A combination of perindopril and indapamide reduced the risk of death as well as the risks of heart and kidney disease among patients with diabetes.
The Action in Diabetes and Vascular Diseases (ADVANCE) trial demonstrated a 14% reduction in all-cause mortality and an 18% reduction in the risk for death from CVD.
Stephen MacMahon, DSc, PhD, said that 1.5 million deaths could be prevented if the benefits of the ADVANCE study are applied to half of the world’s patients with diabetes between 2010 and 2015; 246 million people have diabetes in 2007 and an estimated 380 million will have diabetes in 2025 (representing a 55% increase).
MacMahon, professor of cardiovascular medicine and principal director of The George Institute for International Health at the University of Sydney, Australia, presented the results of the trial in a hotline session at the European Society of Cardiology Congress.
ADVANCE researchers followed 11,140 patients with diabetes for about four years. Patients were 55 years or older and at high risk for CVD. They already took routine treatments for diabetes, including other BP-lowering agents. Half of the patients were assigned a single tablet of perindopril and indapamide (Preterax, Servier) every day and the other half were assigned placebo.
Since 2000, researchers have sought the answers to questions remaining from the results of the United Kingdom Prospective Diabetes Study: If systolic BP is lowered below 145 mm Hg, are there additional benefits? Are there benefits for patients with and without hypertension? Are there benefits in addition to those benefits from other treatments, such as ACE inhibitors?
During follow-up, in the ADVANCE trial, patients taking the combination tablet had a 5.6 mm Hg reduction in systolic BP to an average 134.7 mm Hg (P<.001) and 2.2 mm Hg reduction in diastolic BP to 74.8 mm Hg compared with placebo (P<.001).
In addition to reducing the risk of all-cause mortality and cardiovascular deaths, the combination reduced CHD events by 14% and the risk of new or worsening kidney disease by 21%. There was no clear reduction in cerebrovascular or diabetic eye events. Researchers saw similar benefits in patients with or without hypertension.
The study results positively answer the three earlier questions, MacMahon said.
A true effect?
Discussant Sidney C. Smith Jr., MD, professor of medicine and director of the Center for Cardiovascular Science and Medicine at the University of North Carolina at Chapel Hill, said that despite the impressive nature of the trial, there is no proof that this specific combination works. It did not reduce BP to the guideline-recommended goal for patients with diabetes: 130 mm Hg/ 80 mm Hg.
“We need more data,” Smith said.
“Lowering BP among everyone with diabetes is beneficial,” MacMahon said. “Get as many people on treatment without necessarily trying to reach a goal.”
The overall study is expected to conclude in December.
by Judith Rusk