2003
DOI: 10.1007/s005920300004
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Six-month efficacy of benfluorex vs. placebo or metformin in diet-failed type 2 diabetic patients

Abstract: Six-month efficacy of benfluorex (Mediator) (150-450 mg/day) was assessed in a double-blind multicenter study vs. placebo or metformin hydrochloride (850-2550 mg/day). After a 2-month run-in period of strict dieting, 722 type 2 diabetic patients were randomized (1:2:2) to receive placebo (n=144), benfluorex (n=294) or metformin (n=284). After a 5-week dose-finding phase, the efficacy of benfluorex was compared with that of placebo (test for difference, main analysis) and metformin (non-inferiority test, second… Show more

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Cited by 26 publications
(8 citation statements)
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“…An interesting finding is the concomitant improvement in other metabolic parameters, especially the insulin resistance index and plasma triglycerides, which have been shown to be independent risk factors for coronary heart disease in the type 2 diabetic patient population, whereas no deleterious effect was observed on weight and blood pressure (12). Finally, the reduction in A1C with benfluorex in this study is consistent with the findings of previous studies: means Ϯ SEM Ϫ0.86 Ϯ 0.17% (P Ͻ 0.001) after 29 weeks of monotherapy in 294 patients whose diabetes was inadequately controlled by diet alone (9) and, in a less powered study (68 patients), Ϫ0.66% after 12 weeks of combined treatment with sulfonylurea and benfluorex (8). The magnitude of the effect of benfluorex on blood glucose control is comparable with those observed with other recently registered drugs.…”
Section: Safety and Tolerabilitysupporting
confidence: 92%
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“…An interesting finding is the concomitant improvement in other metabolic parameters, especially the insulin resistance index and plasma triglycerides, which have been shown to be independent risk factors for coronary heart disease in the type 2 diabetic patient population, whereas no deleterious effect was observed on weight and blood pressure (12). Finally, the reduction in A1C with benfluorex in this study is consistent with the findings of previous studies: means Ϯ SEM Ϫ0.86 Ϯ 0.17% (P Ͻ 0.001) after 29 weeks of monotherapy in 294 patients whose diabetes was inadequately controlled by diet alone (9) and, in a less powered study (68 patients), Ϫ0.66% after 12 weeks of combined treatment with sulfonylurea and benfluorex (8). The magnitude of the effect of benfluorex on blood glucose control is comparable with those observed with other recently registered drugs.…”
Section: Safety and Tolerabilitysupporting
confidence: 92%
“…A small-scale exploratory trial demonstrated that in overweight diabetic patients whose diabetes was poorly controlled by a sulfonylurea as monotherapy, the combination with benfluorex over 3 months led to a significant improvement in blood glucose control (8). A recent large-scale, 6-month trial in diet-failed type 2 diabetic patients demonstrated the efficacy of benfluorex versus placebo in monotherapy, with a significant 0.86% reduction in A1C and a good safety profile (9). The most common side effects are gastrointestinal disorders, asthenia, somnolence, dizziness, and headache.…”
Section: Benfluorex (2-[[(1rs)-1-methyl-2-[3-(trifluoromethyl)phenyl]mentioning
confidence: 99%
“…[31][32][33][34][35][36][37][38][39][40][41][42][43][44][45] The longest treatment duration available was the 10-year follow up of metformin-treated overweight patients in the UK Prospective Diabetes Study (UKPDS). 31 Patients receiving conventional, diet-based treatment in this study gained about 2 kg over the course of the trial, with a slightly smaller weight gain of about 1.5 kg in the metformin group and of about 4 kg in the glibenclamide group (Figure 1).…”
Section: Effects Of Metformin On Body Weight In Patients With Type 2 mentioning
confidence: 99%
“…Untreated type 2 diabetes is typically a progressive disease without a tendency to spontaneous improvements. In long-term studies with oral antidiabetics, the HbA 1c value remained unchanged in the placebo group, or even showed an increase [21-23]. In the ‘United Kingdom Prospective Diabetes Study’, the HbA 1c value remained stable under the diet only during the first year, and subsequently worsened continually.…”
Section: Discussionmentioning
confidence: 99%