People with type 2 diabetes who are already showing signs of some kidney damage may be able to significantly lower their risk of death by treating multiple risk factors at once.
That’s the conclusion of a new published Danish study, that found intensive therapy, including tight blood sugar control, low-dose aspirin, and cholesterol- and blood pressure-lowering medications when necessary, lowered the risk of all-cause mortality and cardiovascular death.
"The Steno-2 study shows a 20 percent absolute risk reduction in all-cause mortality in patients who originally were offered intensive therapy when compared with patients given the usual treatment," said the study’s principal investigator, Dr. Oluf Pedersen, director at the Steno Diabetes Center in Copenhagen. "Similarly, the absolute risk for cardiovascular death was reduced by 12.5 percent in absolute terms."
The findings were published the same day that U.S. health officials announced a halt to a large diabetes trial because of high death rates among those receiving aggressive therapy. The study, involving more than 10,000 people, was dubbed the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, and was stopped early on safety concerns after researchers found an increased risk of mortality in those whose blood sugar was aggressively managed.
Although the death rates in both treatment arms of the ACCORD trial were lower than is seen in the general population, 257 people who were on therapy to get their blood sugar levels in the non-diabetic range died versus 203 people receiving standard treatment.
"In the ACCORD trial we wanted to learn, does aggressive glucose lowering decrease the risk of cardiovascular disease? But, we found that in patients whose [blood sugar levels are] high, if we try to drive it to normal, there may be harm," said Dr. Hertzel Gerstein, a principal ACCORD investigator, and a professor of medicine at McMaster University in Hamilton, Ontario, Canada.
The ACCORD researchers are currently analyzing their data to try to figure out why the intensively managed blood glucose group had a higher death rate, Gerstein added.
For the Steno-2 study, Pedersen and his colleagues randomly assigned 160 people with type 2 diabetes and persistent microalbuminuria to receive either intensive management or standard therapy. Microalbuminuria means that albumin — a type of protein — is spilling into the urine, which indicates that some kidney damage has already occurred. The average participant’s age at the start of the study in 1993 was 55.
The goals for the intensive therapy group included an A1C level of 6.5 percent or lower, a fasting blood cholesterol level of 175 milligrams per deciliter, a fasting blood triglyceride level of less than 150 milligrams per deciliter, systolic blood pressure of less than 130 mm/Hg and diastolic blood pressure of less than 80 mm/Hg. In addition, regardless of blood pressure levels, those in intensive management were treated with angiotensin inhibitors — commonly used blood pressure-lowering medications — and daily low-dose aspirin.
"Although most of the patients didn’t achieve the intensive targets, there was an absolute 20 percent different in the death rate compared to the conventional group," said Dr. Kirit Tolia, director of the Joslin Diabates Center at Providence Hospital in Southfield, Mich.
"Diabetes is a very serious disease that needs to be addressed in a very aggressive fashion, and that intervention needs to be multi-targeted," Tolia added.
Nearly 21 million Americans have diabetes, according to the U.S. Centers for Disease Control and Prevention, and their risk of death, particularly cardiovascular death, is much higher than for those without diabetes. Additionally, diabetes increases the risk of high blood pressure, blindness, kidney disease and nerve damage.
However, the CDC reports that good control of blood sugar levels can decrease the risk of complications. For each percentage point drop in A1C levels — a long-term measure of blood sugar control — the risk of eye, kidney and nerve damage drops by 40 percent, according to the CDC.
"It’s not enough to just know your blood glucose, cholesterol and blood pressure levels. You need to take action and do something about those risk factors early — and long-term," Pedersen said.
Of Steno-2, Gerstein noted that the study shows that for people with type 2 diabetes and microalbuminuria, doctors "should use a comprehensive approach to reduce as many risk factors as possible." Both study investigators said their findings are only applicable to those people with type 2 diabetes, not those with type 1.
To reduce the risk for nonfatal cardiovascular disease among patients with type 2 diabetes and microalbuminuria, a multitarget intervention is needed. It includes tight glucose regulation and the use of renin-angiotensin system blockers, aspirin, and lipid-lowering agents.
In patients with type 2 diabetes, multitarget intervention with multiple drug combinations and behavior modification has beneficial effects on the rates of death from any cause and from cardiovascular causes
published in the Feb. 7 issue of the New England Journal of Medicine,
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