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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.1 All cases of VTE.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.1 All cases of VTE.

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Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.8 Cardiovascular events in healthy population.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.8 Cardiovascular events in healthy population.

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Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.14 Death.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.14 Death.

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Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.17 Any serious adverse event.
Figuras y tablas -
Figure 6

Forest plot of comparison: 1 Rosuvastatin versus placebo, outcome: 1.17 Any serious adverse event.

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Comparison 1 Rosuvastatin versus placebo, Outcome 1 All cases of VTE.
Figuras y tablas -
Analysis 1.1

Comparison 1 Rosuvastatin versus placebo, Outcome 1 All cases of VTE.

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Comparison 1 Rosuvastatin versus placebo, Outcome 2 Provoked VTE.
Figuras y tablas -
Analysis 1.2

Comparison 1 Rosuvastatin versus placebo, Outcome 2 Provoked VTE.

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Comparison 1 Rosuvastatin versus placebo, Outcome 3 Unprovoked VTE.
Figuras y tablas -
Analysis 1.3

Comparison 1 Rosuvastatin versus placebo, Outcome 3 Unprovoked VTE.

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Comparison 1 Rosuvastatin versus placebo, Outcome 4 Pulmonary embolism.
Figuras y tablas -
Analysis 1.4

Comparison 1 Rosuvastatin versus placebo, Outcome 4 Pulmonary embolism.

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Comparison 1 Rosuvastatin versus placebo, Outcome 5 Deep vein thrombosis.
Figuras y tablas -
Analysis 1.5

Comparison 1 Rosuvastatin versus placebo, Outcome 5 Deep vein thrombosis.

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Comparison 1 Rosuvastatin versus placebo, Outcome 6 All cases of VTE ‐ gender.
Figuras y tablas -
Analysis 1.6

Comparison 1 Rosuvastatin versus placebo, Outcome 6 All cases of VTE ‐ gender.

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Comparison 1 Rosuvastatin versus placebo, Outcome 7 All cases of VTE ‐ age.
Figuras y tablas -
Analysis 1.7

Comparison 1 Rosuvastatin versus placebo, Outcome 7 All cases of VTE ‐ age.

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Comparison 1 Rosuvastatin versus placebo, Outcome 8 Cardiovascular events in healthy population.
Figuras y tablas -
Analysis 1.8

Comparison 1 Rosuvastatin versus placebo, Outcome 8 Cardiovascular events in healthy population.

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Comparison 1 Rosuvastatin versus placebo, Outcome 9 Non‐fatal MI.
Figuras y tablas -
Analysis 1.9

Comparison 1 Rosuvastatin versus placebo, Outcome 9 Non‐fatal MI.

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Comparison 1 Rosuvastatin versus placebo, Outcome 10 Any MI.
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Analysis 1.10

Comparison 1 Rosuvastatin versus placebo, Outcome 10 Any MI.

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Comparison 1 Rosuvastatin versus placebo, Outcome 11 Non‐fatal stroke.
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Analysis 1.11

Comparison 1 Rosuvastatin versus placebo, Outcome 11 Non‐fatal stroke.

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Comparison 1 Rosuvastatin versus placebo, Outcome 12 Any stroke.
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Analysis 1.12

Comparison 1 Rosuvastatin versus placebo, Outcome 12 Any stroke.

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Comparison 1 Rosuvastatin versus placebo, Outcome 13 Arterial revascularisation.
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Analysis 1.13

Comparison 1 Rosuvastatin versus placebo, Outcome 13 Arterial revascularisation.

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Comparison 1 Rosuvastatin versus placebo, Outcome 14 Death.
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Analysis 1.14

Comparison 1 Rosuvastatin versus placebo, Outcome 14 Death.

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Comparison 1 Rosuvastatin versus placebo, Outcome 15 Death after VTE.
Figuras y tablas -
Analysis 1.15

Comparison 1 Rosuvastatin versus placebo, Outcome 15 Death after VTE.

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Comparison 1 Rosuvastatin versus placebo, Outcome 16 Confirmed death resulting from cardiovascular causes.
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Analysis 1.16

Comparison 1 Rosuvastatin versus placebo, Outcome 16 Confirmed death resulting from cardiovascular causes.

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Comparison 1 Rosuvastatin versus placebo, Outcome 17 Any serious adverse event.
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Analysis 1.17

Comparison 1 Rosuvastatin versus placebo, Outcome 17 Any serious adverse event.

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Comparison 1 Rosuvastatin versus placebo, Outcome 18 Hepatic disorder.
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Analysis 1.18

Comparison 1 Rosuvastatin versus placebo, Outcome 18 Hepatic disorder.

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Comparison 1 Rosuvastatin versus placebo, Outcome 19 Myopathy.
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Analysis 1.19

Comparison 1 Rosuvastatin versus placebo, Outcome 19 Myopathy.

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Comparison 1 Rosuvastatin versus placebo, Outcome 20 Rhabdomyolysis.
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Analysis 1.20

Comparison 1 Rosuvastatin versus placebo, Outcome 20 Rhabdomyolysis.

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Comparison 1 Rosuvastatin versus placebo, Outcome 21 Renal disorder.
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Analysis 1.21

Comparison 1 Rosuvastatin versus placebo, Outcome 21 Renal disorder.

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Comparison 1 Rosuvastatin versus placebo, Outcome 22 Bleeding.
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Analysis 1.22

Comparison 1 Rosuvastatin versus placebo, Outcome 22 Bleeding.

