Table 4

Reasons for randomised patients stopping study simvastatin/placebo tablets

Reason(s) given

Simvastatin-allocated

(n = 10269)

Placebo-allocated

(n = 10267)


Patient wishes

2186

(21.3%)

2113

(20.6%)

Unable or unwilling to attend clinic

757

(7.4%)

745

(7.3%)

Non-study statin started

364

(3.5%)

1401

(13.6%)

Other contraindicated drug started

11

(0.1%)

50

(0.5%)

Poor compliance

88

(0.9%)

120

(1.2%)

Raised liver or muscle enzymes**

57

(0.6%)

46

(0.4%)

Raised liver enzymes

46

(0.4%)

36

(0.4%)

Raised muscle enzymes

11

(0.1%)

2

(0.0%)

Muscle pain or weakness

60

(0.6%)

62

(0.6%)

Medical advice

158

(1.5%)

206

(2.0%)

Medical diagnosis/treatment/investigation

143

(1.4%)

160

(1.6%)

Non-specific adverse events

110

(1.1%)

126

(1.2%)

Other adverse events

229

(2.2%)

225

(2.2%)

Gastrointestinal

114

(1.1%)

104

(1.0%)

Psychological/psychiatric

49

(0.5%)

54

(0.5%)

Rash or skin

22

(0.2%)

22

(0.2%)

Neurological

10

(0.1%)

14

(0.1%)

Other

44

(0.4%)

43

(0.4%)

Other or family reasons

149

(1.5%)

141

(1.4%)

Any of the above*

3440

(33.5%)

4424

(43.1%)

P = 0.0000


* Patient may stop study treatment for more than one reason

** Includes 6 vs 2 myopathy cases (the remaining myopathy patients had no further visits) and 2 vs 1 hepatitis cases

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

Open Data