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Clinical Endocrinology News is an independent news source that provides endocrinologists with timely and relevant news and commentary about clinical developments and the impact of health care policy on the endocrinologist's practice. Specialty topics include Diabetes, Lipid & Metabolic Disorders Menopause, Obesity, Osteoporosis, Pediatric Endocrinology, Pituitary, Thyroid & Adrenal Disorders, and Reproductive Endocrinology. Featured content includes Commentaries, Implementin Health Reform, Law & Medicine, and In the Loop, the blog of Clinical Endocrinology News. Clinical Endocrinology News is owned by Frontline Medical Communications.
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New osteoporosis guideline says start with a bisphosphonate
This is the first update for 5 years since the previous guidance was published in 2017.
It strongly recommends initial therapy with bisphosphonates for postmenopausal women with osteoporosis, as well as men with osteoporosis, among other recommendations.
However, the author of an accompanying editorial, Susan M. Ott, MD, says: “The decision to start a bisphosphonate is actually not that easy.”
She also queries some of the other recommendations in the guidance.
Her editorial, along with the guideline by Amir Qaseem, MD, PhD, MPH, and colleagues, and systematic review by Chelsea Ayers, MPH, and colleagues, were published in the Annals of Internal Medicine.
Ryan D. Mire, MD, MACP, president of the ACP, gave a brief overview of the new guidance in a video.
Systematic review
The ACP commissioned a review of the evidence because it says new data have emerged on the efficacy of newer medications for osteoporosis and low bone mass, as well as treatment comparisons, and treatment in men.
The review authors identified 34 randomized controlled trials (in 100 publications) and 36 observational studies, which evaluated the following pharmacologic interventions:
- Antiresorptive drugs: four bisphosphonates (alendronate, ibandronate, risedronate, zoledronate) and a RANK ligand inhibitor (denosumab).
- Anabolic drugs: an analog of human parathyroid hormone (PTH)–related protein (abaloparatide), recombinant human PTH (teriparatide), and a sclerostin inhibitor (romosozumab).
- Estrogen agonists: selective estrogen receptor modulators (bazedoxifene, raloxifene).
The authors focused on effectiveness and harms of active drugs compared with placebo or bisphosphonates.
Major changes from 2017 guidelines, some questions
“Though there are many nuanced changes in this [2023 guideline] version, perhaps the major change is the explicit hierarchy of pharmacologic recommendations: bisphosphonates first, then denosumab,” Thomas G. Cooney, MD, senior author of the clinical guideline, explained in an interview.
“Bisphosphonates had the most favorable balance among benefits, harms, patient values and preferences, and cost among the examined drugs in postmenopausal females with primary osteoporosis,” Dr. Cooney, professor of medicine, Oregon Health & Science University, Portland, noted, as is stated in the guideline.
“Denosumab also had a favorable long-term net benefit, but bisphosphonates are much cheaper than other pharmacologic treatments and available in generic formulations,” the document states.
The new guideline suggests use of denosumab as second-line pharmacotherapy in adults who have contraindications to or experience adverse effects with bisphosphonates.
The choice among bisphosphonates (alendronate, risedronate, zoledronic acid) would be based on a patient-centered discussion between physician and patient, addressing costs (often related to insurance), delivery-mode preferences (oral versus intravenous), and “values,” which includes the patient’s priorities, concerns, and expectations regarding their health care, Dr. Cooney explained.
Another update in the new guideline is, “We also clarify the specific, albeit more limited, role of sclerostin inhibitors and recombinant PTH ‘to reduce the risk of fractures only in females with primary osteoporosis with very high-risk of fracture’,” Dr. Cooney noted.
In addition, the guideline now states, “treatment to reduce the risk of fractures in males rather than limiting it to ‘vertebral fracture’ in men,” as in the 2017 guideline.
It also explicitly includes denosumab as second-line therapy for men, Dr. Cooney noted, but as in 2017, the strength of evidence in men remains low.
“Finally, we also clarified that in females over the age of 65 with low bone mass or osteopenia that an individualized approach be taken to treatment (similar to last guideline), but if treatment is initiated, that a bisphosphonate be used (new content),” he said.
The use of estrogen, treatment duration, drug discontinuation, and serial bone mineral density monitoring were not addressed in this guideline, but will likely be evaluated within 2 to 3 years.
‘Osteoporosis treatment: Not easy’ – editorial
In her editorial, Dr. Ott writes: “The data about bisphosphonates may seem overwhelmingly positive, leading to strong recommendations for their use to treat osteoporosis, but the decision to start a bisphosphonate is actually not that easy.”
“A strong recommendation should be given only when future studies are unlikely to change it,” continues Dr. Ott, professor of medicine, University of Washington, Seattle.
“Yet, data already suggest that, in patients with serious osteoporosis, treatment should start with anabolic medications because previous treatment with either bisphosphonates or denosumab will prevent the anabolic response of newer medications.”
“Starting with bisphosphonate will change the bone so it will not respond to the newer medicines, and then a patient will lose the chance for getting the best improvement,” Dr. Ott clarified in an email to this news organization.
But, in fact, the new guidance does suggest that, to reduce the risk of fractures in females with primary osteoporosis at very high risk of fracture, one should consider use of the sclerostin inhibitor romosozumab (moderate-certainty evidence) or recombinant human parathyroid hormone (teriparatide) (low-certainty evidence) followed by a bisphosphonate (conditional recommendation).
Dr. Ott said: “If the [fracture] risk is high, then we should start with an anabolic medication for 1-2 years. If the risk is medium, then use a bisphosphonate for up to 5 years, and then stop and monitor the patient for signs that the medicine is wearing off,” based on blood and urine tests.
‘We need medicines that will stop bone aging’
Osteopenia is defined by an arbitrary bone density measurement, Dr. Ott explained. “About half of women over 65 will have osteopenia, and by age 85 there are hardly any ‘normal’ women left.”
“We need medicines that will stop bone aging, which might sound impossible, but we should still try,” she continued.
“In the meantime, while waiting on new discoveries,” Dr. Ott said, “I would not use bisphosphonates in patients who did not already have a fracture or whose bone density T-score was better than –2.5 because, in the major study, alendronate did not prevent fractures in this group.”
Many people are worried about bisphosphonates because of problems with the jaw or femur. These are real, but they are very rare during the first 5 years of treatment, Dr. Ott noted. Then the risk starts to rise, up to more than 1 in 1,000 after 8 years. So people can get the benefits of these drugs with very low risk for 5 years.
“An immediate [guideline] update is necessary to address the severity of bone loss and the high risk for vertebral fractures after discontinuation of denosumab,” Dr. Ott urged.
“I don’t agree with using denosumab for osteoporosis as a second-line treatment,” she said. “I would use it only in patients who have cancer or unusually high bone resorption. You have to get a dose strictly every 6 months, and if you need to stop, it is recommended to treat with bisphosphonates. Denosumab is a poor choice for somebody who does not want to take a bisphosphonate. Many patients and even too many doctors do not realize how serious it can be to skip a dose.”
“I also think that men could be treated with anabolic medications,” Dr. Ott said. “Clinical trials show they respond the same as women. Many men have osteoporosis as a consequence of low testosterone, and then they can usually be treated with testosterone. Osteoporosis in men is a serious problem that is too often ignored – almost reverse discrimination.”
It is also unfortunate that the review and recommendations do not address estrogen, one of the most effective medications to prevent osteoporotic fractures, according to Dr. Ott.
Clinical considerations in addition to drug types
The new guideline also advises:
- Clinicians treating adults with osteoporosis should encourage adherence to recommended treatments and healthy lifestyle habits, including exercise, and counseling to evaluate and prevent falls.
- All adults with osteopenia or osteoporosis should have adequate calcium and vitamin D intake, as part of fracture prevention.
- Clinicians should assess baseline fracture risk based on bone density, fracture history, fracture risk factors, and response to prior osteoporosis treatments.
- Current evidence suggests that more than 3-5 years of bisphosphonate therapy reduces risk for new vertebral but not other fractures; however, it also increases risk for long-term harms. Therefore, clinicians should consider stopping bisphosphonate treatment after 5 years unless the patient has a strong indication for treatment continuation.
- The decision for a bisphosphonate holiday (temporary discontinuation) and its duration should be based on baseline fracture risk, medication half-life in bone, and benefits and harms.
- Women treated with an anabolic agent who discontinue it should be offered an antiresorptive agent to preserve gains and because of serious risk for rebound and multiple vertebral fractures.
- Adults older than 65 years with osteoporosis may be at increased risk for falls or other adverse events because of drug interactions.
- Transgender persons have variable risk for low bone mass.
The review and guideline were funded by the ACP. Dr. Ott has reported no relevant disclosures. Relevant financial disclosures for other authors are listed with the guideline and review.
A version of this article first appeared on Medscape.com.
This is the first update for 5 years since the previous guidance was published in 2017.
It strongly recommends initial therapy with bisphosphonates for postmenopausal women with osteoporosis, as well as men with osteoporosis, among other recommendations.
However, the author of an accompanying editorial, Susan M. Ott, MD, says: “The decision to start a bisphosphonate is actually not that easy.”
