Summary of findings for the main comparison. Statin versus placebo for primary prevention of venous thromboembolism.
| Statin versus placebo for primary prevention of venous thromboembolism | ||||||
| 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 | Statin versus placebo | |||||
| All cases of VTE Follow‐up: median 1.9 years | Study population | OR 0.57 (0.37 to 0.86) | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Figure 1 | |
| 7 per 1000 | 4 per 1000 (3 to 6) | |||||
| Moderate | ||||||
| 7 per 1000 | 4 per 1000 (3 to 6) | |||||
| Pulmonary embolism Follow‐up: mean 1.9 years | See comment | See comment | Not estimable | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 |
| Deep vein thrombosis Follow‐up: median 1.9 years | See comment | See comment | Not estimable | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 |
| Any MI Follow‐up: median 1.9 years | Study population | OR 0.45 (0.3 to 0.69) | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 | |
| 8 per 1000 | 3 per 1000 (2 to 5) | |||||
| Moderate | ||||||
| 8 per 1000 | 4 per 1000 (2 to 6) | |||||
| Any stroke Follow‐up: median 1.9 years | Study population | OR 0.51 (0.34 to 0.78) | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 | |
| 7 per 1000 | 4 per 1000 (2 to 6) | |||||
| Moderate | ||||||
| 7 per 1000 | 4 per 1000 (2 to 5) | |||||
| Death Follow‐up: median 1.9 years | Study population | OR 0.8 (0.66 to 0.96) | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 | |
| 28 per 1000 | 22 per 1000 (18 to 27) | |||||
| Moderate | ||||||
| 28 per 1000 | 23 per 1000 (19 to 27) | |||||
| Any serious adverse event Follow‐up: median 1.9 years | Study population | OR 1.07 (0.95 to 1.2) | 17802 (1 study) | ⊕⊕⊕⊝ moderate1 | Appendix 3 | |
| 66 per 1000 | 70 per 1000 (63 to 78) | |||||
| Moderate | ||||||
| 66 per 1000 | 70 per 1000 (63 to 78) | |||||
| *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 sample size is lower than the calculated optimal information size (OIS). Therefore the evidence was downgraded based on imprecision