HealthDay News — In a clinical practice guideline issued by the American Academy of Pediatrics and published online January 9 in Pediatrics, key action statements and consensus recommendations are presented for the evaluation and treatment of children with overweight and obesity.

Sarah E. Hampl, MD, from the Children’s Mercy Kansas City Center for Children’s Healthy Lifestyles & Nutrition at the University of Missouri-Kansas City School of Medicine, and colleagues developed clinical practice guidelines to inform pediatricians and other health care providers about the standard of care for evaluating and treating children with overweight and obesity.

The guidelines list 13 key action statements and additional consensus recommendations. These include evaluation of children with overweight and obesity for obesity-related comorbidities using a comprehensive patient history, mental, and behavioral health screening. Overweight and obesity and comorbidities should be treated concurrently. For children and adolescents, overweight and obesity should be treated using the principles of the medical home and the chronic care model, employing an approach that acknowledges obesity’s biologic, social, and structural drivers. Based on moderate evidence, motivational interviewing is recommended to engage patients and families in treating overweight and obesity. Children should be provided with or referred to intensive health behavior and lifestyle treatment, which is more effective with greater contact hours. Adolescents aged 12 years and older with obesity should be offered weight loss pharmacotherapy as an adjunct to health behavior and lifestyle treatment. Adolescents aged 13 years and older with severe obesity should be referred for evaluation for metabolic and bariatric surgery.

“Our kids need the medical support, understanding and resources we can provide within a treatment plan that involves the whole family,” Hampl said in a statement.

Clinical Practice Guideline

Executive Summary

Technical Report 1

Technical Report 2

Mikhail N. Kosiborod, MD, from Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, and colleagues randomly assigned 616 patients who had heart failure with preserved ejection fraction, a body mass index of 30 kg/m² or more, and type 2 diabetes to receive semaglutide or placebo once a week for 52 weeks. The change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) and change in body weight were the primary endpoints.

The researchers found that the mean change in KCCQ-CSS was 13.7 and 6.4 points with semaglutide and placebo, respectively, and the corresponding mean percentage changes in body weight were −9.8% and −3.4%. For the confirmatory secondary endpoints, including the estimated between-group difference in change in 6-minute walk distance and estimated treatment ratio for change in C-reactive protein level, the results favored semaglutide over placebo. Serious adverse events were reported in 17.7% and 28.8% of those in the semaglutide and placebo groups, respectively.

“Once-weekly semaglutide at a dose of 2.4 mg led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 52 weeks,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Novo Nordisk, which manufactures semaglutide and funded the study.

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(HealthDay News) — The nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist orforglipron as a once-daily oral therapy is associated with clinically significant weight reduction, according to a study published online June 23 in the New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association, held from June 23 to 26 in San Diego.

Sean Wharton, MD, from McMaster University in Toronto, and colleagues conducted a randomized trial enrolling adults with obesity or with overweight plus at least 1 weight-related coexisting condition, without diabetes. A total of 272 participants were randomly assigned to 36 weeks of orforglipron at 12, 24, 36, or 45mg or placebo once daily.

The researchers found that the mean body weight was 108.7 kg at baseline and mean body mass index was 37.9 kg/m². The mean change from baseline in body weight ranked from −8.6% to −12.6% across the orforglipron dose cohorts at week 26, and was −2.0% with placebo. The mean change ranged from −9.4% to −14.7% with orforglipron and was −2.3%  with placebo at 36 weeks.

By week 36, a weight reduction of at least 10% occurred in 46% to 75% receiving orforglipron and 9% receiving placebo; a weight reduction of at least 15% occurred in 48% and 1% of those receiving orforglipron 45mg and placebo, respectively. The safety profile was consistent with that of the GLP-1 receptor agonist class.

“Further studies are needed to establish whether the health benefits seen with injectable GLP-1 receptor agonists are shared by orforglipron,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Eli Lilly, which manufactures orforglipron and funded the study.

