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Table 3 Serious adverse events considered (before unblinding) to be probably due to study simvastatin

From: Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people

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%)

  1. * Includes 1 patient in each group taking non-study statin in addition to study treatment
  2. ** CK <10 × ULN
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BMC Clinical Pharmacology

ISSN: 1472-6904