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Australian Journal of Pharmacy : April 2005
fessional ATIENTS with pre-existing heart disease who took both high and low doses of atorvastatin calcium (Lipitor) experienced fewer cardiovascular events, according to the results of the five-year Treating to New Targets Trial (TNT) released last month. Moreover, patients on high-dose atorvastatin had signifi- cantly fewer events than those on a lower dose. Atorvastatin reduces risk of heart attack P The TNT study involved 10,000 patients with established coronary heart disease and elevated LDL, or ‘bad’ cho- lesterol levels. The study assessed whether high-dose atorvastatin patients who aggressively lowered their LDL-choles- terol levels to well below the current guidelines (100mg/dL) would experience additional cardiovascular benefits com- pared to atorvastatin patients who main- tained their LDL-cholesterol at recom- mended levels. Patients who received 80mg doses of atorvastatin had 22 per cent fewer car- diovascular events, including CHD death, non-fatal heart attacks, resuscitated car- diac arrest, and fatal or non-fatal strokes compared to patients who took 10mg of atorvastatin. In addition, the risk of new heart disease was reduced by 20 per cent and risk of stroke was reduced by 25 per cent for the high-dose group compared to the low-dose group. The TNT study demonstrated that the musculoskeletal safety profile of atorvas- tatin at 80mg dosing was comparable to atorvastatin 10mg doses. The incidence of liver enzyme elevations in both groups was within existing product labeling. Associate Professor Leon Simons, St Vincent’s Clinical School, University of NSW, told the AJP that the TNT Trial was an important proof-of-concept study. ‘Treatment was generally well toler- ated, about 5 per cent of patients in either group reported muscle pain. Signifi- cantly, elevated enzymes occurred in 0.2 per cent of patients on low dose and 1.2 per cent of those on high dose. This may be regarded as a low and acceptable rate of side effects,’ said Dr Simons. ‘We already new that reduction in LDL cholesterol by statins would reduce the future risk of cardiovascular disease. This study proves that even further reduction below our current Heart Foundation goal of LDL <2.5mmol/L will deliver further benefits to patients,’ he said. TNT is an investigator-led trial coordi- nated by an independent steering com- mittee and was funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries. ‘In addition to providing outstanding benefits at the lowest and highest doses of Lipitor in the TNT study, it’s important to note that patients achieved these ben- efits safely,’ said Pfizer’s chief medical officer Dr Joseph Feczko. ‘ ¦ HILDHOOD immunisation rates are at their highest levels ever and dis- ease rates are down as a consequence, according to a recent report by the National Centre for Immunisation Research and Surveillance of Vaccine- Preventable Diseases (NCIRS) and the Aus- tralian Institute of Health and Welfare. Vaccine preventable diseases and vaccination coverage in Australia 2001–2002 shows that by the end of 2003, levels of full immuni- sation were nearly 95 per cent at 12 months of age, and 90 per cent at 24 months of age. Child immunisation rates up,disease rates down C relevant vaccines are diphtheria, tetanus, and whooping cough (DTP vaccine; Haemophilus influenzae type B (Hib vaccine); measles, mumps, and rubella (MMR vac- cine) and polio. Report co-author and NCIRS director Professor Peter McIntyre said that inci- dence of the eight diseases covered by four vaccines on the routine childhood sched- ule prior to 2002 have all been decreas- ing, in line with the improvements in immunisation levels. The diseases and ‘There was an overall decline in all eight diseases, from an average of 8,046 cases per year in 1997–2000 to 7,806 cases per year in 2001–02, with Australia remaining polio free,’ Professor McIntyre said. ‘The lowest notifications on record in Australia occurred in 2001–02 for four of the diseases—measles, mumps, rubella and Hib. This reduction has been largely due to the combined efforts of govern- ment, healthcare providers and the pub- lic in recognising the importance of these diseases and in implementing and taking up immunisation programs appropriate for our needs.’ ‘Whooping cough remains a challenge to control because while immunised chil- dren are protected, adolescents and adults continue to spread the infection, often without realising it—immunisation rates were low in the past and the vaccine wears off. Babies under six months, too young to be fully immunised, therefore remain at risk,’ Professor McIntyre said. Recent changes to vaccine recommen- dations should help to reduce whooping cough in the future. These include a whooping cough booster vaccine pro- vided for teenagers, and recommended for new or intending parents. Other challenges identified in the report include: high rates of influenza notifications and hospitalisation in young children; and relatively high rates of measles, mumps, rubella and Hepatitis B in young adults, many of whom have not been vaccinated. ¦ THE AUSTRALIAN JOURNAL OF PHARMACY VOL 86 APRIL 2005 ? 239