Table 1.
Principal inclusion criteria for all three studies | |
Patients with heFH who are not adequately controlleda with a maximally-tolerated stable daily dose of statinb for at least 4 weeks prior to the screening visit, with or without other LLT | |
Principal exclusion criteria | |
Not on a stable dose of LLT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit or from screening to randomization | |
Currently taking a statin that is not simvastatin, atorvastatin or rosuvastatin taken daily at a registered dose | |
Receiving daily doses above atorvastatin 80 mg, rosuvastatin 40 mg or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than 1 year, who are eligible) | |
Use of fibrates, other than fenofibrate, within 6 weeks of the screening visit | |
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening visit | |
Known history of homozygous FH | |
FH I and II | HIGH FH |
History of documented CVD and LDL-C <70 mg/dL (<1.81 mmol/L) at the screening visit Without history of documented CVD and LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit |
LDL-C <160 mg/dL (<4.14 mmol/L) at the screening visit AND patient only on statin monotherapy without additional LLT |
CVD cardiovascular disease, FH familial hypercholesterolemia, heFH heterozygous familial hypercholesterolemia, LDL-C low-density lipoprotein cholesterol, LLT lipid-lowering therapy, MI myocardial infarction
aFH I and II: not adequately controlled defined as an LDL-C ≥70 mg/dL at the screening visit in patients with a history of documented CVD OR LDL-C ≥100 mg/dL at the screening visit in patients without a history of documented CVD. HIGH FH: not adequately controlled defined as an LDL-C ≥160 mg/dL at the screening visit
bMaximally-tolerated statin dose defined as: the highest tolerable registered dose of daily statin currently administered to the patient, that is rosuvastatin 20 mg or 40 mg daily; atorvastatin 40 mg or 80 mg daily; simvastatin 80 mg daily (if already on this dose for >1 year). Patients who are not able to be on any of the above statin doses should be treated with the dose of daily atorvastatin, rosuvastatin, or simvastatin which is considered appropriate for the patient, according to the investigator’s judgment