Cardiovascular Diseases
Conditions
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
Interventions
OTHERPharmacogenomics-directed Hyperlipidaemia Management
Pharmacogenomics-directed Hyperlipidaemia Management
Sponsors
Collabring Pte Ltd
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides | 12 months | Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months |
| Change in creatine kinase | 6 months | Changes in creatine kinase from baseline to six months only if myopathy complaints were present. |
| Incidence of myopathy complaints | 6 months | Incidence of myopathy complaints at 1-month, 3-month, and 6-month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare utilisation | 12 months | Healthcare utilisation will be measured as the number of visits over 12 months |
| (Clinician or Prescriber) Adherence to recommendations | 6 months | The proportion of patients whose statin dose was prescribed in adherence to SLCO1B1 and/or ABCG2 phenotype recommendations, the proportion of patients with lipid-lowering drug changes following phenotype results, retrospective exploratory analyses of emerging gene predictors of lipid-control and myopathy |
| Changes to beliefs about medications | 12 months | Drug-Associated Risk Tool (DART)-Beliefs about Medicines Questionnaire (BMQ) scores will be computed. It is expected for responses to become more favourable over time |
| Changes in health-related quality of life | 12 months | Changes in health-related quality of life will be measured using the utility score derived from EQ-5D-5L over 12 months. An improvement in scores imply a better quality of life. |
| Cost effectiveness analysis | 12 months | Cost effectiveness analysis will be measured as total direct medical cost per disability-adjusted life year |
| Direct medical costs | 12 months | Total direct medical costs measured in USD will be computed from consultation costs, laboratory costs, and visits to other healthcare professionals. |
Contacts
Primary ContactDoreen Su-Yin Tan, PharmD
Outcome results
None listed