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NCT Number: NCT07148037

Effect of SLC01B1 (rs4149956) Polymorphism on the Efficacy and Tolerability 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 (rs4149056) in the Pakistani population. To determine the association between SLOC1B1 (rs4149056) polymorphism and the clinical efficacy of atorvastatin To determine the association between SLOC1B1 (rs4149056) polymorphism and the tolerability of atorvastatin

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riphah International University

Rawalpindi, Punjab Province, 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: To identify polymorphism in SLOC1B1 (rs4149056) in the Pakistani population. To determine the association between SLOC1B1 (rs4149056) polymorphism and the clinical efficacy of atorvastatin To determine the association between SLOC1B1 (rs4149056) polymorphism and tolerability of atorvastatin. The participants' blood samples were taken and further genotyping was performed using conventional tetra ARMS 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 40 to 70 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

10mg once a day for 2 months

Other names: Statin

Primary outcomes

  1. To identify genetic polymorphism in SLOC1B1 in the Pakistani population Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay.

    Time frame: 1 month

    To identify genetic polymorphism in SLOC1B1 in the Pakistani population Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay.

  2. Lipid profile Lipid profile

    Time frame: 2 months

    Lipid profile Lipid profile will be measured at 0 and on the 56thth day of atorvastatin therapy on a blood sample. LDL cholesterol was categorized as optimal 190mg/dl. Total cholesterol: 240mg/dl = high. HDL cholesterol: 60mg/dl = high. Triglycerides:<150mg/dl were considered optimal, 150-199mg/dl as Borderline high, and 200-500 mg/dl as high

  3. The SAMS-CI tool

    Time frame: 2 months

    The patient will be assessed for tolerability through the myopathy by Statin-associated myopathy (SAM-CI) tool by filling out the questionnaire on days 0, 14,28,42 and 56. The SAMS-CI tool will be used, to record the location, symmetry, and onset of muscle symptoms at day 0, 14,28,42 and 56 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

Official study title

Effect of SLC01B1 (rs4149056) Polymorphism on the Efficacy and Tolerability of Atorvastatin in Pakistani Population

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

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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