiazolidinedionas/administração & dosagem , Tiazolidinedionas/efeitos adversos , Tiazolidinedionas/uso terapêutico , Redução de Peso/efeitos dos fármacosRESUMO
Maternal plasma levels of human placental lactogen (HPL) are decreased in hypertensive pregnancies and the concentration is related to the severity of the condition. Of infants who had HPL concentrations in the fetal danger zone (more than 2 SD's below normal mean) 75 per cent developed fetal distress, neonatal asphyxia or were light for dates. Patients who are identified in this way have lighter infants and placentae than their unidentified counterparts with normal HPL levels.