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HealthDay News — Oral semaglutide 50mg once daily leads to a superior and clinically meaningful reduction in body weight for adults with overweight or obesity without type 2 diabetes, according to a study published online June 25 in The Lancet to coincide with the annual meeting of the American Diabetes Association, held from June 23 to 26 in San Diego.

Filip K. Knop, MD, from the University of Copenhagen in Denmark, and colleagues conducted a randomized, phase 3 superiority trial involving adults with a body mass index of at least 30 kg/m² or at least 27 kg/m² with bodyweight-related complications and comorbidities, without type 2 diabetes, in a trial conducted at 50 outpatient clinics in 9 countries. A total of 667 participants were randomly assigned to oral semaglutide 50mg or placebo (334 or 333, respectively) once per day for 68 weeks, plus lifestyle intervention.

The researchers found that from baseline to week 68, the estimated mean bodyweight change was −15.1 and −2.4% with semaglutide and placebo, respectively. Compared with placebo, in the semaglutide group, more participants reached bodyweight reductions of at least 5% (85 vs 26%; odds ratio, 12.6), 10% (69 vs 12%; odds ratio, 14.7); 15% (54 vs 6%; odds ratio, 17.9), and 20% (34 vs 3%; odds ratio, 18.5).

“These results indicate that oral semaglutide 50mg could provide an effective, future option for people with overweight or obesity who would benefit from a glucagon-like peptide-1 receptor agonist,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Novo Nordisk, which manufactures semaglutide and funded the study.

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HealthDay News — Once-weekly tirzepatide provides substantial and clinically meaningful reductions in body weight in adults with obesity and type 2 diabetes, according to a study published online June 26 in the The Lancet to coincide with the annual meeting of the American Diabetes Association, held from June 23 to 26 in San Diego.

W. Timothy Garvey, MD, from the UAB Diabetes Research Center at the University of Alabama at Birmingham, and colleagues examined the efficacy and safety of tirzepatide versus placebo for weight management for people with obesity and type 2 diabetes in a phase 3 trial conducted in seven countries. Adults with a body mass index of 27kg/m² or higher and glycated hemoglobin of 7 to 10% were randomly assigned to receive once-weekly, subcutaneous tirzepatide (10 or 15mg) or placebo for 72 weeks (312, 311, and 315, respectively).

The researchers found that the least-squares mean change in bodyweight at week 72 was −12.8, −14.7, and −3.2%, respectively, with tirzepatide 10mg and 15mg, and placebo. Bodyweight reduction thresholds of 5% or higher were met by more participants treated with tirzepatide versus placebo (79 to 83% vs 32%). Gastrointestinal-related adverse events were the most frequent adverse events reported with tirzepatide, and included nausea, diarrhea, and vomiting; most were mild to moderate in severity, and few led to treatment discontinuation (<5%).

“We are encouraged by these weight loss and glycemic control results, especially as weight loss interventions are typically less effective in patients in diabetes,” Garvey said in a statement.

Several authors disclosed ties to pharmaceutical companies, including Eli Lilly, which manufactures tirzepatide and funded the study.

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HealthDay News — Retatrutide treatment for 48 weeks yields substantial reductions in body weight among adults with obesity, according to a study published online June 26 in the New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association, held from June 23 to 26 in San Diego.

Ania M. Jastreboff, MD, PhD, from the Yale University School of Medicine in New Haven, Connecticut, and colleagues conducted a phase 2 double-blind, randomized trial involving adults with a body mass index (BMI) of 30kg/m² or higher or with a BMI of 27 to less than 30kg/m² with at least one weight-related condition. A total of 338 adults were randomly assigned to subcutaneous retatrutide (1 mg, 4mg [initial dose, 2mg], 4mg [initial dose, 4mg], 8mg [initial dose, 2mg], 8mg [initial dose, 4mg], or 12mg [initial dose, 2mg]) or placebo once-weekly for 48 weeks in a 2:1:1:1:1:2:2 ratio.

