Health Care Expenditure Burden High in Adrenal Insufficiency

Posted on April 23, 2017 by MaryO

Patients with adrenal insufficiency may accrue substantial health care costs and have more hospital stays and outpatient visits compared with healthy controls, according to findings published in the Journal of the Endocrine Society.

Candace Gunnarsson, PhD, vice president of health economics and outcomes research at CTI Clinical Trial and Consulting in Cincinnati, and colleagues evaluated data from a U.S.-based payer database on 10,383 patients with adrenal insufficiency to determine the estimated annual health care burden among them.

Participants were divided into groups based on their type of adrenal insufficiency: primary adrenal insufficiency (n = 1,014), adrenal insufficiency secondary to pituitary disease (n = 8,818) or congenital adrenal hyperplasia (n = 551). A group of matched controls was also evaluated for comparison.

Total annual health care expenditures were significantly higher in the primary adrenal insufficiency group ($18,624 vs. $4,320), adrenal insufficiency secondary to pituitary disease group ($32,218 vs. $6,956) and the congenital adrenal hyperplasia group ($7,677 vs. $4,203) compared with controls. The adrenal insufficiency secondary to pituitary disease group had the highest health care expenditure estimated with an incremental health care burden of $25,262, followed by the primary adrenal insufficiency group ($14,304) and the congenital adrenal hyperplasia group ($3,474).

Compared with controls, participants with adrenal insufficiency spent eight to 10 times more days in the hospital and had up to twice as many outpatient visits per year.

“When comparing [adrenal insufficiency] patients within each cohort based on their drug regimen, patients receiving prednisone therapy vs. hydrocortisone therapy had significantly higher total annual expenditures in the [primary adrenal insufficiency] and [congenital adrenal hyperplasia] and significantly lower total expenditures in the [pituitary disease] cohort,” the researchers wrote. “Patients taking only hydrocortisone and meeting the threshold of 50% adherence were found to have lower expenditures when medication adherence was 75% or higher.” – by Amber Cox

Disclosure: Gunnarsson reports being an employee of CTI Clinical Trial and Consulting. Please see the full study for a list of all other authors’ relevant financial disclosures.

From http://www.healio.com/endocrinology/adrenal/news/in-the-journals/%7B8f92bd0c-0c72-4902-beb5-663c356a61cb%7D/health-care-expenditure-burden-high-in-adrenal-insufficiency

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Longer-Acting Growth Hormones Promising for Adult GH Deficiency

Posted on April 3, 2017 by MaryO

Two investigational long-acting growth-hormone (GH) replacement products hold potential for less frequent dosing and improved adherence among adult patients with proven growth-hormone deficiency.

Adult growth-hormone deficiency is a rare disorder characterized by the inadequate secretion of the growth hormone from the pituitary gland. It can be hereditary; can be acquired as a result of trauma, infection, radiation therapy, or brain tumor growth; and can even emerge without a diagnosable cause. Currently, it is treated with once-daily injections of subcutaneous growth hormone.

The new results, from a 26-week phase 3 trial of Novo Nordisk’s once-weekly growth-hormone derivative somapacitan and a dose-finding phase 2 safety study of Versartis’s long-acting recombinant growth hormone somavaratan, both in adult patients with growth-hormone deficiency, were presented here at ENDO 2017: The Endocrine Society Annual Meeting.

“Compliance is often a problem with daily growth-hormone injections in children and even with adults,” session moderator Luma Ghalib, MD, assistant professor in the division of endocrinology, diabetes, and metabolism at Ohio State University Wexner Medical Center, Columbus, told Medscape Medical News.

“Patients will often stop taking the daily medications, sometimes because of the cost but also because the daily injections are cumbersome. So the two longer-acting agents that have been studied will be an amazing breakthrough if they get [US FDA]-approved.”

But, she cautioned, longer-term data are needed. “In the long term, we worry about the metabolic effects. We know growth hormone can increase insulin resistance and diabetes, so we have to keep an eye on the peaks.”

And, she added, there could be a small risk for regrowth of the pituitary adenoma that caused the growth-hormone deficiency. “The risk will probably be slim because we haven’t seen regrowth with the daily dosing, but it hasn’t been studied.”

