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| Name | Class |
|---|---|
| Collabring Pte Ltd | INDUSTRY |
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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.
The primary aims are:
The secondary aims include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Doctor-only care; receiving standard care without genetic information | |
| Intervention Group | Experimental | Pharmacist-guided care; dosing of statin medication based on genetic information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomics-directed Hyperlipidaemia Management | Other | Pharmacogenomics-directed Hyperlipidaemia Management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides | Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months | 12 months |
| Change in creatine kinase | Changes in creatine kinase from baseline to six months only if myopathy complaints were present. | 6 months |
| Incidence of myopathy complaints | Incidence of myopathy complaints at 1-month, 3-month, and 6-month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| (Clinician or Prescriber) Adherence to recommendations | 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 | 6 months |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doreen Su-Yin Tan, PharmD | Contact | +65 8809 8018 | doreen.tan.sy@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Ying Xian Chua | National University Polyclinics | Principal Investigator |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Cost effectiveness analysis | Cost effectiveness analysis will be measured as total direct medical cost per disability-adjusted life year | 12 months |
| Direct medical costs | Total direct medical costs measured in USD will be computed from consultation costs, laboratory costs, and visits to other healthcare professionals. | 12 months |
| Healthcare utilisation | Healthcare utilisation will be measured as the number of visits over 12 months | 12 months |
| Changes in health-related quality of life | 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. | 12 months |
| Changes to beliefs about medications | 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 | 12 months |