Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics

Cardiovascular Diseases Clinical Trial

— LipidPgx  

Official title:

Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217523
• Other study ID #: 2023/00280
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: National University of Singapore
• Contact: Doreen Su-Yin Tan, PharmD
• Phone: +65 8809 8018
• Email: doreen.tan.sy[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Other:
• Pharmacogenomics-directed Hyperlipidaemia Management
Pharmacogenomics-directed Hyperlipidaemia Management

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Collabring Pte Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in creatine kinase	Changes in creatine kinase from baseline to six months only if myopathy complaints were present.	6 months
Primary	Incidence of myopathy complaints	Incidence of myopathy complaints at 1-month, 3-month, and 6-month	6 months
Secondary	(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
Secondary	Cost effectiveness analysis	Cost effectiveness analysis will be measured as total direct medical cost per disability-adjusted life year	12 months
Secondary	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
Secondary	Healthcare utilisation	Healthcare utilisation will be measured as the number of visits over 12 months	12 months
Secondary	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
Secondary	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