The researchers found that the least-squares mean percentage change in body weight at 24 weeks was −7.2% in the 1-mg group, −12.9% in the combined 4mg groups, −17.3% in the combined 8-mg groups, and −17.5% in the 12mg group at 24 weeks, compared with −1.6% in the placebo group. At 48 weeks, the corresponding least-squares mean percentage changes were −8.7, −17.1, −22.8, and −24.2%, compared with −2.1% in the placebo group.

“The results warrant further investigation in the planned phase 3 trial to inform the efficacy and safety of retatrutide for the treatment of obesity,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Eli Lilly, which manufactures retatrutide and funded the study.

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Shebani Sethi, MD, from Stanford Medicine in California, and colleagues investigated the effects of a four-month ketogenic diet on individuals with schizophrenia or bipolar disorder with existing metabolic abnormalities. The analysis included 23 participants in a single arm.

The researchers found improvements in metabolic health, with no participants meeting metabolic syndrome criteria by study conclusion. There were significant reductions in weight (12%), body mass index (12%), waist circumference (13%), and visceral adipose tissue (36%) among adherent individuals. There were also improvements in biomarkers, including a 27% decrease in homeostatic model assessment for insulin resistance and a 25% drop in triglyceride levels. Participants with schizophrenia showed a 32% reduction in Brief Psychiatric Rating Scale scores. Additionally, overall Clinical Global Impression (CGI) severity improved by an average of 31% and the proportion of participants who started with elevated symptomatology improved at least 1 point on the CGI (79%). Participants reported increased life satisfaction (17%) and enhanced sleep quality (19%).

“The ketogenic diet has been proven to be effective for treatment-resistant epileptic seizures by reducing the excitability of neurons in the brain,” Sethi said in a statement. “We thought it would be worth exploring this treatment in psychiatric conditions.”

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In its new presidential advisory, the American Heart Association (AHA) has shined a spotlight on cardiovascular-kidney-metabolic (CKM) syndrome. CKM is a newly described multisystem syndrome highlighting the interactions among risk factors linked to poor health, organ damage, cardiovascular events, and early death. This includes obesity, type 2 diabetes and other metabolic abnormalities, chronic kidney disease (CKD), and cardiovascular disease risk.

According to the advisory, “rather than simply considering cardiorenal syndrome and cardiometabolic disease as separate entities, it is increasingly clear that we need to consider their overlap as a broader construct of CKM syndrome.

“Nearly every major organ system is affected as a consequence of CKM syndrome, with associated clinical challenges including kidney failure, premature cognitive decline, metabolic dysfunction-associated steatotic liver disease (previously nonalcoholic fatty liver disease), obstructive sleep apnea, and increased risk for cancer. However, the greatest clinical impact of CKM syndrome with regard to morbidity and premature mortality is through the disproportionate burden of [cardiovascular disease].”

More than 90 million adults, or 1 in 3 individuals, in the US have at least 3 risk factors for CKM syndrome, according to Chiadi Ndumele, MD, PhD, MHS, a cardiologist and member of the advisory writing committee. Social determinants of health and risk enhancers also play a role in who is prone to developing these risk factors and who receives adequate care, Dr Ndumele, an associate professor at Johns Hopkins University in Baltimore, Maryland, pointed out. Prevention efforts and early life screening for risk factors are major goals of this initiative, he said.

The advisory, published in Circulation, takes an interdisciplinary approach to preventing and managing CKM syndrome throughout a patient’s lifetime from youth to adulthood. It provides guidance on CKM syndrome prevention, staging, prediction, and approaches to holistic and equitable care.

CKM Syndrome Staging

The advisory details a CKM syndrome staging framework designed to help clinicians slow progression by considering the totality of patients’ individual risk exposures. The frequency and intensity of screening should increase with the CKM syndrome stage. The framework outlines how and when to use specific therapies.

