Diabetes Study Sparks Treatment Debate

Diabetes patients who used medicine to lower their
cholesterol and blood pressure to below target levels displayed improvements in
several important markers of heart and vascular disease, a study shows. But the
patients were just as likely as less aggressively treated patients to have
heart attacks and strokes.

The study appears in the April 9 edition of The Journal of the American
Medical Association.

Heart disease is the leading cause of death in adults with diabetes. There
has been much debate about how much to reduce systolic blood pressure (SBP) and
LDL "bad" cholesterol readings in these high-risk patients.

In one of the first controlled trials to address the issue, researchers
randomly assigned 499 middle-aged American Indians with type 2 diabetes to
treatment aimed at reaching either standard blood pressure and lipid targets
(LDL of no more than 100mg/DL and SBP of no more than 130 mm Hg) or more
aggressive lowering of these levels (LDL of no more than 70 mg/dL and SBP of no
more than115 mm Hg).

The patients were all obese (BMI range of 32-34, normal <25); two-thirds
were women.

Aggressive Treatment vs. Standard Treatment

Over the course of the trial, the more aggressively treated patients
experienced regression of plaque buildup in neck arteries (not seen in the
standard treatment group), and greater improvement in heart muscle thickening,
researcher Barbara V. Howard, PhD, tells WebMD.

Both treatment groups also had far fewer heart attacks and strokes than
would have been expected without treatment.

But no advantage was seen for aggressive lowering of LDL and SBP in terms of
heart attack and stroke incidence.  And patients treated to lower SBP
targets experienced more side effects related to their blood pressure
medications.

Howard tells WebMD that the study's relatively small sample size and short
duration of follow-up may explain the failure to demonstrate a difference in
outcomes among the two groups.

"My educated guess is that we will see a difference when we continue to
follow these patients," she says. "Our study suggests that these lower
targets could bring benefits, but we need more research to really understand
the risks vs. benefits of this strategy."

How Low Should You Go?

These findings appear certain to add to the debate within preventive
cardiology about how low to go in reducing cardiovascular risk factors like
high blood pressure, LDL cholesterol, and high blood sugar in diabetic and
other high-risk populations.

The debate hit the front pages of the nation's newspapers early in February
when findings from the 10,000-person ACCORD study suggested that rather than
reducing heart attack and stroke deaths, intensive blood sugar lowering may
increase such risks among people with type 2 diabetes.

"We have basically taken as gospel that if we change risk factors [like
LDL, blood pressure, and blood sugar] good things will happen," Duke
University Medical Center cardiologist Eric D. Peterson, MD, tells WebMD.
"Studies like ACCORD and this one suggest that modifying risk factors alone
may not ensure better outcomes."

In an editorial accompanying the study by Howard and colleagues, Peterson
writes that the findings should give ammunition to both sides of the
debate.

"For the true believers, the study confirms that aggressive lipid and
hypertension treatment has a favorable effect on proven 'early markers' of
disease," he writes. "Thus, with longer duration of follow-up the study
would most assuredly demonstrate improved patient outcomes."

But for those he terms the "therapeutic nihilists" the findings once
again fail to show a clear advantage for very aggressive treatment.

So what is the message to patients and their physicians about aggressive
treatment?

Peterson tells WebMD that there appears to be little downside to lowering
LDL cholestrol to very low levels with statins, but the jury is still out on
aggressive blood pressure lowering.

"We really do have good data showing the benefits of aggressive
cholesterol lowering with statins," he says. "It's a safe assumption
that the benefits are great and the risks are low. But that isn't clear yet
with aggressive blood pressure lowering. We can't say that the benefits
outweigh the risks."

By Salynn Boyles
Reviewed by Elizabeth Klodas
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