As physicians and researchers continue to refine their understanding of autism spectrum disorder (ASD), increasing evidence is shedding light on the distinct manifestation of autism symptoms in women.1 Because of the historical emphasis on the stereotypical presentation of ASD among boys and men, women with ASD have often been overlooked or misdiagnosed due to the unique behavioral patterns and challenges faced by women with ASD.
This has contributed to the development of a sex and gender bias in which neurodevelopmental conditions are diagnosed at a significantly higher rate for boys/men compared to girls/women. In particular, ASD has a 1% prevalence in children with a 3:1 boy-to-girl ratio.1
Correspondingly, women with ASD may not receive an official diagnosis until later in adulthood. Failure to recognize ASD in girls/women at an early age may lead to underdiagnosis or misdiagnosis with other mental health conditions, greatly impacting their mental health, social functioning, and quality of life — compounded by an increased risk of developing comorbid eating disorders, sleep disorders, neurological conditions, and/or psychiatric conditions.2,3
Given the adverse outcomes associated with the under-recognition of ASD symptoms, understanding the presentation of autism symptoms in women can help equip physicians with the knowledge needed to better identify and support women with ASD to improve their quality of life.
What Are the Diagnostic Criteria for Autism?
According to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5), the diagnostic criteria for ASD must include persistent deficits observed in each of the following 3 domains of social communication and interaction:4
Social-emotional reciprocity
Nonverbal communication used for social interactions (ie, lack of facial expressions, lack of nonverbal communication, or abnormalities in eye contact, body language, and use/understanding of gestures)
Relationship development, understanding, and maintenance
In addition to these social and communication deficits, individuals must have a history or current presentation of at least 2 of the 4 types of restricted, repetitive behaviors:4
Stereotyped or repetitive movements, speech, or use of objects
Adherence to inflexible routines, insistence on sameness, or ritualistic patterns of behavior (either verbal or nonverbal)
Restrictive fixations or interests with abnormal intensity or focus
Either hypo- or hyperreactivity to sensory input or atypical interest in sensory aspects of an environment
These 7 diagnostic criteria for ASD are graded on a severity scale by the level of support needed, in which Level 1 requires support, Level 2 requires substantial support, and Level 3 requires very substantial support.4
Gender Differences in Autism Symptom Presentation, Comorbid Conditions
Although the DSM-5 has standardized the diagnostic criteria for ASD, women often elude official diagnosis at an earlier age because their initial symptoms manifest differently, relative to men.
Psychiatry Advisor spoke with Tatiana Rivera Cruz, LICSW, a licensed clinical social worker and therapist, who shared her expertise and insights about these sex- and gender-related differences among individuals with ASD.
She stated, “Boys often [are] diagnosed early on, around 2.5 to 3 years [of age], because the symptoms of autism [are] extremely noticeable and very intense — in particular, extreme, repetitive, behavioral patterns (like hand shaking or repeating certain words) or absence of sensory skills or specific sensory preferences.”
Conversely, she explained that “With girls, the symptoms of autism are muted and not as noticeable. Often times, the symptoms of autism that manifest in women are confused with ADHD, depression, anxiety, or social anxiety.” These misdiagnoses can have a major effect on individuals, as Ms Cruz highlights when discussing her encounter with a patient.
I treated a [woman] who was diagnosed with autism much later in life. The [woman] mentioned that she couldn’t understand what was happening to her because she felt that she couldn’t be social with people or communicate well. She didn’t understand social cues. She didn’t get sarcasm. She didn’t get jokes. She believed it was social anxiety because being around people understandably gave her anxiety since she couldn’t understand them and felt like she didn’t fit in.
When we evaluated her, she met all the criteria for an autism diagnosis — yet for years she received psychotherapy treatments for depression, anxiety, and social anxiety. These treatments weren’t really addressing the underlying problem, rather they were just managing secondary symptoms that developed due to autism.
