In short
Bisoprolol hemifumarate is a beta-blocker medicine used to treat heart conditions. It is being studied in a Phase 3 clinical trial to see if it can help prevent atrial fibrillation after cardiac surgery. The trial, PREV-AF, is authorised and plans to enrol 636 participants.
Key points
- Bisoprolol hemifumarate is a beta-blocker medicine classified under ATC code C07AB07.
- It is authorised as a medicine and available as oral tablets in strengths such as 10 mg.
- The PREV-AF trial is a Phase 3 study investigating prevention of atrial fibrillation after cardiac surgery.
- The trial plans to enrol 636 participants and is currently authorised.
- Bisoprolol is studied as part of a treatment bundle alongside colchicine and amiodarone.
- In a previous large study, bisoprolol significantly reduced all-cause mortality in patients with heart failure.
What is bisoprolol hemifumarate?
Bisoprolol hemifumarate is a beta-blocker medicine. In the United Kingdom, it is listed as a valid prescribable product and is classified under the Anatomical Therapeutic Chemical (ATC) code C07AB07, which places it among beta-blocking agents. The active ingredient in the tablet is bisoprolol fumarate, with a strength of 10 mg per tablet. Bisoprolol is already authorised as a medicine and is used in clinical practice for heart conditions.
How does bisoprolol hemifumarate work?
Bisoprolol hemifumarate belongs to a class of medicines called beta-blockers. These medicines block beta-adrenergic receptors in the body, which slows the heart rate and reduces the workload on the heart. In a large European study called CIBIS-II, bisoprolol was shown to reduce all-cause mortality in patients with stable heart failure: 11.8% of patients on bisoprolol died compared with 17.3% on placebo. The study also found significantly fewer sudden deaths among patients taking bisoprolol (3.6%) compared with placebo (6.3%).
Which conditions is bisoprolol hemifumarate used or studied for?
- Stable heart failure — Bisoprolol is licensed in the UK for heart failure and has been shown to reduce mortality and morbidity in patients with stable heart failure.
- Atrial fibrillation after cardiac surgery — Bisoprolol is being investigated in the PREV-AF trial to see whether it can help prevent atrial fibrillation following cardiac surgery.
How is bisoprolol hemifumarate given?
Bisoprolol hemifumarate is given as an oral tablet. In the PREV-AF trial, the product used is BISOPROLOL BGR 5 mg, a film-coated scored tablet for oral use. The NHS dm+d browser lists bisoprolol 10 mg tablets as an oral tablet form. In the CIBIS-II study, patients started on 1.25 mg daily, with the dose progressively increased up to a maximum of 10 mg per day.
What do the clinical trials show?
One clinical trial in the EU Clinical Trials Information System (CTIS) is investigating bisoprolol hemifumarate. The PREV-AF trial (EU CT number 2025-523209-14-00) is a Phase 3 interventional study that is currently authorised. The trial plans to enrol 636 participants.
The PREV-AF trial studies whether a preventive treatment bundle can reduce the incidence of atrial fibrillation during hospitalisation after cardiac surgery. The bundle associates colchicine, amiodarone, and a posterior pericardial window (a surgical procedure). Bisoprolol is one of the medicines used in the study, alongside amiodarone hydrochloride 200 mg tablets and colchicine 1 mg tablets. Heparin is also used intravenously.
What does the trial measure?
The main outcome measured in the PREV-AF trial is the difference in the number of patients who experience an episode of persistent atrial fibrillation during their hospital stay. Persistent atrial fibrillation is defined as an episode lasting more than 30 minutes, documented by scopic and telemetric monitoring. The standard of care group is compared with the other two study groups, and the assessment takes place between surgery and day 7 after surgery.
What side effects are known?
The provided supplementary sources do not list specific side effects for bisoprolol hemifumarate. The prescribing guide notes that beta-blocker therapy for heart failure should be introduced in a 'start low, go slow' manner, with assessment of heart rate, blood pressure, and clinical status after each dose increase.