Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 主要终点
- Incidence of myopathy complaints
研究概览
简要总结
This trial aims to evaluate the impact of clinical pharmacists' pharmacogenomics-guided choice and statin titration for managing hyperlipidaemia.
The central hypotheses of this trial are (1) clinical pharmacists' pharmacogenomics-guided choice and titration of statins will lead to a more significant reduction in LDL-c; (2) lower incidence of myopathies with the use of statins for hyperlipidaemia management over 12 months compared to usual care by doctors alone. Active follow-up and titration should occur over the first six months. However, the participants will be followed up to 12 months to confirm the sustained LDL level attainment.
详细描述
The primary aims are:
- The changes in Low-Density Lipoprotein cholesterol (LDL-c), total cholesterol, triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c) levels, and
- The incidence of myopathies over 12 months.
The secondary aims include:
- Characterisation of the pharmacogenomic relationship between serum levels of statins (and their metabolites) with the changes in LDL-c levels and incidence of myopathies over six months
- Economic outcomes include but are not limited to the cost-effectiveness of pharmacogenomic testing in attaining LDL-c targets
- Change in health-related quality of life over 12 months is measured using the EuroQoL 5-Dimension 5-Level questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 21 and 75 years old
- •Participants who are planning to start on statin* medication or whose LDL-c goals have not been met, per Appendix B.
- •Participants who are able to communicate in English, Chinese or Malay.
- •Participants who are planning to start or will be started on the following doses are eligible: atorvastatin 10-80 mg/day, rosuvastatin 10-40 mg/day, or simvastatin 10-40 mg/day within the last two to four weeks before enrolment
排除标准
- •Participants who are statin-intolerant or in whom statins are contraindicated
- •Participants on a statin dosing schedule of every other day (EOD)
- •Participants administered on potent Cytochrome P450 3A4 (CYP3A4) or Cytochrome P450 2C9 (CYP2C9) or OATP inhibitors or inducers.
- •Participants on evolocumab and alirocumab prior to enrolment
- •Participants with documented diagnosis of psychiatric conditions
- •Participants requiring palliative care, end-of-life care, or those with a life expectancy of less than one year
- •Pregnant and lactating women
- •Participants with complaints of myalgia or muscle weakness at baseline, before the commencement of statin
- •Participants who are unable to swallow a whole statin tablet
研究组 & 干预措施
Control Group
Doctor-only care; receiving standard care without genetic information
Intervention Group
Pharmacist-guided care; dosing of statin medication based on genetic information
干预措施: Pharmacogenomics-directed Hyperlipidaemia Management (Other)
结局指标
主要结局
Incidence of myopathy complaints
时间窗: 6 months
Incidence of myopathy complaints at 1-month, 3-month, and 6-month
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides
时间窗: 12 months
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months
Change in creatine kinase
时间窗: 6 months
Changes in creatine kinase from baseline to six months only if myopathy complaints were present.
次要结局
- Cost effectiveness analysis(12 months)
- Direct medical costs(12 months)
- (Clinician or Prescriber) Adherence to recommendations(6 months)
- Healthcare utilisation(12 months)
- Changes in health-related quality of life(12 months)
- Changes to beliefs about medications(12 months)
研究者
Tan Su-Yin Doreen
Associate Professor
National University of Singapore