She also queries some of the other recommendations in the guidance.
Her editorial, along with the guideline by Amir Qaseem, MD, PhD, MPH, and colleagues, and systematic review by Chelsea Ayers, MPH, and colleagues, were published in the Annals of Internal Medicine.
Ryan D. Mire, MD, MACP, president of the ACP, gave a brief overview of the new guidance in a video.
Systematic review
The ACP commissioned a review of the evidence because it says new data have emerged on the efficacy of newer medications for osteoporosis and low bone mass, as well as treatment comparisons, and treatment in men.
The review authors identified 34 randomized controlled trials (in 100 publications) and 36 observational studies, which evaluated the following pharmacologic interventions:
- Antiresorptive drugs: four bisphosphonates (alendronate, ibandronate, risedronate, zoledronate) and a RANK ligand inhibitor (denosumab).
- Anabolic drugs: an analog of human parathyroid hormone (PTH)–related protein (abaloparatide), recombinant human PTH (teriparatide), and a sclerostin inhibitor (romosozumab).
- Estrogen agonists: selective estrogen receptor modulators (bazedoxifene, raloxifene).
The authors focused on effectiveness and harms of active drugs compared with placebo or bisphosphonates.
Major changes from 2017 guidelines, some questions
“Though there are many nuanced changes in this [2023 guideline] version, perhaps the major change is the explicit hierarchy of pharmacologic recommendations: bisphosphonates first, then denosumab,” Thomas G. Cooney, MD, senior author of the clinical guideline, explained in an interview.
“Bisphosphonates had the most favorable balance among benefits, harms, patient values and preferences, and cost among the examined drugs in postmenopausal females with primary osteoporosis,” Dr. Cooney, professor of medicine, Oregon Health & Science University, Portland, noted, as is stated in the guideline.
“Denosumab also had a favorable long-term net benefit, but bisphosphonates are much cheaper than other pharmacologic treatments and available in generic formulations,” the document states.
The new guideline suggests use of denosumab as second-line pharmacotherapy in adults who have contraindications to or experience adverse effects with bisphosphonates.
The choice among bisphosphonates (alendronate, risedronate, zoledronic acid) would be based on a patient-centered discussion between physician and patient, addressing costs (often related to insurance), delivery-mode preferences (oral versus intravenous), and “values,” which includes the patient’s priorities, concerns, and expectations regarding their health care, Dr. Cooney explained.
Another update in the new guideline is, “We also clarify the specific, albeit more limited, role of sclerostin inhibitors and recombinant PTH ‘to reduce the risk of fractures only in females with primary osteoporosis with very high-risk of fracture’,” Dr. Cooney noted.
In addition, the guideline now states, “treatment to reduce the risk of fractures in males rather than limiting it to ‘vertebral fracture’ in men,” as in the 2017 guideline.
It also explicitly includes denosumab as second-line therapy for men, Dr. Cooney noted, but as in 2017, the strength of evidence in men remains low.
“Finally, we also clarified that in females over the age of 65 with low bone mass or osteopenia that an individualized approach be taken to treatment (similar to last guideline), but if treatment is initiated, that a bisphosphonate be used (new content),” he said.
The use of estrogen, treatment duration, drug discontinuation, and serial bone mineral density monitoring were not addressed in this guideline, but will likely be evaluated within 2 to 3 years.
‘Osteoporosis treatment: Not easy’ – editorial
In her editorial, Dr. Ott writes: “The data about bisphosphonates may seem overwhelmingly positive, leading to strong recommendations for their use to treat osteoporosis, but the decision to start a bisphosphonate is actually not that easy.”
“A strong recommendation should be given only when future studies are unlikely to change it,” continues Dr. Ott, professor of medicine, University of Washington, Seattle.
“Yet, data already suggest that, in patients with serious osteoporosis, treatment should start with anabolic medications because previous treatment with either bisphosphonates or denosumab will prevent the anabolic response of newer medications.”
“Starting with bisphosphonate will change the bone so it will not respond to the newer medicines, and then a patient will lose the chance for getting the best improvement,” Dr. Ott clarified in an email to this news organization.
But, in fact, the new guidance does suggest that, to reduce the risk of fractures in females with primary osteoporosis at very high risk of fracture, one should consider use of the sclerostin inhibitor romosozumab (moderate-certainty evidence) or recombinant human parathyroid hormone (teriparatide) (low-certainty evidence) followed by a bisphosphonate (conditional recommendation).
Dr. Ott said: “If the [fracture] risk is high, then we should start with an anabolic medication for 1-2 years. If the risk is medium, then use a bisphosphonate for up to 5 years, and then stop and monitor the patient for signs that the medicine is wearing off,” based on blood and urine tests.
‘We need medicines that will stop bone aging’
Osteopenia is defined by an arbitrary bone density measurement, Dr. Ott explained. “About half of women over 65 will have osteopenia, and by age 85 there are hardly any ‘normal’ women left.”
“We need medicines that will stop bone aging, which might sound impossible, but we should still try,” she continued.
“In the meantime, while waiting on new discoveries,” Dr. Ott said, “I would not use bisphosphonates in patients who did not already have a fracture or whose bone density T-score was better than –2.5 because, in the major study, alendronate did not prevent fractures in this group.”
Many people are worried about bisphosphonates because of problems with the jaw or femur. These are real, but they are very rare during the first 5 years of treatment, Dr. Ott noted. Then the risk starts to rise, up to more than 1 in 1,000 after 8 years. So people can get the benefits of these drugs with very low risk for 5 years.
“An immediate [guideline] update is necessary to address the severity of bone loss and the high risk for vertebral fractures after discontinuation of denosumab,” Dr. Ott urged.
“I don’t agree with using denosumab for osteoporosis as a second-line treatment,” she said. “I would use it only in patients who have cancer or unusually high bone resorption. You have to get a dose strictly every 6 months, and if you need to stop, it is recommended to treat with bisphosphonates. Denosumab is a poor choice for somebody who does not want to take a bisphosphonate. Many patients and even too many doctors do not realize how serious it can be to skip a dose.”
“I also think that men could be treated with anabolic medications,” Dr. Ott said. “Clinical trials show they respond the same as women. Many men have osteoporosis as a consequence of low testosterone, and then they can usually be treated with testosterone. Osteoporosis in men is a serious problem that is too often ignored – almost reverse discrimination.”
It is also unfortunate that the review and recommendations do not address estrogen, one of the most effective medications to prevent osteoporotic fractures, according to Dr. Ott.
Clinical considerations in addition to drug types
The new guideline also advises:
- Clinicians treating adults with osteoporosis should encourage adherence to recommended treatments and healthy lifestyle habits, including exercise, and counseling to evaluate and prevent falls.
- All adults with osteopenia or osteoporosis should have adequate calcium and vitamin D intake, as part of fracture prevention.
- Clinicians should assess baseline fracture risk based on bone density, fracture history, fracture risk factors, and response to prior osteoporosis treatments.
- Current evidence suggests that more than 3-5 years of bisphosphonate therapy reduces risk for new vertebral but not other fractures; however, it also increases risk for long-term harms. Therefore, clinicians should consider stopping bisphosphonate treatment after 5 years unless the patient has a strong indication for treatment continuation.
- The decision for a bisphosphonate holiday (temporary discontinuation) and its duration should be based on baseline fracture risk, medication half-life in bone, and benefits and harms.
- Women treated with an anabolic agent who discontinue it should be offered an antiresorptive agent to preserve gains and because of serious risk for rebound and multiple vertebral fractures.
- Adults older than 65 years with osteoporosis may be at increased risk for falls or other adverse events because of drug interactions.
- Transgender persons have variable risk for low bone mass.
The review and guideline were funded by the ACP. Dr. Ott has reported no relevant disclosures. Relevant financial disclosures for other authors are listed with the guideline and review.
A version of this article first appeared on Medscape.com.
This is the first update for 5 years since the previous guidance was published in 2017.
It strongly recommends initial therapy with bisphosphonates for postmenopausal women with osteoporosis, as well as men with osteoporosis, among other recommendations.
However, the author of an accompanying editorial, Susan M. Ott, MD, says: “The decision to start a bisphosphonate is actually not that easy.”
She also queries some of the other recommendations in the guidance.
Her editorial, along with the guideline by Amir Qaseem, MD, PhD, MPH, and colleagues, and systematic review by Chelsea Ayers, MPH, and colleagues, were published in the Annals of Internal Medicine.
Ryan D. Mire, MD, MACP, president of the ACP, gave a brief overview of the new guidance in a video.
Systematic review
The ACP commissioned a review of the evidence because it says new data have emerged on the efficacy of newer medications for osteoporosis and low bone mass, as well as treatment comparisons, and treatment in men.
The review authors identified 34 randomized controlled trials (in 100 publications) and 36 observational studies, which evaluated the following pharmacologic interventions:
- Antiresorptive drugs: four bisphosphonates (alendronate, ibandronate, risedronate, zoledronate) and a RANK ligand inhibitor (denosumab).
- Anabolic drugs: an analog of human parathyroid hormone (PTH)–related protein (abaloparatide), recombinant human PTH (teriparatide), and a sclerostin inhibitor (romosozumab).
- Estrogen agonists: selective estrogen receptor modulators (bazedoxifene, raloxifene).
The authors focused on effectiveness and harms of active drugs compared with placebo or bisphosphonates.
Major changes from 2017 guidelines, some questions
“Though there are many nuanced changes in this [2023 guideline] version, perhaps the major change is the explicit hierarchy of pharmacologic recommendations: bisphosphonates first, then denosumab,” Thomas G. Cooney, MD, senior author of the clinical guideline, explained in an interview.
“Bisphosphonates had the most favorable balance among benefits, harms, patient values and preferences, and cost among the examined drugs in postmenopausal females with primary osteoporosis,” Dr. Cooney, professor of medicine, Oregon Health & Science University, Portland, noted, as is stated in the guideline.
“Denosumab also had a favorable long-term net benefit, but bisphosphonates are much cheaper than other pharmacologic treatments and available in generic formulations,” the document states.
The new guideline suggests use of denosumab as second-line pharmacotherapy in adults who have contraindications to or experience adverse effects with bisphosphonates.
The choice among bisphosphonates (alendronate, risedronate, zoledronic acid) would be based on a patient-centered discussion between physician and patient, addressing costs (often related to insurance), delivery-mode preferences (oral versus intravenous), and “values,” which includes the patient’s priorities, concerns, and expectations regarding their health care, Dr. Cooney explained.
Another update in the new guideline is, “We also clarify the specific, albeit more limited, role of sclerostin inhibitors and recombinant PTH ‘to reduce the risk of fractures only in females with primary osteoporosis with very high-risk of fracture’,” Dr. Cooney noted.
In addition, the guideline now states, “treatment to reduce the risk of fractures in males rather than limiting it to ‘vertebral fracture’ in men,” as in the 2017 guideline.
It also explicitly includes denosumab as second-line therapy for men, Dr. Cooney noted, but as in 2017, the strength of evidence in men remains low.
“Finally, we also clarified that in females over the age of 65 with low bone mass or osteopenia that an individualized approach be taken to treatment (similar to last guideline), but if treatment is initiated, that a bisphosphonate be used (new content),” he said.
The use of estrogen, treatment duration, drug discontinuation, and serial bone mineral density monitoring were not addressed in this guideline, but will likely be evaluated within 2 to 3 years.
‘Osteoporosis treatment: Not easy’ – editorial
In her editorial, Dr. Ott writes: “The data about bisphosphonates may seem overwhelmingly positive, leading to strong recommendations for their use to treat osteoporosis, but the decision to start a bisphosphonate is actually not that easy.”
“A strong recommendation should be given only when future studies are unlikely to change it,” continues Dr. Ott, professor of medicine, University of Washington, Seattle.
“Yet, data already suggest that, in patients with serious osteoporosis, treatment should start with anabolic medications because previous treatment with either bisphosphonates or denosumab will prevent the anabolic response of newer medications.”
“Starting with bisphosphonate will change the bone so it will not respond to the newer medicines, and then a patient will lose the chance for getting the best improvement,” Dr. Ott clarified in an email to this news organization.
But, in fact, the new guidance does suggest that, to reduce the risk of fractures in females with primary osteoporosis at very high risk of fracture, one should consider use of the sclerostin inhibitor romosozumab (moderate-certainty evidence) or recombinant human parathyroid hormone (teriparatide) (low-certainty evidence) followed by a bisphosphonate (conditional recommendation).
Dr. Ott said: “If the [fracture] risk is high, then we should start with an anabolic medication for 1-2 years. If the risk is medium, then use a bisphosphonate for up to 5 years, and then stop and monitor the patient for signs that the medicine is wearing off,” based on blood and urine tests.
‘We need medicines that will stop bone aging’
Osteopenia is defined by an arbitrary bone density measurement, Dr. Ott explained. “About half of women over 65 will have osteopenia, and by age 85 there are hardly any ‘normal’ women left.”
“We need medicines that will stop bone aging, which might sound impossible, but we should still try,” she continued.
“In the meantime, while waiting on new discoveries,” Dr. Ott said, “I would not use bisphosphonates in patients who did not already have a fracture or whose bone density T-score was better than –2.5 because, in the major study, alendronate did not prevent fractures in this group.”
Many people are worried about bisphosphonates because of problems with the jaw or femur. These are real, but they are very rare during the first 5 years of treatment, Dr. Ott noted. Then the risk starts to rise, up to more than 1 in 1,000 after 8 years. So people can get the benefits of these drugs with very low risk for 5 years.
“An immediate [guideline] update is necessary to address the severity of bone loss and the high risk for vertebral fractures after discontinuation of denosumab,” Dr. Ott urged.
“I don’t agree with using denosumab for osteoporosis as a second-line treatment,” she said. “I would use it only in patients who have cancer or unusually high bone resorption. You have to get a dose strictly every 6 months, and if you need to stop, it is recommended to treat with bisphosphonates. Denosumab is a poor choice for somebody who does not want to take a bisphosphonate. Many patients and even too many doctors do not realize how serious it can be to skip a dose.”
“I also think that men could be treated with anabolic medications,” Dr. Ott said. “Clinical trials show they respond the same as women. Many men have osteoporosis as a consequence of low testosterone, and then they can usually be treated with testosterone. Osteoporosis in men is a serious problem that is too often ignored – almost reverse discrimination.”
It is also unfortunate that the review and recommendations do not address estrogen, one of the most effective medications to prevent osteoporotic fractures, according to Dr. Ott.
Clinical considerations in addition to drug types
The new guideline also advises:
- Clinicians treating adults with osteoporosis should encourage adherence to recommended treatments and healthy lifestyle habits, including exercise, and counseling to evaluate and prevent falls.
- All adults with osteopenia or osteoporosis should have adequate calcium and vitamin D intake, as part of fracture prevention.
- Clinicians should assess baseline fracture risk based on bone density, fracture history, fracture risk factors, and response to prior osteoporosis treatments.
- Current evidence suggests that more than 3-5 years of bisphosphonate therapy reduces risk for new vertebral but not other fractures; however, it also increases risk for long-term harms. Therefore, clinicians should consider stopping bisphosphonate treatment after 5 years unless the patient has a strong indication for treatment continuation.
- The decision for a bisphosphonate holiday (temporary discontinuation) and its duration should be based on baseline fracture risk, medication half-life in bone, and benefits and harms.
- Women treated with an anabolic agent who discontinue it should be offered an antiresorptive agent to preserve gains and because of serious risk for rebound and multiple vertebral fractures.
- Adults older than 65 years with osteoporosis may be at increased risk for falls or other adverse events because of drug interactions.
- Transgender persons have variable risk for low bone mass.
The review and guideline were funded by the ACP. Dr. Ott has reported no relevant disclosures. Relevant financial disclosures for other authors are listed with the guideline and review.
A version of this article first appeared on Medscape.com.
FROM THE ANNALS OF INTERNAL MEDICINE
Best diets in 2023: Mediterranean diet wins again
After all, weight loss usually lands one of the top spots on New Year’s resolution surveys.
And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.
Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.
In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets.
In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site.
“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors.
This year’s report ranks plans in 11 categories.
The winners and the categories:
Best diets overall
After the Mediterranean diet, two others tied for second place:
- DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
- Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.
Best weight-loss diets
WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.
- DASH got second place.
- Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels.
Best fast weight-loss diets
The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:
- Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved
- Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
- Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements
- SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day
Best diets for healthy eating
- Mediterranean
- DASH
- Flexitarian
Best heart-healthy diets
- DASH
- Mediterranean
- Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.
Best diets for diabetes
- DASH
- Mediterranean
- Flexitarian
Best diets for bone and joint health
DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.
Best family-friendly diets
This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets.
Best plant-based diets
Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.
Easiest diets to follow
Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.
Best diet programs (formerly called commercial plans)
- WW
- There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.
Methodology
A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss.
Response from diet plans
Representatives from two plans that received mixed reviews in the rankings responded.
Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24.
“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”
Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.
Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.
“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.”
Expert perspective
Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.
“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.
For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said.
She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
How to use the report
Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term.
“Whatever we choose has to work in the long run,” she said.
Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.
Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”
Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.
A version of this article first appeared on Medscape.com.
After all, weight loss usually lands one of the top spots on New Year’s resolution surveys.
And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.
Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.
In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets.
In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site.
“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors.
This year’s report ranks plans in 11 categories.
The winners and the categories:
Best diets overall
After the Mediterranean diet, two others tied for second place:
- DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
- Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.
Best weight-loss diets
WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.
- DASH got second place.
- Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels.
Best fast weight-loss diets
The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:
- Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved
- Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
- Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements
- SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day
Best diets for healthy eating
- Mediterranean
- DASH
- Flexitarian
Best heart-healthy diets
- DASH
- Mediterranean
- Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.
Best diets for diabetes
- DASH
- Mediterranean
- Flexitarian
Best diets for bone and joint health
DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.
Best family-friendly diets
This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets.
Best plant-based diets
Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.