• Stage 0 describes healthy adults with no risk factors whom clinicians can encourage to preserve cardiovascular health through AHA’s life’s essential 8: eating healthy, staying active, maintaining healthy weight, avoiding smoking, and maintaining normal range blood pressure, blood sugar, and lipids. Clinicians should screen these adults every 3 to 5 years to assess blood pressure, triglycerides, HDL cholesterol, and blood sugar. At every stage, clinicians should perform yearly measurement of waist circumference and body mass index and encourage healthy lifestyle behaviors.
• Stage 1 describes adults with excess or dysfunctional adipose tissue from overweight, obesity, abdominal obesity, and/or impaired glucose tolerance. (Women with gestational diabetes fall into this category.) Clinicians should screen every 2 to 3 years for blood pressure, triglycerides, cholesterol, and blood sugar. The goal is at least 5% weight loss, with treatment for glucose intolerance if needed.
• Stage 2 describes adults with metabolic risk factors or CKD. These individuals have type 2 diabetes, hypertension, hypertriglyceridemia, metabolic syndrome, and/or metabolic or nonmetabolic etiologies of CKD. Yearly assessment of blood pressure, triglycerides, cholesterol, and blood sugar is warranted. Kidney function should be assessed at least yearly and more frequently in those at risk for kidney failure. CKD screening should include blood and urine testing for estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR).

Stage 2 warrants intensified lifestyle medication and targeted therapies to control blood pressure, blood sugar, and cholesterol, protect kidney function, and reduce the risk of heart failure. Medications may include glucagon-like peptide 1 (GLP-1) receptor agonists or sodium glucose contransporter 2 inhibitors (SGLT2i).

• Stage 3 describes adults with subclinical atherosclerotic cardiovascular disease or subclinical heart failure. It also includes those with risk equivalents including patients with stage 4 to 5 CKD and those with high predicted cardiovascular risk.

The goal of care in stage 3 is increasing or changing medications or lifestyle efforts to prevent progression to symptomatic cardiovascular disease (eg, heart failure) and kidney failure. Regression may be possible. Clinicians should use coronary artery calcium screening to guide decisions about cholesterol-lowering statin therapy if necessary.

• Stage 4 describes patients with clinical cardiovascular disease including coronary heart disease, heart failure, atrial fibrillation, stroke, or peripheral arterial disease. People may have already had a heart attack or stroke. Stage 4b patients also have end-stage kidney disease (ESKD) and are therefore at the highest risk for cardiovascular events, hospitalizations, and premature death. The goal of management in stage 4 is individualized treatment to optimize care and secondary prevention.

Read more: Heart Failure Medications

Enhancing Risk Prediction With a New Tool

The AHA will be unveiling a new risk calculator that includes CKM components such as cardiovascular disease, CKD, and metabolic disorders. It will gauge an individual’s risk for heart failure in addition to heart attack and stroke.

The new tool – to be presented at AHA’s Scientific Sessions in Philadelphia, Pennsylvania on November 11-13, 2023 – goes beyond the current pooled cohort equation. It starts younger (at age 30 years) and reflects risk in various ethnicities. The calculator will include blood sugar measurement results, eGFR, UACR, and social determinants of health.

The risk calculator will calculate both 10-year and 30-year cardiovascular disease risk.

Risk-Enhancing Factors

The advisory noted specific factors and medical history that can increase the likelihood that CKM syndrome progresses to a more advanced stage. These factors might adversely affect predisposition, lifestyle behaviors, medication exposures, and more.

• Family history of diabetes or kidney failure
• High-sensitivity C-reactive protein of 2.0mg/L or higher
• Chronic inflammatory conditions such as lupus and HIV/AIDS
• High-risk demographic groups such as South Asians and individuals of low socioeconomic status
• Adverse social determinants of health (eg, economic instability, low education, poor health care access, under-resourced neighborhoods, and low social/community context due to racism, etc)
• Mental health disorders
• Sleep disorders
• Sex-specific factors (eg, erectile dysfunction, premature menopause, hypertensive disorders of pregnancy, preterm birth, polycystic ovarian syndrome)

Major goals are to find optimal strategies to support lifestyle change and weight loss at every stage, tailored approaches to selecting cardioprotective anti-hyperglycemic therapies in at-risk patients and those with existing cardiovascular disease, the use of lipid-lowering therapies beyond statins in those with diabetes and/or high risk for CKM syndrome, and management of cardiovascular disease in patients with CKD.

