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Articles by B. H. R. Wolffenbuttel
Total Records ( 2 ) for B. H. R. Wolffenbuttel
  B. H. R. Wolffenbuttel , L. J. Klaff , R. Bhushan , J. L. Fahrbach , H. Jiang and S. Martin
  Aims  To compare starter insulins in the elderly subgroup of the DURABLE trial 24-week initiation phase.

Methods  In a post-hoc analysis of the ≥ 65 years subgroup enrolled in the DURABLE trial, we compared the safety and efficacy of lispro mix 25 (LM25: lispro 25%/insulin lispro protamine suspension 75%), n = 258, vs. glargine, n = 222, added to oral glucose-lowering agents.

Results  Baseline glycated hemoglobin (HbA1c) was similar (LM25 8.7 ± 1.2, glargine 8.8 ± 1.1%, P = 0.612). At 24-weeks, LM25 patients had lower HbA1c (7.0 ± 0.9 vs. 7.3 ± 0.9%, P < 0.001), greater HbA1c reduction (−1.7 ± 1.2 vs. −1.5 ± 1.1%, P < 0.001), and more patients reaching HbA1c < 7.0% (55.6 vs. 41.0%, P = 0.005). LM25 patients were on more insulin (0.40 ± 0.19 vs. 0.33 ± 0.19 u/kg/day, P < 0.001) and experienced more weight gain (3.6 ± 3.6 vs. 1.8 ± 3.2 kg, P < 0.001). Additionally, LM25-treated patients reported a higher mean overall hypoglycaemia rate than glargine patients (40.8 ± 47.6 vs. 31.1 ± 48.5 episodes/patient/year, P = 0.037), while nocturnal hypoglycaemia rates were similar. Over 24 weeks, incidence of severe hypoglycaemia was higher for LM25 (4.3% vs. 0.9%, P = 0.018); however, by 24-week endpoint incidence was similar (0.8% vs. 0.0%P = 0.125).

Conclusions  In this elderly subgroup post-hoc analysis, LM25 demonstrated a lower endpoint HbA1c and a higher % of patients reaching HbA1c target of < 7.0%, but with more weight gain and higher rates of hypoglycaemia compared to glargine.

  S. Simsek , C. G. Schalkwijk and B. H. R. Wolffenbuttel
  Aims  To examine whether high-dose statin therapy in Dutch European patients with Type 2 diabetes and dyslipidaemia influenced variables of glycaemic control.

Methods  The CORALL study, which was a 24-week, open-label, randomized, parallel-group, phase IIIb, multi-centre study, was designed to compare the cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with Type 2 diabetes. Fasting plasma glucose levels and HbA1c levels were collected at baseline and at 6 and 18 weeks.

Results  Treatment with the highest dose of statins, i.e. atorvastatin 80 mg and rosuvastatin 40 mg at 18 weeks from baseline, was associated with increase in HbA1c levels; baseline 57 ± 11 mmol/l (7.4 ± 1.0%) to 61 ± 14 mmol/mol (7.7 ± 1.3%) (range 5.0-11.9) for atorvastatin (P = 0.003) and from baseline 60 ± 11 mmol/mol (7.6 ± 1.0%) to 63 ± 13 mmol/mol (7.9 ± 1.2%) (range 5.7-12.3) for rosuvastatin (P < 0.001). Mean fasting plasma glucose increased from baseline 8.7 ± 2.4 mmol/l to 9.5 ± 3.0 mmol/l upon treatment with atorvastatin 20 mg (P = 0.002) and 9.0 ± 3.0 mmol/l after treatment with 80 mg (not significant compared with baseline). The mean fasting plasma glucose did not change after treatment with rosuvastatin (9.1 ± 2.7 mmol/l at baseline, 8.9 ± 2.7 mmol/l with 10 mg, 9.4 ± 2.9 mmol/l with 40 mg).

Conclusions  Glycaemic control deteriorated in patients with diabetes following high-dose statin therapy. Future controlled studies are needed to verify these findings and, if confirmed, determine whether such changes represent a true decline in glycaemic control. Presently, it appears that, based on the overwhelming prospective trial data available, the preventive effect of statin therapy supersedes that of the slight increase in HbA1c.

 
 
 
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