[Clinical effectiveness and tolerance of acarbose in the treatment of insulin-dependent diabetic patients (type I)].
BACKGROUND
Acarbose is a reversible inhibitor of the intestinal alpha-glucosidases, the oral administration of which delays or diminishes the postprandial increase of glucose and insulin.


METHODS
A multicentric double-blind clinical trial (11 centers), controlled versus placebo, crossed and randomized, was carried out with 137 insulin-dependent diabetic type I patients treated with diet and insulin. During the first 3 months of the trial the patients received placebo or acarbose randomly. Following one month of wash out with placebo the patients received the inverse medication for 3 more months. During the first month of each phase the patients were given 50 mg three times per day of acarbose or placebo and the two following moths received 100 mg x 3/day.


RESULTS
Upon comparison of the two treatments significant statistical differences were found in HbA1 (p = 0.0005) and in postprandial glycemia (p = 0.007). There were differences, although not statistically significant, in the amounts of triglycerides, cholesterol and fasting glycemia. One hundred and two patients referred adverse events, most being gastrointestinal (flatulence, meteorism).


CONCLUSIONS
Acarbose may be useful in the treatment of insulin-dependent diabetic type I patients treated with insulin and diet since it reduces the levels significantly of HbA1 and postprandial glucose.
Escobar-Jiménez
F
F
Hospital Clínico de San Cecilio, Granada.
de Leiva
A
A
Piñón
F
F
Soler
J
J
Tebar
J
J
Sancho
M A
MA
Herrera-Pombo
J L
JL
Pallardo
L F
LF
Vázquez
J A
JA
de la Calle
H
H
D020909:Acarbose; D000328:Adult; D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000628:therapy; D004035:Diet Therapy; D004311:Double-Blind Method; D005260:Female; D065089:Glycoside Hydrolase Inhibitors; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014312:Trisaccharides / Q000627:therapeutic use*
D065089:Glycoside Hydrolase Inhibitors; D007328:Insulin; D014312:Trisaccharides; D020909:Acarbose
Eficacia clínica y tolerancia de la acarbosa en el tratamiento de pacientes diabéticos dependientes de la insulina (tipo I).