Aligned with Ms Cruz’s observations, research indicates that boys with ASD exhibit more pronounced restricted, repetitive behaviors compared with girls, promoting earlier recognition and diagnosis by clinicians.1,5 Girls, on the other hand, demonstrate greater social communication skills, prelinguistic and linguistic functioning, autobiographical memory, and cognitive flexibility than boys with ASD.1
Studies also indicate that women with ASD are more likely to be diagnosed with comorbid cardiovascular, endocrine, gastrointestinal, nutrition, and psychiatric disorders, relative to men with ASD.3
Researchers have theorized that differences in sex hormones during the prenatal period affect brain anatomy, function, and gene expression. These sex-based differences in brain development may in turn contribute to the different manifestations that are observed in ASD, like the ability of women with ASD to more frequently and successfully mask or camouflage their symptoms of ASD due to their heightened skills of observation, analysis, imitation, and communication.1
"
[P]hysicians should consider careful ASD screening assessments that account for autism symptoms in women, instead of relying on the more pronounced manifestations that are commonly associated with boys/men.
Societal Factors Influencing Autism Diagnoses in Women
In addition to the differences in symptom presentation and comorbid conditions observed between girls/women and boys/men, delayed diagnosis of ASD in women may be due to societal factors, including clinician bias, parental education, and compensatory behaviors exhibited by girls/women with ASD.
Clinician Bias
According to qualitative research studies, women diagnosed with ASD in adulthood reported that healthcare providers often dismissed their symptoms and lacked awareness of the differences in ASD symptom manifestation among women, leading to delayed diagnoses.6
A systematic review published in 2021 confirmed these self-reported concerns, as investigators found that clinician bias was a barrier to early ASD diagnosis among women. Parents of girls with ASD perceived a hesitancy or reluctance among clinicians to diagnose girls with ASD, and girls were often misdiagnosed with other conditions. The authors noted that part of this reluctance may correspond to the perceived higher incidence of ASD among boys.5
Lack of Parental Education, Resources
Because ASD has long been associated with the stereotypical presentation displayed by boys, many parents believed that ASD was not a relevant diagnosis for girls — thereby dissuading parents from identifying symptoms and seeking a diagnosis earlier in their child’s life. Overall, parents of boys are around 1.46 times more likely to express 1 or more concerns about ASD than parents of girls.5
Ms Cruz commented, “Misinformation is another thing, especially in social media. This may be a cause for delayed diagnosis because people might get the sense that seeking out a diagnosis or an explanation for why they are different from other people isn’t necessary.” Potential misinformation regarding the importance of an early ASD diagnosis and prompt treatment may thwart parents, or even patients themselves, from taking action to seek a diagnosis of ASD.
Compensatory and Camouflaging Behaviors
Given that girls with ASD more frequently use camouflaging techniques to mask social difficulties when interacting with peers, their symptoms may not be as apparent to parents and physicians.5
In a review of the diagnostic implications of autism symptoms in women, study authors broke down social camouflaging into 3 categories: 1) compensation for autistic traits or behaviors, 2) masking one’s own autistic traits via constant monitoring of personal behaviors (such as eye contact, gestures, facial expressions), and 3) assimilating other people’s behaviors and forcing oneself to perform and pretend during social interactions
To further elaborate, Ms Cruz gave the following examples of camouflaging or masking techniques effectively used by girls and women with ASD:
Suppressing behaviors is a masking technique in which individuals with ASD suppress their emotions, expressions, or socially “unacceptable” behaviors to adapt and conform to social settings.
Studying and imitating social behaviors is a camouflaging technique (whether it is done consciously or subconsciously).7 Individuals will observe people during social events and try to imitate these behaviors. Women with autism may try to plan ahead and try to envision how they will react when placed in certain social situations.
Analyzing body language is another masking technique women with ASD use to imitate and fit in with colleagues and peers to feel more comfortable despite their perceived differences.
Scripting conversations may make it difficult to detect ASD in women. Individuals will imagine conversations involving small talk about basic topics to prepare for social interactions. This is frequently paired with rehearsing those conversations beforehand.
Exhibiting excessive accommodations is another masking technique that women with ASD may use. They may try to be more “go-with-the-flow” and not as strict with the requirements that they need to feel comfortable, but this technique becomes very hard to maintain for longer periods of time.
Lastly, helpfulness is a compensatory technique that women with ASD may exhibit. It might pertain to helping other people, but also helpfulness toward oneself (eg, knowing when to take oneself out of an awkward or uncomfortable situation). Women with autism frequently think about these things in advance and use them to adapt to the situation at hand.
Another aspect that may mask ASD in women is the concept that their “special interests” or intense focuses on particular subjects may align more with their neurotypical peers, such as interests in celebrities or animals, like horses. However, the intensity of interest remains atypical.8
Although these camouflaging behaviors may help women with ASD to fit in socially and interact with their neurotypical peers better, these behaviors are superficial coping methods that can promote autistic burnout, constant feelings of exhaustion, a loss of sense of self, and increased anxiety and stress.8
Studies indicate that women with ASD are objectively more adept at these camouflaging techniques than their male counterparts, and this heightened ability among women to mask their symptoms of ASD is associated with superior signal-detection sensitivity.10 Further, the gender-based expectations of girls/women to “be more social” or “act like a girl/woman” may promote a higher degree of censuring ASD symptoms while simultaneously adopting gender-normative social behaviors.9
Consequences of Delayed Diagnosis
A delayed diagnosis of ASD likely results in long-term consequences, given that early interventions during critical developmental stages in childhood can make a major difference in symptom trajectory. Ms Cruz extrapolated on these consequences, stating, “Not catching autism early can lead to increased difficulties with speech and language issues, executive function, self-regulation, and sensory sensitivities if these symptoms of autism are not treated early.”
Women with ASD are more likely to be prescribed psychotropic medications, such as antidepressants, anticonvulsants, and mood stabilizers, while men with ASD have higher odds of being prescribed anticonvulsants, stimulants, or other medications typically used to treat attention-deficit hyperactivity disorder (AHDH) to help manage their symptoms impulsivity, hyperactivity, and distractibility.10
These gender disparities in prescription trends parallel women’s experiences in medicine more generally, and are in line with Ms Cruz’s observation that women often are diagnosed with secondary mental health conditions, such as anxiety or depression, instead of their underlying disorder. These prescription differences reinforce the notion that ASD does in fact manifest differently in women and men.10
Undiagnosed ASD in women may also promote autistic burnout. Although symptoms of autistic burnout differ from case by case, it has been described as “an overwhelming sense of physical exhaustion.”11
Some individuals with autistic burnout may experience uncontrollable emotional outbursts of sadness or anger, intense anxiety, or even suicidal ideation. Autistic burnout can also exacerbate certain symptoms of ASD, including repetitive behaviors, heightened sensitivity to sensory input, or increased difficulty accepting changes to daily routines.11
Evidence suggests that autistic burnout often results as a consequence of camouflaging and mimicking neurotypical behavior, such as small talk, eye contact, and suppressing repetitive behaviors — all of which require significant effort and energy on the part of the individual with ASD.11
Ms Cruz recounted,
Most of the patients that I have seen with autism have said that they have coped with autism for a long time until a point where they can’t do it anymore. That feeling was the driving force behind them eventually seeking help and an official diagnosis. They coped for so many years trying to overcome situations, avoid other situations, manage symptoms, or change the way they saw or did things. At the end, they just can’t do it anymore.
Clinical Challenges Diagnosing Autism in Adults
Diagnosing ASD in adult women may prove challenging to clinicians for several reasons. For example, developmental trajectories and outcomes of social communication vary more during adolescence and adulthood than childhood.12
Additionally, ASD is a neurodevelopmental disorder that by definition manifests in early childhood. If this diagnosis is missed during childhood, it may prove more challenging to diagnose in adults because their parents or other family members may no longer be present to provide reliable childhood medical history or symptom reporting. This is particularly important as patients may not be able to accurately recall or identify autistic traits they may have exhibited at a young age. 12
Given that women with ASD have an increased likelihood to develop comorbid conditions relative to men, clinicians may inadvertently focus more on the management of these conditions and thereby overlook the more subtle symptoms of ASD that are present in women.12
With this in mind, physicians should consider careful ASD screening assessments that account for autism symptoms in women, instead of relying on the more pronounced manifestations that are commonly associated with boys/men. Additionally, women who present with symptoms of ADHD, depression, anxiety, or social anxiety may warrant a full ASD assessment to ensure diagnostic accuracy.
Active efforts are needed to remedy this health disparity. Identifying this “lost generation”12 of adult women with ASD is the first step in validating the struggles that they are enduring, but just might be better at hiding.
Editor’s note: Some responses have been revised for clarity and length.
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Ketamine clinic popularity has surged in recent years, with a growing number of psychedelic med spas appearing across the United States and globally. However, patients and providers alike have raised regulatory, legal, efficacy, and safety concerns about these clinics.
Ketamine: From Club Drug to Breakthrough Therapy
In the 1970s, ketamine was considered a single-use anesthetic confined to intravenous or intramuscular injection at a surgeon’s office. But it wasn’t long before ketamine emerged beyond the walls of the inpatient setting onto the club scene, where it became a highly popular recreational drug given its dissociative effects. By 1999, this gained the attention of the Drug Enforcement Administration (DEA), which then classified ketamine as a Schedule III controlled substance due to its high risk of dependence, lethal side effects, and potential for abuse.1
Despite its controversial history, interest in ketamine for therapeutic applications began to build around 2015 and in recent years there has been a rapid rise of ketamine clinics, enthusiastic to meet this newfound demand. These clinics offer off-label ketamine for a wide range of conditions, including neuropathic pain, anxiety, Lyme disease, and rheumatoid arthritis.2 As ketamine clinics popped up around the country, the Food and Drug Administration (FDA) approved a nasal spray containing esketamine (the S+ enantiomer) in 2019, called Spravato®, which is approved in conjunction with an oral antidepressant for 1) treatment-resistant depression and 2) patients with major depressive disorder (MDD) presenting with acute suicidal ideation or behavior.3
Although only meant for these specific indications, the approval of Spravato® helped drive ketamine’s perceived legitimacy for chronic disease management. Shortly after Spravato® was approved, the COVID-19 pandemic took over the world and led to a major shift in medical treatment modality as telehealth became both necessary and increasingly popular. As a result, a deregulated ketamine marketplace flourished online under the cover of telemedicine. This expanding market has raised serious red flags among healthcare providers and government agencies, now playing catch-up to protect public safety.4
"
These safeguards don’t apply to the off-label ketamine often provided at ketamine clinics.
To understand if today’s ketamine clinics are serving patients' best interests — or simply taking advantage of a lucrative loophole — we spoke with Lisa M Harding, MD, Board Certified Psychiatrist and Assistant Clinical Professor at Yale School of Medicine, and Griffen Thorne, JD, Partner Attorney at Harris Sliwoski, to learn more.
Do Ketamine Clinics Benefit Patients?
On the surface, ketamine clinics seem to improve access to care for patients in rural areas or places with limited resources. However, Dr Harding is skeptical about the sudden proliferation of ketamine clinics, especially as they don’t take insurance.5 “Access to care has never meant giving substandard care. The folks operating in a space with no formal rules say they are improving access to seem less nefarious,” she explained. “There is no way that one kind of treatment required by the FDA to be delivered in a medical setting is equal to a similar treatment delivered outside of a medical setting just because there are no written rules. The safety challenges are still there.”
While early ketamine clinics relied on intravenous infusion centers with medical supervision, today’s online clinics allow clients to fill generic prescriptions in the form of lozenges that they then take at home with the help of a designated “sitter” — who isn’t necessarily a medical professional.5
“Ketamine is now prescribed online, and in some cases even mailed to patients,” shared Thorne. But this wasn’t always the case. “A federal law, the Ryan Haight Act of 2008, prohibited physicians from prescribing controlled substances without at least 1 in-person evaluation beforehand. But this requirement was suspended during the COVID public health emergency declaration, so now things that weren’t available before are now available online. Some of these laws didn’t immediately change back after the COVID emergency ended,” he said.
Nonetheless, some patients argue that at-home ketamine has been a life-changing treatment and advocate for the continued allowance of telemedicine ketamine treatment. “The DEA is trying to work through a middle ground where telehealth is still available for those who need it,” explained Thorne.
However, many psychiatrists and regulators worry that ketamine treatment outside of a medical setting puts patients at risk.4 Dr Harding explained,
Ketamine was only studied in the short term. No long-term efficacy study has been done on ketamine. Many papers look at retrospective data or comment on models implemented at academic institutions. For example, most patients in treatment with intravenous ketamine get treated once a month with an infusion and are evaluated with a face-to-face physician visit every 3-6 months once they are stable.
However, she shared that esketamine does have a long-term safety study (the Sustain III trial), which enabled the approval of Spravato®. “Patients are treated once a week or once every two weeks, and the data published at the 4-year mark show no new safety signals. Patients in maintenance are assessed by their care team.”
Dr Harding notes in her published work that esketamine is the only antidepressant of its kind to be researched and FDA-approved for depression symptoms in suicidal patients. It works within hours of administration, offering a significant advantage over other antidepressants that can take weeks.6
The FDA only approved Spravato® to be administered in a regulated environment. A Risk Evaluation and Mitigation Strategy (REMS) requires patients to stay in an approved facility for monitoring 2 hours after treatment and data is recorded after every treatment.7 These safeguards don’t apply to the off-label ketamine often provided at ketamine clinics.4
Is It Legal to Prescribe Ketamine?
Ketamine can regularly be administered under the supervision of a licensed doctor in a medical setting, but ketamine prescriptions for at-home use aren’t legal in every state.8 Thorne advised, “Physicians who want to administer ketamine need a DEA registration like any other Schedule III controlled substance.”
Because of the many state, federal, and healthcare regulations that exist, Thorne recommends having a robust compliance plan before operating a ketamine clinic.9 He said the rules change regularly, and what works in some states won’t pass in others. For example, certain states like New York and California have a rule called the Corporate Practice of Medicine (CPOM). This means that businesses like ketamine clinics generally must be owned by a licensed physician. However, CPOM laws vary greatly from state to state, so the requirements in one state may be completely inapplicable to its neighbor. Furthermore, states that don’t require CPOM may have different licensing requirements that need to be followed.
“With ketamine, you deal with healthcare regulations, which are very complicated. And it’s all regulated under state law.” He discussed how this differs from cannabis, which is a Schedule 1 controlled substance. Any time a state legalizes cannabis for recreational use, it still cannot legally be prescribed because it is a Schedule I controlled substance. Doctors can recommend cannabis to patients who can purchase it themselves from a dispensary. But ketamine, which requires a prescription and is subject to greater penalties, is much more heavily regulated in its prescription and administration.
Thorne also noted that just because someone is a doctor and has the legal authority to prescribe ketamine, it doesn’t necessarily mean they’re the best person for the job. “There are all kinds of licensed folks who try to get in on the action, which can lead to some concern, like if you’re dealing with ketamine therapy and you’re actually a podiatrist. Typically, anesthesiologists are involved, especially with infusions. Getting the right people is one of the main issues, especially if you want the drug to be given in a safe, effective, and appropriate way,” said Thorne.
The Future of Ketamine and Other Drugs
Thorne admits that some providers push the limits when it comes to prescribing off-label ketamine. He predicts that more regulation is likely as a result. He also suspects that certain psychedelic drugs are likely to get approved in the next few years, and the DEA will make more rules on how clinics can operate.
“There’s a big interest in all the psychedelics, and there’s a strong chance of approval by 2026, if not sooner, for MDMA and maybe even psilocybin drugs,” Thorne explained. “Oregon has some state allowances for psilocybin, which are soon to come for Colorado. But there isn’t a retail market where you can buy and take it home. It’s all in an office or ‘service center,’ and someone licensed needs to watch you through the course of the drug. If a physician is to participate in that process, it’s not clear to say whether the state boards will approve it.”
Thorne goes on to describe how cost can be a barrier.
It would be a challenge to have insurance cover it. In some ways, these state-level programs are designed to fail because it’s a long time for a licensed facility to be there monitoring. It’s not a sustainable market because only a select group of people can afford it. If it’s going to be so expensive, people will need it to be insured at the federal level, which won’t happen with things like MDMA and psilocybin until the FDA approves them, at the very least. Even with ketamine, which has been used clinically for years, most physicians still only take cash.
According to Dr Harding, the need for more mental health therapies is apparent, but she’s not convinced that ketamine or psychedelics are the answer. “To date, there is no cure for depression,” she shared. “Data tells us that if a patient has more than three bouts of depression, they will be in care for the majority of their life and will always be at risk. Treatment is always individualized, and there must always be informed consent. Patients must understand the risks, benefits, alternatives, and risks of no treatment at all.”
Dr Harding agreed that patients need more options to care for their mental health, but only when supported by solid evidence. “I think there should be further trials to support mood disorders. We don't have good treatments for [post-traumatic stress disorder] or bipolar depression. But we need clinical trials to support us,” she said.
For now, Dr Harding encourages providers and patients to use caution when it comes to ketamine. “For providers, there is a lot of continuing education through the American Psychiatric Association to understand specific state laws… For patients, talk to your current treating providers. They are connected in communities and can connect you with care. Not every treatment is right for you. If an expert tells you that they don't think it will help, they are probably right,” she advised.
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Our easy-to-read fact sheets provide clinicians with reliable information to share with patients and their caregivers.
A predominant risk factor for type 2 diabetes is being overweight or obese, so weight loss goals while maintaining normal blood sugar levels are very important for some patients. In addition to lifestyle modifications, medications for type 2 diabetes may aid in losing weight.1,2
Obesity
Obesity is defined as a body mass index (BMI) of 30 kg/m2 or higher and is associated with many major health issues including cardiovascular disease, osteoarthritis, and type 2 diabetes. A weight loss of 5% to 15% can improve obesity-related complications.1,2
There are approved medications to help treat obesity, including phentermine (Lomaira®), orlistat (Alli®), topiramate (Trokendi XR®), and naltrexone/bupropion (Contrave®). However, these are not indicated to treat type 2 diabetes.3
Type 2 Diabetes
Type 2 diabetes is a chronic disease due to a progressive loss of insulin secretion and/or increased insulin resistance. As a result, the body’s naturally produced insulin becomes less effective in reducing the amount of sugar in your blood. Excess weight or excess percentage of body fat can cause some degree of insulin resistance. Most, but not all, patients with type 2 diabetes have overweight or obesity.
Different antidiabetic medications work through different mechanisms to help lower blood sugar. Some of these medications also provide additional benefits for patients, including weight loss. The medications with weight loss benefits include metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists.2
Type 2 Diabetes Medications That Induce Weight Loss
The following is a list of FDA-approved medications for the management of type 2 diabetes that may also result in weight loss. It is important to note that the amount of weight loss can vary depending on the medication, dose, duration of therapy, and lifestyle changes. Speak with your provider to know additional information.
Simulates GLP-1 receptors to increase insulin secretion and decrease glucagon secretion14
Nausea Vomiting Diarrhea Acute kidney injury Injection site reactions24
Weight Loss Differences
Biguanides
In a long-term study, patients who took metformin maintained an average weight loss of 6.2% between 6 and 15 years of treatment. Patients who experienced greater long-term weight loss were those who (1) lost more weight during their first year of treatment, and (2) were older in age.5,6
SGLT2 Inhibitors
Various studies demonstrate long-term weight loss effects among patients taking SGLT2 inhibitors. In an analysis of multiple studies, patients had an average weight loss of between 1.5 kg and 2 kg after 4 years of treatment. These effects increased with increasing doses of these medications. Other studies have revealed average weight loss percentages between 2.2% and 3.3% of patients’ starting weight.5, 10-12
Other studies show improved weight loss among patients combining SGLT2 inhibitors with other drugs, such as metformin or GLP-1 receptor agonists. SGLT2 inhibitors may therefore be the drug of choice for patients also with heart and kidney disease.22,23 However, low blood sugar is more likely to occur when they are used as add-ons rather than used alone.30
GLP-1 Receptor Agonists
Studies report a wide range of weight loss effects associated with GLP-1 receptor agonists, from 1 kg to 15 kg depending on the medication.15-21 Weight loss effects depend on dose and treatment durations.5
Like SLGT2 inhibitors, GLP-1 receptor agonists can be used as add-on therapies for patients with heart and kidney disease, but low blood sugar is more likely to occur. 22, 23, 30
Frequently Asked Questions
Can I eat anything I want while on these medications?
No, food choices still play a significant role in diabetes management.
Different types of diets for patients with diabetes include Mediterranean, low-fat, low-carb, vegetarian, and vegan diets. Additionally, the Dietary Approaches to Stop Hypertension (DASH) approach could prevent more serious complications such as heart or kidney disease among those who have or are at risk for high blood pressure and high cholesterol.22,23
Diet modifications can also enhance natural GLP-1 and insulin production/sensitivity and prevent escalation of antidiabetic therapies while satisfying nutritional needs.24
Do I still have to exercise while on these medications?
Yes, it is recommended to engage in physical activity regularly, even if on medications that can result in weight loss, to prevent development and progression of heart- and kidney-related complications.
Patients with type 2 diabetes are advised to do 150 minutes per week of moderate to vigorous exercise or 75 minutes per week of high intensity exercise over a course of 3 or more days per week.25 Studies report that physical activity can contribute to increased effectiveness of certain medications, including GLP-1 receptor agonists and metformin.25-27
How can I prevent side effects such as nausea, vomiting, diarrhea, bloating, and constipation?
Metformin can cause an upset stomach on initial treatment so it should be taken with food. Note that these side effects should go away over time, so do not skip doses or stop taking metformin without speaking with your provider.7,8
The initial dose of a GLP-1 receptor agonist or SGLT2 inhibitor is typically low to prevent stomach issues but not high enough to help manage your blood sugar. For this reason, your provider may start you on a higher dose, but you should let them know if the stomach side effects become unmanageable for you.28,29
Can I be on multiple of these medications at the same time?
Yes, GLP-1 receptor agonists and/or SGLT2 inhibitors are preferred over other drug classes as add-on treatments to metformin, especially for patients at risk for heart or kidney disease, according to the American Association of Clinical Endocrinology and American Diabetes Association guidelines.
Before adding these medications, your doctor may consider factors such as heart and kidney disease, potential weight loss, and potential adverse effects.22,23 The use of GLP-1 receptor agonists with metformin may also exacerbate diarrhea.29
The Advisory Council on Alzheimer’s Research, Care, and Services presented updates on Alzheimer Disease (AD) and AD and related dementias (ADRD) treatments and ongoing AD research in a virtual meeting held in January.
Representatives from the National Alzheimer Project Act (NAPA) research committee, Washington University School of Medicine (WashU), and the Alzheimer’s Association reported on the developments in disease modifying therapies (DMTs), funding, resources for dementia caregivers, and the connection between AD and Down syndrome.1
DMTs for AD
From 2016 to 2023, researchers have observed advancements in AD treatment. Most recently, the US Food and Drug Administration (FDA) approved Leqembi (lecanemab), an amyloid beta-targeting antibody for patients with AD and those in the mild cognitive impairment (MCI) or mild dementia stage of the disease. The FDA’s decision on donanemab, also an amyloid beta-targeting antibody, for the treatment of patients with early AD, is anticipated in the first quarter of 2024.
The approved route of administration for lecanemab is intravenous (IV). Eisai Pharmaceuticals is testing a subcutaneous route of administration. Compared with the IV route, initial reports suggest that subcutaneous formulations clear 14% more plaque, have an 11% higher area under the curve (AUC), and have lower systemic injection reaction rates.2
On January 31, 2024, Biogen Inc. decided to discontinue Aduhelm (aducanumab-avwa) production, sales, and the affiliated clinical study. Instead, they will allocate their resources to the development of other treatment methods for AD and prioritize moving forward with lecanemab.3
Growing Resources for Dementia Caregivers
With recent progress in AD treatments, progress has also been made in the availability of resources for dementia caregivers. The Alzheimer's Association collaborated with the Centers for Disease Control and Prevention (CDC), Building Our Largest Dementia (BOLD) Public Health Center of Excellence on Dementia Caregiving, and Emory University to initiate a free interactive public health curriculum for clinicians, students, and educators. The goal is to increase awareness and knowledge about the importance of dementia caregiving and how public health may affect it.
Representatives of the advisory board addressed further initiatives concerning racial/ethnic diversity needs between patients and caregivers and demanded an increase in caregiver wage. Although a resolution has not been reached, caregiving networks are optimistic to find ways to implement changes in the near future.4
"
The research and the investments that have been made over the past decades led to these advancements in understanding the disease, how it starts and progresses, and figuring out ways to intervene in it.
Revisions and Updates to Funding AD Research
Various extensions and reauthorizations have been made to continue AD research. There is bipartisan agreement that AD research needs more attention. The National Institutes of Health (NIH) and the CDC are looking to:
Extend and reauthorize NAPA
Continue advising the Centers for Medicare and Medicaid Services (CMS) to implement a dementia care management model
In the senate budget requests for the 2024 fiscal year, the NIH requested a $321 million increase and the CDC requested $35 million for the BOLD infrastructure for the Alzheimer Act. The Act focuses on AD diagnosis, treatment, and dementia caregiving.5
Increases in federal funding have advanced AD research and the progression of clinical trials. “It’s research that changes the cookbook of medicine ... The research and the investments that have been made over the past decades led to these advancements in understanding the disease, how it starts and progresses, and figuring out ways to intervene in it,” Randall Bateman, MD, Charlotte and Paul Hagemann distinguished professor of neurology at WashU in St. Louis, said at the meeting.6
Researchers at WashU have identified challenges that have limited treatment objectives.7
Overall Barriers to AD Research
Racial & Ethnic Disparity
- Racial and ethnic groups are excluded from testing - Overall lack of research about patients with AD who belong to racial and ethnic groups
Accessibility to Infusion Centers
- Patients who live in rural areas have difficulty accessing infusion centers - Infusion treatments are time consuming. Patients often miss due to vacation, travel, and other illnesses. - 6–8-month waitlist for treatment - Small window for treatment
Cost of treatment
- Treatment costs $50,000 per year - Medicare finances only 80% of treatment expenses, which could leave patients with ~$10,000 bill out of pocket - AD biomarker testing is not offered insurance coverage
Effectiveness of DMTs
- Need for precision medicine for an individual's unique disease profile - Dosage and duration vary per patient - Some patients need to switch medications
Although limitations are presented in the infrastructure for AD/ADRD treatment, the researchers highlight initiatives for AD prevention. These include the early administration of lecanemab and the implementation of the combination of DMTs.8
The Connection Between AD and Down Syndrome
In highlighting the existing challenges with AD treatments, Elizabeth Head, MA, PhD, professor at the University of California, spoke about the connection between AD and Down syndrome (DS). By age 40, patients with DS have sufficient plaque and tangle pathology for an AD diagnosis. Dr Head mentioned that it is widespread for older patients with DS to develop AD, and it is one of the leading causes of death for this patient population.
Though there is a connection between AD and DS, patients with DS are often excluded from AD trials, presenting a barrier in research. Ultimately, there is a lack of racial and ethnic diversity in trials; only White patients have a higher survival rate.
Since there is still a limited amount of evidence, it is difficult to identify pharmacologic intervention effectiveness for cognitive decline in patients with DS. Dr Head urged that researchers should begin to expand AD studies to this patient population. The inclusion of patients with DS in cohort trials would result in advanced AD research and a better understanding of DS.9
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