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Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration

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Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration

Sübutlu məlumatların xülasələri
30.12.2014 • Sonuncu dəyişiklik 30.12.2014
Editors

There appears to be no significant difference regarding safety between intravitreal bevacizumab and ranibizumab in the first two years of treatment in patients with neovascular age-related macular degeneration.

The quality of evidence is downgraded by study limitations (high loss to follow-up in relation to observed absolute effect).

Summary

A Cochrane review included data from 9 RCTs (six published and three unpublished), with a total of 3665 participants (2745 + 920), to assess the systemic safety of intravitreal bevacizumab compared with intravitreal ranibizumab in people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.

OutcomeRelative effect (95% CI) No of participants (studies) Assumed risk: RanibizumabCorresponding risk: Bevacizumab
All-cause death Follow-up: 1 to 2 yrs RR 1.10 (0.78 to 1.57) 3338 (8) 34 per 100037 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 1000240 per 1000 (200 to 291)
InfectionRR 1.34 (0.97 to 1.86) 3190 (6) 37 per 100050 per 1000 (36 to 69)
Arterial thromboembolic eventRR 0.92 (0.62 to 1.37) 3190 (6) 35 per 100032 per 1000 (21 to 47)
Myocardial infarctionRR 0.84 (0.42 to 1.66) 3190 (6) 14 per 100012 per 1000 (6 to 23)
StrokeRR 0.83 (0.42 to 1.66) 3190 (6) 11 per 10009 per 1000 (5 to 19)
Gastrointestinal disordersRR 1.82 (1.04 to 3.19) 3190 (6) 16 per 100029 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).

Clinical comments

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Ədəbiyyat

  1. Moja L, Lucenteforte E, Kwag KH et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev 2014;9():CD011230.