Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To identify genetic polymorphism in SLOC1B1 in the Pakistani population
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient taking other lipid-lowering medications
- •Moderate and severe systemic diseases
- •Patients taking medications and diet that can interact with atorvastatin
- •Hypothyroidism
- •Recent history of surgical procedure or trauma
结局指标
主要结局
To identify genetic polymorphism in SLOC1B1 in the Pakistani population
时间窗: 1 month
Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay.
Lipid profile
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点