Репозиторий Университета

© 2018 The Author(s). Background: Although the number of antihyperglycemic agents has expanded significantly, sulfonylureas (in particular gliclazide) remain an important option because of a variety of patient and health system factors. The large, real world, observational, and international EASYDia trial evaluated the effectiveness of gliclazide modified release (MR) 60 mg in individuals with type 2 diabetes with a broad range of diabetes history, body mass index (BMI) and background antihyperglycemic treatment. Methods: A total of 7170 participants from eight countries, age ≥ 35 years with HbA1c ≥ 7.5% and not treated with insulin, were prescribed 30-120 mg of gliclazide MR 60 mg once daily. HbA1c goals were individualized and dosing uptitrated, as required, over the 6-month long study. In this post hoc subanalysis, efficacy endpoints were analyzed according to stratified baseline HbA1c levels, weight and glucose-lowering regimens. Episodes of hypoglycemia requiring assistance were documented. Results: At baseline, mean age was 58.9 years, HbA1c 8.8%, BMI 30.1 kg/m2, and diabetes duration 5.1 years. At study end, clinically significant HbA1c improvements (mean change - 1.78%) were noted across all baseline HbA1c strata (> 7.0 to ≤ 8.0%, > 8.0 to ≤ 9.0%, > 9.0 to ≤ 10.0%, and > 10.0%), BMI classifications (18.5 to < 25.0, 25.0 to < 30.0, and ≥ 30.0 kg/m2), and regardless of the original diabetes treatment regimen (P < 0.001 in all cases). In contrast to the subgroups with BMI 25.0-30.0 and ≥ 30.0 kg/m2 that registered weight losses of 0.9 and 2.2 kg, respectively (P < 0.001 vs. baseline weight); the BMI 18.5-24.9 kg/m2 subgroup gained a mean 0.5 kg (P < 0.02 vs. baseline weight). Severe hypoglycemic events were rare (0.06%). Conclusions: Progressive gliclazide MR 60 mg uptitration was well tolerated and lowered HbA1c across a broad range of HbA1c, BMI and background glucose-lowering therapy. Weight loss was noted when BMI was ≥ 25.0 kg/m2. Individuals with the highest baseline HbA1c and BMI experienced the greatest HbA1c and weight improvements. Trial registration ISRCTN Registry ISRCTN00943368 on 1st July 2011

© 2018 Universiteit Gent. All Rights Reserved. Due to the recent introduction of golimumab into paediatric rheumatology practice, an overview of the clinical studies of this tumour necrosis factor alpha inhibitor, most of which were conducted with adult patients with rheumatic diseases, has been presented. Clinical laboratory effects and tolerability of golimumab in the form of subcutaneous injections have been analysed for rheumatoid arthritis, psoriatic arthritis, and spondylitis. Evaluation of the efficacy and tolerability of golimumab in long-term observational studies (up to 5 years) has been discussed.