ROADMAP is a large scale clinical trial. It is being conducted in 19 European countries. The acronym stands for Randomized Olemesartan And Diabetes MicroAlbuminuria prevention.
The primary objective of ROADMAP was to evaluate whether the angiotensin II receptor blocker (ARB) olemsartan medoxomil can prevent the onset of microalbuminuria in patients with Type 2 diabetes. Microalbuminuria is one of the early signs of kidney disease. It is also an important risk factor in cardiovascular disease.
This was a randomized, double-blind, placebo controlled, parallel-group, multi center study. To understand it, it's necessary to break it down.
Double-blind ~ A test procedure in which the identity of those receiving the intervention is concealed from both the administrators and the subjects until after the test is completed. This means that no one can be treated differently, as no one knows who is getting which medications.
Placebo controlled ~ Refers to a clinical study in which the control patients receive a placebo. The experience of the control group of patients is compared with that of patients who received the investigational drug to determine the safety and efficacy of the therapy being studied. Many are familiar with the placebo effect. Patients who receive the placebo often do well because the believe they are on the medication.
Parallel-group ~ A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation.
Participants involved in the study had to have Type 2 diabetes. They had to be nonmicroalbuminuria. The numbers that were used to determine nonmicroalbuminuria were less than or equal to 35 mg albmin/g urine creatinine for women. Men had to be less than or equal to 25 mg albmin/g urine creatinine. The participants also had to have at least one cardiovascular risk factor.
The study included 4,449 men and women. It was an ongoing study for a five year period. According to the New England Journal of Medicine the results were as follows.
The targeted blood pressure of 130/80 was achieved in almost 80% of the participants who received the olmesartan. The numbers were not a whole lot different for the participants on the placebo. They came in at 71%.
In the other area of the study microalbuminuria developed in 8.2% of the patients that were taking olmesartan. In the placebo group it was 9.8%.
The basic overall conclusion that was stated was that olmesartan did delay the onset of microalbuminuria. It is important to note that in the blood pressure rates were excellent in both groups and showed promising results.