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Florida sees spike in deadly bacterial infections after Hurricane Ian
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
Psoriatic arthritis has greater impact on women than men
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
FROM THE JOURNAL OF RHEUMATOLOGY
Don’t be afraid of weight gain with hyperthyroid treatment
MONTREAL – Amid common patient concerns about weight gain in the treatment of hyperthyroidism, findings from a large study suggest the therapy with the most favorable survival rate – radioiodine – is not associated with an increased risk of weight gain or obesity.
“EGRET is the first large study using population-based linked community and hospital data to elucidate the long-term consequences of treatment modalities for hyperthyroidism,” said co-author Kristien Boelaert, MD, PhD, while presenting the research at the American Thyroid Association annual meeting.
“The administration of [radioiodine] for hyperthyroidism is associated with a survival benefit for patients with hyperthyroidism and is not associated with increased risks of becoming obese,” Dr. Boelaert, a professor of endocrinology and consultant endocrinologist with the Institute of Applied Health Research, University of Birmingham, England, told this news organization.
However, “overall, there was a nearly 10% risk of major adverse cardiac events [MACE] in patients with hyperthyroidism regardless of the treatment modality used,” she noted.
Commenting on the findings, Jonathon O. Russell, MD, said the study offers surprising – but encouraging – results.
The discovery that radioiodine shows no increase in weight gain “contradicts numerous previous studies which have consistently demonstrated weight gain following definitive radioiodine,” Dr. Russell told this news organization.
Overall, however, “these findings reinforce our knowledge that definitive treatment of an overactive thyroid leads to a longer life – even if there is some weight gain,” added Dr. Russell, who is chief of the Division of Head and Neck Endocrine Surgery at Johns Hopkins, Baltimore.
Hyperthyroidism associated with serious long-term cardiometabolic issues
Hyperthyroidism is associated with serious long-term cardiovascular and metabolic morbidity and mortality, and treatment is therefore essential. However, the swing to hypothyroidism that often occurs afterward commonly results in regaining the weight lost due to the hyperthyroidism, if not more, potentially leading to obesity and its attendant health risks.
To investigate those risks in relation to the three key hyperthyroidism treatments, the authors conducted the EGRET trial. They identified 62,474 patients in the United Kingdom population-based electronic health record database who had newly diagnosed hyperthyroidism and were treated with antithyroid drugs (73.4%), radioiodine (19.5%), or thyroidectomy (7.1%) between April 1997 and December 2015.
Exclusion criteria included those with less than 6 months of antithyroid drugs as the only form of treatment, thyroid cancer, or pregnancy during the first episode.
With a median follow-up of about 8 years, those who were treated with thyroidectomy had a significantly increased risk of gaining weight, compared with the general population (P < .001), and of developing obesity (body mass index > 30 kg/m2; P = .003), while the corresponding increases with antithyroid drugs and radioiodine were not significantly different, compared with the general population over the same period.
In terms of survival, with an average follow-up of about 11 years per person, about 14% of the cohort died, with rates of 14.4% in the antithyroid drug group, 15.8% in the radioiodine group, and 9.2% in the thyroidectomy group.
Mortality rates were further assessed based on an average treatment effects analysis in which the average change was estimated, compared with the index of antithyroid drugs – for instance, if all were treated instead with radioiodine. In that extension of life analysis, those treated with radioiodine could be expected to die, on average, 1.2 years later than those taking antithyroid drugs (P < .001), while those treated with thyroidectomy would be expected to die 0.6 years later, which was not statistically significant.
Using the same average treatment effects analysis, Dr. Boelaert noted, “we found a slightly increased risk of major adverse cardiovascular events following radioiodine, compared with antithyroid drugs; [however], the risk was very small and may not be clinically relevant.”
“Previous data from our and other groups have shown reduced risks of mortality and cardiovascular death following radioiodine-induced hypothyroidism, although this is not confirmed in all studies.”
Weight gain after hyperthyroid treatment drives concerns
The findings are important because weight gain associated with hyperthyroidism treatment is no small matter for many patients, even prompting a lack of adherence to therapy for some, despite its importance, Dr. Boelaert noted.
“Since the majority of patients lose weight as a consequence of being hyperthyroid, it can be expected that they will at least regain the lost weight and possibly even have a weight overshoot,” she explained. “Indeed, many patients are reluctant to accept definitive treatment with surgery or radioiodine out of fear of weight gain.”
“This may cause difficulties to some patients who occasionally may even stop taking antithyroid drugs to prevent this weight regain. Such lack of adherence may have dire consequences and is likely a contributing factor to the increased mortality in these patients,” she observed.