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Comparison 1 Rosuvastatin versus placebo, Outcome 23 Muscular weakness, stiffness, or pain.
Figuras y tablas -
Analysis 1.23

Comparison 1 Rosuvastatin versus placebo, Outcome 23 Muscular weakness, stiffness, or pain.

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Comparison 1 Rosuvastatin versus placebo, Outcome 24 Gastrointestinal disorder.
Figuras y tablas -
Analysis 1.24

Comparison 1 Rosuvastatin versus placebo, Outcome 24 Gastrointestinal disorder.

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Summary of findings for the main comparison. Rosuvastatin versus placebo for prevention of venous thromboembolism

Rosuvastatin versus placebo for prevention of VTE

Patient or population: 17,802 patients with low to normal levels of low density lipoprotein (LDL) cholesterol (< 130 mg/dL)
Settings: 1315 sites in 26 countries on 4 continents, including North and South America, Europe, and Africa
Intervention: Rosuvastatin 20 mg daily versus placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Rosuvastatin versus placebo

All cases of VTE

Study population

OR 0.57
(0.37 to 0.86)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

7 per 1000

4 per 1000
(3 to 6)

Medium risk population

7 per 1000

4 per 1000
(3 to 6)

Pulmonary embolism

Study population

OR 0.77
(0.41 to 1.46)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

2 per 1000

2 per 1000
(1 to 3)

Medium risk population

3 per 1000

2 per 1000
(1 to 4)

Deep vein thrombosis

Study population

OR 0.45
(0.25 to 0.79)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

4 per 1000

2 per 1000
(1 to 3)

Medium risk population

4 per 1000

2 per 1000
(1 to 3)

Any MI

Study population

OR 0.45
(0.30 to 0.69)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

8 per 1000

4 per 1000
(2 to 6)

Medium risk population

8 per 1000

4 per 1000
(2 to 6)

Any stroke

Study population

OR 0.51
(0.34 to 0.78)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

8 per 1000

4 per 1000
(2 to 5)

Medium risk population

8 per 1000

4 per 1000
(2 to 5)

Death after VTE

Study population

OR 0.50
(0.20 to 1.24)

17,802
(1 study)

⊕⊕⊕⊝
moderate1

2 per 1000

1 per 1000
(0 to 2)

Medium risk population

2 per 1000

1 per 1000
(0 to 2)

Any serious adverse event

Study population

OR 0.98
(0.90 to 1.06)

17,802
(1 study)

⊕⊕⊕⊕
high

155 per 1000

152 per 1000
(142 to 163)

Medium risk population

155 per 1000

152 per 1000
(142 to 163)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 total number of events is less than 300

Figuras y tablas -
Summary of findings for the main comparison. Rosuvastatin versus placebo for prevention of venous thromboembolism
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Table 1. Published studies reporting the frequency of venous thromboembolism (VTE) in statin users and nonusers

Study

Type

No. of participants

Drug

Result

JUPITER trial

RCT (secondary outcome)

8901/8901

Rosuvastatin 20 mg daily versus placebo

HR 0.57 (95% CI 0.37 to 0.86)

Ramcharan 2009

Case‐control

4538/5914

Any statin

OR 0.55 (95% CI 0.46 to 0.67)

Sørensen 2009

Case‐control

5824/58240

Any statin

OR 0.74 (95% CI 0.63 to 0.85)

Smeeth 2009

Cohort study

129,288/600,241

Any statin

HR no statin versus statin 1.18 (95% CI 1.06 to 1.31)

Lacut 2004

Case‐control

377/377

Any statin

OR 0.42 (95% CI 0.23 to 0.76)

Lacut 2008

Case‐control

677/677

Any statin

OR 0.53 (95% CI 0.37 to 0.78)

Herrington 2002

Non‐randomised comparison (part of HERS)

1712/1051

Any statin

HR 0.40 (95% CI 0.18 to 0.91)

Yang 2002

Retrospective cohort study

22,993/61,100

Any statin

IRR current/recent statin use 0.8 (95% CI 0.3 to 2.7)

Ray 2001a

Retrospective cohort study

77,993/47,869

Any statin

HR 0.78 (95% CI 0.69 to 0.87)

Huerta 2007

Case‐control

6,550/10,000

Any statin

OR 0.70 (95% CI 0.50 to 0.97)

Doggen 2004

Case‐control

465/1962

Simvastatin, pravastatin

simvastatin OR 0.51 (95% CI 0.29 to 0.91)

pravastatin OR 1.85 (95% CI 0.65 to 5.26)

CI: confidence interval
HERS: Heart and Estrogen/Progestin Replacement Study
HR: hazard ratio
IRR: incidence rate ratio
OR: odds ratio

Figuras y tablas -
Table 1. Published studies reporting the frequency of venous thromboembolism (VTE) in statin users and nonusers
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Comparison 1. Rosuvastatin versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All cases of VTE Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Provoked VTE Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Unprovoked VTE Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4 Pulmonary embolism Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5 Deep vein thrombosis Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6 All cases of VTE ‐ gender Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 men

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 women

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 All cases of VTE ‐ age Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7.1 Aged 70 ‐ 97 y

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Aged 50 ‐ 69 y

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Cardiovascular events in healthy population Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9 Non‐fatal MI Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Any MI Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Non‐fatal stroke Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12 Any stroke Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

13 Arterial revascularisation Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14 Death Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

15 Death after VTE Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

16 Confirmed death resulting from cardiovascular causes Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

17 Any serious adverse event Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

18 Hepatic disorder Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

19 Myopathy Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

20 Rhabdomyolysis Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

21 Renal disorder Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

22 Bleeding Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

23 Muscular weakness, stiffness, or pain Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

24 Gastrointestinal disorder Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Rosuvastatin versus placebo
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