Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (LipidPgx)

National University of Singapore

Status

Not yet enrolling

Conditions

Cardiovascular Diseases

Treatments

Other: Pharmacogenomics-directed Hyperlipidaemia Management

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06217523

2023/00280

Details and patient eligibility

About

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.

Full 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

Enrollment

700 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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