Bisoprolol

(Cardicor )
For the treatment of chronic heart failure

Committee’s Verdict: RESTRICTED USE BNF: 2.4

Confirmation of the diagnosis of chronic heart failure is essential before starting beta-blocker therapy.
Treatment with bisoprolol should be initiated and managed either by a GP with a special interest and experience
in the treatment of chronic heart failure, or by a GP with the advice of a specialist and the guidance of an ESCA.
The SPC and NICE guidelines should be consulted for initial titration of the dose and monitoring.
The previous MTRAC guidance on bisoprolol was updated to reflect changes in prescribing practice.

Licensed Indication in a meta-analysis, there were significantly lower

‘Treatment of stable chronic moderate to severe
heart failure with reduced systolic ventricular
function (ejection fraction ≤35%, based on
echocardiography) in addition to ACE inhibitors and
diuretics and optionally cardiac glycosides’.
Clinical Efficacy
Bisoprolol for the treatment of chronic heart failure
has been evaluated in two key randomised, double-
blind, placebo-controlled trials; CIBIS (n= 641) and
CIBIS II (n=2,647). Patients enrolled in these trials
were about 60 years old, predominantly male with
NYHA class III heart failure, treated with diuretics
and ACE inhibitors (and digoxin in some cases).
The planned duration of these trials was 2 years.
The CIBIS II trial was however stopped early (mean
follow up of 1.3 years) when a significant reduction
in mortality with bisoprolol treatment became
evident.
In the CIBIS II trial, bisoprolol treatment for 1.3 years
significantly reduced all-cause mortality (RRR 32%,
p<0.0001), cardiovascular deaths (RRR 25%,
p<0.005), and hospital admissions for all causes
(RRR 15%, p< 0.001) compared with placebo.
These benefits were not apparent in the smaller
CIBIS trial, in which the maximum dose of bisoprolol
was 5mg/day, compared with 10mg/day in CIBIS II.
When the results from the two studies were pooled
risks with bisoprolol compared with placebo for the
following endpoints: all-cause death (RR 0.71),
cardiovascular death (RR 0.72), sudden death (RR
0.63), hospital admission (RR 0.85), hospital
admission and death (RR 0.82).
Safety
Adverse events reported in the clinical trials with
bisoprolol included dizziness, bradycardia and
hypotension.
Additional Information
The Summary of Product Characteristics (SPC)
states that ‘it is recommended that the treating
physician should be experienced in the management
of chronic heart failure’.
NICE guidelines on chronic heart failure state that
‘beta-blockers licensed for heart failure should be
initiated in patients with heart failure due to left
ventricular systolic dysfunction after diuretic and
ACE inhibitor therapy (regardless of whether or not
symptoms persist)’.
Patients should be optimally treated with an ACE
inhibitor and diuretic before treatment with bisoprolol
is commenced. See SPC for dosing titration and
cautions.
At current prices one year’s treatment costs
• £125 for bisoprolol 10mg once daily
• £327 for carvedilol 25mg twice daily

Launch date: December 1999 Manufacturer: Merck Pharmaceuticals Marketing Authorisation PL00493/0179-84
WARNING: This sheet should be read in conjunction with the Summary of Product Characteristics
This guidance is based upon the published information available in English at the time the drug was considered. It remains
open to review in the event of significant new evidence emerging.
A summary sheet with more detailed information can be obtained from MTRAC at the Department of Medicines Management, Keele University,
Keele, Staffordshire ST5 5BG Tel: 01782 584131 Fax: 01782 713586 Web: http://mtrac.co.uk

Date: March 2004 ©Midland Therapeutic Review & Advisory Committee, VS04/07
Department of Medicines Management

(THIS VERDICT SHEET REPLACES VS00/23)