Daiichi Sankyo has reported blinded one-year blood pressure reduction data from the first-ever large-scale Roadmap clinical trial to assess how type 2 diabetes patients respond to the angiotensin II receptor blocker olmesartan medoxomil.
The secondary objective of the Roadmap trial, being conducted in 19 European countries, includes incidence of cardiovascular and renal morbidity and mortality. A qualitative parameter in the secondary objective was to measure cuff blood pressure (BP).
Professor of medicine and pharmacology at SUNY-Buffalo, Joseph Izzo, Jr, said that in Roadmap the company has achieved some of the lowest BP levels ever in a clinical trial.
“It is essential to manage blood pressure very aggressively in diabetics because their heart attack and stroke rates are more closely related to their blood pressure levels than to their blood sugar levels,” he said.
The double-blinded one-year data showed that a strict BP control (<130/80) regimen in the Roadmap trial improved BP compared to baseline in type 2 diabetes (T2DM) patients.
The data presented represents the blinded total patient population, which includes patients randomised either to olmesartan or placebo in addition to standard antihypertensive treatment.
After one year of treatment, 61% of patients in Roadmap achieved the recommended BP goal of <130/80mmHg, a significant increase from a baseline of 28% controlled. The prevalence of stage 1 and stage 2 hypertension decreased from 32 to 11% and from 9 to 2%, respectively.
The Roadmap study also showed a decrease in the prevalence of stage 1 hypertension from 32 to 11%, as well as decrease in the prevalence of stage 2 hypertension from 9 to 2%. In addition, the prevalence of normotension increased from 11 to 22%.
Olmesartan medoxomil is available in the US under the brand name Benicar.