HyperlipidemiasNCT07148037
Effect of SLC01B1 (rs4149956) Polymorphism on the Efficacy and Tolerability 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 (rs4149056) in the Pakistani population. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Atorvastatin
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2024to 31 Jul 2025
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani Population
Who may be able to join
- Pakistani individuals aged between 40 to 70 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
Official title: Effect of SLC01B1 (rs4149056) Polymorphism on the Efficacy and Tolerability of Atorvastatin in Pakistani Population
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
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 (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.
- 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
Also called Statin
10mg once a day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | 10mg once a day for 2 months Receives: Genetic: Atorvastatin |
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.
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
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
Measured: 2 months
The SAMS-CI tool
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Waqar, MBBS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148037
- Sponsor's protocol ID
- Riphah/IIMC/IRC/24/1095
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- 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 32178672Zhang 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 35968761Marin 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 33608664
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SLC01B1 (rs4149056) Polymorphism on the Efficacy and Tolerability of Atorvastatin in Pakistani Population
- ClinicalTrials.gov ID
- NCT07148037
- Acronym / sponsor ID
- Riphah/IIMC/IRC/24/1095
- Conditions
- Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | – | Genetic: Atorvastatin10mg once a day for 2 months |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani Population
Key inclusion criteria (4 listed)
- Pakistani individuals aged between 40 to 70 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 |
|---|---|---|
| AtorvastatinAlso: Statin10mg once a day for 2 months | Genetic | Atorvastatin |
Primary outcome
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.
Time frame: 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
Time frame: 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
Time frame: 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.
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 29 Aug 2025.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- 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.
Sidra Waqar, 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 29 Aug 2025. 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 Genetic polymorphism in SLOC1B1 in the Pakistani population will be assessed by ARMS PCR assay. (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 NCT07148037, which also lists 5 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 29 Aug 2025.