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Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study.

Gao, Y; Guo, X H; Vaz, J A.
Diabetes Obes Metab; 11(1): 33-40, 2009 Jan.
Artigo em Inglês | MEDLINE | 2009 | ID: mdl-18494806
Resumo: AIM: PRESENT (Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy) is the largest, multinational, open-labelled, uncontrolled and completed observational study of the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) treatment in clinical practice. We present results of 3 months of treatment in Chinese patients with type 2 diabetes mellitus who were inadequately controlled on current treatment. METHODS: Patients received BIAsp 30 treatment with or without oral antidiabetic drugs (OADs). Patients were categorized according to their treatment prior to entering the study: drug-naive (n = 3697), OAD (n = 4754), insulin (n = 2392) or OAD + insulin (n = 817). RESULTS: At 3 months, significant reductions from baseline were observed in the mean haemoglobin A(1c) (HbA(1c)) (-2.24 +/- 1.67, -2.04 +/- 1.57, -1.82 +/- 1.49 and -1.86 +/- 1.61%), fasting plasma glucose (-3.93 +/- 3.12, -3.51 +/- 2.55, -2.99 +/- 2.93 and -3.38 +/- 3.16 mmol/l) and postprandial plasma glucose (-7.09 +/- 4.92, -6.51 +/- 4.02, -5.20 +/- 4.31 and -5.50 +/- 4.32 mmol/l) in the drug-naive, OAD, insulin and insulin + OAD groups respectively (p < 0.001). The proportions of patients in each group achieving target HbA(1c) of less than 7% were higher at 3 months (49.5, 51.8, 51.0 and 48.3%) compared with baseline (3.2, 4.2, 7.1 and 8.3%). The rates of hypoglycaemic episodes (events per patient-year) were lower at the end of the study in all the groups compared with baseline. Hypoglycaemic episodes were mostly minor and diurnal in nature. A total of 151 adverse drug reactions were reported, of which five were serious adverse drug reaction (SADRs). These SADRs were all symptoms of local hypersensitivity. CONCLUSIONS: The use of BIAsp 30 monotherapy or in combination with OADs in clinical practice was efficacious and safe in Chinese patients with poorly controlled type 2 diabetes.