Easiest diets to follow
Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.
Best diet programs (formerly called commercial plans)
- WW
- There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.
Methodology
A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss.
Response from diet plans
Representatives from two plans that received mixed reviews in the rankings responded.
Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24.
“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”
Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.
Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.
“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.”
Expert perspective
Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.
“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.
For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said.
She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
How to use the report
Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term.
“Whatever we choose has to work in the long run,” she said.
Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.
Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”
Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.
A version of this article first appeared on Medscape.com.
After all, weight loss usually lands one of the top spots on New Year’s resolution surveys.
And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.
Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.
In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets.
In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site.
“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors.
This year’s report ranks plans in 11 categories.
The winners and the categories:
Best diets overall
After the Mediterranean diet, two others tied for second place:
- DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
- Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.
Best weight-loss diets
WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.
- DASH got second place.
- Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels.
Best fast weight-loss diets
The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:
- Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved
- Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
- Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements
- SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day
Best diets for healthy eating
- Mediterranean
- DASH
- Flexitarian
Best heart-healthy diets
- DASH
- Mediterranean
- Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.
Best diets for diabetes
- DASH
- Mediterranean
- Flexitarian
Best diets for bone and joint health
DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.
Best family-friendly diets
This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets.
Best plant-based diets
Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.
Easiest diets to follow
Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.
Best diet programs (formerly called commercial plans)
- WW
- There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.
Methodology
A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss.
Response from diet plans
Representatives from two plans that received mixed reviews in the rankings responded.
Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24.
“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”
Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.
Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.
“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.”
Expert perspective
Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.
“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.
For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said.
She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
How to use the report
Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term.
“Whatever we choose has to work in the long run,” she said.
Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.
Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”
Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.
A version of this article first appeared on Medscape.com.
Mediterranean diet linked with fewer pregnancy complications
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
FROM JAMA NETWORK OPEN
Diabetes surge expected in young people
published in Diabetes Care.
according to a new studyIt is expected that as many as 526,000 people younger than 20 years in the United States will have diabetes by 2060, researchers from the Centers for Disease Control and Prevention report. Their projections found that the number of young people with diabetes will increase 12%, from 213,000 in 2017 to 239,000 in 2060.
The estimates include a 673% rise in the number of youth with type 2 diabetes and a 65% increase in cases of type 1 diabetes over the next 4 decades.
Most of the new cases are projected to occur among non-Hispanic Blacks, exacerbating the already significant racial disparities in type 2 diabetes in particular, the study found.
“This study’s startling projections of type 2 diabetes increases show why it is crucial to advance health equity and reduce the widespread disparities that already take a toll on people’s health,” Christopher Holliday, PhD, MPH, FACHE, director of CDC’s Division of Diabetes Translation, said in a press release about the new estimates.
Even if trends remain the same in coming decades, researchers said diagnoses of type 2 diabetes will rise almost 70% and that diagnoses of type 1 diabetes will increase by 3%.
The researchers attribute the increase in diabetes cases among youth to a variety of factors, including the growing prevalence of childhood obesity and the presence of diabetes in women of childbearing age, which is linked to obesity in their offspring.
Debra Houry, MD, MPH, acting principal director of the CDC, said the focus should be on prevention.
“This new research should serve as a wake-up call for all of us. It’s vital that we focus our efforts to ensure all Americans, especially our young people, are the healthiest they can be,” she said in a press release.
The findings come from the SEARCH for Diabetes in Youth study, funded by the CDC and the National Institutes of Health. Dr. Houry and Dr. Holliday report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
published in Diabetes Care.
according to a new studyIt is expected that as many as 526,000 people younger than 20 years in the United States will have diabetes by 2060, researchers from the Centers for Disease Control and Prevention report. Their projections found that the number of young people with diabetes will increase 12%, from 213,000 in 2017 to 239,000 in 2060.
The estimates include a 673% rise in the number of youth with type 2 diabetes and a 65% increase in cases of type 1 diabetes over the next 4 decades.
Most of the new cases are projected to occur among non-Hispanic Blacks, exacerbating the already significant racial disparities in type 2 diabetes in particular, the study found.
“This study’s startling projections of type 2 diabetes increases show why it is crucial to advance health equity and reduce the widespread disparities that already take a toll on people’s health,” Christopher Holliday, PhD, MPH, FACHE, director of CDC’s Division of Diabetes Translation, said in a press release about the new estimates.
Even if trends remain the same in coming decades, researchers said diagnoses of type 2 diabetes will rise almost 70% and that diagnoses of type 1 diabetes will increase by 3%.
The researchers attribute the increase in diabetes cases among youth to a variety of factors, including the growing prevalence of childhood obesity and the presence of diabetes in women of childbearing age, which is linked to obesity in their offspring.
Debra Houry, MD, MPH, acting principal director of the CDC, said the focus should be on prevention.
“This new research should serve as a wake-up call for all of us. It’s vital that we focus our efforts to ensure all Americans, especially our young people, are the healthiest they can be,” she said in a press release.
The findings come from the SEARCH for Diabetes in Youth study, funded by the CDC and the National Institutes of Health. Dr. Houry and Dr. Holliday report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
published in Diabetes Care.
according to a new studyIt is expected that as many as 526,000 people younger than 20 years in the United States will have diabetes by 2060, researchers from the Centers for Disease Control and Prevention report. Their projections found that the number of young people with diabetes will increase 12%, from 213,000 in 2017 to 239,000 in 2060.
The estimates include a 673% rise in the number of youth with type 2 diabetes and a 65% increase in cases of type 1 diabetes over the next 4 decades.
Most of the new cases are projected to occur among non-Hispanic Blacks, exacerbating the already significant racial disparities in type 2 diabetes in particular, the study found.
“This study’s startling projections of type 2 diabetes increases show why it is crucial to advance health equity and reduce the widespread disparities that already take a toll on people’s health,” Christopher Holliday, PhD, MPH, FACHE, director of CDC’s Division of Diabetes Translation, said in a press release about the new estimates.
Even if trends remain the same in coming decades, researchers said diagnoses of type 2 diabetes will rise almost 70% and that diagnoses of type 1 diabetes will increase by 3%.
The researchers attribute the increase in diabetes cases among youth to a variety of factors, including the growing prevalence of childhood obesity and the presence of diabetes in women of childbearing age, which is linked to obesity in their offspring.
Debra Houry, MD, MPH, acting principal director of the CDC, said the focus should be on prevention.
“This new research should serve as a wake-up call for all of us. It’s vital that we focus our efforts to ensure all Americans, especially our young people, are the healthiest they can be,” she said in a press release.
The findings come from the SEARCH for Diabetes in Youth study, funded by the CDC and the National Institutes of Health. Dr. Houry and Dr. Holliday report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DIABETES CARE
Women with cycle disorders across their life span may be at increased risk of cardiovascular disease
This finding is demonstrated in a new analysis of the Nurses’ Health Study II.
“To date, several studies have reported increased risks of cardiovascular risk factors or cardiovascular disease in connection with cycle disorders,” Yi-Xin Wang, MD, PhD, a research fellow in nutrition, and associates from the Harvard School of Public Health, Boston, wrote in an article published in JAMA Network Open.
Ute Seeland, MD, speaker of the Gender Medicine in Cardiology Working Group of the German Cardiology Society, said in an interview“We know that women who have indicated in their medical history that they have irregular menstrual cycles, invariably in connection with polycystic ovary syndrome (PCOS), more commonly develop diabetes and other metabolic disorders, as well as cardiovascular diseases.”
Cycle disorders’ role
However, the role that irregular or especially long cycles play at different points of a woman’s reproductive life span was unclear. Therefore, the research group investigated the associations in the Nurses’ Health Study II between cycle irregularity and cycle length in women of different age groups who later experienced cardiovascular events.
At the end of this study in 1989, the participants also provided information regarding the length and irregularity of their menstrual cycle from ages 14 to 17 years and again from ages 18 to 22 years. The information was updated in 1993 when the participants were aged 29-46 years. The data from 2019 to 2022 were analyzed.
“This kind of long-term cohort study is extremely rare and therefore something special,” said Dr. Seeland, who conducts research at the Institute for Social Medicine, Epidemiology, and Health Economics at the Charité – University Hospital Berlin.
The investigators used the following cycle classifications: very regular (no more than 3 or 4 days before or after the expected date), regular (within 5-7 days), usually irregular, always irregular, or no periods.
The cycle lengths were divided into the following categories: less than 21 days, 21-25 days, 26-31 days, 32-39 days, 40-50 days, more than 50 days, and too irregular to estimate the length.
The onset of cardiovascular diseases was determined using information from the participants and was confirmed by reviewing the medical files. Relevant to the study were lethal and nonlethal coronary heart diseases (such as myocardial infarction or coronary artery revascularization), as well as strokes.
Significant in adulthood
The data from 80,630 study participants were included in the analysis. At study inclusion, the average age of the participants was 37.7 years, and the average body mass index (BMI) was 25.1. “Since it was predominantly White nurses who took part in the study, the data are not transferable to other, more diverse populations,” said Dr. Seeland.
Over 24 years, 1,816 women (2.4%) had a cardiovascular event. “We observed an increased rate of cardiovascular events in women with an irregular cycle and longer cycle, both in early an in mid-adulthood,” wrote Dr. Wang and associates. “Similar trends were also observed for cycle disorders when younger, but this association was weaker than in adulthood.”
Compared with women with very regular cycles, women with irregular cycles or without periods who were aged 14-17 years, 18-22 years, or 29-49 years exhibited a 15%, 36%, and 40% higher risk of a cardiovascular event, respectively.
Similarly, women aged 18-22 years or 29-46 years with long cycles of 40 days or more had a 44% or 30% higher risk of cardiovascular disease, respectively, compared with women with cycle lengths of 26-31 days.
“The coronary heart diseases were decisive for the increase, and less so, the strokes,” wrote the researchers.
Classic risk factors?
Dr. Seeland praised the fact that the study authors tried to determine the role that classic cardiovascular risk factors played. “Compared with women with a regular cycle, women with an irregular cycle had a higher BMI, more frequently increased cholesterol levels, and an elevated blood pressure,” she said. Women with a long cycle displayed a similar pattern.
It can be assumed from this that over a woman’s life span, BMI affects the risk of cardiovascular disease. Therefore, Dr. Wang and coauthors adjusted the results on the basis of BMI, which varies over time.
Regarding other classic risk factors that may have played a role, “hypercholesterolemia, chronic high blood pressure, and type 2 diabetes were only responsible in 5.4%-13.5% of the associations,” wrote the researchers.
“Our results suggest that certain characteristics of the menstrual cycle across a woman’s reproductive lifespan may constitute additional risk markers for cardiovascular disease,” according to the authors.
The highest rates of cardiovascular disease were among women with permanently irregular or long cycles in early to mid adulthood, as well as women who had regular cycles when younger but had irregular cycles in mid adulthood. “This indicates that the change from one cycle phenotype to another could be a surrogate marker for metabolic changes, which in turn contribute to the formation of cardiovascular diseases,” wrote the authors.
The study was observational and so conclusions cannot be drawn regarding causal relationships. But Dr. Wang and associates indicate that the most common cause of an irregular menstrual cycle may be PCOS. “Roughly 90% of women with cycle disorders or oligomenorrhea have signs of PCOS. And it was shown that women with PCOS have an increased risk of cardiovascular disease.”
They concluded that “the associations observed between irregular and long cycles in early to mid-adulthood and cardiovascular diseases are likely attributable to underlying PCOS.”
For Dr. Seeland, however, this conclusion is “too monocausal. At no point in time did there seem to be any direct information regarding the frequency of PCOS during the data collection by the respondents.”
For now, we can only speculate about the mechanisms. “The association between a very irregular and long cycle and the increased risk of cardiovascular diseases has now only been described. More research should be done on the causes,” said Dr. Seeland.
This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.
This finding is demonstrated in a new analysis of the Nurses’ Health Study II.
“To date, several studies have reported increased risks of cardiovascular risk factors or cardiovascular disease in connection with cycle disorders,” Yi-Xin Wang, MD, PhD, a research fellow in nutrition, and associates from the Harvard School of Public Health, Boston, wrote in an article published in JAMA Network Open.
Ute Seeland, MD, speaker of the Gender Medicine in Cardiology Working Group of the German Cardiology Society, said in an interview“We know that women who have indicated in their medical history that they have irregular menstrual cycles, invariably in connection with polycystic ovary syndrome (PCOS), more commonly develop diabetes and other metabolic disorders, as well as cardiovascular diseases.”
Cycle disorders’ role
However, the role that irregular or especially long cycles play at different points of a woman’s reproductive life span was unclear. Therefore, the research group investigated the associations in the Nurses’ Health Study II between cycle irregularity and cycle length in women of different age groups who later experienced cardiovascular events.
At the end of this study in 1989, the participants also provided information regarding the length and irregularity of their menstrual cycle from ages 14 to 17 years and again from ages 18 to 22 years. The information was updated in 1993 when the participants were aged 29-46 years. The data from 2019 to 2022 were analyzed.
“This kind of long-term cohort study is extremely rare and therefore something special,” said Dr. Seeland, who conducts research at the Institute for Social Medicine, Epidemiology, and Health Economics at the Charité – University Hospital Berlin.
The investigators used the following cycle classifications: very regular (no more than 3 or 4 days before or after the expected date), regular (within 5-7 days), usually irregular, always irregular, or no periods.
The cycle lengths were divided into the following categories: less than 21 days, 21-25 days, 26-31 days, 32-39 days, 40-50 days, more than 50 days, and too irregular to estimate the length.
The onset of cardiovascular diseases was determined using information from the participants and was confirmed by reviewing the medical files. Relevant to the study were lethal and nonlethal coronary heart diseases (such as myocardial infarction or coronary artery revascularization), as well as strokes.
Significant in adulthood
The data from 80,630 study participants were included in the analysis. At study inclusion, the average age of the participants was 37.7 years, and the average body mass index (BMI) was 25.1. “Since it was predominantly White nurses who took part in the study, the data are not transferable to other, more diverse populations,” said Dr. Seeland.
Over 24 years, 1,816 women (2.4%) had a cardiovascular event. “We observed an increased rate of cardiovascular events in women with an irregular cycle and longer cycle, both in early an in mid-adulthood,” wrote Dr. Wang and associates. “Similar trends were also observed for cycle disorders when younger, but this association was weaker than in adulthood.”
Compared with women with very regular cycles, women with irregular cycles or without periods who were aged 14-17 years, 18-22 years, or 29-49 years exhibited a 15%, 36%, and 40% higher risk of a cardiovascular event, respectively.
Similarly, women aged 18-22 years or 29-46 years with long cycles of 40 days or more had a 44% or 30% higher risk of cardiovascular disease, respectively, compared with women with cycle lengths of 26-31 days.
“The coronary heart diseases were decisive for the increase, and less so, the strokes,” wrote the researchers.
Classic risk factors?
Dr. Seeland praised the fact that the study authors tried to determine the role that classic cardiovascular risk factors played. “Compared with women with a regular cycle, women with an irregular cycle had a higher BMI, more frequently increased cholesterol levels, and an elevated blood pressure,” she said. Women with a long cycle displayed a similar pattern.
It can be assumed from this that over a woman’s life span, BMI affects the risk of cardiovascular disease. Therefore, Dr. Wang and coauthors adjusted the results on the basis of BMI, which varies over time.
Regarding other classic risk factors that may have played a role, “hypercholesterolemia, chronic high blood pressure, and type 2 diabetes were only responsible in 5.4%-13.5% of the associations,” wrote the researchers.
“Our results suggest that certain characteristics of the menstrual cycle across a woman’s reproductive lifespan may constitute additional risk markers for cardiovascular disease,” according to the authors.
The highest rates of cardiovascular disease were among women with permanently irregular or long cycles in early to mid adulthood, as well as women who had regular cycles when younger but had irregular cycles in mid adulthood. “This indicates that the change from one cycle phenotype to another could be a surrogate marker for metabolic changes, which in turn contribute to the formation of cardiovascular diseases,” wrote the authors.
The study was observational and so conclusions cannot be drawn regarding causal relationships. But Dr. Wang and associates indicate that the most common cause of an irregular menstrual cycle may be PCOS. “Roughly 90% of women with cycle disorders or oligomenorrhea have signs of PCOS. And it was shown that women with PCOS have an increased risk of cardiovascular disease.”
They concluded that “the associations observed between irregular and long cycles in early to mid-adulthood and cardiovascular diseases are likely attributable to underlying PCOS.”
For Dr. Seeland, however, this conclusion is “too monocausal. At no point in time did there seem to be any direct information regarding the frequency of PCOS during the data collection by the respondents.”
For now, we can only speculate about the mechanisms. “The association between a very irregular and long cycle and the increased risk of cardiovascular diseases has now only been described. More research should be done on the causes,” said Dr. Seeland.
This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.
This finding is demonstrated in a new analysis of the Nurses’ Health Study II.
“To date, several studies have reported increased risks of cardiovascular risk factors or cardiovascular disease in connection with cycle disorders,” Yi-Xin Wang, MD, PhD, a research fellow in nutrition, and associates from the Harvard School of Public Health, Boston, wrote in an article published in JAMA Network Open.
Ute Seeland, MD, speaker of the Gender Medicine in Cardiology Working Group of the German Cardiology Society, said in an interview“We know that women who have indicated in their medical history that they have irregular menstrual cycles, invariably in connection with polycystic ovary syndrome (PCOS), more commonly develop diabetes and other metabolic disorders, as well as cardiovascular diseases.”
Cycle disorders’ role
However, the role that irregular or especially long cycles play at different points of a woman’s reproductive life span was unclear. Therefore, the research group investigated the associations in the Nurses’ Health Study II between cycle irregularity and cycle length in women of different age groups who later experienced cardiovascular events.
At the end of this study in 1989, the participants also provided information regarding the length and irregularity of their menstrual cycle from ages 14 to 17 years and again from ages 18 to 22 years. The information was updated in 1993 when the participants were aged 29-46 years. The data from 2019 to 2022 were analyzed.