Once-Weekly Somapacitan Found Safe, Well-Tolerated

Gudmundur Johannsson, MD, PhD, professor and chief physician at the University of Gothenburg, Sweden, reported findings from the 26-week multicenter, multinational, randomized open-label parallel-group trial of somapacitan, a reversible albumin-binding human GH derivative intended for once-weekly subcutaneous administration.

A total of 92 adults (aged 18-79 years) who had been previously treated with once-daily growth-hormone replacement for at least 6 months were randomized 2:1 (after a 1-day washout) to either once-weekly somapacitan or once-daily somatropin (Norditropin, Novo Nordisk). Doses of both were titrated for the first 8 weeks to achieve normal insulinlike growth factor (IGF)-1 levels (target 0–2 standard deviation scores) and remained fixed for the subsequent 18 weeks.

Patients were around 50 years of age, 45% female, with body mass index 28 kg/m2. After remaining stable in both arms following titration, mean serum IGF-1 standard-deviation scores at week 25 were 0.22 for somapacitan and 0.35 for somatropin.

The primary outcome, incidence of adverse events including injection-site reactions, was similar between the two groups. Total adverse events occurred in 53 of 61 (86.9%) with somapacitan vs 21 of 31 (67.5%) with somatropin and included nasopharyngitis, headache, fatigue, dizziness, and arthralgia. Serious adverse events occurred in four (6.6%) with somapacitan and two (6.5%) with somatropin.

Of more than 1500 somapacitan injections given, there were two mild, transient, injection-site reactions (hematoma and bruising). No antibodies to somapacitan or GH were detected.

At week 26, patients’ scores on the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) for convenience, effectiveness, and satisfaction all favored somapacitan over somatropin.

Additional phase 3 trials in adults with growth-hormone deficiency are ongoing, as well as a phase 2 trial in children, a Novo Nordisk spokesperson told Medscape Medical News.

Somavaratan Dose-Finding Study Yields 2-Week Response

Kevin CJ Yuen, MD, MBChB, medical director of the Swedish Pituitary Center, Swedish Neuroscience Institute, Seattle, Washington, presented findings from an open-label, multicenter phase 2 study of somavaratan, a novel long-acting form of recombinant human growth hormone. The study aimed to evaluate starting dose, dose titration plan, and safety and to determine the IGF-1 response with 30-day dosing.

Patients were allocated into three starting dose cohorts: 0.6 mg/kg/month for those aged 35 and older, 0.8 mg/kg/month for those younger than 35, and 1.0 mg/kg/month for women on oral estrogen, regardless of age. All received five monthly subcutaneous doses of somavaratan with a target IGF-1 standard deviation score of 0–1.5. In all, 32 of 49 patients completed the study.

The most common adverse events were injection-site reactions (19.4%) and headache (11.1%), mostly mild or moderate. No severe adverse events were deemed related to somavaratan.

Mean IGF-I SDS increased from -1.32 at baseline to +2.31 at 7 days after the first dose, with subjects within each cohort who received higher doses tending to have higher IGF-1 responses. Following the last study dose, IGF-1 standard-deviation scores returned to baseline by day 22.

Thus, Dr Yuen said, twice-monthly administration will be studied going forward. Starting somavaratan dose and administration frequency are being investigated further in the extension study and then will be carried forward in a new phase 3 study.

Speaking about both products, Dr Ghalib told Medscape Medical News: “We are waiting. Less frequent dosing will make our lives and definitely the patients’ lives a lot easier.”

Dr Johannsson is a consultant and/or speaker for Viropharma, Shire, AstraZeneca, Novartis, Otsuka, Novo Nordisk, Merck, Serono, Pfizer, and Ipsen. Dr Yuen is an investigator and/or medical advisory board member for Pfizer, Opko, Novo Nordisk, Versartis, and Sandoz. Dr Ghalib has no relevant financial relationships.  

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ENDO 2017. April 1, 2017; Orlando, Florida. Abstract OR22-1, Abstract OR22-2

From http://www.medscape.com/viewarticle/878088

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Postsurgical treatment often necessary in persistent, recurrent Cushing’s disease

Posted on March 30, 2017 by MaryO

Nearly half of adults with Cushing’s disease that persists or recurs after surgical treatment require second and sometimes third therapeutic interventions, including pituitary surgical reintervention, radiotherapy, pharmacotherapy or bilateral adrenalectomy, study data from Mexico show.

Moisés Mercado, MD, FRCPC, of the ABC Hospital Neurological and Cancer Centers in Mexico City, and colleagues evaluated 84 adults (median age, 34 years; 77 women) with Cushing’s disease to determine the long-term efficacy of secondary interventions for persistent and recurrent Cushing’s disease. Median follow-up was 6.3 years.

Overall, 81 participants were primarily treated with transsphenoidal surgery. More than half experienced long-lasting remission (61.7%); disease remained active in 16%, who were diagnosed with persistent Cushing’s disease; and 22% experienced relapse after remission and were diagnosed with recurrent Cushing’s disease.

After the initial procedure, 18 participants required pituitary surgical reintervention, including 10 with recurrent and eight with persistent disease. Radiation therapy was administered to 14 participants, including two as primary therapy and 12 after failed pituitary surgery. Pharmacologic treatment with ketoconazole was prescribed for 15 participants at one point during the course of disease. Bilateral adrenalectomy was performed in 12 participants.

Pituitary surgical reintervention was the most commonly used secondary treatment (22.2%), followed by pharmacologic therapy with ketoconazole (16%), radiotherapy (14.8%) and bilateral adrenalectomy (14.8%). More than half of participants experienced early remissions after a second operation (66.6%) and radiotherapy (58.3%), whereas long-lasting remission was reached in only 33.3% of participants who underwent a second surgery and 41.6% of participants who underwent radiotherapy. Half of participants who underwent bilateral adrenalectomy were diagnosed with Nelson’s syndrome.

Overall, 88% of participants achieved remission, and disease was biochemically controlled with pharmacologic treatment in 9.5% of participants after their initial, secondary and third-line treatments.

“The efficacy of treatment alternatives for recurrent or persistent [Cushing’s disease] vary among patients, and often, more than one of these interventions is required in order to achieve a long-lasting remission,” the researchers wrote. – by Amber Cox

Disclosure: The researchers report no relevant financial disclosures.

From http://www.healio.com/endocrinology/adrenal/news/in-the-journals/%7B5519b312-5912-4c65-b2ed-2ece3f68e83f%7D/postsurgical-treatment-often-necessary-in-persistent-recurrent-cushings-disease

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Science Teacher Receives Support After Cushing’s Disease Diagnosis

Posted on March 26, 2017 by MaryO

I find it amazing that it’s newsworthy in this day and age for anyone receiving support after a diagnosis.  Of course, a diagnosed person should be getting support as a matter of course.  If she had cancer, everyone would be all over this.

For Kara Murrow, the most rewarding moments as a teacher come when students learn about animals in the classroom. So it’s difficult for the Bonham Elementary fifth-grade science and social studies teacher to be away from school while she prepares for surgery.

“I enjoy it, and I know my kids enjoy the class and enjoy science because of it,” Murrow said. “With the science club I do after school once a week, the kids get upset when it gets canceled because of meetings. Not having it now is upsetting, too.”

Murrow was diagnosed this month with Cushing’s disease, a condition that develops when a tumor on the pituitary gland causes it to secrete too much adrenocorticotropic hormone. Murrow, who moved to West Texas from Arizona three years ago, said she has received support from Midland ISD employees and others in the local community.

Murrow’s mother, Louise Gonzalez, also appreciates Midlanders’ concerns for her daughter.

“People in Midland have been wonderful, considering how new we are to the area,” Gonzalez said. “The school district sent out the GoFundMe page and there’s been an outpouring of support for that. People at my church always ask me.”

Murrow’s family is collecting donations from the website GoFundMe to cover the costs of medical and travel expenses. Murrow and her husband, Kai, recently spent money on hospital stays connected to their 4-year-old son’s food sensitivities.

“They’ve been paying off those bills and doing OK until this came,” Gonzalez said. “Plus, she’s been going to the doctor about this. Because Cushing’s is so rare, doctors don’t recognize it.”

Murrow was diagnosed with the disease after medical professionals discovered a tumor on her pituitary gland. For six years, she experienced symptoms — including weight gain, dizziness and headaches — but said doctors couldn’t determine the cause. Murrow was thankful when she received an answer.

