(Statins) and Fixed-dose Combination Products Containing a Statin

Final Report Update 5 Drug Effectiveness Review Project
Table 9. Outpatient and community-based placebo-controlled trials of statins with
coronary heart disease endpoints
Trial
(Quality)
Trials of atorvastatin
171, 172
ASCOT
Atorvastatin
10 mg
(Fair-Good)
CARDS 125
Atorvastatin
10 mg
(Good)
4D 134 (Fair)
ASPEN 142
Risk status/
Average annual
event rate in
placebo group
HTN plus CHD risk
factors/
0.9%
Type 2 diabetes, no
history of CVD
2.3%
Type 2 diabetes,
receiving dialysis
39%
Type 2 diabetes, low
LDL levels
Xu 145
Diabetes, coronary
artery disease
Trials of fluvastatin
ALERT 173
Fluvastatin 40
mg
(Good)
Riegger 129
Fluvastatin 40
mg
(Fair)
Trials of lovastatin
AFCAPS 126
Lovastatin 20
mg-40 mg
(Good)
Trials of pravastatin
ALLHAT-
LLC 121
Pravastatin
40 mg
(Fair-Good)
CARE 122
Pravastatin
40 mg
(Good)
LIPID 130 ;
Pravastatin
40 mg
(Good)
Patients with renal
transplant
1.0%
Symptomatic CAD/
2.8%
Average risk, no
history of CAD/
1.1%
Hypertensive
moderately high LDL-
C and at least 1
additional
CHD risk factor/
1.7%
History of CAD/
2.6%
History of CAD/
2.6%
Baseline
LDL
(mg/dL)
Study
duration
(years)
133 3.3 35%
% LDL
reduction
Reduction in
coronary events
(relative risk
reduction) a
36%
117 3.9 36% 37% 31
126 4.0 42%
18%
(including PTCA
and CABG)
113 4.25 29% 10.4% vs. 10.8%
125 1.75 24%
160 5.1 32%
198 1 26.9%
150 5.2 25%
145 4.8 24%
139 5 28%
150 6.1 25%
Number
needed to
treat to
prevent a
coronary
event b
94
18
37% (including
revascularization) 7
Primary endpoint
not significant
(P=0.139), but
35% reduction in
cardiac deaths or
non-fatal MI
38%
37%
9%
24%
24%
Results not
significant
Results not
significant
Results not
significant
49
Results not
significant
Statins Page 40 of 128
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