Strelitz Diabetes Center and Neuroendocrine Unit, Norfolk, Virginia, USA.
Endocr Pract. 2012 Nov-Dec;18(6):931-43. doi: 10.4158/EP12187.OR.
To investigate the effect of Bromocriptine-QR on glycemic control in patients with type 2 diabetes whose glycemia is poorly controlled on one or two oral anti-diabetes agents.
Five hundred fifteen Type 2 Diabetes Mellitus (T2DM) subjects (ages 18 to 80 and average body mass index [BMI] of 32.7) with baseline HbA1c ≥ 7.5 and on one or two oral anti-diabetes (OAD) medications (metformin, sulfonylurea, and/or thiazolidinediones) were randomized 2:1 to bromocriptine-QR (1.6 to 4.8 mg/day) or placebo for a 24 week treatment period. Study investigators were allowed to adjust, if necessary, subject anti-diabetes medications during the study to attempt to achieve glycemic control in case of glycemic deterioration. The impact of bromocriptine-QR treatment intervention on glycemic control was assessed in subjects on any one or two OADs (ALL treatment category) (N = 515), or on metformin with or without another OAD (Met/OAD treatment category) (N = 356), or on metformin plus a sulfonylurea (Met/SU treatment category) (N = 245) 1) by examining the between group difference in change from baseline a) concomitant OAD medication changes during the study, and b) HbA1c and 2) by determining the odds of reaching HbA1c of ≤ 7.0% on bromocriptine-QR versus placebo.
Significantly more patients (approximately 1.5 to 2-fold more; P<.05) intensified concomitant anti-diabetes medication therapy during the study in the placebo versus the bromocriptine-QR arm. In subjects that did not change the intensity of the baseline diabetes therapy (72%), and that were on any one or two OADs (ALL), or on metformin with or without another OAD (Met/OAD), or on metformin plus sulfonylurea (Met/SU), the HbA1c change for bromocriptine-QR versus placebo was -0.47 versus +0.22 (between group delta of -0.69, P<.0001), -0.55 versus +0.26 (between group delta of -0.81, P<.0001) and -0.63 versus +0.20 (between group delta of -0.83, P<.0001) respectively, after 24 weeks on therapy. The odds ratio of reaching HbA1c of ≤ 7.0% was 6.50, 12.03 and 11.45 (P<.0002) for these three groups, respectively.
In T2DM subjects whose hyperglycemia is poorly controlled on one or two oral agents, bromocriptine-QR therapy for 24 weeks can provide significant added improvement in glycemic control relative to adding placebo.
研究溴隐亭 QR 在血糖控制不佳的 2 型糖尿病（T2DM）患者中的作用，这些患者在使用一种或两种口服抗糖尿病药物（OAD）时血糖控制不佳。
515 名 T2DM 受试者（年龄 18 至 80 岁，平均体重指数 [BMI]为 32.7），基线 HbA1c≥7.5，使用一种或两种 OAD（二甲双胍、磺酰脲类和/或噻唑烷二酮类），随机分为溴隐亭 QR（1.6 至 4.8 mg/天）或安慰剂组，治疗 24 周。研究研究者允许在研究期间根据需要调整受试者的抗糖尿病药物，以在出现血糖恶化时尝试控制血糖。在使用任何一种或两种 OAD 的受试者中（ALL 治疗类别）（n=515），或在使用二甲双胍加或不加另一种 OAD 的受试者中（Met/OAD 治疗类别）（n=356），或在使用二甲双胍加磺酰脲类的受试者中（Met/SU 治疗类别）（n=245），通过评估从基线变化的组间差异，评估溴隐亭 QR 治疗干预对血糖控制的影响：a）研究期间同时使用 OAD 药物的变化；b）HbA1c 和 c）确定 HbA1c 达到≤7.0%的溴隐亭 QR 与安慰剂的比值。
与溴隐亭 QR 组相比，安慰剂组在研究期间有更多的患者（约 1.5 至 2 倍；P<.05）强化了同时使用的抗糖尿病药物治疗。在未改变基线糖尿病治疗强度的受试者中（72%），且使用任何一种或两种 OAD（ALL）、使用二甲双胍加或不加另一种 OAD（Met/OAD）、或使用二甲双胍加磺酰脲类（Met/SU），与安慰剂相比，溴隐亭 QR 的 HbA1c 变化为-0.47 与+0.22（组间差值为-0.69，P<.0001）、-0.55 与+0.26（组间差值为-0.81，P<.0001）和-0.63 与+0.20（组间差值为-0.83，P<.0001），分别为 24 周治疗后。在这些三组中，达到 HbA1c≤7.0%的优势比分别为 6.50、12.03 和 11.45（P<.0002）。
在使用一种或两种口服药物血糖控制不佳的 2 型糖尿病患者中，溴隐亭 QR 治疗 24 周可显著改善血糖控制，优于安慰剂。
