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Australian Journal of Pharmacy : May 2008
educaTion AJPCPD continuing Professional develoPment current drug information coversyl plus reduces mortality in patients with type 2 diabetes B lood pressure is an important determinant of the risks of macrovascular and microvascular complications of type 2 diabetes, and guidelines recommend intensive lowering of blood pressure for diabetic patients with hypertension. The effects of the routine administration of an angiotensin converting enzyme (ACE) inhibitor– diuretic combination on serious vascular events in patients with diabetes, irrespective of initial blood pressure-levels or the use of other blood pressure lowering drugs have been investigated.1 Two hundred and fifteen collaborating centres in 20 countries were involved in the trial. After a six-week active run-in period, 11,140 patients with type 2 diabetes were randomised to treatment with a fixed combination of perindopril and indapamide or matching placebo, in addition to current therapy. The primary endpoints measured were composites of major macrovascular and microvascular events, defined as death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction, and new or worsening renal or diabetic eye disease. The macrovascular and microvascular composites were analysed jointly and separately. After a mean of 4.3 years of follow-up, 73% of those assigned active treatment and 74% of those assigned control remained on randomised treatment. Compared with patients assigned placebo, those assigned active therapy had a mean reduction in systolic blood pressure of 5.6 mm/ Hg and diastolic blood pressure of 2.2 mm/Hg. The relative risk of a major macrovascular or microvascular event was reduced by 9% in those taking active therapy as compared with placebo. The separate reductions in macrovascular and microvascular events were similar but were not independently significant. • The relative risk of death from cardiovascular disease was reduced by 18%. • The relative risk of death from any cause was reduced by 14%. There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline. It was concluded: ‘Routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events, including death. Although the confidence limits were wide, the results suggest that over five years, one death due to any cause would be averted among every 79 patients assigned active therapy’. Two interesting but different comments have been made concerning the this study. John Chalmers, co-principal investigator of the study and chairman of the study group at The George Institute for International Health in Sydney, said: ‘The simplicity of a single combination tablet given to all diabetic patients will make a huge difference in lowering blood pressures across the board. It would be a bit like taking an aspirin a day if you have CHD’. But discussing the results, Sidney Smith, director of the Centre of Cardiovascular Science at the University of Carolina, was more cautious and said: ‘It seems that the typical person who benefited in this trial was a 55-year- old who had had diabetes for several years and had a [baseline] systolic blood pressure of about 145mmHg. ‘I can’t see much evidence that a 35-year-old diabetic with blood pressure of 130/80mmHg would benefit much from more drug therapy.’ As the recommended systolic blood pressure in many national guidelines is now 130/80mmHg, the last comment seems somewhat irrelevant. available in australia coversyl plus 4/1.25—Perindopril 1. Patel a, advance collaborative group collaborators. effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the advance trial): a randomised controlled trial. the lancet 2007;370:829–40. the australian journal of Pharmacy vol.89 may 2008 91