Clinical trial NCT06674044: Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population
Official title: Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemias
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani Population

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 (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.

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 (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.

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

Eligibility criteria: Inclusion Criteria:

1. Pakistani individuals aged between 30 to 60 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

Primary outcomes:
measure: To identify genetic polymorphism in SLOC1B1 in the Pakistani population
timeFrame: 1 month
measure: Lipid profile
timeFrame: 1 month
measure: The SAMS-CI tool
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: IIMC, Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Tayaba Farooq, MBBS
role: PRINCIPAL_INVESTIGATOR
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