HyperlipidemiasNCT06674044
Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population
An observational study of Hyperlipidemias, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Atorvastatin
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pakistani Population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemias
- Being tested
- Atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinGenetic
Atorvastatin 10mg once a day for 1 month
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayaba Farooq, MBBS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674044
- Sponsor's protocol ID
- Riphah/IIMC/IRC/23/30104
- Status last verified
- Nov 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32178672Firnhaber JM. Hyperlipidemia management: A calibrated approach. J Fam Pract. 2023 Apr;72(3):126-132. doi: 10.12788/jfp.0576.
PubMed 37075215Zhang 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.
PubMed 32411300Bharath 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.
PubMed 35968761Na 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.
PubMed 32581780Marin 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.
PubMed 32326111Turongkaravee 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.
PubMed 33608664Farooq T, Naeem U, Siddique A, Kausar S, Waheed A, Mumal S. Impact of SLCO1B1 (rs2306283) polymorphism on personalized atorvastatin dosing in a genetically distinct South Asian cohort. BMC Pharmacol Toxicol. 2025 Nov 12;26(1):189. doi: 10.1186/s40360-025-01022-x.
PubMed 41225666
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population
- ClinicalTrials.gov ID
- NCT06674044
- Acronym / sponsor ID
- Riphah/IIMC/IRC/23/30104
- Conditions
- Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pakistani Population
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patient taking other lipid-lowering medications
- Moderate and severe systemic diseases
- Pregnancy
- Patients taking medications and diet that can interact with atorvastatin
- Hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin 10mg once a day for 1 month | Genetic | – |
Primary outcome
To identify genetic polymorphism in SLOC1B1 in the Pakistani population
Time frame: 1 month
Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay.
Lipid profile
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 32178672Hedayatnia 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.
- Background: PubMed 37075215Firnhaber JM. Hyperlipidemia management: A calibrated approach. J Fam Pract. 2023 Apr;72(3):126-132. doi: 10.12788/jfp.0576.
- Background: PubMed 32411300Zhang 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.
- Background: PubMed 35968761Bharath 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.
- Background: PubMed 32581780Na 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.
- Background: PubMed 32326111Marin 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.
- Background: PubMed 33608664Turongkaravee 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.
- Derived from this study: PubMed 41225666Farooq T, Naeem U, Siddique A, Kausar S, Waheed A, Mumal S. Impact of SLCO1B1 (rs2306283) polymorphism on personalized atorvastatin dosing in a genetically distinct South Asian cohort. BMC Pharmacol Toxicol. 2025 Nov 12;26(1):189. doi: 10.1186/s40360-025-01022-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayaba Farooq, MBBS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemias, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify genetic polymorphism in SLOC1B1 in the Pakistani population (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674044, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.