Dr. Michael Mauer, professor of pediatrics and medicine at the University of Minnesota and lead author of the study, stated that the drugs used in the trail to prevent worsening of kidney problems in diabetics enalapril (Vasotec) and losartan (Hyzaar), are commonly prescribed after 15 years of the diagnose of the disease.
"Some physicians have been willing to extrapolate to treat at very early stages of the condition, but no studies such as ours had been conducted," said Mauer.
Cohort study conducted
Mauer and colleagues conducted a study of 285 type-1 diabetes patients, who were under treatment for an average of 11 years. The subjects had normal blood pressure and albumin levels and were administered either 100 mg/day losartan, 20 mg/day enalapril, or placebo.
The scientist clarified that each drug acts in a different way to counter the effects of angiotensin, which raises blood pressure by tightening arteries.
The three groups of participants were followed over the course of five years.
After recording the detailed measurements of kidney function the scientists observed no difference in the damage seen in the three groups.
The study showed that the drugs did not protect the participants' kidneys from damage or from losing function.
"From the kidney perspective, it was more of a disappointment than a surprise," Mauer said.
Secondary results of the study
The results of the study were unexpected and the researchers were surprised by the eye component of the study.
The participants who were administered either of the medications experienced a positive effect in slowing of the progression of diabetic eye injury.
Mauer stated, "Although neither medication delayed early kidney tissue injury or early loss of kidney function, the advantage to a study with negative findings such as this one is that physicians now know that this treatment is ineffective for this purpose, and they can pursue other treatment options that may improve their patients' outcomes.”
Mauer also cautioned that drugs should not be prescribed to pregnant women as they can cause fetal damage.
However, he added that the drugs are safe and the results of the study should not affect the prescription of the drugs in later stages of Type-1 diabetes.
"They are commonly used for people who already have signs of kidney disease. They have been shown to have more effective blood pressure effects than other drugs, and they seem to have additional advantages in slowing the progression of kidney disease,” said Mauer.
The study was funded by Merck, which makes both drugs, along with the U.S. National Institutes of Health and the Canadian Institutes of Health Research.
Mauer's study "Renal and Retinal Effects of Enalapril and Losartan in Type 1 Diabetes" is published in the July 2nd issue of The New England Journal of Medicine.
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