Addition of pramlintide to insulin therapy lowers HbA1c in conjunction with weight loss in patients with type 2 diabetes approaching glycaemic targets

被引:44
作者
Hollander, P
Ratner, R
Fineman, M
Strobel, S
Shen, L
Maggs, D
Kolterman, O
Weyer, C
机构
[1] Amylin Pharmaceut Inc, San Diego, CA 92121 USA
[2] Baylor Univ, Med Ctr, Dallas, TX USA
[3] Medstar Res Inst, Washington, DC USA
关键词
HbA(1c); pramlintide; type; 2; diabetes; weight loss;
D O I
10.1046/j.1463-1326.2003.00295.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aim: Two long-term, randomized, double-blind, placebo-controlled clinical trials in insulin-using patients with type 2 diabetes, spanning a wide range of baseline glycaemic control, have shown that the addition of pramlintide, an analogue of the beta-cell hormone amylin, to pre-existing insulin regimens results in reductions in HbA(1c) that are accompanied by weight loss. Methods: To assess whether this profile of pramlintide is observed in patients approaching, but not yet reaching, glycaemic targets, we conducted a pooled post hoc analysis of the two trials, including all patients with an entry HbA(1c) between 7.0 and 8.5%. Within this subset of patients, 80 were treated with placebo + insulin [baseline HbA(1c) 8.0 +/- 0.3%, weight 87.3 +/- 19.3 kg (mean +/- s.d.)] and 86 with pramlintide (120 mug bid) + insulin [HbA(1c) 8.0 +/- 0.4%, weight 92.5 +/- 20.4 kg (mean +/- s.d.)]. Endpoints included changes from baseline to Week 26 in HbA(1c), body weight, and the event rate of severe hypoglycaemia. Results: Adjunctive therapy with pramlintide resulted in significant reductions in both HbA(1c) and body weight from baseline to Week 26 (-0.43% and -2.0 kg differences from placebo, respectively, both p < 0.001). These changes were achieved without a concomitant increase in the overall rate of severe hypoglycaemic events (0.13 pramlintide vs. 0.19 placebo, events/patient year of exposure). Conclusions: The data from this post hoc analysis indicate that the addition of pramlintide to insulin therapy may help patients with type 2 diabetes who are approaching, but not yet reaching, glycaemic targets to achieve further reductions in HbA(1c) without concomitant weight gain and increased risk of severe hypoglycaemia.
引用
收藏
页码:408 / 414
页数:7
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