Healthy Skepticism Library item: 8021

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pollack A.
Drug That Treats Vision Problems May Increase Stroke Risk
New York Times 2007 Jan 27Health
http://www.nytimes.com/2007/01/26/health/26cnd-drug.html

Full text:

Use of Genentech’s new eye drug, Lucentis, might raise the risk of stroke, according to a letter the company has begun sending to doctors.

In the letter, Genentech said that interim data from a clinical trial showed that 1.2 percent of patients treated with a high dose of Lucentis had a stroke – compared with 0.3 percent of patients treated with a low dose. The difference is considered statistically significant.

The new findings could conceivably dampen some demand for Lucentis, because the high dose, 0.5 milligrams per injection, is the one that is marketed.

Approved to treat age-related macular degeneration, the leading cause of blindness in the elderly, Lucentis is the first drug shown in clinical trials to improve eyesight for a significant number of patients, as opposed to merely slowing the rate of vision loss.

Still some doctors said today that the results were preliminary – the patients had been followed for an average of 230 days since starting treatment – and that while they would monitor the situation they would wait for the final results from a full year of the study.

“Right now, it will have no impact on my use of Lucentis,” said Dr. Philip J. Rosenfeld, a retina specialist at the University of Miami’s Bascom Palmer Eye Institute. “When given a choice between 100 percent blindness or a 1 percent risk of stroke, I think most patients will choose their vision.”

Lucentis, approved in late June, had sales of $380 million in 2006, an amount that greatly exceeded the expectations of some analysts. Genentech executives have cautioned that sales growth might moderate as patients already on the drug are treated less frequently.

The label for Lucentis already has a label warning about a theoretical risk of blood-clotting events like strokes and heart attacks, although it says the rate seen in studies was “low” – at less than 4 percent. Genentech said it did not expect the new data to lead to a change in the label.

In the new study, the rate of heart attacks and vascular death did not differ significantly between the two doses, the company said today.