Table 3

Serious adverse events considered (before unblinding) to be probably due to study simvastatin

Event

Simvastatin-allocated

Placebo-allocated

(n = 10269)

(n = 10267)


Myopathy/rhabdomyolysis*

7

(0.1%)

2

(0.0%)

Muscle pain/weakness**

0

(0.0%)

1

(0.0%)

Hepatitis

1

(0.0%)

1

(0.0%)

GI haemorrhage

1

(0.0%)

0

(0.0%)

Renal failure

0

(0.0%)

1

(0.0%)

Neurological

0

(0.0%)

2

(0.0%)


* Includes 1 patient in each group taking non-study statin in addition to study treatment

** CK <10 × ULN

MRC/BHF Heart Protection Study Collaborative Group BMC Clinical Pharmacology 2009 9:6   doi:10.1186/1472-6904-9-6

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