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Australian Journal of Pharmacy : November 2006
ucation randomised trials of statins. Weighted estimates were obtained of effects on different clinical outcomes per 1.0mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C). The authors interpreted their results by stating: ‘Statin therapy can safely reduce the five-year incidence of major coronary events, coronary revascularisation, and stroke by about one fifth per mmol/L reduction in LDL cholesterol, largely irrespective of the initial lipid profile or other presenting characteristics. ‘The absolute benefit relates chiefly to an individual’s absolute risk of such events and to the absolute reduction in LDL cholesterol achieved. ‘These findings reinforce the need to consider prolonged statin treatment with substantial LDL cholesterol reductions in all patients at high risk of any type of major vascular event.’ Lipid-lowering drugs with increased PBS access Atorvastatin—Lipitor Fluvastatin sodium—Lescol, Vastin. Pravastatin sodium—Cholstat, Chem mart Pravastatin Tablets, GenRx Pravastatin Tablets, Lipostat, Pravachol, Pravastatin- 1. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol- lowering treatment: prospective meta-analysis of data from 90056 participants in 14 randomised trials of statins. Lancet 2005; 366:1267–1278. ¦ Increased birth defects are related to use of nicotine replacement therapy A N investigation has been carried out to determine if maternal smoking and use of nicotine substitutes during the first 12 weeks of pregnancy increased the prevalence of congenital malformations in general and of certain congenital malformations in particular.1 The study involved 76,768 pregnant women who were questioned about smoking habits and the use of nicotine replacement therapy in the first 12 weeks of pregnancy. Birth outcomes were collected by linkage to the Central Population Register, the National Patients Register, and the National Birth Register. The investigators identified congenital malformations from the Hospital Medical Birth Registry as they were recorded at birth or in the first year of follow-up. It was found that: • Children exposed to prenatal tobacco smoking (20,603 chil- dren) had no increase in congenital malformations prevalence compared with the non-exposed children in both crude and adjusted analyses. • Among mothers using nicotine replacement therapy com- pared with the other non-smokers, there was a 60 per cent greater risk of birth defects (relative prevalence rate ratio 1.61 per cent). • When the analysis was restricted to musculoskeletal malfor- mations, the relative prevalence rate ratio was 2.63. It was concluded: ‘Our results showed no increase in congenital malformations related to prenatal tobacco smoking. However, we identified an increase of malformations risk in THE AUSTRALIAN JOURNAL OF PHARMACY, VOL.87 NOVEMBER 2006 ? 79 non-smokers using nicotine substitutes. This finding needs to be replicated in other data sources.’ In Australia nicotine replacement products are classified as Category D, which is defined as: ‘Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.’ 1. Morales-Suárez-Varela MM, Bille C, Christensen K, Olsen J. Smoking habits, nicotine use, and congenital malformations. Obstetrics & Gynecology 2006;107:51–57. ¦ AJPCPE CONTINUING PROFESSIONAL EDUCATION RL Tablets, Terry White Chemists Pravastatin Tablets. Simvastatin—Chem mart Simvastatin, GenRx Simvastatin, Lipex, Simvar, Simvastatin-DP, Simvastatin-RL, Terry White Chemists Simvastatin, Zimstat, Zocor. Fenofibrat—Lipidil. Gemfibrozil—Ausgem, Chem mart Gemfibrozil Tablets, Gemfibrozil-BC, Gemhexal, GenRx Gemfibrozil Tablets, Jezil, Lipazil, Lopid, Terry White Gemfibrozil Tablets. Ezetimibe/Simvastatin—Vytorin. Ezetimibe—Ezetrol. Vytorin and Ezetrol are not in the statins class of drugs. However, eligibility for Vytorin and Ezetrol is linked to eligibility for statins, and therefore these drugs are covered by the extended eligibility criteria. All patients will be expected to maintain good diet in addition to drug therapy and dietary therapy should be reviewed annually.