1. Studies reviewed for relevant adverse events.
| Study | Population size | Duration of follow‐up (years) | Outcomes | Included in Review | Adverse events reported | |||||||
| Death (all‐ causes) | Death (CV causes) | Non‐fatal MI | Stroke | Angina | Revascularisation | VTE | PE | |||||
| CHART 2006 | 1265 | 2 | Bone mineral density Serum lipids (LDL, HDL, TG) Endometrial hyperplasia and proliferation |
No | ||||||||
| de Maat 2007² | 436 | 5 | CRP Fibrinogen |
No | ||||||||
| ERT II 1979 | 168 | 10 | Not specified | Yes | ✓ | ✓ | ✓ | |||||
| Genant 1997 | 406 | 2 | Bone mineral density Serum lipids Endometrial tissue structure |
No (no events in placebo arm) |
✓ | ✓ | ||||||
| Greenspan 2005 | 373 | 3 | Time to rise from a chair Timed walking Balance Instrumental Activities of Daily Living Physical Activity Scale of the Elderly Folstein Mini‐Mental State Examination Falls |
Yes | ✓ | ✓ | ✓ | |||||
| Hart 1984 | 72 | 10 | Bone mineral density Serum lipids |
No | ||||||||
| Heikkinen 1997 | 232 | 3 | Serum lipids | No | ||||||||
| HOPE 2002 | 2673 | 2 | Number and severity of hot flushes
Papanicolaou smear with vaginal maturation index Bone mineral density Serum lipids Lipoproteins Glucose tolerance Coagulation/fibrinolytic factors |
No | ||||||||
| Kim 1996 | 551 | 1 | Serum lipids, Lipoproteins |
No | ||||||||
| Leggate 1984 | 54 | 10 | Bone mineral density | No | ||||||||
| OPAL 2006 | 571 | 3 | Change in carotid intima media thickness | No (no events in one group) |
✓ | ✓* | ✓* | ✓* | ✓* | |||
| PEPI 1995 | 875 | 3 | HDL Systolic blood pressure Serum insulin Serum glucose Fibrinogen |
No (no events in some groups) |
✓ | ✓* | ✓* | ✓* | ✓* | |||
| SMART‐5 2012 | 503 | 1 | Endometrial hyperplasia | No (no events in one group) |
✓✝ | ✓ | ||||||
| Stevenson 2005 | 579 | 2 | Serum lipids | No | ||||||||
| STOP IT 2001 | 369 | 3 | Bone mineral density Serum 25‐hydroxyvitamin D Serum lipids Depression Calcium absorption Serum PTH Osteocalcin Urinary N ‐telopeptides/creatinine ratio |
Yes | ✓ | ✓ | ✓ | ✓ | ||||
| Tofteng 2002² | 429 | 5 | Bone mineral density | No | ||||||||
| WELL‐HART 2003 | 226 | 3.3 | Change in coronary stenosis | Yes | ✓ | ✓* | ✓* | ✓* | ✓* | ✓* | ✓* | ✓* |
| WHISP 2006 | 100 | 0.58 (7 months) |
Serum lipids Antithrombin Factor VII Fibrinogen |
Yes | ✓ | ✓¹ | ✓ | ✓¹ | ✓ | |||
| *Part of a composite endpoint. ✝In a non‐relevant treatment group (bazedoxifene and oestrogen). ¹Not included in analysis as no event in one of the groups. ²Sub‐study of DOPS 2012 | ||||||||||||