FH clinical studies Flashcards
How long was the FHI and FHII study
78 weeks
How many patients were in the FHI & FHII study
735 patients
When and in which journal was the study published
2015 in the European Heart Journal
What was the objective of the study?
Efficacy & Safety of Praluent in pts with HeFH on max tolerated LLT for 78 weeks
What was the inclusion criteria
Patients were were over 18yrs with HeFH and an LDL-C level above target (^2.6 mmol/l) without History of CV (>1.8 mmol/l for patients who had a myocardial infarction or IS)
When was the dose of 75 mg Praluent change to 150mg
If LDL-C target of less than 1.8 was not achieved at week 8 than the pt. was up titrated to 150mg at week 12.
How was HeFH diagnosed
Either by genotyping or clinical criteria(Simon Broome or WHO/Dutch Lipid network)
What were the endpoints?
Primary: LDL-C change from baseline at week 24
2nd: Proportion of pts. reaching a pre-specified target of LDL-C at week 24.
Safety: AE, lab data, electrocardiogram, and vital signs and adjudicated CV events & deaths.
What were the baseline characteristics
History of CHD 46% & 36%
CHD risk equivalents 16% & 18%
50% on Etizimibe
100% on statins with 80% on max dose.
Define CHD?
CHD define as acute MI, silent MI, unstable angina, or coronary revascularisation .
Define CHD risk equivalents?
IS, Peripheral artery disease or diabetes with 2 additional risk factors, moderate kidney disease
What were the LDL-C reductions at week 24?
48.8% and 48.7%
What % of pts. achieved their pre-specified target at week 8?
FHI 56.6%
FHII 61.4% were maintained on 75 mg dose.
What was the baseline LDL-C in the study of FHI & FHII study?
3.75 mmol/l and 3.49 mmol/l
What % of pts. achieved their pre-specified target at week 24 ?
FHI: 59.8% and FHII: 68.2%
