Adverse events with droxicam in the early clinical trials.

J Sánchez, A Bartlett, A Costa, J Estruch, R Estiarte, C Soucheiron
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Abstract

This study analyses the results of 8 randomized, controlled clinical trials and one open study carried out with droxicam (a new NSAID, pro-drug of piroxicam), comparing the adverse events and gastrointestinal tolerance of this compound against those of the control drugs used in these trials. The frequency of adverse events was lower in the droxicam treated patients. Adverse events concerning the gastrointestinal area were also lower. No differences were found in the distribution of adverse events by age of sex among the drugs compared. The pattern of side effects found was that expected in all non-steroidal anti-inflammatory agents. These results seem to sustain the hypothesis of a better tolerance of droxicam than that of piroxicam, indomethacin or diclofenac, especially in the gastrointestinal area.

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在早期临床试验中的不良事件。
本研究对droxicam(一种新型非甾体抗炎药,piroxicam的前药)进行的8项随机对照临床试验和1项开放研究的结果进行了分析,比较了该化合物与对照药物的不良事件和胃肠道耐受性。不良事件发生的频率较低。与胃肠道有关的不良事件也较低。不同药物间不良事件的年龄和性别分布没有差异。发现的副作用模式与所有非甾体抗炎药的预期相同。这些结果似乎支持了droxicam比piroxicam、吲哚美辛或双氯芬酸耐受性更好的假设,特别是在胃肠道区域。
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