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PREDICTION OF THE EFFICACY OF A MEDICAMENT ON RENAL OR CARDIOVASCULAR CLINICAL OUTCOMES

机译:预测药物对肾或心血管临床结果的有效性

摘要

For obtaining a prediction of the long-term efficacy of a medicament on reducing a risk of a renal clinical outcome or a cardiovascular clinical outcome, a multivariate risk relation is determined from values (8) of a plurality of biomarkers and the occurrence in the past (11) of said clinical outcome. The biomarkers include systolic blood pressure, ratio between albumin and creatinine contents in urine, and potassium, Hb A1c, and total cholesterol contents in blood. The risk relation is applied to reference biomarker values (16, 18a) for determining a reference estimate of a risk of future occurrence of that clinical outcome (2a) and to medicament affected biomarker values after a short-term treatment period (18b) for determining a medicament affected estimate of a long-term risk of future occurrence of that clinical outcome (2b). The long-term medicament efficacy estimate (19) is determined from the reference risk estimate and the medicament affected risk estimate.
机译:为了获得药物对降低肾脏临床结局或心血管临床结局风险的长期疗效的预测,从多种生物标志物的值(8)和过去的发生情况确定多元风险关系(11)表示临床预后。生物标志物包括收缩压,尿液中白蛋白和肌酐含量之比,血钾,血红蛋白和总胆固醇含量。将该风险关系应用于参考生物标志物值(16、18a),以确定该临床结果(2a)未来发生风险的参考估计,并应用于短期治疗期(18b)后受药物影响的生物标志物值,以确定受药物影响的该临床结果未来发生的长期风险的估计值(2b)。根据参考风险估计值和药物影响的风险估计值确定长期药物疗效估计值(19)。

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