DPCA 2-3_100-110_wm

CPD module
levels and a history of intolerance to two or more
statins. The trial started with a 24-week crossover
procedure using atorvastatin 20 mg or placebo
to identify the patients having symptoms with
the statin only (phase A). Following a 2-week
washout period, patients were randomised
to ezetimibe (10 mg/day) or evolocumab
(420 mg/month) for 24 weeks (phase B). The
co-primary endpoints were the mean percentage
change in LDL cholesterol from baseline to the
mean of weeks 22 and 24, and from baseline to
week 24 levels.
Of the 491 patients who entered phase A
(mean age 60.7 years, 50.1% female, 34.6%
with CHD, entry mean LDL cholesterol level
212.3 mg/dL [5.5 mmol/L]), muscle symptoms
occurred in 42.6% (n=209) when taking
atorvastatin but not when taking placebo. Of these,
199 entered phase B, together with 19 who were
fast-tracked to phase B due to elevated creatine
kinase (n=218; 73 randomised to ezetimibe,
145 to evolocumab, entry mean LDL cholesterol
level 219.9 mg/dL [5.7 mmol/L]; Nissen et al, 2016).
For the mean of weeks 22 and 24, the LDL
cholesterol level was 183.0 mg/dL (4.7 mmol/L)
with ezetimibe (mean percentage change −16.7%,
absolute change −31.0 mg/dL [0.8 mmol/L]) and
103.6 mg/dL (2.7 mmol/L) with evolocumab
(mean percentage change −54.5%, absolute change
−106.0 mg/dL [2.7 mmol/L]). At week 24, the
LDL cholesterol level was 181.5 mg/dL (4.7 mmol/L)
with ezetimibe (mean percentage change −16.7%,
absolute change −31.2 mg/dL [0.8 mmol/L]) and
104.1 mg/dL (2.7 mmol/L) with evolucumab
(mean percentage change −52.8%, absolute change
−102.9 mg/dL (2.7 mmol/L; P