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Australian Journal of Pharmacy : November 2006
extend the growing body of evidence indicating that lowering LDL cholesterol levels well below currently recommended levels have clinical benefit’.3 Intensive regimen lowers risk of death These results supported previous research, including the Pravastatin or Atorvastatin Evaluation and Infection Therapy- Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial.4 This trial consisted of 4,162 patients who had been hospitalised for an acute coronoary syndrome within the preceding 10 days. In their discussion, the authors wrote: ‘...intensive therapy with high-dose atorvastatin resulted in a median cholesterol level of [1.6mmol/L], as compared with a level of [2.5mmol/L] for standard dose pravastatin. Among patients who had recently been hospitalised for an acute coronary syndrome, the more intensive regimen resulted in a lower risk of death from any cause or major cardiac events than did a more moderate degree of lipid lowering with the use of a standard dose of a statin. Although prior placebo-controlled studies have shown that a standard dose statin is beneficial, we demonstrated that more intensive lipid lowering significantly increased this clinical benefit’.4 Absolute LDL cholesterol reductions The TNT results were also confirmed by a recent meta-analysis, Efficacy and Safety of Cholesterol-lowering treatment,5 which assessed data from 90,056 people in 14 randomised trials. This meta-analysis demonstrated that reductions in the incidence of major coronary events, coronary revascularisations and strokes were approximately related to the absolute reductions in LDL cholesterol achieved. Further, proportional reductions in these major vascular events per mmol/L of LDL cholesterol reduction were similar, irrespective of pre-treatment cholesterol concentrations or other characteristics such as age, sex, or pre-existing disease. In their discussion, the authors of the meta-analysis wrote: ‘The results of this meta-analysis suggest, however, that [current guidelines] may not realise the potential of such treatment’. The authors stated that treatment goals for statin treatment should primarily aim to achieve substantial reductions in LDL cholesterol (rather than achieve particular target levels of LDL cholesterol), since the risk reductions are proportional to the absolute LDL cholesterol reductions.5 Changing Guidelines The importance of absolute reductions in LDL was further underlined in the Position Statement on Lipid Management—2005by the National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand,6 which serves as an interim update to the groups’ 2001 Guidelines. Under the sub-heading, ‘Indications for Lipid-Modifying Therapy: The Importance of Absolute Risk’, the Position Statementsays: ‘In order to initiate the most cost-effective cardiovascular disease (CVD) risk factor management strategies there is a need to identify those individuals who have the most to benefit. There is an international trend realising that the best way to achieve this is to implement an absolute risk approach. Absolute risk can be expressed as the chance of experiencing the predefined outcome(s), usually expressed as a percentage over a particular period of time (typically 5 or 10 years). This contrasts with relative risk which is the ratio of risk for future events in individuals with a particular risk exposure (eg current smoking), compared to those without.’6 REFERENCES 1. New Eligibility Criteria for Cholesterol-Lowering Drugs on the PBS-media release 5 September 2006. Minister for Health and Ageing. 2. PBS-Eligibility Criteria For Lipid Lowering Drugs—Fact Sheet. www.health. gov.au/internet/wcms/publishing.nsf/Content/lipid_eligibilitycriteria.htm 3. La Rosa JC et al. Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease. N Engl J Med 2005;352(14):1425–35. 4. Cannon CP et al. Comparison of Intensive and Moderate Lipid Lowering with Statins after Acute Coronary Syndromes. N Engl J Med 2004;350;(15):1495–504. 5. Cholesterol Treatment Trialists Collaborators. Efficacy and Safety of Cholesterol-Lowering Treatment: prospective meta- analysis of Data from 90,056 participants in 14 randomised trials of statins. www.thelancet.com: Vol 366;267–78. 6. Position Statement on Lipid Management-2005. National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand. Heart Lung and Circulation LIPITOR (atorvastatin calcium). Supplier: Pfizer Australia Pty Ltd, ABN 50 008 422 348, 38-42 Wharf Road, West Ryde NSW 2114. Pfizer Medical Affairs 1800 675 229. Dosage and administration: 10-80mg/day as a single daily dose. LIPITOR can be taken at any time of the day, with or without food. Contraindications: Hypersensitivity to any component of this medication; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and lactation. Women of child-bearing potential, unless on an effective contraceptive and highly unlikely to conceive. Precautions: Patients who consume substantial quantities of alcohol and/or have a history of liver disease; Myopathy (monitor CK); Risk factors predisposing to development of renal failure secondary to rhabdomyolysis; Use of concomitant medication that may reduce activity/ levels of steroid hormones (ketoconazole, spironolactone and cimetidine); Interactions with other medicines: inhibitors of cytochrome P450 3A4, other HMG-CoA reductase inhibitors, antacid, colestipol, erythromycin/clarithromycin, protease inhibitors, digoxin, oral contraceptives. Adverse reactions: Headache, asthenia, abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhoea, insomnia, myalgia. Full disclosure Product Information approved by the TGA on 27 January 2005. Date of most recent amendment: 13 July 2006. PBS dispensed price, August 2006: 10mg $41.19; 20mg $58.32; 40mg $80.03; 80mg $112.19. LIPITOR® Registered trademark Pfizer Inc. www.pfizer.com.au PBS Information: Restricted benefit. For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs. THE AUSTRALIAN JOURNAL OF PHARMACY VOL.86 NOVEMBER 2006 ? 21