-- Robert Preidt
WEDNESDAY, March 7 (HealthDay News) -- An experimental drug
called pasireotide reduced levels of the "stress hormone" cortisol
and improved symptoms in patients with Cushing's disease, a new
Cushing's disease is a rare (three to five cases per million
people) hormonal disorder that causes a wide range of health
problems and, if untreated, significantly increases a patient's
risk of dying at a much younger age than normal, researchers said
in a news release.
Weight gain, high blood pressure, mood swings, irregular or
absent menstrual periods, insulin resistance, glucose intolerance
and type 2 diabetes are among the symptoms of Cushing's disease. It
is a form of Cushing's syndrome, which is caused by prolonged
exposure of the body's tissues to high levels of the hormone
This phase 3 study of 162 patients in 18 countries found that
treatment with pasireotide reduced cortisol secretion by an average
of 50 percent and returned some patient's cortisol levels to
A phase 3 study means that a drug is in the final stages of
testing that drugs undergo before they can be approved for
treatment of a specific disease.
The study, funded by Novartis Pharma, appears in the March 8
issue of the
New England Journal of Medicine.
Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital in
New York City, is not associated with the study but is familiar
with its findings.
Mezitis said the study showed that the experimental treatment
"improved metabolic abnormalities and emotional difficulties.
Therefore, pasireotide injections become an alternative to surgical
resection of the pituitary ACTH-secreting tumor, and may be shown
to work with the FDA-approved mifepristone, which blocks the action
of cortisol at receptors in the body."
Elevated blood sugar (glucose) levels occurred in 73 percent of
the patients who took the drug, a side effect that requires close
attention, according to senior study author Dr. Beverly Biller, of
Massachusetts General Hospital.
Cushing's patients already have difficulty processing glucose,
"Those patients who already were diabetic had the greatest increases in blood sugar, and those who were prediabetic were more likely to become diabetic than those who began with normal blood sugar," Biller said in the hospital news release. "So this is real and needs to be monitored carefully."
Mezitis agreed that careful patient monitoring is important.
"Blood-sugar elevations are dose-dependent with pasireotide and
will need to be managed as indicated for diabetes," he said.
The U.S. National Institute of Diabetes and Digestive and Kidney
Diseases has more about
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