Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 700
- Primary Endpoint
- Incidence of myopathy complaints
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control Group
Doctor-only care; receiving standard care without genetic information
Intervention Group
Pharmacist-guided care; dosing of statin medication based on genetic information
Intervention: Pharmacogenomics-directed Hyperlipidaemia Management (Other)
Outcomes
Primary Outcomes
Incidence of myopathy complaints
Time Frame: 6 months
Incidence of myopathy complaints at 1-month, 3-month, and 6-month
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides
Time Frame: 12 months
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months
Change in creatine kinase
Time Frame: 6 months
Changes in creatine kinase from baseline to six months only if myopathy complaints were present.
Secondary Outcomes
- (Clinician or Prescriber) Adherence to recommendations(6 months)
- Healthcare utilisation(12 months)
- Changes in health-related quality of life(12 months)
- Cost effectiveness analysis(12 months)
- Direct medical costs(12 months)
- Changes to beliefs about medications(12 months)
Investigators
Tan Su-Yin Doreen
Associate Professor
National University of Singapore