The call to action centers on addressing research gaps and improving patients’ social determinants of health, access to pharmacotherapies, CKM syndrome education, interdisciplinary care, obesity management, and community support.

“We actually now have therapies that converge together and meaningfully improve outcomes, whether from a metabolic, cardiovascular, or kidney perspective,” said Janani Rangaswamy, MD, a nephrologist and coauthor of the paper. She is also professor of medicine at the George Washington University School of Medicine in Washington, DC. Dr Rangaswamy mentioned, for example, that high-level evidence supports SGLT2i for cardio-kidney protection in patients who have CKD with and without diabetes across albuminuria categories and patients who have heart failure with preserved or reduced ejection fraction. Combined use of SGLT2i and GLP-1 RA may be considered for those with multiple CKM syndrome risk factors in the setting of high predicted cardiovascular risk. In patients with CKD and diabetes, finerenone, a nonsteroidal mineralocorticoid receptor antagonist, shows benefit on top of renin angiotensin aldosterone system inhibitors.

The advisory proposed value-based care whereby patients with at least 2 criteria for CKM syndrome see a multidisciplinary care team that includes representation from primary care, cardiology, nephrology, and endocrinology with oversight from a care coordinator. The goal is upfront, guideline-recommended treatment.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

HealthDay News — As demand for the wildly popular weight-loss drug Wegovy continues to climb, drug maker Novo Nordisk said Thursday that it will continue restrictions on starter doses of the medication into 2024. The new plan extends by months existing restrictions and means patients who are not already taking the medication will have to wait to start.

“We are going to continue to supply the market, but it’s just going to be on a limited form so we can have that continuity of care,” Doug Langa, executive vice president of North America Operations for Novo Nordisk, told CNN. “We’re still producing all strengths and we’re still supplying all strengths to the market.” The company had previously expected the restriction to last through September.

Eli Lilly is also struggling with supply and demand issues for its type 2 diabetes medication Mounjaro. That medication does not yet have US Food and Drug Administration approval as a weight-loss drug. “Supply will likely remain tight in the coming months and quarters due to significant demand,” Eli Lilly Chief Financial Officer Anat Ashkenazi told CNN.

Prescriptions for Ozempic are now at almost 500,000, about 200,000 higher than last year, CNN reported. Meanwhile, about 80,000 people use Wegovy. Wegovy was shown in a recent trial to also reduce the risk for heart attack, stroke, or heart-related death by 20%.

Based on body mass index, 120 million Americans would qualify to take Wegovy, Langa said. A person must have a BMI of 27 or higher, plus a weight-related health condition. “This is categorically the largest unmet need that I know of in life science,” Langa said. “We’re super happy to be able to be bringing something that is so meaningful.”

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Rony Abou-Khalil, PhD, from the Holy Spirit University of Kaslik in Jounieh, Lebanon, and colleagues examined the effects of ACV consumption on weight and blood glucose, triglyceride, and cholesterol levels in 120 individuals of the Lebanese population with overweight and obesity. Participants were randomly assigned to an intervention group receiving 5, 10, or 15mL of ACV or a control group receiving a placebo during a 12-week period. At weeks 0, 4, 8, and 12, measurements of anthropometric parameters, fasting blood glucose, and triglyceride and cholesterol levels were taken.

The researchers observed associations for daily consumption of the three doses of ACV for four to 12 weeks with significant reductions in anthropometric variables (weight, body mass index, waist/hip circumferences, and body fat ratio), blood glucose, and triglyceride and cholesterol levels. During the 12 weeks of ACV intake, there were no significant risk factors observed.

