Pragmatic clinical trial to assess the utility of SLCO1B1, ABCG2, and CYP2C9 preepmtive genotyping and pharmacogenetics training on the incidence of musculoskeletal adverse reactions in patients treated with statins in primary and specialized care.
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
Overview
Brief Summary
The main objective is to evaluate the differences in the outcomes of musculoskeletal adverse reactions in a group of patients treated with statines according to clinical practice (control group) vs patients with a prescribed statin based on the prosprective genotyping of SLCO1B1, ABCG2 and CYP2C9 (intervention group), in a follow-up period of 6 months in patients treated from primary attention (healthcare centers) and hospitals ( Hospital de La Princesa).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults, with any type of cardiovascular risk (high, moderate or low): a) In which it is indicated statins as a treatment at any dose. b) Pacients who must be outpatients, recruited in a health care centre (primary attention) or in hospitals (primary or secundary prevention). c) Pacients who must have never taken statins or who have started statin treatment less tan 15 days ago, or who had their statin dose increased or changed to a more potent statin due to bad control of LDL levels in the last 15 days. d) Patients who have to give their inform consent form written
Exclusion Criteria
- •a) Pacients who statins are not prescribed as standard clinical practice. b) Pacients who suffer a malignant or terminal disease whose live expectancy will be less than 6 months. c) Pacients who have statins contraindicated for treatment d) Pregnant or breast-feeding patients.
Outcomes
Primary Outcomes
The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
Secondary Outcomes
- The incidence of musculoskeletal adverse reactions at 12 months or longer follow up.
Investigators
Francisco Abad Santos
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa