The risk of ischemic cardiovascular events associated with oxycodone/naloxone use

Study identification

• EU PAS number:
  EUPAS7545
• Study ID:
  29020
• Official title and acronym:
  The risk of ischemic cardiovascular events associated with oxycodone/naloxone use
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Opioid-induced constipation (OIC) is one of the most common adverse effects of opioid therapy and several approaches have been made to reverse OIC without compromising pain relief. Targin® is an oral fixed combination of the extended-release (ER) high potency opioid (HPO) oxycodone and the opioid antagonist naloxone. It is approved in Germany for the treatment of severe pain and has been proven to provide comparable analgesic efficacy to that of oxycodone, while improving OIC. However, the long-term safety of opioid antagonists is not clear. The FDA for example expressed concerns over potential cardiac safety risks associated with use of opioid antagonists discussing withdrawal as possible cause for these risks. This study will estimate the risk of cardiovascular events such as myocardial infarction or ischemic stroke in patients receiving oxycodone/naloxone compared to those being treated with ER oxycodone or another ER HPO.
• Study status:
  Finalised

Research institutions and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Planned:08/09/2013

Actual:08/09/2013

Study start date

Planned:01/01/2004

Actual:01/01/2004

Data analysis start date

Planned:15/04/2014

Actual:15/04/2014

Date of interim report, if expected

Planned:15/10/2014

Actual:05/12/2014

Date of final study report

Planned:31/12/2014

Actual:31/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Purdue Pharma L.P.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable