Effect of SLC01B1 (rs4149956) Polymorphism on the Efficacy and Tolerability of Atorvastatin in Pakistani Population

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07148037

Enrollment

150

Registered

2025-08-29

Start date

2024-09-01

Completion date

2025-07-31

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias

Brief summary

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

Detailed description

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.

Interventions

GENETICAtorvastatin

10mg once a day for 2 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Pakistani individuals aged between 40 to 70 years 2. Patients with deranged lipid profile 3. Newly diagnosed patients of dyslipidemia taking atorvastatin (Lipiget) 10mg/day 4. Normal hepatic and renal function

Exclusion criteria

1. Patient taking other lipid-lowering medications 2. Moderate and severe systemic diseases 3. Pregnancy 4. Patients taking medications and diet that can interact with atorvastatin 5. Hypothyroidism 6. Recent history of surgical procedure or trauma

Design outcomes

Primary

Measure	Time frame	Description
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.	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.
Lipid profile Lipid profile	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
The SAMS-CI tool	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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026