National Heart and Lung Institute, Imperial College London, London, UK.
Institute of Cardiovascular Science, University College London, London, UK.
Pharmacol Res Perspect. 2021 Feb;9(1):e00710. doi: 10.1002/prp2.710.
The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints.
Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS).
Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%.
Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online.
ORBITA 试验是一项针对稳定型心绞痛患者的经皮冠状动脉介入治疗(PCI)与安慰剂治疗的临床试验,在英国的六个中心通过家庭监测和电话咨询进行。患者接受了详细的药物依从性评估,这使我们能够测量优化方案的实施效果,并解释主要试验终点。
在整个试验过程中收集处方数据。评估自我报告的依从性,并在随机分组前和随访时收集尿液样本,使用高效液相色谱-串联质谱法(HPLC-MS/MS)直接评估依从性。
在两个治疗组的两个阶段,所有药物的自我报告依从率均>96%。在 PCI 组和安慰剂组中,分别在随机分组前和随访时检测到药物的样本百分比为:氯吡格雷,96%比 90%和 98%比 94%;阿托伐他汀,95%比 92%和 92%比 91%;培哚普利,95%比 97%和 85%比 100%;比索洛尔,98%比 99%和 96%比 97%;氨氯地平,99%比 99%和 94%比 96%;尼可地尔,98%比 96%和 94%比 92%;伊伐布雷定,100%比 100%和 100%比 100%;雷诺嗪,100%比 100%和 100%比 100%。
通过自我报告方法进行量化时,研究过程中依从性水平较高,尿液检测到的药物比例也较高。结果表明,通过电话提供的优化方案得到了成功实施,这种方法可以作为治疗慢性疾病的模式,特别是随着咨询越来越多地在线进行。