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Pancreatic enzymes improve autism symptoms

Pancreatic replacement therapy for maladaptive behaviors in preschool children with autism spectrum disorder; JAMA Network Open, Nov. 30, 2023. 

Taking high-protease pancreatic enzyme supplements 3 times per day improved symptoms of irritability and maladaptive behavior in children with autism spectrum disorder (ASD), a study in JAMA Network Open reported.

The findings support previous research linking pancreatic insufficiency and autism.

The pancreas plays a key role in regulating the metabolism of sugar and in glucose control, through its production and release of insulin, a hormone.

Perhaps less appreciated is the organ’s role in releasing digestive enzymes that are essential for digesting the three main macronutrients found in foods: carbohydrates, protein and fat. These enzymes include lipase (for processing fats), amylase (carbohydrates) and protease (proteins).

Investigators recruited 190 subjects (150 male) ages 3-6 and tested them for ASD symptoms at baseline. Half received 900 milligrams of a pancreatic enzyme preparation, which was mostly protease (protein-digesting) for 12 weeks. The other half took a placebo.

Clinically meaningful improvements in the two ASD measures were noted at 12 weeks but even greater symptom resolution was observed at 36 weeks — six months after treatment stopped.

ASD previously was associated with low blood levels of amino acids — protein breakdown products — and amino acid-derived neurotransmitters that regulate mood. Proteases are thought to restore these chemicals to healthy levels.

ADHD drugs linked to long-term heart risk

Attention-deficit/hyperactivity disorder medications and long-term risk of cardiovascular diseases; JAMA Psychiatry, Nov. 22, 2023.

The longer someone takes attention-deficit/hyperactivity disorder (ADHD) drugs the greater their risk for a later heart disease diagnosis, according to a study in JAMA Psychiatry.

Researchers at Sweden’s Karolinska Institute enrolled 278,027 subjects, ages 6-64, based on either an ADHD diagnosis or a prescription for ADHD medications between 2007 and 2020. Of those, 10,388 already had some form of heart disease.

This was the “treatment” group followed for heart symptoms from their enrollment date until the end of the study.

The researchers also recruited 51,672 individuals without ADHD or heart disease.

Heart risks among ADHD-medicated and -unmedicated were similar for the first treatment year but increased thereafter. Medicated subjects’ risk increased 9% after 1-2 years on ADHD meds and rose to 15% after 2-3 years, 27% after 3-5 years, and 65% for those on ADHD drugs for more than 5 years.

Patients who took the medication for three to five years had a 72% higher risk of high blood pressure and a 65% higher risk of arterial disease. Patients who took the medications for five or more years had an 80% higher risk of high blood pressure and a 49% higher risk of arterial disease.

The study’s prospective design means its predictive value was high, but missed or misdiagnosis among either or both treatment or placebo groups could have affected the results.

COVID vaccination linked to musculoskeletal disorders

Correlation between COVID-19 vaccination and inflammatory musculoskeletal disorders; British Medical Journal, Nov. 22, 2023.

People vaccinated against COVID-19 face an increased risk for eight musculoskeletal diseases (MSDs) compared with the unvaccinated, according to a paper in The British Medical Journal.

The risk became apparent two weeks after vaccination and increased over time, regardless of the type or brand of COVID-19 vaccine received.

Researchers followed 1,882,640 vaccinated and 336,075 unvaccinated subjects for 12 weeks, comparing the incidence of eight musculoskeletal diseases between the two groups.

The risk at 12 weeks post-vax increased significantly for all eight conditions studied: plantar fasciitis, rotator cuff syndrome, adhesive capsulitis, herniated intervertebral disc, spondylosis, bursitis, Achilles tendinitis, and de-Quervain tenosynovitis.

Researchers concluded that “all COVID-19 vaccines were identified as significant risk factors for each inflammatory musculoskeletal disorder,” with risk increases ranging from 40% to 370%.

This paper was available as a preprint and was not peer-reviewed.

Few clinical trials for COVID treatments included kids

Enrollment of Pediatric Patients in COVID-19 Interventional Trials; Jama Health Forum, Nov. 22, 2023.

Fewer than 10% of the 1,126 registered clinical studies on COVID-19 treatments during 2020-2022 included any children, and just 1.6% recruited only children, according to a research letter in JAMA Health Forum.

For all studies involving kids, barely 48% involved drugs, biologics or medical devices.

Studies that included some or only children increased during the study period, however, from 7.1% in 2020 to 15.7% in 2022.

Compared with adult-only trials, pediatric studies tended to focus on prevention (47.5% for pediatric vs. 23.0 adult), behavioral interventions (25.8% vs. 16.8%) or to test COVID-19 vaccines (14.2% vs. 5.8%).

The findings are consistent with earlier studies showing substantial underrepresentation of children in clinical trials, even for illnesses involving large numbers of children.

For safety reasons, pediatric Phase 1 studies don’t typically begin until adult Phase 3 trials are almost completed. However, an improved understanding of pediatric metabolism and “adaptive trial designs” may now allow those studies to proceed earlier, the study authors concluded.

FDA approves another diabetes drug for weight loss

FDA green-lights tirzepatide, marketed as Zepbound, for chronic weight management; JAMA, Nov. 15, 2023.

The U.S. Food and Drug Administration on Nov. 8  approved tirepatide (brand name Zepbound) for weight loss.

Like Wegovy and Ozempic, two diabetes drugs recently licensed for weight loss, Zepbound activates receptors for glucagon-like peptide 1, which reduces appetite by delaying the exit of food from the stomach.

Taken as a once-weekly injection, Zepbound is approved for people with a body mass index of 30 or greater, or who are overweight with at least one weight-related condition like high blood pressure, high cholesterol, Type 2 diabetes, sleep apnea or heart disease.

Zepbound has been associated with dozens of side effects, and is known to cause thyroid tumors in rats “at clinically relevant exposures.”

Approximately 70% of American adults are overweight and many also have a weight-related condition. Losing 5% to 10% of body weight through diet and exercise may lower heart risk in the overweight, but the long-term effects of diabetes drugs in non-diabetics remain largely unstudied.