Wed06192013

Last update 04:08:53 PM EST

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Endocrinology

First Cushing’s Syndrome Treatment Approved

Corcept

The FDA recently approved Corcept Therapeutics’ drug, Korlym (mifepristone), for the treatment of Cushing’s syndrome.

Endogenous Cushing’s syndrome is a rare multisystem disorder caused by overproduction of cortisol, a steroid hormone, which increases blood sugar levels. Korlym was approved for patients with type 2 diabetes or glucose intolerance, that are not considered candidates for surgery, or didn’t respond to surgery in the past.

According to the FDA, Cushing’s syndrome affects people between the age of 25 and 40. Since only about 5,000 patients will be eligible for this drug, the FDA designated Korlym orphan drug status.

A phase III study consisting of 50 patients with endogenous Cushing’s syndrome, who were not eligible or had a relapse from surgery showed that after treatment with Korlym, 60% of patients with glucose intolerant had greater than a 25% improvement in a test.

In the clinical trials, common side effects for patients taking Korlym consisted of nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Korlym should not be taken by women who may be pregnant.

According to Corcept, Korlym will be available in May, at a limited amount of endocrinologists who treat patients with Cushing’s syndrome.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292462.htm

High Costs Associated with Precocious Puberty, Researchers Say

In the first study to assess the economic burden of precocious puberty, costs directly related to the condition totaled $10,472 in the year following the diagnosis, according to Shih-Yin Chen, MD, of BioSource Corp., in Lexington, Mass., and colleagues, MedPage Today reported.

But because these children have significantly more comorbidities than developmentally normal children, the total costs accrued during that year reached $21,715 compared with a total of $923 in controls, the researchers said in a poster session at the annual meeting of the Endocrine Society.

Central precocious puberty is the gonadotropin-dependent premature onset of secondary sex characteristics in girls before age eight and in boys before age nine.

The condition occurs in some 1 in 5,000 to 10,000 children, with girls being affected ten times more often than boys.

While medical management has been known to be expensive, few data have been available that quantify the specific costs.

To answer those cost questions, Chen and colleagues identified a cohort of 181 children with precocious puberty and 724 matched controls from a commercial claims database.

Patients included in the study had to have at least one gonadotropin-releasing hormone agonist prescribed during the 12 months after the diagnosis.

At the time of diagnosis, 2.2% of patients were younger than three years, while 3.9% were four to five years old, 23.8% were six to seven, and 42.5% were eight to nine years.

Risk factors of affected children included trauma to the central nervous system, low birth weight, neonatal encephalopathy, hypothyroidism, hydrocephalus, and brain tumors.

Even during the year before diagnosis, affected children had significantly more medical costs than their healthy counterparts in hospital admissions, physician office visits, emergency department visits, and use of laboratory services (all P<0.05). They also had significantly more visits to mental health and dermatology specialists both before and after the diagnosis (P<0.05).

And while almost 10% had been to an endocrinologist during the year before diagnosis, compared with a negligible percentage of controls, almost 60% required specialist endocrinology services in the year following diagnosis.

The investigators also charted median monthly healthcare costs pre- and post-diagnosis, and while costs for controls remained flat, at about $100 per month, costs for the children with precocious puberty ranged from $200 to $400 in the year before diagnosis and climbed to higher than $1,200 each month thereafter.

To view the entire MedPage article, which includes disclaimers, references, and funding data, please click here.


Hormone Improves Long-Term Recovery From Stroke

Hormone Improves Long-Term Recovery From Stroke

Insulin-like growth factor I, IGF-I, is a hormone that is found in the blood and contributes to, among other things, growth and bone mass. The levels of this hormone are higher in people who exercise regularly and those with good health. Scientists at the Sahlgrenska Academy have shown for the first time that high levels of this hormone are associated with better long-term recovery after a stroke. The study has been accepted for publication in the Journal of Clinical Endocrinology and Metabolism, a publication of The Endocrine Society.

"This study is interesting for two reasons. The first is that we show that a hormone is associated with improved long-term recovery, and thus there is still the prospect of improvement - even after three months after the stroke. The second is that levels of this hormone are known to be elevated in those who exercise often", said David Åberg, associate professor at the Sahlgrenska Academy and lead author of the study. "It is, however, important to add that the levels of IGF-I are controlled also by other factors such as other growth hormones, heredity and nutrition."

The study is based on 407 patients who are participating in the SAHLSIS study at the Sahlgrenska Academy, in which people aged 18-70 years who are affected by stroke are followed up for two years after the event. SAHLSIS is an acronym for "The Sahlgrenska Academy Study on Ischemic Stroke".

Scientists have measured the levels of IFG-I in these 407 patients and seen that increased levels are associated with better recovery, when the degree of recovery is determined between 3 and 24 months after the stroke. Previous research (Bondanelli et al) has also shown a positive effect of high IGF-I levels in the early phase after a stroke, while the scientists at the Sahlgrenska Academy have now demonstrated that the positive effects on recovery remain long after the stroke event.

"Our results may explain why patients who exercise more actively, with physiotherapy and physical exercise, demonstrate better recovery after a stroke," said Åberg. "Unfortunately, we do not know how much our patients exercised after the stroke. This means that we need to carry out further studies in which we measure both the amount of physical activity and the levels of IGF-I, in order to understand the exact relationships better."

These results pave the way for further studies on whether drug treatments that raise IGF-I levels can improve long-term recovery after stroke. David Åberg believes that two avenues are open: either to treat with IGF-I, or to treat with the better known growth hormone (GH). This can stimulate the body's own production of IGF-I.

"Of course, these possibilities must be tested in carefully constructed clinical trials, so that we discover any undesired effects that must be considered. This is particularly true during the acute phase of a stroke, while treatment during the recovery phase is probably easier and has greater benefit", said Åberg.

Source:

Endocrine Society

Osteoporosis Recs Urge Screening for More Women

Endocrinology

The U.S. Preventive Services Task Force (USPSTF) has finalized new guidelines expanding the pool of women for whom osteoporosis screening is recommended.

The guidance, which was released in draft form in July, recommends screening for all women ages 65 and older, as well as younger women who have a level of risk equivalent to a 65-year-old white woman with no additional risk factors.

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Antidepressant a Chill Pill for Hot Flashes

The antidepressant escitalopram (Lexapro) modestly turns down the frequency and severity of hot flash symptoms for menopausal women, according to results of a randomized clinical trial.

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