Category Archives: Endocrinology

Endocrinology

No Link Between GLP-1 Drugs and Suicide, Says European Regulator – Medpage Today

The European Medicines Agency (EMA) found no evidence to support a causal link between GLP-1 receptor agonists and suicidal thoughts, a committee said on Friday following a 9-month review.

An investigation was launched in July 2023 over reports of suicidal ideation and self-harm thoughts and actions not previously reported in any clinical trials. The investigation was extended again last November when the committee requested more postmarketing data from the drugmakers.

But after reviewing the totality of evidence from non-clinical studies, clinical trials, and post-marketing surveillance data, the committee said that an update to the product information is not warranted.

"The marketing authorization holders for these medicines will continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs)," the committee noted.

This more definitive conclusion comes on the heels of the FDA's preliminary evaluation of the issue, which was released in January.

At that time, the FDA said that while it "cannot definitively rule out that a small risk may exist," its preliminary evaluation did not suggest a causal link. "We will communicate our final conclusions and recommendations after we complete our review or have more information to share," the agency wrote in its safety communication.

The EMA's conclusion was based on the recent Nature Medicine study of 240,618 patients who had overweight or obesity taking semaglutide (Ozempic, Rybelsus, Wegovy). Interestingly, there was a significantly lower risk of suicidal ideation among these patients compared with those on non-GLP-1 anti-obesity medications (0.11% vs 0.43%; HR 0.27, 95% CI 0.20-0.36).

This study also looked at 1,572,885 patients with type 2 diabetes on semaglutide, who had a significantly lower risk of suicidal ideation compared with patients taking other anti-diabetes medications (0.13% vs 0.36%; HR 0.36, 95% CI 0.25-0.53).

In addition, the review included an analysis that the EMA conducted independently that compared type 2 diabetes patients on a GLP-1 receptor agonist with those on an SGLT2 inhibitor, but no results were reported.

The EMA's announcement was exclusive to agents in the GLP-1 receptor agonist class currently approved in Europe -- semaglutide, liraglutide (Victoza, Saxenda), liraglutide/insulin degludec (Xultophy), dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), lixisenatide (Adlyxin), and lixisenatide/insulin glargine (Soliqua). It didn't include FDA-approved tirzepatide (Mounjaro, Zepbound), a dual GIP/GLP-1 receptor agonist. These agents have indications for the treatment of type 2 diabetes, obesity, or both.

If you or someone you know is considering suicide, call or text 988 or go to the 988 Suicide and Crisis Lifeline website.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, shes worked at the company since 2015.

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No Link Between GLP-1 Drugs and Suicide, Says European Regulator - Medpage Today

Endocrinology

Surgical Remission of Cushing’s Disease Tied to New Autoimmune Conditions – Medpage Today

Development of autoimmune disease was more common in patients with surgical remission of Cushing's disease than in those with surgically treated nonfunctioning pituitary adenomas (NFPAs), according to a retrospective matched cohort study.

At 3 years after surgery, 10.4% of patients with Cushing's disease developed new-onset autoimmune disease compared with 1.6% of those with NFPAs (HR 7.80, 95% CI 2.88-21.10), reported Lisa Nachtigall, MD, of Massachusetts General Hospital in Boston, and colleagues.

Those with Cushing's had a higher prevalence of postoperative adrenal insufficiency compared with patients with NFPAs (93.8% vs 16.5%), and lower postoperative nadir serum cortisol levels (63.8 nmol/L vs 282.3 nmol/L), they noted in the Annals of Internal Medicine.

Patients with surgical remission of Cushing's should be evaluated for autoimmune and inflammatory disorders, Nachtigall told MedPage Today. As for patients who have symptoms of steroid withdrawal after being treated for Cushing's -- such as joint and muscle pain and weakness -- she said clinicians should suspect a new inflammatory process or flare of a pre-existing autoimmune disease.

"It is important for doctors to be aware that autoimmune disease may occur in patients after surgical remission of Cushing's disease, particularly so that such patients are not misdiagnosed as having steroid withdrawal syndrome, since specific treatments are available for autoimmune disease and may be indicated," she added.

While the exact mechanism behind the link between adrenal insufficiency in surgically treated Cushing's patients and the development of autoimmune disease isn't known, Nachtigall noted it's possible that low cortisol stimulates an inflammatory process, though more research is needed.

"It might also be interesting to evaluate if this same phenomena occurs in the wake of post-traumatic stress syndrome or after severe acute illness or injury, and other states in which cortisol levels are very high," she continued.

Among the Cushing's patients who went on to develop post-surgical autoimmune disease, a lower preoperative 24-hour urine-free cortisol ratio was observed compared with patients with Cushing's without autoimmune disease (2.7 vs 6.3), as was a higher prevalence of family history of autoimmune disease (41.2% vs 20.9%).

While all patients received either 0.5 or 1 mg of dexamethasone per day during the first week after surgery, more patients without autoimmune disease received supraphysiologic doses of glucocorticoids -- an >25 mg hydrocortisone-equivalent dose -- compared with patients who developed an autoimmune disease (41.8% vs 17.6%). Those who had an autoimmune disease also received slightly lower doses of glucocorticoid replacement during the first postoperative month (17.1 vs 18.7 mg/day).

"It surprised us that relatively small dose differences in glucocorticoid replacement in the immediate post-op period seemed to have an effect on the likelihood of developing autoimmune disease," said Nachtigall, "such that slightly higher replacement doses may be protective against getting autoimmune disease later."

For this study, the researchers performed a chart review of patients who underwent transsphenoidal surgery -- the first-line treatment for the majority of hypersecreting pituitary adenomas -- for Cushing's (n=194) or NFPAs (n=92) at Massachusetts General Hospital between 2005 and 2019.

For inclusion, patients had to have biochemical evidence of Cushing's defined as elevated levels of 24-hour urine-free cortisol, late-night salivary cortisol, or both, and/or failure of cortisol suppression in response to a low-dose dexamethasone suppression test with clinical evidence after evaluation by a neuroendocrine expert. All patients had a central source of adrenocorticotropic hormone (ACTH) excess confirmed by preoperative inferior petrosal sinus sampling or postoperative pathology.

The average age of Cushing's patients in the study was 43.5, and 88% were women. Mean body mass index was 34.5, and average tumor size was 5.7 mm. About a quarter of patients had a personal history of autoimmune disease. The most common types of new-onset autoimmune disease in this group were autoimmune thyroiditis, Sjgren syndrome, and autoimmune seronegative spondyloarthropathy.

"While this study was specifically in patients who had adrenal insufficiency after successful surgical therapy for ACTH-secreting tumors, the findings may apply to other patients with Cushing's," Nachtigall said, such as those with the condition due to ectopic or adrenal tumors or supraphysiologic exogenous replacement.

The findings may also hold clinical relevance for patients on high-dose exogenous steroids for other medical conditions, who may be at risk for developing autoimmune conditions due to suppression of the hypothalamic-pituitary-adrenal axis as steroids are tapered or stopped.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, shes worked at the company since 2015.

Disclosures

The primary funding source for this study was Recordati Rare Diseases. The research also was supported by the Harvard Catalyst, the Harvard Clinical and Translational Science Center, and financial contributions from Harvard University and its affiliated academic healthcare centers.

Nachtigall and co-authors reported relationships with Recordati, Corcept, the Endocrine Society, Pfizer, and Amgen.

Primary Source

Annals of Internal Medicine

Source Reference: Nyanyo DD, et al "Autoimmune disorders associated with surgical remission of Cushing's disease" Ann Intern Med 2024; DOI: 10.7326/M23-2024.

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Surgical Remission of Cushing's Disease Tied to New Autoimmune Conditions - Medpage Today

Endocrinology

Dr. Marcus D. Goncalves Inducted into the American Society for Clinical Investigation – Weill Cornell Medicine Newsroom

Dr. Marcus D. Goncalves, the Ralph L. Nachman, M.D. Research Scholar and an assistant professor of medicine in the Division of Endocrinology, Diabetes and Metabolism at Weill Cornell Medicine, has been elected as a member of the American Society for Clinical Investigation (ASCI) for 2024.

The ASCI is one of the nations oldest nonprofit medical honor societies and focuses on the unique role of physician-scientists in research, clinical care and medical education. It is comprised of more than 3,000 physician-scientists representing all medical specialties in the upper ranks. ASCI members are leaders in their fields in translating laboratory findings into clinical advancements. Dr. Goncalves is among 100 new members elected this year and will be officially inducted at the organizations annual meeting in April.

Its a high honor for me to be included in this group, said Dr. Goncalves, who is also an assistant professor of biochemistry at Weill Cornell Medicine. Im very grateful to the selection committee and the people who nominated me because ASCI membership represents a significant milestone in my career and has been a dream of mine ever since I was an MD-PhD student.

Dr. Goncalves clinical research encompasses the intersection between endocrinology and cancer biology, with his lab focusing on the effects of diet and cancer on the host tissues that regulate systemic nutrient metabolism. We investigate how cancer impacts systemic metabolism and, on the contrary, how systemic hormones and metabolites can promote or slow tumor growth, he said.

A particular focus of Dr. Goncalves research is cachexia, a debilitating wasting syndrome that involves muscle and fat loss and often occurs in people with advanced cancer. He is co-leader of the Cancer Cachexia Action Network (CANCAN), which was established in 2022 and funded through a Cancer Grand Challenges award from the National Cancer Institute and Cancer Research UK, and seeks to explore the underlying mechanisms of cachexia in cancer. The team consists of clinicians, patient advocates and scientists with expertise in cancer, metabolism, immunology and more from 14 institutions across the United States and the U.K.

With cachexia, some people may lose weight because theyre not eating. Others, with high metabolism, may lose weight despite eating more than they need, Dr. Goncalves said. In either case, weight loss from cachexia increases the risk of death and leads to poor outcomes in terms of treatment response. Theres no known mechanism for why cachexia develops or how to treat it, he said. My goal and our research teams goal is to try and identify the different subtypes of people who are experiencing cancer-related weight loss and develop targeted treatments for the condition.

Election into the ASCI, which is based on outstanding scholarly achievement, will provide Dr. Goncalves with the opportunity to engage with other physician-scientists who are conducting innovative research in a variety of medical specialties. Its an honor to be elected to the ASCI at this stage of my career, he said, and it validates the work weve been doing.

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Dr. Marcus D. Goncalves Inducted into the American Society for Clinical Investigation - Weill Cornell Medicine Newsroom

Endocrinology

Alpha Lipoic Acid for Diabetic Neuropathy: Does It Work? – diaTribe Foundation

Alpha-lipoic acid is an omega-3 fatty acid naturally found in food. Some studies suggest that supplementing with ALA may play a role in treating diabetic neuropathy.

You already know how important diet is for keeping a lid on diabetes symptoms and glucose levels.

If you live with diabetic neuropathy, a type of nerve damage resulting from diabetes, certain natural compounds found in foods may help slow progression and relieve symptoms.

One is called alpha-lipoic acid (ALA), and some studies suggest it may play a role in treating neuropathy. Additionally, as an antioxidant, it may be beneficial for keeping your cells and organs like your brain and liver healthy.

What does research say so far about ALA? Lets find out.

ALA is an antioxidant found in foods like broccoli, spinach, and red meat. Your bodys cells also make it in small amounts.

Antioxidants are thought to protect cells against damage that, over time, can lead to chronic diseases making them crucial components of your immune system. Fruit, vegetables, and nuts are a few examples of foods rich in antioxidants. ALA is one antioxidant that early research has found may be beneficial if you have diabetes.

ALA is considered more of a supplemental therapy that may have effects on diabetic neuropathy, says Dr. Maamoun Salam, an associate professor of endocrinology at Washington University School of Medicine in St. Louis. It also has some glucose-lowering effects.

Alpha-lipoic acid is not to be confused with alpha-linolenic acid, an omega-3 fatty acid your body does not make. Same initials, different compounds.

When you have chronically high blood sugar, it can damage nerves and the small blood vessels that nourish your nerves. Thats how diabetic neuropathy is developed.

ALA may help neuropathy in multiple ways. On its own, its an effective antioxidant. Taking an ALA dietary supplement can also boost vitamin C and E levels, which in turn can increase your bodys supply of glutathione, another antioxidant. Together, these two antioxidants may clear free radicals molecules that can cause cell damage more efficiently.

Thats particularly important when you have diabetes as people with the condition either produce more free radicals, clear them slower, or both. Fewer free radicals may mean less nerve damage and milder diabetic neuropathy symptoms.

Dr. Salam points to a trio of trials of ALA in people with diabetes that showed improvements in pain, numbness, and paresthesia. However, he notes, the sample sizes were small and the study durations short, so its difficult to conclude whether ALA is effective for diabetic neuropathy.

For people with diabetes, ALA may also extend beyond diabetic neuropathy treatment and aid blood sugar management.

Researchers suggest ALA works by binding to certain insulin receptors in liver cells. The compound has been called an insulin-mimetic agent, meaning it mimics the effects of insulin. Though research is limited to animal studies, the increase in the antioxidant glutathione that results from ALA supplementation may play a role in glucose management.

All cells in the body naturally produce some ALA. You can get more through foods such as:

Broccoli

Brussels sprouts

Organ meats like liver

Red meat

Rice bran

Tomatoes

Spinach

Yeast

You can also get it from dietary supplements, though its important to note these are expensive. Since ALA is both water- and fat-soluble, you dont need to take it with food like you would with a purely fat-soluble compound such as vitamin D.

ALA is a dietary supplement and therefore does not require the same level of evidence and rigorous scientific testing as a pharmaceutical medicine. Similar to other dietary supplements, it only needs to be considered safe and effective by the U.S. Food and Drug Administration to be sold.

ALA is not generally found in tablets or capsules greater than 600 mg because studies suggest that higher doses are not more effective. Side effects can include:

Rare cases have been reported in which ALA appears to have induced insulin autoimmune syndrome, a rare type of hypoglycemia caused by too many insulin autoantibodies.

Sometimes I will offer it as add-on therapy for those who do not wish to switch to another approved agent or increase the dose of an agent they are using because they want to avoid side effects, said Salam.

Speak to a healthcare professional before trying dietary supplements like ALA. Supplements are no substitute for being mindful about diet, physical activity, maintaining a healthy weight, and taking any and all prescription medications as directed.

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Alpha Lipoic Acid for Diabetic Neuropathy: Does It Work? - diaTribe Foundation

Endocrinology

Changed Endocrinology in Postmenopausal Women: A Comprehensive View – Cureus

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Changed Endocrinology in Postmenopausal Women: A Comprehensive View - Cureus