Home' Australian Pharmacist : June 2011 Contents Vol. 30 -- June #06
Onglyza (saxagliptin) 5 mg
is now PBS listed for type 2 diabetes1
As of 1 June 2011, Onglyza 5 mg - a once-daily selective dipeptidyl
peptidase-4 (DPP-4) inhibitor - is PBS listed for eligible patients
with type 2 diabetes.1 Similar to other DPP-4 inhibitors, Onglyza is a
streamlined authority required item. Onglyza is reimbursed for dual
oral combination therapy with metformin or a sulfonylurea in patients
whose HbA1c is >7% (prior to initiation with a DPP-4 inhibitor, a
thiazolidinedione or a glucagon-like peptide-1) despite treatment with
metformin or a sulfonylurea and where a combination of metformin
and a sulfonylurea is contraindicated or not tolerated.1 While Onglyza
is also indicated for use as initial combination therapy, this indication
is not reimbursed. In six randomised, double-blind studies of 4148 patients with type 2 diabetes,
Onglyza 5 mg significantly improved haemoglobin A1c, fasting plasma glucose and postprandial
glucose compared to control.2 Fewer patients experienced hypoglycaemia and there was no
associated weight gain when Onglyza 5 mg added to metformin was compared with metformin plus
a sulfonylurea (glipizide).3 Onglyza 5 mg is available in packs of 28 tablets.2
PLEASE NOTE: For further information they can contact: Bristol-Myers Squibb
Medical Information on 1800 067 567.
1. PBS Schedule, June 2011. 2. Onglyza Approved Product Information 7 March 2011.
3. Goke B et al. Int J Clin Pract 2010;64(12):1619-1631.
PBS LISTED -- STREAMLINED AUTHORITY CODE 3540
PBS Information: Authority Required (STREAMLINED).
Refer to PBS Schedule for full authority information.
Before prescribing please review full Product Information available on request from
Bristol-Myers Squibb on 1800 067 567 or AstraZeneca.
provides a significant step forward in
reducing the incidence of strokes in
patients with the condition.6
Findings from the RE-LY (Randomised
Evaluation of Long-term anticoagulant
TherapY) trial -- the world's largest
stroke prevention study in patients
with atrial fibrillation, which
randomised more than 18,000 patients
worldwide (including sites in Australia)
-- show that when compared to well-
controlled warfarin (INR 2-3):7
• Pradaxa 150 mg bd reduced the risk
of stroke and systemic embolism
• (P<0.001), without increasing the
risk of major bleeding;
• Pradaxa 110 mg bd was associated
with comparable rates of stroke
and systemic embolism, with a
20% reduction in the risk of major
• The risk of intracranial bleeding
(a secondary endpoint), a feared
complication of anticoagulation,
was significantly reduced with both
doses of Pradaxa (59% reduction
with Pradaxa 150 mg bd and 70%
with Pradaxa 110 mg bd [P<0.001]).
1. Connolly S. et al. Dabigatran versus warfarin in
patients with atrial fibrillation. NEJM 2009;361:1139--
2. Boehringer Ingelheim. Approved Pradaxa Product
3. Hart R. et al. Meta-analysis: Antithrombotic therapy to
prevent stroke in patients who have non-valvular atrial
fibrillation. Ann Intern Med 2007;146:857--67.
4. Boulanger L. et al. Patterns of use of antithrombotic
therapy and quality of anticoagulation among patients
with non-valvular atrial fibrillation in clinical practice.
Int J Clin Pract 2006;60(3):258--64.
5. Hankey G. Eikelboom J. The beginning of the end of
warfarin? MJA 2004;180:549--51.
6. Camm J. The RE-LY study: Randomised Evaluation
of Long-term anticoagulant therapY: Dabigatran vs.
warfarin. Eur Heart J 2009;30(21):2554--55.
7. Connolly S. et al. Newly identified events in the RE-LY
trial. NEJM 2010;363(19):1875--76.
Australians suffering from the
severe and immobilising effects
of advanced Parkinson's disease,
now have a subsidised a treatment
option available to help control this
chronic disease. The treatment
Duodopa (levodopa/carbidopa) was
PBS from 1 May for the management
of advanced Parkinson's disease in
The first and only therapy proven to
provide superior stroke protection* to
warfarin1 in patients with non-valvular
atrial fibrillation is now available in
Australia, ending the 50-year wait for
a viable alternative to warfarin in this
patient group. Pradaxa (dabigatran
etexilate 150 mg and 110 mg twice
daily) is now approved for the
prevention of stroke and systemic
embolism in patients with non-valvular
atrial fibrillation and at least one
additional risk factor for stroke.2 The
medication was already approved for the
prevention of venous thromboembolism
(VTE) in patients undergoing total hip or
Associate Professor John Amerena,
Director of Cardiology Research
at Geelong Hospital and National
Coordinator of the RE-LY trial, said
the availability of Pradaxa marked a
significant milestone in the prevention
of stroke in this patient population.
'We now have an alternative to
warfarin that is not only more
effective, but also simpler to use -- for
us and our patients,
' he said.
Warfarin has been the gold standard
for stroke prevention in atrial
fibrillation for the past 50 years. It
has been shown to reduce the risk of
stroke by 64% compared to placebo,3
but also requires regular INR blood
monitoring and dose adjustments to
ensure adequate stroke protection is
achieved without placing the patient at
unnecessary risk of bleeding.4
With less than half of all atrial
fibrillation patients receiving warfarin,5
and warfarinised patients falling
outside the therapeutic range (INR
2-3) more than half the time,4 Pradaxa,
according to Boehringer Ingelheim,
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