DPCA 2-3_entire_v3
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CPD module<br />
levels and a history of intolerance to two or more<br />
statins. The trial started with a 24-week crossover<br />
procedure using atorvastatin 20 mg or placebo<br />
to identify the patients having symptoms with<br />
the statin only (phase A). Following a 2-week<br />
washout period, patients were randomised<br />
to ezetimibe (10 mg/day) or evolocumab<br />
(420 mg/month) for 24 weeks (phase B). The<br />
co-primary endpoints were the mean percentage<br />
change in LDL cholesterol from baseline to the<br />
mean of weeks 22 and 24, and from baseline to<br />
week 24 levels.<br />
Of the 491 patients who entered phase A<br />
(mean age 60.7 years, 50.1% female, 34.6%<br />
with CHD, entry mean LDL cholesterol level<br />
212.3 mg/dL [5.5 mmol/L]), muscle symptoms<br />
occurred in 42.6% (n=209) when taking<br />
atorvastatin but not when taking placebo. Of these,<br />
199 entered phase B, together with 19 who were<br />
fast-tracked to phase B due to elevated creatine<br />
kinase (n=218; 73 randomised to ezetimibe,<br />
145 to evolocumab, entry mean LDL cholesterol<br />
level 219.9 mg/dL [5.7 mmol/L]; Nissen et al, 2016).<br />
For the mean of weeks 22 and 24, the LDL<br />
cholesterol level was 183.0 mg/dL (4.7 mmol/L)<br />
with ezetimibe (mean percentage change −16.7%,<br />
absolute change −31.0 mg/dL [0.8 mmol/L]) and<br />
103.6 mg/dL (2.7 mmol/L) with evolocumab<br />
(mean percentage change −54.5%, absolute change<br />
−106.0 mg/dL [2.7 mmol/L]). At week 24, the<br />
LDL cholesterol level was 181.5 mg/dL (4.7 mmol/L)<br />
with ezetimibe (mean percentage change −16.7%,<br />
absolute change −31.2 mg/dL [0.8 mmol/L]) and<br />
104.1 mg/dL (2.7 mmol/L) with evolucumab<br />
(mean percentage change −52.8%, absolute change<br />
−102.9 mg/dL (2.7 mmol/L; P