Wednesday, January 02, 2008

Reader Question: Lucentis and risk of stroke?

I received this question recently:

My mom is 54 years old, she had a stroke (clot blood) one year ago and started to get treatment after 1 month of the stroke. She does not have blood pressure, cholesterol or diabetes mellitus. The major causes according to the doctors are smoking and hormone (Estrogens) which she has taken for many years because she had no uterus since 1994.

She is taking one tablet daily of dipyridamole. She was treated with laser+cortisone injection two times and she had one injection of Avastin. After 10 months of treatment a little of vascular growth have started and the main sign was that the eye is full with edema. Because of that doctors decided to give her Lucentis, and she had the first one two weeks ago.

My questions are: Is there a possibility that my mother will has a new stroke by taking Lucentis? How many Lucentis injection do you think she’ll need?

My answer:
First she should stop smoking and probably the estrogen but I will leave that up to her doctors to decide. Anyone with AMD, especially wet AMD, should stop smoking.

There is no proof that Lucentis causes an increased risk of strokes. So far, the percentage of strokes and heart attacks in the various trials was about the same between the Lucentis and placebo groups. The concern is that Lucentis is part of another drug called Avastin which does increase the risk of strokes when given intravenously for colon cancer. I don’t think we can really implicate Lucentis or Avastin for that matter, on this basis since the Avastin dose used intravenously is 300 times the dose used in the eye.

Genentech, in a “Dear Doctor” letter on January 24, 2007, stated that a planned interim analysis of the accruing data in the SAILOR study showed a higher risk of strokes, (1.2%) in the group receiving 0.5mg of Lucentis than in the group receiving 0.3mg (0.3%). People with a history of a previous stroke were at higher risk. Both groups of patients had been followed an average of 230 days or a little less than eight months. Doctors were not too worried about this letter because the follow-up was short and the overall risk of stroke seemed fairly low. We have not heard from Genentech since that letter so I’m guessing that the increased rate of stroke didn’t continue or wasn’t significant. The latest results from the Sailor study results will be presented at ARVO this April.

A recent article found that the risk of ischemic stroke was about 3.5% a year in Medicare patients whether they had AMD or not. Patients who had a history of a heart attack or stroke had a 35% risk of having another stroke in the following year. The average age of this group of patients was 80.5 years so they were on average much older than your mother and hopefully that means your mother’s risk is lower than 35%.

The bottom line is that we really don’t know but Lucentis is probably pretty safe. The people we are most concerned about however are those like your mother who has already had a stroke. I would encourage her doctors to use Lucentis as infrequently as possible. I would also try to determine how important the vision is in her affected eye. For instance, if the affected eye has very poor vision, the doctors don't think it will get much better even with treatment, and the other eye is very good, then it would be reasonable to forgo more treatment for this eye.

1. Alexander SL, et al., “Annual Rates of Arterial Thromboembolic Events in Medicare Neovascular Age-Related Macular Degeneration Patients.” Ophthalmology 2007;114:2174-2178.


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