Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: an 18 to 34-week, open-label, extension period.
OBJECTIVE
The aim of this trial was to obtain further data on the efficacy and safety of benfluorex as an add-on therapy in type 2 diabetic patients insufficiently controlled by sulfonylurea monotherapy who had a limitation for the use of metformin during a 4-month extension period following a 4-month double-blind trial.


METHODS
Patients who completed the 18-week double-blind period entered the 16-week extension period. Patients in the benfluorex group during the double-blind period continued benfluorex 450 mg/day (B-B group), whilst patients in the placebo group switched to benfluorex 450 mg/day (P-B group). The main efficacy criterion was HbA(1c), analyzed as the change from week 18 (W18) to the end of treatment using a two-sided Student paired t-test. Secondary criteria were fasting plasma glucose (FPG), insulin resistance and lipids.


RESULTS
Between W18 and the end of treatment, HbA(1c) decreased in the P-B group from 8.53+/-1.37% to 7.49+/-1.04% (P<0.001) and remained stable in the B-B group from 7.52+/-1.07% to 7.53+/-1.14% (NS). In the P-B group, parameters of glycemic control showed improvements from W18 to week 34 (W34) which were similar to those observed from baseline to W18 in the B-B group. Overall, the target HbA(1c) (<or=7%) was achieved in 36% (103 of 289) of patients and a decrease in HbA(1c) of at least 1% was seen in 44% (128 of 289) of patients. Digestive disorders were the most common adverse events and the incidence of diarrhoea was 4.9% in patients receiving benfluorex for 34 weeks.


CONCLUSIONS
The beneficial effect of benfluorex as add-on therapy in lowering HbA(1c) at W18 was maintained at W34 without evidence for a loss of efficacy or an increased incidence of side effects over a 34-week follow-up.
Moulin
P
P
Service d'endocrinologie - unité 11, hôpital cardiovasculaire Louis-Pradel, hospices civils de Lyon, université Lyon-1, 28, avenue Doyen-Lepine, 69677 Bron cedex, France. philippe.moulin@chu-lyon.fr
André
M
M
Alawi
H
H
Dos Santos
L C
LC
Khalid
A K
AK
Koev
D
D
Moore
R
R
Serban
V
V
Picandet
B
B
Francillard
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005277:Fenfluramine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012449:Safety; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D055815:Young Adult
D001786:Blood Glucose; D005277:Fenfluramine; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D013453:Sulfonylurea Compounds; C001584:benfluorex