“These results suggest that ACV might have potential benefits in improving metabolic parameters related to obesity and metabolic disorders in obese individuals,” the authors write. “The results may contribute to evidence-based recommendations for the use of ACV as a dietary intervention in the management of obesity.”

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HealthDay News — Patients undergoing bariatric surgery for obesity use fewer lipid-lowering, cardiovascular, and antidiabetic medications over the long term vs patients with obesity not undergoing surgery, according to a study published online May 24 in JAMA Surgery.

Joonas H. Kauppila, MD, PhD, from the Karolinska Institutet in Stockholm, and colleagues assessed the long-term postoperative trajectories of medications for hyperlipidemia, cardiovascular disease, and diabetes following bariatric surgery. The analysis included 26,396 patients with obesity who underwent bariatric surgery with gastric bypass or sleeve gastrectomy.

The researchers found that the proportion of lipid-lowering medication after bariatric surgery decreased from 20.3% at baseline to 12.9% after 2 years and 17.6% after 15 years, whereas the proportion of lipid-lowering medication increased in the no-surgery group from 21.0% at baseline to 44.6% after 15 years. Decreases were seen for cardiovascular medications (60.2% of bariatric surgery patients at baseline versus 43.2% after 2 years), but an increase was seen after 15 years (74.6%). In the no-surgery group, use increased from 54.4% at baseline to 83.3% after 15 years. A similar trend was seen for antidiabetic medications (bariatric surgery group: 27.7% at baseline, 10.0% after 2 years, and 23.5% after 15 years vs 27.7% at baseline and 54.2% after 15 years for the no-surgery group).

“Undergoing bariatric surgery was associated with a substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications compared with no surgery for obesity, while for cardiovascular medications this reduction was only transient,” the authors write.

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The Mediterranean Diet was picked as the best diet overall for 2023, according to new rankings released by US News & World Report.

A 33 person panel of physicians, registered dietitian nutritionists, and nutritional epidemiologists assessed 24 diets (down from 40 last year) to come up with the final results. Using an in-depth survey to assess each diet, the experts evaluated the likelihood of short-term and long-term weight loss, how easy the diet was to follow, how well it conformed to current nutrition standards, and whether it could be an effective tool for diabetes and cardiovascular disease prevention. The panel also examined how the diets affect bone and joint health, as well as inflammation.

Tied for second for best overall diet was the DASH (Dietary Approaches to Stop Hypertension) and Flexitarian Diet. The WeightWatchers Diet, which the experts found to be nutritionally sound with proven health benefits, was ranked #1 for best weight loss diet, with the DASH Diet coming in second, followed by the Mayo Clinic Diet and the TLC (Therapeutic Lifestyle Changes) Diet (tied for #3).

The Raw Food Diet, which was found to be unsafe for some individuals, came last in the overall list. The low ranking was given based on limited research to support its use and the potential for nutritional deficits. Diets that also made the bottom of the list included the Optavia, SlimFast, and Atkins diets.

For diabetes prevention and management, the DASH Diet was given the top spot, followed by the Mediterranean Diet (#2) and the Flexitarian Diet (#3). The best heart-healthy diets included the DASH Diet (#1), the Mediterranean Diet (#2) and the Flexitarian and Ornish diets (tied for #3).

The 2023 diet rankings included 2 new categories for the experts to consider. The DASH and Mediterranean Diet tied for the top spot for Best Diets for Bone and Joint Health. These diets were both found to reduce inflammation and included foods that support strong bones. The Flexitarian, Mediterranean and TLC diets tied for Best Family-Friendly Diets. Diets in this category were ranked based on adaptability (eg, age, body type, activity level) to provide the best opportunity for families to eat healthy together.

For those looking for a quick way to drop the extra holiday pounds, the experts chose the Keto Diet (#1), with the Atkins, Nutrisystem, OPTAVIA and SlimFast diets all tied for second.

For a deeper dive into the methodology behind the rankings listen to the latest episode of the MPR Weekly Dose Podcast in which we have a conversation with US News’ managing health editor, Gretel Schueller.

