Back grey_arrow_rt.gif
 
 
No Microvascular Benefit With Intense BP, Glucose Control
 
 
  By Kristina Fiore, Staff Writer, MedPage Today

Published: September 15, 2011
LISBON -- Aggressively lowering blood pressure and blood glucose together won't provide any microvascular benefits to type 2 diabetes patients, researchers said here.

Action Points

· Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

· Explain that the combination of intensive blood pressure and glucose management did not protect against microvascular endpoint measures compared with standard care in a study of type 2 diabetics.

· Note that the combination of intensive therapies also did not affect single markers of microvascular disease compared with either therapy alone.

In an analysis of data from the ACCORD trial, neither intense glycemic management nor intense blood pressure control reduced the risk of a composite of microvascular outcomes, Patrick O'Connor, MD, of HealthPartners Research Foundation in Minneapolis, reported during an oral session at the European Association for the Study of Diabetes meeting here.

There was no interaction between the two treatments on that outcome; nor did the combination have significant effects on a host of individual microvascular outcomes including microalbuminuria, macroalbuminuria, or renal failure.

"None of the prespecified outcomes were further significantly reduced in those intensively treated for both glycemia and blood pressure compared with either regimen alone, signifying the lack of an additional beneficial effect from combined intensive management," O'Connor said.

Some work has shown that lowering blood pressure and blood glucose individually diminish some microvascular complications of type 2 diabetes, but there are few data on the combined effects of these interventions.

O'Connor and colleagues analyzed data from the ACCORD blood pressure trial, totaling 4,733 adults with type 2 diabetes and hypertension.

Patients were randomized to either intensive blood pressure control, with a systolic target of 120 mm Hg or less, or standard control of 140 mm Hg or less. They were also separately randomized to either intense blood glucose management (HbA1c under 6%) or a standard target (HbA1c 7% to 7.9%).

Prespecified outcomes included one composite microvascular outcome measure -- dialysis or renal transplantation, high serum creatinine, and retinal photocoagulation or virectomy -- and nine single measures of kidney, eye, or peripheral nerve function.

The researchers looked at two-way interactions between glycemia and blood pressure treatment.

They found that over a mean of 4.7 years, the primary microvascular outcome occurred in 11.4% of those in the intensive blood pressure arm and 10.9% of those in the standard blood pressure arm.

Overall, neither intensive intervention had any effect on whether patients reached the primary composite outcome of microvascular disease.

Nor were there many significant effects on the nine individual markers of microvascular disease, except those on intensive blood pressure management were less likely to develop microalbuminuria (HR 0.84, P=0.02).

Moreover, those on intensive glycemic management had a reduced risk of three outcomes: macroalbuminuria (HR 0.68, P=0.002), loss of vibratory sensation (HR 0.89, P=0.02), and loss of pressure sensation (HR 0.76, P=0.001).

O'Connor and colleagues found no significant interactions between intensive blood pressure and glycemic management for any of the outcomes.

"The benefits seen on the one hand with blood pressure control, or on the other hand with glucose control, were not amplified by an interaction," he said during the session.

In regression analyses, assignment to either intensive program was not a predictor of renal failure as defined by initiation of dialysis or end-stage renal disease. The only significant predictors were serum creatinine and albuminuria at baseline.

O'Connor noted, however, that the low proportions of patients who achieved the primary endpoint could have reduced the power of the analysis.

"The short duration of the study doesn't permit for the full assessment of the impact of the interventions," he said.

Primary source: European Association for the Study of Diabetes

Source reference:

O'Connor PJ, et al "Microvascular effects of intensive blood pressure control and its relation to glycemic control in the ACCORD blood pressure trial" EASD 2011; Abstract OP07-40.

-----------------------------------------------------

Intensive Glucose Control Cuts Renal Risks

By Kristina Fiore, Staff Writer, MedPage Today

Published: September 14, 2011

LISBON -- Intensive glucose-lowering may protect against end-stage renal disease (ESRD) in diabetic patients, according to an analysis of data from the ADVANCE trial.

Over a mean follow up of five years, those on intensive glucose control had a significant 65% decreased risk of ESRD, compared with those on standard glucose-lowering therapy, Sophia Zoungas, MD, PhD, of the University of Sydney in Australia, reported during an oral session at the European Association for the Study of Diabetes meeting here.

Their risk of microalbuminuria or macroalbuminuria was also diminished, Zoungas said.

Action Points

· Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

· Explain that lowering glucose to a target HbA1c 6.5% or below may protect against ESRD in diabetic patients.

· Note that the risk of micro- or macroalbuminuria was also diminished.

"Renal outcomes should not be forgotten as an important part of care of patients with diabetes," she said.

Blood glucose levels have been linked with a higher risk of kidney disease, but the effects of intensive glucose control on major kidney outcomes among diabetes patients aren't known.

Zoungas and colleagues looked at data from the ADVANCE trial, which compared the effects of an intensive glucose lowering target (HbA1c 6.5% or below) with standard target of 7% or lower.

The original trial of 11,140 patients showed a 10% relative risk reduction in combined microvascular and macrovascular endpoints, as well as a 21% relative risk reduction in a secondary endpoint of nephropathy.

To determine the effects of glucose lowering on renal outcomes, they assessed data from the full cohort for the following outcomes:

· New microalbuminuria or macroalbuminuria

· ESRD (defined as the need for dialysis or transplantation)

· Renal death

· Transient or sustained doubling of creatinine (more than 200 mcmol/L)

Over a mean of five years of follow up, the researchers found a significantly lower risk of microalbuminuria and macroalbuminuria for those in the intensive arm(HR 0.91, 95% CI 0.85 to 0.98, P=0.012, and HR 0.70, 95% CI 0.57 to 0.85, P=0.0004, respectively).

Intensive therapy patients also had a significant 65% reduction in risk of ESRD (95% CI 0.15 to 0.83, P=0.012).

While there was a trend toward a diminished risk of renal death for these patients, it was not significant, Zoungas reported.

She said this was likely because of the number of patients that hit the endpoint in the trial. "The effect was small but in the right direction," she said. "If we have further cases, we would show it."

There was an increased likelihood of the doubling of creatinine for those in the intensely managed group, but it was not significant.

The interpretation of the doubling of creatinine "as a component of renal endpoints requires further consideration," Zoungas said.

She concluded that the overall effects on hard renal outcomes and microalbuminuria were generally consistent, and were likely mediated by the albuminuric pathway.

The study was limited by a small number of hard outcomes, by its open-label nature, and by the fact that the effects of glucose lowering, versus the specific effects of the drug therapy involved, could not be teased out.

Zoungas called for further studies of glucose lowering in diabetics at high risk of ESRD that involve large numbers of patients, have long follow-up time, and a careful definition of outcomes.

Primary source: European Association for the Study of Diabetes

Source reference:

Zoungas S, et al "Intensive glucose lowering and end stage kidney disease: new data from the ADVANCE trial" EASD 2011; Abstract OP07-39.

 
 
 
  icon paper stack View Older Articles   Back to Top   www.natap.org