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

NCT06674044 | Completed

• 1 other identifier: Riphah/IIMC/IRC/23/30104
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (3)

• 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

• Lipid profile

  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

  1 month

• The SAMS-CI tool

  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.

  1 month

Interventions

Atorvastatin GENETIC

Atorvastatin 10mg once a day for 1 month

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pakistani Population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

IIMC, Riphah International University

Islamabad, Federal, Pakistan

Location

Related Publications (7)

• Hedayatnia M, Asadi Z, Zare-Feyzabadi R, Yaghooti-Khorasani M, Ghazizadeh H, Ghaffarian-Zirak R, Nosrati-Tirkani A, Mohammadi-Bajgiran M, Rohban M, Sadabadi F, Rahimi HR, Ghalandari M, Ghaffari MS, Yousefi A, Pouresmaeili E, Besharatlou MR, Moohebati M, Ferns GA, Esmaily H, Ghayour-Mobarhan M. Dyslipidemia and cardiovascular disease risk among the MASHAD study population. Lipids Health Dis. 2020 Mar 16;19(1):42. doi: 10.1186/s12944-020-01204-y.

  PMID: 32178672 BACKGROUND

• Firnhaber JM. Hyperlipidemia management: A calibrated approach. J Fam Pract. 2023 Apr;72(3):126-132. doi: 10.12788/jfp.0576.

  PMID: 37075215 BACKGROUND

• Zhang X, Xing L, Jia X, Pang X, Xiang Q, Zhao X, Ma L, Liu Z, Hu K, Wang Z, Cui Y. Comparative Lipid-Lowering/Increasing Efficacy of 7 Statins in Patients with Dyslipidemia, Cardiovascular Diseases, or Diabetes Mellitus: Systematic Review and Network Meta-Analyses of 50 Randomized Controlled Trials. Cardiovasc Ther. 2020 Apr 23;2020:3987065. doi: 10.1155/2020/3987065. eCollection 2020.

  PMID: 32411300 BACKGROUND

• Bharath G, Vishnuprabu DP, Preethi L, Nagappan AS, Dhianeshwaran Isravanya RT, Bhaskar LV, Swaminathan N, Munirajan AK. SLCO1B1 and ABCB1 variants synergistically influence the atorvastatin treatment response in South Indian coronary artery disease patients. Pharmacogenomics. 2022 Aug;23(12):683-694. doi: 10.2217/pgs-2022-0044. Epub 2022 Aug 15.

  PMID: 35968761 BACKGROUND

• Na Nakorn C, Waisayarat J, Dejthevaporn C, Srisawasdi P, Wongwaisayawan S, Sukasem C. Genetic Variations and Frequencies of the Two Functional Single Nucleotide Polymorphisms of SLCO1B1 in the Thai Population. Front Pharmacol. 2020 Jun 5;11:728. doi: 10.3389/fphar.2020.00728. eCollection 2020.

  PMID: 32581780 BACKGROUND

• Marin JJG, Serrano MA, Monte MJ, Sanchez-Martin A, Temprano AG, Briz O, Romero MR. Role of Genetic Variations in the Hepatic Handling of Drugs. Int J Mol Sci. 2020 Apr 20;21(8):2884. doi: 10.3390/ijms21082884.

  PMID: 32326111 BACKGROUND

• Turongkaravee S, Jittikoon J, Lukkunaprasit T, Sangroongruangsri S, Chaikledkaew U, Thakkinstian A. A systematic review and meta-analysis of genotype-based and individualized data analysis of SLCO1B1 gene and statin-induced myopathy. Pharmacogenomics J. 2021 Jun;21(3):296-307. doi: 10.1038/s41397-021-00208-w. Epub 2021 Feb 19.

  PMID: 33608664 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood was withdrawn, and DNA extraction was performed using Chelex method.

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Tayaba Farooq, MBBS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)