Genetic Polymorphism of Rosuvastatin

IMPACT OF GENETIC POLYMORPHISM OF ROSUVASTATIN TRANSPORTER GENES ON ITS PLASMA LEVELS AND LIPID LOWERING EFFICACY IN HYPERLIPIDEMIC PAKISTANI PATIENTS

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221127056625N1

Enrollment

384

Registered

2022-12-22

Start date

2022-12-05

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients of hyperlipidemia with LDLc> 130mg/dL.

Interventions

Intervention group: Patients will receive rosuvastatin once daily for a period of 12 weeks.

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Both males and females belonging to different Pakistani regions Age 30-70 years Patients with elevated LDL-c levels more than 130 mg/dL (3.4 mmoles/L) Patients with normal serum CPK levels 10-120 mcg/dL

Exclusion criteria

Exclusion criteria: Patients taking antihyperlipidemic drugs other than rosuvastatin Hepatic and kidney diseases Patients with raised serum CPK levels >120 mcg/dL Concurrent use of potent cytochrome inducer or inhibitor with documented interaction with rosuvastatin Pregnant and nursing females . Hypersensitivity to rosuvastatin

Design outcomes

Primary

Measure	Time frame
Prevalence of genetic polymorphism of rosuvastatin transporter genes SLCO1B3 and ABCG2 for their variant alleles i.e. SLCOIB3 334T >G (rs4149117), 699 G>A (rs7311358) and ABCG2 421 C>A (rs2231142), 34G >A (rs2231137). Timepoint: After 12 weeks of intervention with rosuvastatin drug. Method of measurement: Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) and Allele Specific Polymerase Chain Reaction (AS-PCR).	—

Measure

Time frame

Prevalence of genetic polymorphism of rosuvastatin transporter genes SLCO1B3 and ABCG2 for their variant alleles i.e. SLCOIB3 334T >G (rs4149117), 699 G>A (rs7311358) and ABCG2 421 C>A (rs2231142), 34G >A (rs2231137). Timepoint: After 12 weeks of intervention with rosuvastatin drug. Method of measurement: Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) and Allele Specific Polymerase Chain Reaction (AS-PCR).

—

Secondary

Measure	Time frame
Plasma rosuvastatin levels. Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: High Performance Liquid Chromatography (HPLC).;Impact of polymorphic alleles of rosuvastatin transporter genes on biochemical parameters like Lipid Profile ( TC, LDL-c, HDL-c, TG and VLDL) ii. Serum Creatine Phospho Kinase (CPK) iii. Liver Function Tests iv. Renal Function Tests v. C-Reactive Protein (CRP). Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: Biochemical analysis.	—

Measure

Time frame

Plasma rosuvastatin levels. Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: High Performance Liquid Chromatography (HPLC).;Impact of polymorphic alleles of rosuvastatin transporter genes on biochemical parameters like Lipid Profile ( TC, LDL-c, HDL-c, TG and VLDL) ii. Serum Creatine Phospho Kinase (CPK) iii. Liver Function Tests iv. Renal Function Tests v. C-Reactive Protein (CRP). Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: Biochemical analysis.

—

Countries

Pakistan

Contacts

Public ContactDr. Mahjabeen Sharif

Army Medical College Rawalpindi, National University of Medical Sciences (NUMS) Rawalpindi

mahjabeen30@hotmail.com+92 333 5077896

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026