[Clinical efficacy and tolerance to acarbose in the treatment of non-insulin-dependent diabetic patients].
BACKGROUND
Acarbose is a pseudotetrasacaride which reversibly and competitively inhibits the intestinal alpha-glycosidases leading to a decrease in the increase of postprandial glycemia.


METHODS
A multicentric double-blind clinical trial (8 centers), controlled versus placebo, crossover and randomized was carried out in 90 non insulin dependent diabetic patients under treatment with diet or with diet and sulphonilureas. During the first three months of the trial the patients received placebo or acarbose randomly. Following one months of wash-out with placebo the patients received the inverse medication for 3 more months. During the first month of each phase the patients received 3 x 50 mg/day of acarbose or placebo and the following 2 months 3 x 100 mg/day.


RESULTS
Upon comparison of the two treatments significant statistical differences were observed in HbA1 (p = 0.0115) and in postprandial glycemia (p = 0.0001). There were differences, although not significant, in the levels of triglycerides, cholesterol, fasting glycemia, and postprandial insulinemia. Episodes of hypoglycemia appeared in 12 patients and 57 patients referred undesirable gastrointestinal effects.


CONCLUSIONS
The results of this trial indicate that acarbose may be useful in the treatment of non insulindependent diabetic patients since it significantly reduces the amount of postprandial glycemia and HbA1.
de Leiva
A
A
Hospital de la Santa Creu i Sant Pau, Barcelona.
Piñón
F
F
Tébar
J
J
Escobar-Jiménez
F
F
de la Calle
H
H
Herrera-Pombo
J L
JL
Soler
J
J
Pallardo
L F
LF
Gil
E
E
Guardiola
E
E
D020909:Acarbose; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014312:Trisaccharides / Q000627:therapeutic use*
D007004:Hypoglycemic Agents; D014312:Trisaccharides; D020909:Acarbose
Eficacia clínica y tolerancia de la acarbosa en el tratamiento de pacientes diabéticos no dependientes de la insulina (tipo II).