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Göteborgs universitets publikationer

Topiramate in the treatment of obese subjects with drug-naive type 2 diabetes.

Författare och institution:
Kaj Stenlöf (Institutionen för medicin, avdelningen för klinisk prövning och entreprenörskap); S Rössner (-); F Vercruysse (-); A Kumar (-); M Fitchet (-); Lars Sjöström (Institutionen för medicin, avdelningen för molekylär och klinisk medicin)
Publicerad i:
Diabetes, obesity & metabolism, 9 ( 3 ) s. 360-8
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
AIM: The aim of this study was to examine the efficacy and safety of topiramate as an adjunct to diet and exercise in drug-naive, obese subjects with type 2 diabetes. METHODS: Drug-naive individuals with type 2 diabetes, body mass index (BMI) of > or =27 and <50 kg/m(2) and haemoglobin A(1c) (HbA(1c)) of <10.5% were enrolled into the study. All the individuals participated in a non-pharmacologic weight loss program (Pathways to Change((R)); Johnson & Johnson Healthcare Systems, Piscataway, NJ, USA) throughout the trial. After a 6-week placebo run-in, the subjects were randomized to placebo, topiramate 96 mg/day or topiramate 192 mg/day. Subjects were scheduled for 8-week titration and 52-week maintenance phases. The study was ended early; efficacy data were reported for a predefined modified intent-to-treat (MITT) population (n = 229), with 40 weeks of treatment. All the subjects who provided any safety data were included in the safety population (n = 535). RESULTS: Baseline mean weight was 103.7 kg, BMI 36 kg/m(2) and HbA(1c) 6.7% across all treatment groups. By the end of week 40, the placebo, the topiramate 96 mg/day and topiramate 192 mg/day groups lost 2.5, 6.6 and 9.1% of their baseline body weight respectively (p < 0.001 vs. placebo, MITT population using last observation carried forward). The decrease in HbA(1c) was 0.2, 0.6 and 0.7% respectively (p < 0.001 vs. placebo, MITT). Topiramate significantly reduced blood pressure and urinary albumin excretion; a weight-loss-independent HbA(1c) improving effect of topiramate was demonstrated. Adverse events were predominantly related to central nervous system (CNS). CONCLUSIONS: Topiramate as an add-on treatment to lifestyle improvements produced significant weight loss and improved glucose homeostasis in obese, drug-naive subjects with type 2 diabetes. These treatment advantages should be balanced against the occurrence of adverse events in the CNS.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Endokrinologi och diabetes ->
Albuminuria, complications, Anti-Obesity Agents, adverse effects, therapeutic use, Blood Glucose, analysis, Blood Pressure, drug effects, Diabetes Mellitus, Type 2, complications, Double-Blind Method, Female, Fructose, adverse effects, analogs & derivatives, therapeutic use, Hemoglobin A, Glycosylated, analysis, Humans, Lipid Metabolism, drug effects, Male, Middle Aged, Nervous System Diseases, chemically induced, Obesity, complications, drug therapy, Treatment Outcome, Weight Loss, drug effects
Postens nummer:
Posten skapad:
2010-04-08 13:35
Posten ändrad:
2011-01-20 10:00

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