Reference

US News Reveals the 2023 Best Diets. News release. US News & World Report. Accessed January 3, 2023. https://www.prnewswire.com/news-releases/us-news-reveals-the-2023-best-diets-301711172.html.

Qiao-Li Wang, MD, PhD, from Harvard Medical School in Boston, and colleagues examined the rates of subsequent cancer diagnoses over 12 months among health professionals with weight loss during the prior two years compared with those without recent weight loss. The prospective cohort analysis consisted of women aged 40 years and older from the Nurses’ Health Study and men aged 40 years and older from the Health Professionals Follow-Up Study.

The researchers identified 15,809 incident cancer cases during 1.64 million person-years of follow-up among 157,474 participants (incident rate, 964 cases/100,000 person-years). During the 12 months after reported weight change, there were 1362 and 869 cancer cases/100,000 person-years among those with recent weight loss of greater than 10 percent of body weight and those without recent weight loss, respectively (between-group difference, 493 cases/100,000 person-years). Among participants characterized with low intentionality for weight loss, there were 2687 and 1220 cancer cases/100,000 person-years among those with weight loss of greater than 10.0% of body weight and those without recent weight loss, respectively (between-group difference, 1467 cases/100,000 person-years). Among participants with recent weight loss, cancer of the upper gastrointestinal tract was particularly common.

“Although cancer risk was higher in participants with recent weight loss, many individual cancer types, including breast, genital, urinary, brain, and melanoma, were not associated with recent weight loss,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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HealthDay News — There is a causal association for plasma caffeine concentrations with adiposity and risk for type 2 diabetes, according to a study published online March 14 in BMJ Medicine.

Susanna C. Larsson, PhD, from the Karolinska Institutet in Stockholm, and colleagues conducted a 2-sample Mendelian randomization study using genome-wide association study summary data for 2 single nucleotide polymorphisms associated with plasma caffeine at the genome-wide significance threshold and their association with outcomes among individuals of European ancestry.

The researchers found that higher genetically predicted plasma caffeine concentrations were associated with lower body mass index (beta, −0.08 standard deviation [SD], where 1 SD equals about 4.8 kg/m² in body mass index, for every SD increase in plasma caffeine) and whole-body fat mass (beta, −0.06 SD, where 1 SD equals about 9.5 kg), but not fat-free mass. In 2 consortia, higher genetically predicted plasma caffeine concentrations were associated with a lower risk for type 2 diabetes (combined odds ratio, 0.81). Overall, 43% of the effect of caffeine on type 2 diabetes was estimated to be mediated via the reduction in body mass index. Genetically predicted plasma caffeine concentrations were not strongly associated with a risk for any of the studied cardiovascular diseases.

“This mendelian randomization study found evidence to support causal associations of higher plasma caffeine concentrations with lower adiposity and risk of type 2 diabetes,” the authors write. “Randomized controlled trials are warranted to assess whether noncaloric caffeine containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”

One author disclosed financial ties to Novo Nordisk.

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HealthDay News — Twenty-two states have an adult obesity prevalence at or above 35%, up from 2021, according to data recently released by the US Centers for Disease Control and Prevention.

State-based adult obesity prevalence was calculated by race, ethnicity, and location based on self-reported height and weight data from the Behavioral Risk Factor Surveillance System.

The 22 states with an adult obesity prevalence of 35% or greater include Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin. In 2021, only 19 states had an adult obesity prevalence of 35% or greater, and 10 years ago, no state had an adult obesity prevalence of 35% or greater. The researchers observed differences in obesity prevalence by race and ethnicity, with American Indian or Alaska Native adults having a prevalence of 33%, Black adults 38%, Hispanic adults 32%, and White adults 14%.

“Our updated maps send a clear message that additional support for obesity prevention and treatment is an urgent priority,” Karen Hacker, M.D., director of the CDC National Center for Chronic Disease Prevention and Health Promotion, said in a statement. “However, we know the key strategies that work include addressing the underlying social determinants of health such as access to health care, healthy and affordable food, and safe places for physical activity.”

