Published: 6 June 2013

Pramipexole and Heart Failure

Prescriber Update 34(2):22–23
June 2013

Key Messages

  • Pramipexole use has been associated with a small increased risk of heart failure, which is possibly greater in the first three months of use and for those aged 80 years and over.
  • Prescribers should take this into account when assessing the risks and benefits for an individual patient.
  • Prescribers should continue to follow recommendations in the current pramipexole data sheet.
  • Patients should be advised to seek medical attention if they experience symptoms of heart failure.

The use of pramipexole, a dopamine agonist used to treat Parkinson’s disease, has been associated with a risk of heart failure in two separate studies1,2. Prescribers should be aware of possible signs and symptoms of heart failure in patients taking pramipexole and report any adverse events to the Centre for Adverse Reactions Monitoring (CARM).

The first study was a case-control study conducted within a cohort of almost 27,000 users of anti-parkinsonian drugs from the United Kingdom General Practice Research Database1. The 783 newly diagnosed heart failure cases were matched to 7454 controls.

The results demonstrated an increased rate of heart failure with the current use of any dopamine agonist compared to no use (Relative Risk [RR]: 1.58, 95% CI: 1.26–1.96). However, this was particularly so for pramipexole use (RR: 1.86, 95% CI: 1.21–2.85) and cabergoline use (RR: 2.07, 95% CI: 1.39–3.07) compared to no use.

The second study was another case-control study within a cohort of Parkinson’s disease patients2. The 518 incident cases of heart failure were matched to a total of 38,641 controls. Results found that, compared to levodopa use, there was no increased risk of heart failure for any individual ergot dopamine agonist, or for non-ergot dopamine agonists as a class.

Among the individual non-ergot dopamine agonists, only pramipexole was associated with an increased risk of heart failure (Odds Ratio [OR]: 1.61, 95% CI: 1.09–2.38). This was especially so in the first three months of use (OR: 3.06, 95% CI: 1.74–5.39) and for patients aged 80 years and over (OR: 3.30, 95% CI: 1.62–7.13).

In contrast to the previous study, this study did not find a statistically significant increased risk of heart failure for cabergoline users.

In New Zealand, there have been only two reports of cardiovascular adverse events associated with pramipexole use. Causality was assessed as unlikely in both these reports.

Medsafe are currently working with the relevant pharmaceutical companies to update the datasheets and clarify the potential risk of heart failure. This includes the following wording:

"In clinical studies and post-marketing experience cardiac failure has been reported in patients with pramipexole. In a pharmacoepidemiological study, pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole".

As always, please report any adverse events to CARM. This can be done via either the Medsafe website ( or by reporting directly to CARM (

  1. Renoux C, Dell'Aniello S, Brophy JM, et al. 2012. Dopamine agonist use and the risk of heart failure. Pharmacoepidemiology and Drug Safety 21: 34–41.
  2. Mokhles MM, Trifiro G, Dieleman JP, et al. 2012. The risk of new onset heart failure associated with dopamine agonist use in Parkinson's disease. Pharmacological Research 65: 358–64.