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Podcast for Healthcare Professionals:Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. Today I am updating you about an ongoing safety review of Stalevo and an increased risk for developing prostate cancer.

Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan. Both Stalevo and Comtan are used to treat symptoms of Parkinson's disease.

The data being reviewed are from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson's Disease, otherwise known as the STRIDE-PD trial. The STRIDE-PD trial was a double blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including 31 sites in the United States, between September 2004 and November 2008.The purpose of the trial was to evaluate the time to onset of dyskinesia, or difficulty controlling voluntary movement, in patients with Parkinson's disease taking Stalevo compared to those taking only carbidopa/levodopa. A total of 745 patients with Parkinson's disease were enrolled in the trial and 541 completed treatment. Of the patients who completed treatment, 265 patients received Stalevo and 276 received carbidopa/levodopa. Treatment lasted between 2.6 years and 4 years with a mean duration of 2.7 years. The average age of patients in the trial was approximately 60 years. The majority of subjects, 95.2% were Caucasian and 62.7% were male.

A total of 467 men received randomized treatment in the trial. Among those who received treatment, there was a higher number of cases of prostate cancer in patients in the Stalevo group compared to those in the carbidopa/levodopa group. Specifically, 9 out of 245 males had prostate cancer in the Stalevo group compared to the 2 out of 222 males in the carbidopa/levodopa group. The incidence rate of prostate cancer was 14 cases/1,000 patient years for Stalevo and 3.2 cases/1,000 patient years for carbidopa/levodopa. The odds ratio for the occurrence of prostate cancer in males taking Stalevo was 4.19 (95% Confidence Interval: 0.90– 19.63). Duration of therapy prior to diagnosis of prostate cancer in the Stalevo-treated group ranged from 148 days to 949 days (mean: 664 days).

STRIDE-PD is the first long-term clinical trial evaluating Stalevo in Parkinson's disease. Previous clinical trials with Stalevo did not find an increased risk for prostate cancer. Most of these trials evaluating this drug were conducted for less than a year, whereas STRIDE-PD was conducted over a 4 year period, with a mean duration of exposure of 2.7 years.

At this time, FDA recommends that healthcare professionals:

  1. Be aware that in the STRIDE-PD trial, there were a higher number of cases of prostate cancer in subjects in the Stalevo group compared to those in the carbidopa/levodopa group.
  2. Know that other controlled clinical trials evaluating Stalevo or Comtan did not find an increased risk of prostate cancer.
  3. Understand that FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer.
  4. Follow the recommendations in the drug label when prescribing Stalevo or Comtan.
  5. Continue to monitor patients for the development of prostate cancer as recommended by the current prostate cancer screening guidelines since most men taking Stalevo or Comtan are in the age groups most often associated with this disease.
  6. Report any adverse events with the use of Stalevo to FDA's MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach the Division of Drug Information at the following email address: druginfo@fda.hhs.gov.


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