Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population

The goal of this prospective cohort study was to identify the effect of SLC01B1 gene polymorphism in the Pakistani population. The main questions it aims to answer are:

To identify polymorphism in SLOC1B1 (rs2306283) in the Pakistani population. To determine the association between SLOC1B1 (rs2306283) polymorphism and the clinical efficacy of atorvastatin To determine the association between SLOC1B1 (rs2306283) polymorphism and the safety profile of atorvastatin.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IIMC, Riphah International University

Islamabad, Federal, Pakistan

About this study

The goal of this prospective cohort study was to identify the effect of SLC01B1 gene polymorphism in the Pakistani population, due to the high prevalence of this variant in the Pakistani Population

The main questions it aims to answer are:

The participants' blood samples were taken and further genotyping was performed using conventional tetraARMS PCR. The results were visualized by gel electrophoresis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pakistani individuals aged between 30 to 60 years
Patients with deranged lipid profile
Newly diagnosed patients of dyslipidemia taking atorvastatin (Lipiget) 10mg/day
Normal hepatic and renal function

Exclusion criteria

Patient taking other lipid-lowering medications
Moderate and severe systemic diseases
Pregnancy
Patients taking medications and diet that can interact with atorvastatin
Hypothyroidism
Recent history of surgical procedure or trauma

Treatment and study plan

Atorvastatin

Genetic

Atorvastatin 10mg once a day for 1 month

Primary outcomes

To identify genetic polymorphism in SLOC1B1 in the Pakistani population

Time frame: 1 month

Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay.
Lipid profile

Time frame: 1 month

Lipid profile will be measured at 0 and on the 28th day of atorvastatin therapy on a blood sample.

LDL cholesterol was categorized as optimal <100mg/dl, Near or above optimal = 100-129mg/dl, Borderline = 130-159mg/dl, high = 160-189mg/dl, and very high >190mg/dl.

Total cholesterol: <200mg/dl = desirable, 200-239mg/dl = borderline high, >240mg/dl = high.

HDL cholesterol: <40mg/dl = low and >60mg/dl = high.

Triglycerides: <150mg/dl were considered optimal, 150-199mg/dl as Borderline high, and 200-500 mg/dl as high
The SAMS-CI tool

Time frame: 1 month

The patient will be assessed for safety profile through the myopathy by Statin-associated myopathy (SAM-CI) tool by filling out the questionnaire on days 0, 14, and 28. The SAMS-CI tool will be used, to record the location, symmetry, and onset of muscle symptoms at day 0, 14, and 28 of atorvastatin therapy. Patients reporting the presence of muscular pain will be further divided into "Unlikely", "Possible", and "Probable" categories based on their SAMS-CI score.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Nov 5, 2024
Registry last updated: Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed