Patients with acromegaly provide a unique challenge to endocrine clinicians. Shlomo Melmed, MB, ChB, discusses the latest breakthroughs in treating these patients which includes newly approved pharmaceuticals in his session, “Update on Acromegaly: Treatment Based on the New Guidelines.”
This year, the Endocrine Society’s Clinical Endocrinology Update (CEU) will take place online as the COVID-19 pandemic continues to roil the U.S. It would be technically correct to say this meeting is an unprecedented scenario, but it’s coming right after the record-breaking ENDO Online 2020, which saw the most attendees for an annual meeting in the Society’s history. So as always, CEU attendees can brush up on the latest breakthroughs and best ways to care for patients as presenters share what they’ve learned and what they practice on the cutting edge of endocrine science.
One subspecialty of endocrinology that has enjoyed several promising developments over the past couple of years is acromegaly, the chronic condition characterized by somatic overgrowth, multiple comorbidities, premature mortality, and physical disfigurement, according to the Society’s Clinical Practice Guideline. Treatment usually involves surgery to excise the tumor causing growth hormone (GH) hypersecretion, followed by medication management.
Shlomo Melmed, MB, ChB, executive vice president and dean at Cedars-Sinai Medical Center, is one of the world’s leading experts on pituitary tumors and growth factor regulation. He has been a recipient of the Endocrinology Award of the Royal Society of Medicine, the Endocrine Society Clinical Investigator and Outstanding Scholarly Physician Awards, the Society of Endocrinology Transatlantic Medal, the Foundation IPSEN Endocrine Regulation Prize, and the Pituitary Society’s Lifetime Achievement Award. He was also one of the authors on the Society’s Acromegaly Clinical Practice Guideline.
The Society invited Melmed to share his knowledge with CEU attendees through his on-demand presentation, “Update on Acromegaly: Treatment Based on the New Guidelines,” during which he will highlight the new or evidence-based reimagined approaches to treating patients with acromegaly and how endocrinologists can improve and extend their lives.
A Look at New Drugs
Melmed tells Endocrine News that his talk will focus on new medications that were introduced or recently approved by the Food and Drug Administration (FDA). He points to pasireotide, a somatostatin analog that preferentially targets SSTR5 rather than SSTR2, which has been shown to be more effective than octreotide or lanreotide. However, pasireotide causes high blood sugar and diabetes in a majority of patients, Melmed says.
“They should come away with the understanding that we have to control comorbidities and improve quality of life, in addition to normalizing biochemical hormonal abnormalities.” – Shlomo Melmed, MB, ChB, executive vice president and dean, Cedars-Sinai Medical Center, Los Angeles, Calif.
Then there are the combination therapies. Several new studies now show that combining somatostatin receptor ligands (SRLs) with the growth hormone receptor antagonist may improve efficacy and enable optimal suppression of growth hormone and IGF-1 levels, Melmed says. “The downside is that this approach is costly, i.e. using two expensive injectable drugs,” he says. “Attaining cost-effective combination is a viable option for maximal control.”
Avoiding the “Breakout Effect”
In late June, the FDA approved octereotide capsules as the first and only oral somatostatin analog for long-term maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide. Melmed explains that the capsules contain the same octereotide molecule, so side effect profile should be the similar since the drug has not been changed, just the delivery method.
“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers.” – Shlomo Melmed, MB, ChB, executive vice president and dean, Cedars-Sinai Medical Center, Los Angeles, Calif.
“This will be of advantage to patients for several reasons,” Melmed says. “Firstly, it’s an oral capsule administered twice a day, and many patients may prefer a pill to an injection. Secondly, injections are quite painful, inconvenient and time-consuming. The patient has to come to the clinic or to the hospital for their monthly injection. They may have to miss work, have to find parking, and register. Therefore, receiving the injection is not a trivial undertaking, and some patients experience bruising, pain, and local site inflammation. For patients who suffer from injection phobia, availability of a safe oral alternative is an advantage.”
“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” says Jill Sisco, president of the Acromegaly Community, Inc. “The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers.”
Melmed explains that the benefits are scientific as well, as the new delivery system of octereotide seems to eliminate the “breakout effect” that patients report towards the end of the injections cycle. Somatostatin receptor ligands (SRLs) are classically injected every four weeks in a depot preparation, which means toward the end of the four-week period, patients may report returning symptoms as the drug wanes in their systems. “They may experience recurring headaches, sweating, and joint pains,” Melmed says. “And so, hopefully by taking a consistent dose of an oral drug every day, they will avoid this breakout effect”
Weighing Treatment Options
Melmed has long been a champion of the CEU meetings, and even though the COVID-19 pandemic means 2020’s meeting will take place in the virtual world, he sees our current reality as an exciting opportunity to touch lots of people around the world without having to worry about the hassle of travel and time differences. Anyone interested in the advances in acromegaly treatment has the chance to learn from Melmed’s expertise and experience from the comfort of their own home or office.
“I think they should attend the talk to understand the advantages and disadvantages of all the wonderful treatment options that we have available today for our patients with acromegaly,” Melmed says. “And they should come away with the understanding that we have to control comorbidities and improve quality of life, in addition to normalizing biochemical hormonal abnormalities. Participants in CEU should come away with an understanding of the efficacy and safety of the different formulations, which are now available for treating our patients.”
— Bagley is the senior editor of Endocrine News. He wrote the July cover story on how telemedicine and telehealth have gained popularity with both patients and healthcare providers during the COVID-19 pandemic.