The Cardiovascular Safety of Lucentis® compared to Macugen®

We’re getting more data to assess the safety of these two drugs when injected intraocularly to treat AMD. The VISION trial group released both one and two-year safety data on pegaptanib (Macugen®). At one-year, serious thromboembolic events occurred in 4% of patient in both the sham and the Macugen groups. After two years, the risk of all thromboemblic events was 5% in the Macugen group and 10% in the sham group, although there were only 51 patients in the sham group. The serious thromboembolic events at two years were 3% in the Macugen group and 8% in the sham group. (1)

Miller at ARVO, presented the two-year study results for the MARINA trial which used intravitreal ranibizumab (Lucentis®). At two-years, the risk of cerebral vascular events or heart attacks was 3% in the sham group; 4.6% in the 0.3mg Lucentis group; and 4.2% in the 0.5mg Lucentis group. (2)

To me these results mean:

1. About 5% of patients with wet AMD are going to have a stroke or a heart attack over two years without any treatment for wet AMD.




2. The risk in patients who have had intravitreal Macugen nor Lucentis is about the same as the untreated groups.




3. That therefore probably neither drug increases the risk of a stroke or heart attacks.




4. That both drugs have about the same risk or more accurately, the same non-risk.

References

1. D'Amico DJ; VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group; Patel M, Adamis AP, Cunningham ET Jr, Guyer DR, Katz B. Pegaptanib sodium for neovascular age-related macular degeneration: two-year safety results of the two prospective, multicenter, controlled clinical trials. Ophthalmology. 2006 Jun;113(6):992-1001. (Ophthalmology. 2006 Jun;113(6):1001.e1-6. Epub 2006 Apr 27.)




2. Miller JW, et al. Randomized, controlled phase III study of ranibizumab (Lucentis™) for minimally classic or occult neovascular age-related macular degeneration: two-year safety results of the MARINA study. [ARVO 2006 poster 3539]. Available from http://tinyurl.com/gbqsp, program number 3539. Accessed June 15, 2006.