“This kind of long-term cohort study is extremely rare and therefore something special,” said Dr. Seeland, who conducts research at the Institute for Social Medicine, Epidemiology, and Health Economics at the Charité – University Hospital Berlin.
The investigators used the following cycle classifications: very regular (no more than 3 or 4 days before or after the expected date), regular (within 5-7 days), usually irregular, always irregular, or no periods.
The cycle lengths were divided into the following categories: less than 21 days, 21-25 days, 26-31 days, 32-39 days, 40-50 days, more than 50 days, and too irregular to estimate the length.
The onset of cardiovascular diseases was determined using information from the participants and was confirmed by reviewing the medical files. Relevant to the study were lethal and nonlethal coronary heart diseases (such as myocardial infarction or coronary artery revascularization), as well as strokes.
Significant in adulthood
The data from 80,630 study participants were included in the analysis. At study inclusion, the average age of the participants was 37.7 years, and the average body mass index (BMI) was 25.1. “Since it was predominantly White nurses who took part in the study, the data are not transferable to other, more diverse populations,” said Dr. Seeland.
Over 24 years, 1,816 women (2.4%) had a cardiovascular event. “We observed an increased rate of cardiovascular events in women with an irregular cycle and longer cycle, both in early an in mid-adulthood,” wrote Dr. Wang and associates. “Similar trends were also observed for cycle disorders when younger, but this association was weaker than in adulthood.”
Compared with women with very regular cycles, women with irregular cycles or without periods who were aged 14-17 years, 18-22 years, or 29-49 years exhibited a 15%, 36%, and 40% higher risk of a cardiovascular event, respectively.
Similarly, women aged 18-22 years or 29-46 years with long cycles of 40 days or more had a 44% or 30% higher risk of cardiovascular disease, respectively, compared with women with cycle lengths of 26-31 days.
“The coronary heart diseases were decisive for the increase, and less so, the strokes,” wrote the researchers.
Classic risk factors?
Dr. Seeland praised the fact that the study authors tried to determine the role that classic cardiovascular risk factors played. “Compared with women with a regular cycle, women with an irregular cycle had a higher BMI, more frequently increased cholesterol levels, and an elevated blood pressure,” she said. Women with a long cycle displayed a similar pattern.
It can be assumed from this that over a woman’s life span, BMI affects the risk of cardiovascular disease. Therefore, Dr. Wang and coauthors adjusted the results on the basis of BMI, which varies over time.
Regarding other classic risk factors that may have played a role, “hypercholesterolemia, chronic high blood pressure, and type 2 diabetes were only responsible in 5.4%-13.5% of the associations,” wrote the researchers.
“Our results suggest that certain characteristics of the menstrual cycle across a woman’s reproductive lifespan may constitute additional risk markers for cardiovascular disease,” according to the authors.
The highest rates of cardiovascular disease were among women with permanently irregular or long cycles in early to mid adulthood, as well as women who had regular cycles when younger but had irregular cycles in mid adulthood. “This indicates that the change from one cycle phenotype to another could be a surrogate marker for metabolic changes, which in turn contribute to the formation of cardiovascular diseases,” wrote the authors.
The study was observational and so conclusions cannot be drawn regarding causal relationships. But Dr. Wang and associates indicate that the most common cause of an irregular menstrual cycle may be PCOS. “Roughly 90% of women with cycle disorders or oligomenorrhea have signs of PCOS. And it was shown that women with PCOS have an increased risk of cardiovascular disease.”
They concluded that “the associations observed between irregular and long cycles in early to mid-adulthood and cardiovascular diseases are likely attributable to underlying PCOS.”
For Dr. Seeland, however, this conclusion is “too monocausal. At no point in time did there seem to be any direct information regarding the frequency of PCOS during the data collection by the respondents.”
For now, we can only speculate about the mechanisms. “The association between a very irregular and long cycle and the increased risk of cardiovascular diseases has now only been described. More research should be done on the causes,” said Dr. Seeland.
This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
FDA approves Wegovy (semaglutide) for obesity in teens 12 and up
The Food and Drug Administration has approved semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the additional indication of treating obesity in adolescents aged 12 years and older.
This is defined as those with an initial body mass index at or above the 95th percentile for age and sex (based on CDC growth charts). Semaglutide must be administered along with lifestyle intervention of a reduced calorie meal plan and increased physical activity.
When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a “game changer.”
The new approval is based on the results of the STEP TEENS phase 3 trial of once-weekly 2.4 mg of semaglutide in adolescents 12- to <18 years old with obesity, the drug’s manufacturer, Novo Nordisk, announced in a press release.
In STEP TEENS, reported at Obesity Week 2022 in November, and simultaneously published in the New England Journal of Medicine, adolescents with obesity treated with semaglutide for 68 weeks had a 16.1% reduction in BMI compared with a 0.6% increase in BMI in those receiving placebo. Both groups also received lifestyle intervention. Mean weight loss was 15.3 kg (33.7 pounds) among teens on semaglutide, while those on placebo gained 2.4 kg (5.3 pounds).
At the time, Claudia K. Fox, MD, MPH, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota – who was not involved with the research – told this news organization the results were “mind-blowing ... we are getting close to bariatric surgery results” in these adolescent patients with obesity.
Semaglutide is a GLP-1 agonist, as is a related agent, also from Novo Nordisk, liraglutide (Saxenda), a daily subcutaneous injection, which was approved for use in adolescents aged 12 and older in December 2020. Wegovy is the first weekly subcutaneous injection approved for use in adolescents.
Other agents approved for obesity in those older than 12 in the United States include the combination phentermine and topiramate extended-release capsules (Qsymia) in June 2022, and orlistat (Alli). Phentermine is approved for those aged 16 and older.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the additional indication of treating obesity in adolescents aged 12 years and older.
This is defined as those with an initial body mass index at or above the 95th percentile for age and sex (based on CDC growth charts). Semaglutide must be administered along with lifestyle intervention of a reduced calorie meal plan and increased physical activity.
When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a “game changer.”
The new approval is based on the results of the STEP TEENS phase 3 trial of once-weekly 2.4 mg of semaglutide in adolescents 12- to <18 years old with obesity, the drug’s manufacturer, Novo Nordisk, announced in a press release.
In STEP TEENS, reported at Obesity Week 2022 in November, and simultaneously published in the New England Journal of Medicine, adolescents with obesity treated with semaglutide for 68 weeks had a 16.1% reduction in BMI compared with a 0.6% increase in BMI in those receiving placebo. Both groups also received lifestyle intervention. Mean weight loss was 15.3 kg (33.7 pounds) among teens on semaglutide, while those on placebo gained 2.4 kg (5.3 pounds).
At the time, Claudia K. Fox, MD, MPH, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota – who was not involved with the research – told this news organization the results were “mind-blowing ... we are getting close to bariatric surgery results” in these adolescent patients with obesity.
Semaglutide is a GLP-1 agonist, as is a related agent, also from Novo Nordisk, liraglutide (Saxenda), a daily subcutaneous injection, which was approved for use in adolescents aged 12 and older in December 2020. Wegovy is the first weekly subcutaneous injection approved for use in adolescents.
Other agents approved for obesity in those older than 12 in the United States include the combination phentermine and topiramate extended-release capsules (Qsymia) in June 2022, and orlistat (Alli). Phentermine is approved for those aged 16 and older.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the additional indication of treating obesity in adolescents aged 12 years and older.
This is defined as those with an initial body mass index at or above the 95th percentile for age and sex (based on CDC growth charts). Semaglutide must be administered along with lifestyle intervention of a reduced calorie meal plan and increased physical activity.
When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a “game changer.”
The new approval is based on the results of the STEP TEENS phase 3 trial of once-weekly 2.4 mg of semaglutide in adolescents 12- to <18 years old with obesity, the drug’s manufacturer, Novo Nordisk, announced in a press release.
In STEP TEENS, reported at Obesity Week 2022 in November, and simultaneously published in the New England Journal of Medicine, adolescents with obesity treated with semaglutide for 68 weeks had a 16.1% reduction in BMI compared with a 0.6% increase in BMI in those receiving placebo. Both groups also received lifestyle intervention. Mean weight loss was 15.3 kg (33.7 pounds) among teens on semaglutide, while those on placebo gained 2.4 kg (5.3 pounds).
At the time, Claudia K. Fox, MD, MPH, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota – who was not involved with the research – told this news organization the results were “mind-blowing ... we are getting close to bariatric surgery results” in these adolescent patients with obesity.
Semaglutide is a GLP-1 agonist, as is a related agent, also from Novo Nordisk, liraglutide (Saxenda), a daily subcutaneous injection, which was approved for use in adolescents aged 12 and older in December 2020. Wegovy is the first weekly subcutaneous injection approved for use in adolescents.
Other agents approved for obesity in those older than 12 in the United States include the combination phentermine and topiramate extended-release capsules (Qsymia) in June 2022, and orlistat (Alli). Phentermine is approved for those aged 16 and older.
A version of this article first appeared on Medscape.com.
