This intervention study will run for at least 5 years and will be geared to find differences in both surrogate end points and hard end points.
In diabetic hypertensives, 2 relatively large RCTs show that the blood pressure can be reduced by DHP-based therapy in diabetics, with a reduction in hard end points.
Some, but not all, randomized clinical trials on either corticosteroid monotherapy, mycophenolate mofetil monotherapy, or immunosuppressive combination therapy have provided evidence for a benefit on either surrogate parameters such as proteinuria or hard end points such as renal failure.
In addition, many studies use composite end points, which include not only "hard" end points like heart attack or death (which are pretty hard to misdiagnose) but also "softer" end points like the "need" for revascularization or the occurrence of acute coronary syndromes.
In fact the prognostic value of BP variability has not been tested by proper longitudinal studies and the few available ones are limited by small study size, short follow up or conclusions based on surrogate markers (progression of left ventricular hypertrophy or arterial wall thickening) rather than on the incidence of hard end points, such as cardiovascular events [3].
Beyond these hard end points, however, patients' subjective conceptions of their disease are also important.
Cardiovascular hard end points included diagnosed myocardial infarction, coronary revascularization, or stroke.
"I am of the opinion," Stern continued, "that we really need studies that show an impact on hard end points".
We selected myocardial infarction and stroke since they are "hard" end points for which estimates of incidence are available.
Guidelines use HbA1c as a surrogate in a lack of hard end points for most antidiabetic treatments [ 2].
