RESUMO
AIMS: This paper presents the treatment outcomes for patients intiated on biphasic insulin aspart 30 (BIAsp 30) treatment: BIAsp 30-only, BIAsp 30 + sulphonylureas (SU), BIAsp 30 + biguanides (BI), BIAsp 30 + SU + BI, BIAsp 30 + alpha-glucosidase inhibitors (GI), and BIAsp 30 + BI + thiazolidinediones (TZD) after failing oral antidiabetic drugs (OADs) treatment. METHODS: This was a multi-national, multi-centre, six-month, prospective, open-labelled, uncontrolled, clinical experience evaluation study, with the exception of a three-month study in one country (China) ("all exclude China" and "China"). Initiation and discontinuation of BIAsp 30 treatment were entirely at the discretion of the attending physicians. RESULTS: Mean HbA(1c), FPG and PPPG were significantly reduced from baseline at three and six months in all groups (P < 0.001). In "all exclude China", reductions in mean HbA(1c), FPG and PPPG at six months were as follows: BIAsp 30-only group (-2.12 +/- 1.76% points; -4.82 +/- 3.86 mmol/L; -6.89 +/- 4.74 mmol/L), BIAsp 30 + BI group (-2.24 +/- 1.77% points; -4.48 +/- 3.68 mmol/L; -6.66 +/- 4.55 mmol/L), BIAsp 30 + SU group (-1.95 +/- 1.59% points; -3.98 +/- 3.19 mmol/L; -6.25 +/- 4.45 mmol/L) and BIAsp 30 + SU + BI group (-1.78 +/- 1.20% points; -3.57 +/- 2.78 mmol/L; -5.89 +/- 3.98 mmol/L). The only serious adverse drug reaction was reported by the BIAsp 30-only group. In the "China" group, reductions in mean HbA(1c), FPG and PPPG at three months were: BIAsp 30-only group (-2.16 +/- 1.52% points; -3.34 +/- 2.49 mmol/L; -6.29 +/- 3.92 mmol/L), BIAsp 30 + BI group (-2.44 +/- 1.52% points; -4.01 +/- 2.50 mmol/L; -7.10 +/- 3.96 mmol/L), BIAsp 30 + GI group (-2.33 +/- 1.41% points; -4.34 +/- 2.52 mmol/L; -7.97 +/- 3.99 mmol/L) and BIAsp 30 + BI + TZD group (-1.21 +/- 1.60% points; -3.50 +/- 2.29 mmol/L; -5.97 +/- 3.39 mmol/L). No serious ADR were reported in China. The most frequent hypoglycaemic episodes were diurnal and minor in nature. CONCLUSIONS: BIAsp 30 treatment in a clinical setting improved glycaemic control in type 2 diabetes patients failing OADs.
RESUMO
The PRESENT study was a 6-month multinational observational study in patients with type 2 diabetes receiving biphasic insulin aspart 30 (BIAsp 30). Data from PRESENT were analysed according to predefined subgroups stratified by age, body mass index (BMI) and ethnic origin. Achieved HbA1c levels were similar in each of: four age subgroups (<40 years 7.82%, 40-50 years 7.70%, 50-60 years 7.75%, >or=65 years 7.75%); five BMI subgroups (<25 kg/m(2): 7.78%, 25-30 kg/m(2): 7.58%, 30-35 kg/m(2): 7.57%, 35-40 kg/m(2): 7.74%, >or=40 kg/m(2): 7.93%); and Asian/Pacific Islander, Middle Eastern/Asian, White ethnic-origin subgroups (7.78%, 7.40%, 7.59%, respectively). The Black ethnic-origin subgroup had a higher baseline HbA1c of 11.61% (other groups 9.29-9.63%) and achieved a final HbA1c of 8.59%. Major hypoglycaemia was reported by fewer than 1% of subjects in any subgroup at end of study; overall end of study hypoglycaemia rates were less than four events/subject year (all subgroups). In conclusion, data from subgroups in the PRESENT study indicate that BIAsp 30 can be initiated and titrated effectively to help patients of all ages, of all degrees of obesity, and from a variety of ethnic origins, to achieve clinically relevant improvements in glycaemic control with low rates of hypoglycaemia.