OBJECTIVE: To clinically assess effectiveness of therapeutic interchange from glibenclamide to gliclazide in the hospital setting. METHODS: An open-label prospective, randomized study with two groups of patients: a reference group (patients still receiving their previous outpatient regimen ofglibenclamide) and an interchange group (patients with gliclazide substituted for glibenclamideaccording to a hospital-approved interchange protocol). The efficacy endpoint used was blood glucose at 3 and 6 days post-intervention. A patient with blood glucose < 200 mg/L was considered clinically controlled, and blood glucose changes < or > 30 mg/dL were considered significant. RESULTS:One hundred and sixteen patients were randomized. Blood glucose on the day before the intervention was 177.9 mg/dL +/- 63.4 in the reference group versus 171.3 mg/dL +/- 52.1 in the interchange group (p = 0.92). Mean blood glucose during the first 3 days post-intervention was 156.1 mg/dL +/- 47.5 and 177.7 mg/dL +/- 36.0 (p = 0.14) in the reference and interchange groups, respectively; and mean values for the first 6 days post-intervention were 142.1 mg/dL +/- 36.0 and 172.8 mg/dL +/- 28.2, respectively (p = 0.01). The overall analysis of blood glucose levels showed a better control in the reference group versus baseline values, which was not seen in the interchange group, where blood glucose remained stable and similar to baseline. In no case were 3-day and 6-day blood glucose mean levels above 200 mg/dL, which may be considered acceptable within the hospital setting. CONCLUSIONS: Therapeutic interchange may be safely performed with no clinical impairment, but better controls were achieved in the reference group.
RCT Entities:
OBJECTIVE: To clinically assess effectiveness of therapeutic interchange from glibenclamide to gliclazide in the hospital setting. METHODS: An open-label prospective, randomized study with two groups of patients: a reference group (patients still receiving their previous outpatient regimen of glibenclamide) and an interchange group (patients with gliclazide substituted for glibenclamide according to a hospital-approved interchange protocol). The efficacy endpoint used was blood glucose at 3 and 6 days post-intervention. A patient with blood glucose < 200 mg/L was considered clinically controlled, and blood glucose changes < or > 30 mg/dL were considered significant. RESULTS: One hundred and sixteen patients were randomized. Blood glucose on the day before the intervention was 177.9 mg/dL +/- 63.4 in the reference group versus 171.3 mg/dL +/- 52.1 in the interchange group (p = 0.92). Mean blood glucose during the first 3 days post-intervention was 156.1 mg/dL +/- 47.5 and 177.7 mg/dL +/- 36.0 (p = 0.14) in the reference and interchange groups, respectively; and mean values for the first 6 days post-intervention were 142.1 mg/dL +/- 36.0 and 172.8 mg/dL +/- 28.2, respectively (p = 0.01). The overall analysis of blood glucose levels showed a better control in the reference group versus baseline values, which was not seen in the interchange group, where blood glucose remained stable and similar to baseline. In no case were 3-day and 6-day blood glucose mean levels above 200 mg/dL, which may be considered acceptable within the hospital setting. CONCLUSIONS: Therapeutic interchange may be safely performed with no clinical impairment, but better controls were achieved in the reference group.