“It was a huge relief to finally have a diagnosis and know that I wasn’t crazy or making things up,” Murrow said. “It’s weird to be excited about a brain tumor. It’s a relief to know what was happening and that I have a solution.”

Murrow traveled this week to Barrow Neurological Institute in Phoenix, where she’s scheduled to undergo surgery to remove the tumor. Though Murrow said recovery lasts several months, she hopes to return to the classroom next school year.

Jaime White, fourth-grade language arts and social studies teacher at Bonham, said both staff and students miss her presence. She said Murrow expresses concern for her students during her time away.

“She’s worried about how kids will do on the STAAR [State of Texas Assessments of Academic Readiness],” White said. “She doesn’t want them to think she abandoned them. The disease has to take center stage.”

At school, White said she noticed her colleague’s dedication toward helping her students understand science.

“She’s hands-on,” White said. “When it comes to science, she’s always making sure the kids are doing some sort of experiment. She wants to make sure the kids grasp it.”

Murrow teaches students about animals through dissections and presentations. Before she became a teacher nine years ago, she coordinated outreach programs at an Arizona zoo.

When she came to MISD, Murrow saw an opportunity to generate enthusiasm about science. She launched an invite-only science club for fifth-graders who show interest in the subject.

“I started it because there wasn’t really anything,” Murrow said. “They have tutorials for reading and math. There’s not a lot kids can do with science after school. They get science in the younger grades, but the focus is on reading and math. Science is something kids really enjoy.”

Though Murrow is disappointed about not being able to facilitate the club, she recognizes the importance of her upcoming surgery. She’s happy her mother, husband and two children will be in Phoenix for support.

“I hope that it will bring about a sense of relief to all the symptoms I’ve been dealing with and provide a chance for myself and my family to continue along with a full life,” Murrow said.

From http://www.mrt.com/news/local/article/Science-teacher-receives-support-after-11026581.php

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Postoperative ACTH, cortisol levels may predict Cushing’s disease remission rate

Posted on March 22, 2017 by MaryO

Early and midterm nonremission after transsphenoidal surgery in people with Cushing’s disease may be predicted by normalized early postoperative values for adrenocorticotropic hormone and cortisol, study data show.

Prashant Chittiboina, MD, MPH, assistant clinical investigator in the neurosurgery unit for pituitary and inheritable diseases at the National Institute of Neurological Diseases and Stroke at the NIH, and colleagues evaluated 250 patients with Cushing’s disease who received 291 transsphenoidal surgery procedures during the study period to determine remission after the procedure. Patients were treated between December 2003 and July 2016. Early remission was assessed at 10 days and medium-term remission was assessed at 11 months.

Early nonremission was predicted by normalized early postoperative values for cortisol (P = .016) and by normalized early postoperative values for adrenocorticotropic hormone (ACTH; P = .048). Early nonremission was further predicted with 100% sensitivity, 39% specificity, 100% negative predictive value and 18% positive predictive value for a cutoff of –12 µg/mL in normalized early postoperative values for cortisol and with 88% sensitivity, 41% specificity, 96% negative predictive value and 16% positive predictive value for a cutoff of –40 pg/mL in normalized early postoperative values for ACTH.

Medium-term nonremission was also predicted by normalized early postoperative values for cortisol (P = .023) and ACTH (P = .025).

“We evaluated the utility of early postoperative cortisol and ACTH levels for predicting nonremission after transsphenoidal adenomectomy for Cushing’s disease,” the researchers wrote. “Postoperative operative day 1 values at 6 a.m. performed best at predicting early nonremission, albeit with a lower [area under the receiver operating characteristic curve]. Normalizing early cortisol and ACTH values to post-[corticotropin-releasing hormone] values improved their prognostic value. Further prospective studies will explore the utility of normalized very early postoperative day 0 cortisol and ACTH levels in identifying patients at risk for nonremission following [transsphenoidal surgery] in patients with [Cushing’s disease].” – by Amber Cox

Disclosure: The researchers report no relevant financial disclosures.

From http://www.healio.com/endocrinology/adrenal/news/in-the-journals/%7B7de200ed-c667-4b48-ab19-256d90a7bbc5%7D/postoperative-acth-cortisol-levels-may-predict-cushings-disease-remission-rate

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