Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naive patients with type 2 diabetes mellitus
Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naive patients with type 2 diabetes mellitus
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DOI：
10.1111/j.1463-1326.2008.01021.x
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发表时间：
2009-06-01
影响因子：
5.8
通讯作者：
Maldonado-Lutomirsky, M.
中科院分区：
文献类型：
--
作者：
Rosenstock, J.;Niggli, M.;Maldonado-Lutomirsky, M.
为了评估维格列汀与罗格列酮在药物初治的2型糖尿病患者中的长期安全性和持续血糖控制的比较，这是一项为期24周的核心研究的额外80周、多中心、双盲和主动对照扩展，比较维格列汀(50 mg，每天2次，n=396)和罗格列酮(8 mg，每天1次，n=202)的治疗。主要疗效变量是从核心研究基线(第1天)到第104周末(延长终点)的平均HbA1c变化。维达格列汀和罗格列酮显示HbA1c从核心平均基线的8.6%和8.7%持续下降到7.8%和7.3%，具有统计学意义(均为显著，p<；0.001)。然而，罗格列酮治疗的患者显示出显著更大的平均HbA1c下降(平均差异0.62%，S.E.0.13p<；0.001)与维达格列汀比较。与罗格列酮治疗相比，维格列汀显著改善了患者的总体血脂状况。服用维格列汀的患者体重保持不变，尽管血糖控制有所改善，但服用罗格列酮的患者体重显著增加(与核心研究基线4.67千克相比平均增加4.67千克)(p<；0.001)。值得注意的是，与罗格列酮治疗组(11.1%)相比，维达格列汀治疗组周围水肿的发生率(4.6%)较低。维格列汀治疗组的严重不良事件发生率(12.5%)明显高于罗格列酮治疗组(9.1%)，但两组均仅有1例患者怀疑与研究药物有关。报告了3例未经研究的药物相关死亡(维格列汀：2例和罗格列酮：1例)。维格列汀观察到四种轻微的低血糖事件。这项研究表明，维格列汀和罗格列酮治疗104周后，类似的短期HbA1c下降比维格列酮治疗更持久。然而，罗格列酮的这种更好的耐受性是以体重增加(近5公斤)为代价的，周围水肿的发生率更高，而且与维格列汀相比，血脂水平较差。
To assess the long-term safety and the sustained glycaemic control of vildagliptin compared with rosiglitazone over 2-year treatment in drug-naive type 2 diabetes mellitus patients.This was an additional 80-week, multicentre, double-blind and active-controlled extension to a 24-week core study comparing the treatments of vildagliptin (50 mg b.i.d., n = 396) to rosiglitazone (8 mg q.d., n = 202). The primary efficacy variable was the mean change in haemoglobin A1c (HbA1c) from the core study baseline (day 1) to the end of 104 weeks (the extension endpoint).Vildagliptin and rosiglitazone showed statistically significant and sustained HbA1c reductions from a core mean baseline of 8.6 and 8.7% to 7.8 and 7.3% respectively (both significant, p < 0.001). However, rosiglitazone-treated patients showed significantly greater mean HbA1c reductions (mean difference 0.62%, s.e. 0.13, p < 0.001) compared with vildagliptin. The overall lipid profile significantly improved with vildagliptin compared to rosiglitazone treatment. Body weight remained unchanged in vildagliptin-treated patients despite improvements in glycaemic control but significantly increased (mean change from core study baseline 4.67 kg) in rosiglitazone-treated patients (p < 0.001). Notably, a lower incidence of peripheral oedema was seen with vildagliptin (4.6%) compared with rosiglitazone treatment (11.1%). More serious adverse events (SAEs) occurred in vildagliptin- than rosiglitazone-treated patients (12.5 and 9.1% respectively), but only one SAE each in both treatment group was suspected to be related to study drug. Three non-study drug-related deaths (vildagliptin: 2 and rosiglitazone: 1) were reported. Four mild hypoglycaemic events were observed with vildagliptin.This study showed that the similar short-term HbA1c reductions seen with both vildagliptin and rosiglitazone treatments were more durable after 104 weeks of treatment with rosiglitazone than vildagliptin. However, this greater durability with rosiglitazone was at the expense of weight gain (almost 5 kg), higher incidences of peripheral oedema and a less favourable plasma lipid profile compared with vildagliptin.