FDA Reviewing Data on Possible Increased Prostate Cancer Risk With Stalevo in PD

Susan Jeffrey

Disclosures

April 01, 2010

April 1, 2010 — The US Food and Drug Administration (FDA) today notified healthcare professionals that the agency is evaluating data from a clinical trial indicating that patients with Parkinson's disease (PD) receiving treatment with a combination of entacapone, carbidopa, and levodopa (Stalevo, Novartis) may be at increased risk for prostate cancer.

The trial, called Stavelo Reduction in Dyskinesia Evaluation – Parkinson's Disease (STRIDE-PD), is a randomized comparison of entacapone/carbidopa/levodopa vs carbidopa/levodopa (Sinemet) in patients with PD.

"At this time, FDA's review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made," the MedWatch alert cautions. Healthcare professionals should be aware of this possible risk, they add, and follow current guidelines for prostate cancer screening.

STRIDE-PD

The STRIDE-PD trial was a double-blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including the United States, the release notes. The primary endpoint was time to onset of dyskinesia in PD patients between treatment groups. A total of 745 PD patients were enrolled, and 541 completed treatment, 265 receiving entacapone/levodopa/carbidopa and 276 receiving carbidopa/levodopa only.

Mean treatment duration was 2.7 years, ranging up to 4 years. The average age of patients was approximately 60 years, the age at which prostate cancer is most commonly diagnosed, the alert points out; most were white (95.2%) and male (62.7%).

"An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer compared to those taking carbidopa/levodopa," the alert notes.

Specifically, 9 of 245 men (3.7%; 95% confidence interval [CI], 1.69% – 6.86%) had prostate cancer in the entacapone/levodopa/carbidopa group vs 2 of 222 men (0.9%) in the carbidopa/levodopa group, for an incidence rate of 14 cases per 1,000 with entacapone/levodopa/carbidopa compared with 3.2 cases per 1,000 with carbidopa/levodopa.

The odds ratio for the occurrence of prostate cancer in men taking entacapone/levodopa/carbidopa was 4.19 (95% CI, 0.90 – 19.63) vs carbidopa/levodopa.

Duration of entacapone/levodopa/carbidopa therapy before a diagnosis of prostate cancer ranged from 148 to 949 days, with a mean of 664 days. Previous trials of this entacapone/levodopa/carbidopa therapy did not indicate any such increased risk for prostate cancer, but most of these trials were conducted for less than a year, the alert points out.

The additional drug in this combination, entacapone, is also sold as a single-ingredient product (Comtan), also used to treat PD symptoms, and likewise has not been previously associated with an increased risk for prostate cancer.

"The agency is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer," they write. "This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete."

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