Study of beliefs about what causes cancer sparks debate
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
Top cardiology societies call for revamp of clinical trials
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Time for a rest
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Does vitamin D deficiency cause obesity or vice versa?
A recent study found that people with obesity have lower blood levels of vitamin D than people of healthy weight. This association of obesity with low vitamin D levels has led to much speculation on whether low vitamin D levels cause obesity or whether obesity causes low vitamin D levels. The interest in this topic is piqued by the possibility that if vitamin D deficiency causes obesity, perhaps treatment could be as simple as providing vitamin D supplementation to enhance weight loss.
What is known about vitamin D’s role in the body?
It’s well known that vitamin D is essential for bone health as well as balancing the minerals calcium and phosphorus, but what is its role in weight management? Approximately 80%-90% of vitamin D in the body is from the skin synthesis of cholecalciferol through ultraviolet B radiation from sun exposure. The normal range of 25-hydroxy vitamin D is measured as nanograms per milliliter (ng/mL). Most experts recommend a level between 20 and 40 ng/mL, but this has been a controversial topic of never-ending debate in the medical literature.
Vitamin D levels and obesity
This has been noted for many years without identifying the underlying reasons beyond the sequestering of vitamin D in adipose tissue, although I’ll discuss other possibilities.
The inverse correlation between vitamin D and obesity has been seen in other diseases, such as cardiovascular disease, hypertension, prediabetes, and insulin resistance, as well as in sarcopenia and aging. Most studies emphasized the correlation between increasing adiposity with vitamin D deficiency in all ethnic and age groups. The causes and potential direct consequences of the vitamin D deficiency state in obesity are not well understood.
Vitamin D and adipose tissue
It’s been proposed that low vitamin D status in obesity might be due to increased vitamin D clearance from serum and enhanced storage of vitamin D by adipose tissue.
In adipose tissue, vitamin D exerts a variety of effects on inflammation, innate immunity, metabolism, and differentiation and apoptosis in many cell types. There is a stronger association between 25(OH)D and visceral fat as compared to subcutaneous adipose tissue, which suggests an influence of inflammation and components of the metabolic syndrome on vitamin D metabolism.
Because vitamin D has anti-inflammatory properties, it’s possible that low vitamin D status contributes to adipose tissue inflammation, a key link between obesity and its associated metabolic complications in obesity. A higher storage of vitamin D in adipose tissue, if accompanied by a parallel increase in the local synthesis of 1,25(OH)2D3 and action, may conceivably modulate adipocyte function as well as the activity of adipose tissue macrophages and hence the level of adipose tissue inflammation. In addition, it seems likely that 1,25(OH)2D3 also regulates the function of macrophages and other immune cell populations within adipose tissue.
It’s well known that vitamin D is stored in body fat, leading to the assumption that this was important in the evolution of vertebrates, including humans, who lived at latitudes where vitamin D could not be made in the winter and vitamin D stores had to be mobilized to maintain vitamin D sufficiency.
What is vitamin D’s role in obesity?
The main question that has eluded an answer so far is this one: Is vitamin D deficiency only a coincidental finding in obesity due to sequestration of the vitamin in fat, or does it have a role in the development of obesity and its complications, such as cardiovascular disease, type 2 diabetes, and hypertension?
Low vitamin D usually leads to impaired calcium absorption in the intestine and a lower calcium level, and eventually enhanced bone turnover and impaired bone mineral density (BMD).
However, it is known that in obesity there is greater BMD than in those who are lean. This leads to the conclusion that because there is a lack of vitamin D deficiency effects on bone in those with obesity, there is not really a vitamin D deficiency, and it may be that the sequestration in adipose tissue leads to a permanent supply that can maintain bone health.
An alternative explanation is that there is greater skeletal loading in obesity, and elevations in hormones such as estrogen and leptin could compensate for the vitamin D deficiency, leading to greater BMD in obesity.
Several other potential mechanisms besides sequestration of vitamin D in adipose tissue have been identified for low vitamin D and obesity. These include impaired hepatic 25-hydroxylation in nonalcoholic fatty liver disease, less sunlight exposure due to lower mobility and different clothing habits in people with obesity vs. their lean counterparts, and adverse dietary habits. For example, people with higher BMIs spend less time exercising outdoors and are more sedentary in general than their lean counterparts. Therefore, they are less likely to get sun exposure because of a decrease in time spent outdoors. Those with higher BMIs also tend to cover their bodies, showing less skin when outdoors than their leaner counterparts, and thus there is likely to be less conversion to vitamin D via skin and sun exposure in people with obesity.
Some studies suggest that an increased level of parathyroid hormone due to vitamin D deficiency promotes lipogenesis because of greater calcium influx in adipocytes. Another hypothesis is that the active form of vitamin D, 1,25(OH) D, inhibits adipogenesis through actions modulated by vitamin D receptors. These studies are promising, but prospective randomized trials are needed to determine whether vitamin D supplementation is a treatment option in preventing obesity. So far, vitamin D supplementation shows inconsistent results.
To conclude, there is a high prevalence of vitamin D deficiency in obesity, most likely because of dilution and sequestration in greater volumes of fat, blood muscle, and liver in obesity. Low vitamin D levels can’t be ruled out as a cause of obesity because of the research showing some interesting findings in vitamin D receptors in adipose tissue. Vitamin D deficiency in obesity doesn’t seem to affect bone mass but could have deleterious effects on other organ systems.
Weight loss improves obesity and complications, including the risk for cardiovascular disease and type 2 diabetes as well as vitamin D deficiency.
What do the guidelines say?
Treatment of vitamin D deficiency requires higher doses in obesity to achieve the same serum concentration compared with lean persons. Maintenance doses should not differ between those with obesity and lean persons.
The association of vitamin D and obesity remains elusive. Studies need to focus on vitamin D, vitamin D receptors, and actions of vitamin D in adipose tissue to investigate this relationship further.
In the meantime, media attention remains focused on the potential treatment and prevention of obesity with the mighty, all-purpose vitamin D, even though there is scant evidence.
Dr. Apovian is codirector at the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine in the division of endocrinology, diabetes and hypertension at Harvard University, Boston. She disclosed conflicts of interest with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.
A version of this article first appeared on Medscape.com.
A recent study found that people with obesity have lower blood levels of vitamin D than people of healthy weight. This association of obesity with low vitamin D levels has led to much speculation on whether low vitamin D levels cause obesity or whether obesity causes low vitamin D levels. The interest in this topic is piqued by the possibility that if vitamin D deficiency causes obesity, perhaps treatment could be as simple as providing vitamin D supplementation to enhance weight loss.
What is known about vitamin D’s role in the body?
It’s well known that vitamin D is essential for bone health as well as balancing the minerals calcium and phosphorus, but what is its role in weight management? Approximately 80%-90% of vitamin D in the body is from the skin synthesis of cholecalciferol through ultraviolet B radiation from sun exposure. The normal range of 25-hydroxy vitamin D is measured as nanograms per milliliter (ng/mL). Most experts recommend a level between 20 and 40 ng/mL, but this has been a controversial topic of never-ending debate in the medical literature.
Vitamin D levels and obesity
This has been noted for many years without identifying the underlying reasons beyond the sequestering of vitamin D in adipose tissue, although I’ll discuss other possibilities.
The inverse correlation between vitamin D and obesity has been seen in other diseases, such as cardiovascular disease, hypertension, prediabetes, and insulin resistance, as well as in sarcopenia and aging. Most studies emphasized the correlation between increasing adiposity with vitamin D deficiency in all ethnic and age groups. The causes and potential direct consequences of the vitamin D deficiency state in obesity are not well understood.
Vitamin D and adipose tissue
It’s been proposed that low vitamin D status in obesity might be due to increased vitamin D clearance from serum and enhanced storage of vitamin D by adipose tissue.
In adipose tissue, vitamin D exerts a variety of effects on inflammation, innate immunity, metabolism, and differentiation and apoptosis in many cell types. There is a stronger association between 25(OH)D and visceral fat as compared to subcutaneous adipose tissue, which suggests an influence of inflammation and components of the metabolic syndrome on vitamin D metabolism.
Because vitamin D has anti-inflammatory properties, it’s possible that low vitamin D status contributes to adipose tissue inflammation, a key link between obesity and its associated metabolic complications in obesity. A higher storage of vitamin D in adipose tissue, if accompanied by a parallel increase in the local synthesis of 1,25(OH)2D3 and action, may conceivably modulate adipocyte function as well as the activity of adipose tissue macrophages and hence the level of adipose tissue inflammation. In addition, it seems likely that 1,25(OH)2D3 also regulates the function of macrophages and other immune cell populations within adipose tissue.
It’s well known that vitamin D is stored in body fat, leading to the assumption that this was important in the evolution of vertebrates, including humans, who lived at latitudes where vitamin D could not be made in the winter and vitamin D stores had to be mobilized to maintain vitamin D sufficiency.
What is vitamin D’s role in obesity?
The main question that has eluded an answer so far is this one: Is vitamin D deficiency only a coincidental finding in obesity due to sequestration of the vitamin in fat, or does it have a role in the development of obesity and its complications, such as cardiovascular disease, type 2 diabetes, and hypertension?
