Clear Sailing

Last March (March 1, 2007), I commented on the “Dear Dr.” letter sent from Genentech about the higher risk of stokes in patients receiving 0.5mg Lucentis® compared to those receiving 0.3mg. This risk was found in an interim analysis of the large SAILOR trial which compared the two doses. My general message in that blog was that we should withhold judgment until the one year results are known.

The one-year results have now been announced Dr. David Boyer. The stroke rates at one year in the SAILOR trial were 0.7% for the 0.3mg Lucentis group and 1.2% for the 0.5mg group. There was no significant difference between these two rates.

My blog on January 2, 2008 discussed a recent article that found the annual risk of stroke was about 3.5% in Medicare patients regardless whether they had AMD or not. Thus the stroke risks in the SAILOR trial were much lower than seen in the Medicare population as a whole. Does that mean that Lucentis protects against strokes? Probably not. The reason is probably because the SAILOR trial attracted healthier patients than found in an average Medicare population. This was no conspiracy. Doctors generally don’t offer trials to sick patients and sick patients often don’t want to participate in trials which require monthly follow-up visits and testing. So the SAILOR patients were healthier to being with. The results are still reassuring and show that Lucentis at either dose probably doesn’t increase the risk of stroke.

Reference:

1. Avery RL, Ho AC. Good News for Anti-VEGF Therapy. Retina Today 2008; 3(2):7.