Mol Peter G M, Arnardottir Arna H, Straus Sabine M J, de Graeff Pieter A, Haaijer-Ruskamp Flora M, Quik Elise H, Krabbe Paul F M, Denig Petra
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Dutch Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands.
Br J Clin Pharmacol. 2015 Jun;79(6):978-87. doi: 10.1111/bcp.12566.
To compare the values regulators attach to different drug effects of oral antidiabetic drugs with those of doctors and patients.
We administered a 'discrete choice' survey to regulators, doctors and patients with type 2 diabetes in The Netherlands. Eighteen choice sets comparing two hypothetical oral antidiabetic drugs were constructed with varying drug effects on glycated haemoglobin, cardiovascular risk, bodyweight, duration of gastrointestinal complaints, frequency of hypoglycaemia and risk of bladder cancer. Responders were asked each time which drug they preferred.
Fifty-two regulators, 175 doctors and 226 patients returned the survey. Multinomial conditional logit analyses showed that cardiovascular risk reduction was valued by regulators positively (odds ratio 1.98, 95% confidence interval 1.11-3.53), whereas drug choices were negatively affected by persistent gastrointestinal problems (odds ratio 0.24, 95% confidence interval 0.14-0.41) and cardiovascular risk increase (odds ratio 0.49, 95% confidence interval 0.27-0.87). Doctors and patients valued these effects in a similar manner to regulators. The values that doctors attached to large changes in glycated haemoglobin and that both doctors and patients attached to hypoglycaemia and weight gain also reached statistical significance. No group's drug choice was affected by a small absolute change in risk of bladder cancer when presented in the context of other drug effects. When comparing the groups, the value attached by regulators to less frequent hypoglycaemic episodes was significantly smaller than by patients (P = 0.044).
Regulators may value major benefits and risks of drugs for an individual diabetes patient mostly in the same way as doctors and patients, but differences may exist regarding the value of minor or short-term drug effects.
比较监管机构、医生和患者对口服抗糖尿病药物不同药效的重视程度。
我们对荷兰的监管机构人员、医生和2型糖尿病患者进行了一项“离散选择”调查。构建了18组选择集，比较两种假设的口服抗糖尿病药物，这些药物在糖化血红蛋白、心血管风险、体重、胃肠道不适持续时间、低血糖频率和膀胱癌风险方面具有不同的药效。每次询问应答者他们更喜欢哪种药物。
52名监管机构人员、175名医生和226名患者回复了调查。多项条件logit分析表明，监管机构人员对降低心血管风险给予积极评价（比值比1.98，95%置信区间1.11 - 3.53），而持续的胃肠道问题（比值比0.24，95%置信区间0.14 - 0.41）和心血管风险增加（比值比0.49，95%置信区间0.27 - 0.87）对药物选择有负面影响。医生和患者对这些药效的重视方式与监管机构人员相似。医生对糖化血红蛋白大幅变化的重视程度以及医生和患者对低血糖和体重增加的重视程度也具有统计学意义。当在其他药物效应背景下呈现时，膀胱癌风险的小幅度绝对变化对任何组的药物选择均无影响。在比较各组时，监管机构人员对低血糖低血糖发作低血糖发作频率较低的重视程度明显低于患者（P = 0.044）。
监管机构人员对个体糖尿病患者用药主要益处和风险的重视程度可能与医生和患者基本相同，但在次要或短期药物效应的重视程度上可能存在差异。