Low vitamin D usually leads to impaired calcium absorption in the intestine and a lower calcium level, and eventually enhanced bone turnover and impaired bone mineral density (BMD).
However, it is known that in obesity there is greater BMD than in those who are lean. This leads to the conclusion that because there is a lack of vitamin D deficiency effects on bone in those with obesity, there is not really a vitamin D deficiency, and it may be that the sequestration in adipose tissue leads to a permanent supply that can maintain bone health.
An alternative explanation is that there is greater skeletal loading in obesity, and elevations in hormones such as estrogen and leptin could compensate for the vitamin D deficiency, leading to greater BMD in obesity.
Several other potential mechanisms besides sequestration of vitamin D in adipose tissue have been identified for low vitamin D and obesity. These include impaired hepatic 25-hydroxylation in nonalcoholic fatty liver disease, less sunlight exposure due to lower mobility and different clothing habits in people with obesity vs. their lean counterparts, and adverse dietary habits. For example, people with higher BMIs spend less time exercising outdoors and are more sedentary in general than their lean counterparts. Therefore, they are less likely to get sun exposure because of a decrease in time spent outdoors. Those with higher BMIs also tend to cover their bodies, showing less skin when outdoors than their leaner counterparts, and thus there is likely to be less conversion to vitamin D via skin and sun exposure in people with obesity.
Some studies suggest that an increased level of parathyroid hormone due to vitamin D deficiency promotes lipogenesis because of greater calcium influx in adipocytes. Another hypothesis is that the active form of vitamin D, 1,25(OH) D, inhibits adipogenesis through actions modulated by vitamin D receptors. These studies are promising, but prospective randomized trials are needed to determine whether vitamin D supplementation is a treatment option in preventing obesity. So far, vitamin D supplementation shows inconsistent results.
To conclude, there is a high prevalence of vitamin D deficiency in obesity, most likely because of dilution and sequestration in greater volumes of fat, blood muscle, and liver in obesity. Low vitamin D levels can’t be ruled out as a cause of obesity because of the research showing some interesting findings in vitamin D receptors in adipose tissue. Vitamin D deficiency in obesity doesn’t seem to affect bone mass but could have deleterious effects on other organ systems.
Weight loss improves obesity and complications, including the risk for cardiovascular disease and type 2 diabetes as well as vitamin D deficiency.
What do the guidelines say?
Treatment of vitamin D deficiency requires higher doses in obesity to achieve the same serum concentration compared with lean persons. Maintenance doses should not differ between those with obesity and lean persons.
The association of vitamin D and obesity remains elusive. Studies need to focus on vitamin D, vitamin D receptors, and actions of vitamin D in adipose tissue to investigate this relationship further.
In the meantime, media attention remains focused on the potential treatment and prevention of obesity with the mighty, all-purpose vitamin D, even though there is scant evidence.
Dr. Apovian is codirector at the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine in the division of endocrinology, diabetes and hypertension at Harvard University, Boston. She disclosed conflicts of interest with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.
A version of this article first appeared on Medscape.com.
A recent study found that people with obesity have lower blood levels of vitamin D than people of healthy weight. This association of obesity with low vitamin D levels has led to much speculation on whether low vitamin D levels cause obesity or whether obesity causes low vitamin D levels. The interest in this topic is piqued by the possibility that if vitamin D deficiency causes obesity, perhaps treatment could be as simple as providing vitamin D supplementation to enhance weight loss.
What is known about vitamin D’s role in the body?
It’s well known that vitamin D is essential for bone health as well as balancing the minerals calcium and phosphorus, but what is its role in weight management? Approximately 80%-90% of vitamin D in the body is from the skin synthesis of cholecalciferol through ultraviolet B radiation from sun exposure. The normal range of 25-hydroxy vitamin D is measured as nanograms per milliliter (ng/mL). Most experts recommend a level between 20 and 40 ng/mL, but this has been a controversial topic of never-ending debate in the medical literature.
Vitamin D levels and obesity
This has been noted for many years without identifying the underlying reasons beyond the sequestering of vitamin D in adipose tissue, although I’ll discuss other possibilities.
The inverse correlation between vitamin D and obesity has been seen in other diseases, such as cardiovascular disease, hypertension, prediabetes, and insulin resistance, as well as in sarcopenia and aging. Most studies emphasized the correlation between increasing adiposity with vitamin D deficiency in all ethnic and age groups. The causes and potential direct consequences of the vitamin D deficiency state in obesity are not well understood.
Vitamin D and adipose tissue
It’s been proposed that low vitamin D status in obesity might be due to increased vitamin D clearance from serum and enhanced storage of vitamin D by adipose tissue.
In adipose tissue, vitamin D exerts a variety of effects on inflammation, innate immunity, metabolism, and differentiation and apoptosis in many cell types. There is a stronger association between 25(OH)D and visceral fat as compared to subcutaneous adipose tissue, which suggests an influence of inflammation and components of the metabolic syndrome on vitamin D metabolism.
Because vitamin D has anti-inflammatory properties, it’s possible that low vitamin D status contributes to adipose tissue inflammation, a key link between obesity and its associated metabolic complications in obesity. A higher storage of vitamin D in adipose tissue, if accompanied by a parallel increase in the local synthesis of 1,25(OH)2D3 and action, may conceivably modulate adipocyte function as well as the activity of adipose tissue macrophages and hence the level of adipose tissue inflammation. In addition, it seems likely that 1,25(OH)2D3 also regulates the function of macrophages and other immune cell populations within adipose tissue.
It’s well known that vitamin D is stored in body fat, leading to the assumption that this was important in the evolution of vertebrates, including humans, who lived at latitudes where vitamin D could not be made in the winter and vitamin D stores had to be mobilized to maintain vitamin D sufficiency.
What is vitamin D’s role in obesity?
The main question that has eluded an answer so far is this one: Is vitamin D deficiency only a coincidental finding in obesity due to sequestration of the vitamin in fat, or does it have a role in the development of obesity and its complications, such as cardiovascular disease, type 2 diabetes, and hypertension?
Low vitamin D usually leads to impaired calcium absorption in the intestine and a lower calcium level, and eventually enhanced bone turnover and impaired bone mineral density (BMD).
However, it is known that in obesity there is greater BMD than in those who are lean. This leads to the conclusion that because there is a lack of vitamin D deficiency effects on bone in those with obesity, there is not really a vitamin D deficiency, and it may be that the sequestration in adipose tissue leads to a permanent supply that can maintain bone health.
An alternative explanation is that there is greater skeletal loading in obesity, and elevations in hormones such as estrogen and leptin could compensate for the vitamin D deficiency, leading to greater BMD in obesity.
Several other potential mechanisms besides sequestration of vitamin D in adipose tissue have been identified for low vitamin D and obesity. These include impaired hepatic 25-hydroxylation in nonalcoholic fatty liver disease, less sunlight exposure due to lower mobility and different clothing habits in people with obesity vs. their lean counterparts, and adverse dietary habits. For example, people with higher BMIs spend less time exercising outdoors and are more sedentary in general than their lean counterparts. Therefore, they are less likely to get sun exposure because of a decrease in time spent outdoors. Those with higher BMIs also tend to cover their bodies, showing less skin when outdoors than their leaner counterparts, and thus there is likely to be less conversion to vitamin D via skin and sun exposure in people with obesity.
Some studies suggest that an increased level of parathyroid hormone due to vitamin D deficiency promotes lipogenesis because of greater calcium influx in adipocytes. Another hypothesis is that the active form of vitamin D, 1,25(OH) D, inhibits adipogenesis through actions modulated by vitamin D receptors. These studies are promising, but prospective randomized trials are needed to determine whether vitamin D supplementation is a treatment option in preventing obesity. So far, vitamin D supplementation shows inconsistent results.
To conclude, there is a high prevalence of vitamin D deficiency in obesity, most likely because of dilution and sequestration in greater volumes of fat, blood muscle, and liver in obesity. Low vitamin D levels can’t be ruled out as a cause of obesity because of the research showing some interesting findings in vitamin D receptors in adipose tissue. Vitamin D deficiency in obesity doesn’t seem to affect bone mass but could have deleterious effects on other organ systems.
Weight loss improves obesity and complications, including the risk for cardiovascular disease and type 2 diabetes as well as vitamin D deficiency.
What do the guidelines say?
Treatment of vitamin D deficiency requires higher doses in obesity to achieve the same serum concentration compared with lean persons. Maintenance doses should not differ between those with obesity and lean persons.
The association of vitamin D and obesity remains elusive. Studies need to focus on vitamin D, vitamin D receptors, and actions of vitamin D in adipose tissue to investigate this relationship further.
In the meantime, media attention remains focused on the potential treatment and prevention of obesity with the mighty, all-purpose vitamin D, even though there is scant evidence.
Dr. Apovian is codirector at the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine in the division of endocrinology, diabetes and hypertension at Harvard University, Boston. She disclosed conflicts of interest with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.
A version of this article first appeared on Medscape.com.