Home' Australian Pharmacist : March 2011 Contents Please review the full Product Information (PI) before prescribing. Product Information is available on
request from Abbott Products Pty Ltd. Omacor® (omega-3-acid ethyl esters 90): 1,000 mg Soft capsules; 28's Indications: Adjuvant treatment in
secondary prevention after myocardial infarction; hypertriglyceridaemia (Type IV & V as monotherapy; Type IIb as add-on therapy to statins, when control of triglycerides with statins
has been shown to be insufficient). Dosage: Post Myocardial Infarction - One capsule per day; Hypertriglyceridaemia - 4 capsules per day. Contraindications: Hypersensitivity to
the active substance, to soya or to any of the excipients. Precautions: Some studies with omega-3-acids demonstrated a prolongation of bleeding time (normal limits not exceeded
and no clinically significant bleeding episodes observed). Patients receiving treatment with Omacor® and an anticoagulant or other drug affecting coagulation (e.g. acetylsalicylic acid,
warfarin, and coumarin) should be monitored periodically, and the dosage of anticoagulant therapy adjusted if necessary. Interactions: Anticoagulants: PT/INR must be checked
when Omacor® is combined with drugs affecting the PT/INR or when treatment with Omacor® is stopped. Adverse reactions: hypersensitivity; dyspepsia;
dizziness; dysgeusia; nausea; abdominal pain; gastrointestinal disorders. Latest amendment of approved PI: 28 July 2010. ® Omacor is a registered trademark.
Abbott Australasia, Established Products Division, 32-34 Lord St, Botany NSW 2019 Australia. 240111-12. SOMA4246/AP/ADV/S. 02/11. Ward6.
References: 1. Omacor Approved Product Information. 2. GISSI-Prevenzione Investigators. Lancet 1999; 354: 447--52. 3. Brunton S and Collins N. Curr Med Res Opin 2007; 32(5): 1139--45.
4. Fish Oil Supplements. Med Lett Drugs Ther 2006; 48: 59--60. 5. Lawson LD and Hughes BG. Biochem Biophys Res Commun 1988; 152: 328--35. 6. Bryhn M et al. Prostaglandins Leukot
Essent Fatty Acids 2006; 75: 19--24. 7. Ikeda I et al. J Agric Food Chem 1993; 41: 431--5. 8. GISSI-Prevenzione Investigators. Circulation 2002; 105(16): 1897--903. 9. Larson MK et al. Thromb
Haemost 2008; 100(4): 634--41. 10. Gajos G et al. J Am Coll Cardiol 2010; 55(16): 1671--8. 11. Lev EI et al. J Am Coll Cardiol 2010; 55(2): 114--21. 12. Colquhoun D et al. Fish, fish oils,
n-3 polyunsaturated fatty acids and cardiovascular health. 2008. Available from: www.heartfoundation.org.au/SiteCollectionDocuments/HW_FS_FishOils_PS_FINAL_web.pdf Accessed on: 26.10.10.
13. Turner MB. Medicines Safety Update. Australian Prescriber 2010; 2. 14. National Heart Foundation of Australia. Guidelines for the management of acute coronary syndromes. Med J Aust 2006; 184(8):
S1--S30. 15. McKenney JM and Sica D. Pharmacotherapy 2007; 27(5): 715--728. 16. Simons LA and Hickie JB. Atherosclerosis 1985; 54: 75--88. 17. Harris WS. J Lipid Res 1989; 30: 785--807.
PBS: This medication is not available on the PBS.
Omacor is available in pharmacies now and
is available on private prescription only.
Omacor may potentiate the antiplatelet effects of aspirin
and clopidogrel;9,10 therapies all post-MI patients should
already be taking. Initial research studies suggest that
Omacor may restore sensitivity to aspirin in aspirin-
resistant individuals and sensitivity to clopidogrel in
most clopidogrel-resistant individuals.10,11
There is some misunderstanding around whether
Omacor and omega-3 supplements in general should
be used in patients on warfarin. A 2008 review of the
literature by the National Heart Foundation of Australia
(NHF) has shown that there is no significant interaction
with warfarin and more recently another review by
the Australian Prescriber reinforced this finding.12 ,13
Nevertheless, PT/INR should be monitored during
combination therapy and if Omacor is discontinued.
5. What type of patients would benefit most
from using Omacor?
In accordance with the NHF's Guidelines for the
Management of Acute Coronary Syndromes (ACS),
and its approved indications, Omacor is clearly
indicated for all post-MI patients.14
Omacor is also indicated to lower triglycerides in
hypertriglyceridaemia. It is indicated as monotherapy
for patients with types IV and V hypertriglyceridaemia
and as an adjunct therapy to statins in patients with
type IIb hypertriglyceridaemia.1 In patients with
hypertriglyceridaemia, Omacor is as effective as
fibrates in lowering triglycerides.15 --17
6. How does Omacor fit in with the current
guidelines and prescribing practices?
Omacor fits in very well with the NHF's current ACS
Guidelines, which recommend that all post-MI patients
should receive 1 g EPA/DHA per day.14 This particular
dose recommendation is partly based on the evidence
from the GISSI-P study. The guidelines don't specify
a specific form of omega-3 but, of course, it is most
convenient for patients to have a concentrated form
because they will achieve this therapeutic dose with
just one capsule a day. Compliance is highly dependent
on the number of tablets taken. Only taking one tablet
per day will support compliance extremely well.
This dosing regimen for Omacor is as simple and as
straightfor ward as for other established therapies for
post-MI patients, such as beta blockers, ACE inhibitors
or statins. These therapies are also given as single
tablets taken once a day at any time of the day.
And we know that the efficacy for Omacor has been
demonstrated on top of other key established therapies
for post-infarct patients too.2
In addition, the use of the GISSI-P-proven form of
omega-3 in Omacor is an evidence-based medicine
approach for post-MI patients.
If patients consume an oily-fish meal daily (e.g. 200 g
of salmon) they may achieve a therapeutic dose.14
Nonetheless, the benefits of Omacor for post-MI
patients shown in the GISSI-P study were also on top
of a Mediterranean diet that involved a high level of
7. How would you explain the benefits of
Omacor to a patient?
Patients who have experienced an MI should be advised
that Omacor is a very effective therapy in improving
sur vival and is recommended by the National Heart
Foundation of Australia as a key first-line therapy
in addition to other standard therapy (e.g. statins,
antiplatelet medicinal products, beta-blockers, ACE
inhibitors) following a heart attack. They should know that
Omacor is simple, natural and has very few side-effects.
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