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2022 Adult Obesity Prevalence Maps

Certain dosage strengths of Wegovy (semaglutide) will be in short supply through September 2023, according to Novo Nordisk.

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30kg/m² or greater (obesity) or 27kg/m² or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia); and in pediatric patients aged 12 years and older with an initial BMI at the 95^th percentile or greater for age and sex (obesity).

Wegovy is supplied in a prefilled, single-dose pen in 5 dosage strengths: 0.25mg/0.5mL, 0.5mg/0.5mL, 1mg/0.5mL, 1.7mg/0.75mL, and 2.4mg/0.75mL.  Novo Nordisk noted that while the capacity of production has increased, the supply of the 0.25mg, 0.5mg, and 1mg dosage strengths will likely be limited through September. With regard to the 1.7mg and 2.4mg, the Company does not anticipate supply interruptions for these dosage strengths.

In a letter to health care providers, the Company recommended that “health care providers take into consideration the limited supply of the 0.25mg, 0.5mg, and 1mg dose strengths of Wegovy as part of their decision-making when initiating new patients on therapy, recognizing the possibility of disruption in care.”

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is currently approved by the Food and Drug Administration (FDA) under the trade names Ozempic and Rybelsus for the treatment of diabetes and as Wegovy for the treatment of obesity. There are currently no FDA-approved generic versions of semaglutide and Novo Nordisk is the only company manufacturing the approved versions of branded semaglutide at this time.

An analysis of the products produced by these compounding pharmacies showed several concerning findings, including unknown impurities and peptides that carry significant safety risks, as well as inaccurate labeling.

“Following several analyses of compounded drugs claiming to contain semaglutide, we have seen concerning levels of unknown impurities as high as 33 percent and lower levels of strength than labeled in the compounded products, which could potentially put patient’s health at risk,” said Jason Brett, Executive Director, Medical Affairs at Novo Nordisk Inc.

Novo Nordisk intends to pursue legal action to prevent Wells Pharmacy and Brooksville Pharmaceuticals from the unlawful sale of these adulterated and misbranded drugs claiming to contain semaglutide. The Company has already filed 12 legal actions this year against medical spas, weight loss or medical clinics, and compounding pharmacies producing products claiming to contain semaglutide. 

To help distinguish between the FDA-approved medications and counterfeit products, Novo Nordisk has launched semaglutide.com.

Counterfeit Ozempic (semaglutide) injection 1mg has been identified in the US drug supply chain, according to the Food and Drug Administration (FDA).

Wholesalers, retail pharmacies, health care practitioners and patients are being advised not to distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. The Agency has seized thousands of units of the counterfeit product and is currently testing it, along with manufacturer Novo Nordisk.

Analyses completed thus far show that the needles from the seized products are counterfeit, presenting a possible risk of infection for patients who use the product. The counterfeit needles have the following characteristics: 

• The paper tab on the counterfeit needles is imprinted with the Ozempic product carton lot number NAR0074. 
• The inner needle cover has a blue transparent color.
• The paper tab states “NovoFine”.

Additional counterfeit components include the pen label, the health care professional and patient information package insert, and the carton.

To date, the Agency has been notified of 5 adverse events linked to this lot. All of the reported adverse reactions (nausea, vomiting, diarrhea, abdominal pain, constipation) were consistent with the known safety profile of authentic Ozempic. 

Retail pharmacies are being advised to only purchase Ozempic through authorized distributors of Novo Nordisk. The FDA is recommending that patients only obtain Ozempic through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

Adverse events related to the use of this product should be reported to the FDA’s MedWatch program. Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500.

Novo Nordisk recently announced that it was pursuing legal proceedings against 2 compounding pharmacies for selling adulterated and misbranded injectable compounded drugs that contain semaglutide. The Company has also filed 12 legal actions against medical spas, weight loss or medical clinics, and other compounding pharmacies producing products claiming to contain semaglutide.