The quality of evidence is downgraded by study limitations (high loss to follow-up in relation to observed absolute effect).
A Cochrane review [Abstract] 1 included data from 9 RCTs (six published and three unpublished), with a total of 3665 participants (2745 + 920), to assess the systemic safety of intravitreal bevacizumab compared with intravitreal ranibizumab in people with neovascular age-related macular degeneration (AMD). Head-to-head comparisons were included, irrespective of dosage, whether treatment is continuous or discontinuous, or duration of follow-up. None of the included studies was supported by industry.
All-cause deaths and all serious systemic adverse events (SSAEs) were defined as primary outcomes. Secondary outcomes included myocardial infarction (MI), stroke, angina, ischaemic heart disease, thrombosis, death from cardiovascular diseases, serious haemorrhage, serious neutropenia, gastrointestinal perforation, serious infection and treatment-related drug discontinuation. The main results are summarized in Table 1.
Outcome | Relative effect(95% CI) | No of participants(studies) | Assumed risk: Ranibizumab | Corresponding risk: Bevacizumab |
---|---|---|---|---|
All-cause deathFollow-up: 1 to 2 yrs | RR 1.10(0.78 to 1.57) | 3338(8) | 34 per 1000 | 37 per 1000(27 to 53) |
All SSAEs. Follow-up: 1 to 2 yrs | RR 1.08(0.90 to 1.31) | 3665(9) | 222 per 1000 | 240 per 1000(200 to 291) |
Infection | RR 1.34(0.97 to 1.86) | 3190(6) | 37 per 1000 | 50 per 1000(36 to 69) |
Arterial thromboembolic event | RR 0.92(0.62 to 1.37) | 3190(6) | 35 per 1000 | 32 per 1000(21 to 47) |
Myocardial infarction | RR 0.84(0.42 to 1.66) | 3190(6) | 14 per 1000 | 12 per 1000(6 to 23) |
Stroke | RR 0.83(0.42 to 1.66) | 3190(6) | 11 per 1000 | 9 per 1000(5 to 19) |
Gastrointestinal disorders | RR 1.82(1.04 to 3.19) | 3190(6) | 16 per 1000 | 29 per 1000(16 to 50) |
In a fixed-effect analysis for all SSAEs, an increased risk for bevacizumab was shown (RR 1.12; 95% CI 1.00 to 1.26, 9 studies, n =3665).
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