[A prospective randomized study of sulphonylureas therapeutic interchange in patients with type 2 diabetes mellitus].
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.
Crespí Monjo
M
M
Servicio de Farmacia, Hospital Universitario Son Dureta, Palma de Mallorca. rfarmacia@hsd.es
Delgado Sánchez
O
O
Ventayol Bosch
P
P
Lafuente Fló
A
A
Pinteño Blanco
M
M
Escrivá Torralva
A
A
Puigventós Latorre
F
F
Martínez-López
I
I
D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D005907:Gliclazide / Q000008:administration & dosage*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D013453:Sulfonylurea Compounds / Q000008:administration & dosage*; D016896:Treatment Outcome
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D005907:Gliclazide