Fifteen years of statin therapy started in childhood: efficacy, safety, compliance and tolerability in patients with familial hypercholesterolemia

Fifteen years of statin therapy started in childhood: efficacy, safety, compliance and tolerability in patients with familial hypercholesterolemia - AfterFifteen-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42815

Enrollment

290

Registered

2015-10-05

Start date

2015-12-11

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

familial high cholesterol familial hypercholesterolemia

Interventions

none

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with FH who previously participated in a randomized double-blinded placebo-controlled study (JAMA 2004; 292(3):331-7) evaluating the 2-years efficacy and safety of pravastatin, and their 95 unaffected siblings.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
- Difference in carotid IMT and aspect of the carotid arteries (echo, MRI) between FH patients who started with statin therapy in childhood, and their non-affected siblings after 15 years of follow-up - The difference in cardiovascular endpoints between FH patients who started with statin therapy in childhood, and their non-affected siblings after 15 years of follow-up	—

Secondary

Measure	Time frame
For patients with FH: - Association between age at start statins and the incidence of cardiovascular endpoints - Association between age at start statins and the intima-media thickness and aspect of the carotid arteries (ultrasound, MRI) - Incidence of side effects - Degree of compliance	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)