Table 1.
Main characteristics of randomised controlled trials included in review
| Study | Location | Mean follow-up (years) | Patients | Comparison | No (total) | Mean (SD) age | Primary outcome | Outcomes abstracted | Data* |
|---|---|---|---|---|---|---|---|---|---|
| ACE inhibitors v control: | |||||||||
| CASSIS 199544 | Multicentre Czech Republic and Slovakia | 0.2 | Patients with chronic congestive heart failure | Spirapril or enalapril v placebo | 200 v 48 (248) | 57.5 (10) | Assessment of changes in exercise tolerance | Serious pneumonia† | Published |
| TRACE 199545 | Multicentre Denmark | 4.0 | Patients with left ventricular ejection fraction after myocardial infarction | Trandolapril v placebo | 876 v 873 (1749) | 67.5 | Death from any cause | Pneumonia† | Published |
| GISEN 199746 | Multicentre Italy | 1.3 | Patients with chronic nephropathy and persistent proteinuria | Ramipril v placebo | 78 v 88 (166) | 49.3 (13.6) | Rate of decline in glomerular filtration | Drug withdrawal due to bronchopneumonia† | Published |
| HOPE 200047 | Multicentre worldwide (not Asia) | 4.0 | Patients at high risk of developing a major cardiovascular event | Ramipril v placebo | 4645 v 4652 (9297) | 66 (7) | Myocardial infarction, stroke, or death due to cardiovascular disease | Serious pneumonia† | Unpublished |
| PROGRESS 200420 48 | Multicentre worldwide | 3.9 | Patients with previous stroke or transient ischaemic attack | Perindopril v placebo | 3051 v 3054 (6105) | 64 (10) | Fatal or non-fatal stroke | Fatal and non-fatal pneumonia | Published |
| Kanda 200449 | Single centre Japan | 4.0 | Patients aged ≥65 with history of stroke and admitted with community acquired pneumonia | Imidapril+amantadine+standard care v standard care | 33 v 35 (68) | 78 (8) | In-hospital mortality, duration of antibiotic use, and infection with MRSA | Hospital death | Published |
| Hou 200650 | Single centre China | 3.4 | Patients with non-diabetic chronic kidney disease | Benazepril v placebo | 216 v112 (328) | 44.8 (14.6) | Composite of doubling of serum creatinine level, end stage renal disease, and death | Pneumonia as cause of mortality | Published |
| ARBs v control: | |||||||||
| Weber 199751 | Worldwide | 0.3 | Patients with essential hypertension and heart failure | Losartan v placebo | 125 v 29 | 54 | Adverse events | Pneumonia† | Published |
| IDNT 200152 | Multicentre worldwide | 4.8 | Patients with hypertension and with type 2 diabetes and overt proteinuria | Irbesartan v placebo or amlodipine | 579 v 569 (placebo) (1148) | 58.9 (7.8) | Time to first occurrence of doubling of baseline serum creatinine level, end stage renal disease, or death | Pulmonary infection† | Unpublished |
| IRMA-2 200153 | Multicentre Europe | 2.0 | Patients with hypertension and with type 2 diabetes, microalbuminuria, and normal renal function | Irbesartan 100 mg v irbesartan 300 mg v placebo | 389 v 201 (590) | 58.0 (8.1) | Time to occurrence of clinical overt albuminuria | Pulmonary infection† | Unpublished |
| LIFE 200254 | Multicentre Europe and USA | 4.8 | Patients with essential hypertension and signs of left ventricular hypertrophy on electrocardiogram | Losartan v atenolol | 4605 v 4588 (9193) | 66.9 (7.0) | Morbidity and mortality due to cardiovascular disease | Pneumonia and serious pneumonia† | Published and unpublished |
| CHARM 200355 | Multicentre worldwide | 3.1 | Patients with symptomatic heart failure and reduced or preserved left ventricular ejection fraction | Candesartan v placebo | 3803 v 3796 (7599) | 66.6 (10.7) | All cause mortality | Serious pneumonia and death due to pneumonia† | Unpublished |
| MOSES 200556 | Multicentre Germany and Austria | 2.5 | High risk patients with hypertension and with cerebral event during past 24 months | Eprosartan v nitrendipine | 681 v 671 (1352) | 67.9 (10) | Total mortality and all cardiovascular and cerebrovascular events | Pneumonia† | Published |
| TRANSCEND 200857 | Multicentre worldwide | 4.8 | Patients with high risk of developing a cardiovascular event and who were intolerant to ACE inhibitors | Telmisartan v placebo | 2954 v 2972 (5926) | 66.9 (7.4) | Composite endpoint consisting of death due to cardiovascular disease, non-fatal myocardial infarction, non-fatal stroke, and admission to hospital for congestive heart failure | Serious pneumonia† | Unpublished |
| PRoFESS 200858 | Multicentre worldwide | 2.0 | Patients with recent ischaemic stroke without treatment with ACE inhibitors | Telmisartan v placebo | 5589 v 5277 (10866) | 66.2 (8.6) | Time to first recurrent stroke | Serious pneumonia† | Unpublished |
| HIJ-CREATE 200959 | Multicentre Japan | 4.2 | Patients admitted to hospital with coronary artery disease and hypertension between 20 and 80 years old | Candesartan v non-ARB | 1024 v 1025 (2049) | 65 (9) | Time to first major adverse cardiovascular event | Pneumonia† | Published |
| ACE inhibitors v ARBs: | |||||||||
| HEAVEN 200260 | Sweden | 0.2 | Patients with stable mild or moderate heart failure and systolic dysfunction | Enalapril v valsartan | 71 v 70 (141) | 68 | Exercise capacity measured as distance walked during six minute walk test | Death due to pneumonia | Published |
| ONTARGET 200861 | Multicentre worldwide | 4.6 | Patients at high risk of developing major cardiovascular event | Ramipril v telmisartan v telmisartan+ramipril | 8576 (ramipril) v 8542 (telmisartan) (17118) | 66.4 | Time to first occurrence of either death due cardiovascular disease, myocardial infarction, stroke, or admission to hospital for congestive heart failure | Serious pneumonia† | Unpublished |
ACE=angiotensin converting enzyme; ARB=angiotensin receptor blocker; MRSA=meticillin resistant Staphylococcus aureus.
*Data for unpublished articles were obtained from FDA regulatory documents.
†Adverse event.