In a previous study of 1,373 patients, Dr. Boelaert and colleagues found that men treated for hyperthyroidism gained an average of 8.0 kg (17.6 lb), and women gained an average of 5.5 kg (12.1 lb).
Compared with the background population, men were significantly more likely to gain weight over the study period (odds ratio, 1.7; P < .001) as were women (OR, 1.3; P < .001). Also in that study, radioiodine was associated with greater weight gain (0.6 kg; P < .001), compared with antithyroid drug treatment alone.
Dr. Russell added that even when weight gain does occur, the payoff of having treated the potentially serious state of hyperthyroidism is a highly beneficial trade-off.
Ultimately, “the goal of treating any patient with Graves’ should be to get them to become hypothyroid as quickly as possible,” he said. “Patients have options, and all of these options can be safe in the right situation.”
“It is unrealistic to think that going from a hyperthyroid state to a low thyroid state will not result in weight gain for many patients,” Dr. Russell added. “But the key point is that overall health is better despite this weight gain.”
Dr. Boelaert has disclosed consulting fees paid to the University of Birmingham by Lilly and Eisai. Dr. Russell has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MONTREAL – Amid common patient concerns about weight gain in the treatment of hyperthyroidism, findings from a large study suggest the therapy with the most favorable survival rate – radioiodine – is not associated with an increased risk of weight gain or obesity.
“EGRET is the first large study using population-based linked community and hospital data to elucidate the long-term consequences of treatment modalities for hyperthyroidism,” said co-author Kristien Boelaert, MD, PhD, while presenting the research at the American Thyroid Association annual meeting.
“The administration of [radioiodine] for hyperthyroidism is associated with a survival benefit for patients with hyperthyroidism and is not associated with increased risks of becoming obese,” Dr. Boelaert, a professor of endocrinology and consultant endocrinologist with the Institute of Applied Health Research, University of Birmingham, England, told this news organization.
However, “overall, there was a nearly 10% risk of major adverse cardiac events [MACE] in patients with hyperthyroidism regardless of the treatment modality used,” she noted.
Commenting on the findings, Jonathon O. Russell, MD, said the study offers surprising – but encouraging – results.
The discovery that radioiodine shows no increase in weight gain “contradicts numerous previous studies which have consistently demonstrated weight gain following definitive radioiodine,” Dr. Russell told this news organization.
Overall, however, “these findings reinforce our knowledge that definitive treatment of an overactive thyroid leads to a longer life – even if there is some weight gain,” added Dr. Russell, who is chief of the Division of Head and Neck Endocrine Surgery at Johns Hopkins, Baltimore.
Hyperthyroidism associated with serious long-term cardiometabolic issues
Hyperthyroidism is associated with serious long-term cardiovascular and metabolic morbidity and mortality, and treatment is therefore essential. However, the swing to hypothyroidism that often occurs afterward commonly results in regaining the weight lost due to the hyperthyroidism, if not more, potentially leading to obesity and its attendant health risks.
To investigate those risks in relation to the three key hyperthyroidism treatments, the authors conducted the EGRET trial. They identified 62,474 patients in the United Kingdom population-based electronic health record database who had newly diagnosed hyperthyroidism and were treated with antithyroid drugs (73.4%), radioiodine (19.5%), or thyroidectomy (7.1%) between April 1997 and December 2015.
Exclusion criteria included those with less than 6 months of antithyroid drugs as the only form of treatment, thyroid cancer, or pregnancy during the first episode.
With a median follow-up of about 8 years, those who were treated with thyroidectomy had a significantly increased risk of gaining weight, compared with the general population (P < .001), and of developing obesity (body mass index > 30 kg/m2; P = .003), while the corresponding increases with antithyroid drugs and radioiodine were not significantly different, compared with the general population over the same period.
In terms of survival, with an average follow-up of about 11 years per person, about 14% of the cohort died, with rates of 14.4% in the antithyroid drug group, 15.8% in the radioiodine group, and 9.2% in the thyroidectomy group.
Mortality rates were further assessed based on an average treatment effects analysis in which the average change was estimated, compared with the index of antithyroid drugs – for instance, if all were treated instead with radioiodine. In that extension of life analysis, those treated with radioiodine could be expected to die, on average, 1.2 years later than those taking antithyroid drugs (P < .001), while those treated with thyroidectomy would be expected to die 0.6 years later, which was not statistically significant.
Using the same average treatment effects analysis, Dr. Boelaert noted, “we found a slightly increased risk of major adverse cardiovascular events following radioiodine, compared with antithyroid drugs; [however], the risk was very small and may not be clinically relevant.”
“Previous data from our and other groups have shown reduced risks of mortality and cardiovascular death following radioiodine-induced hypothyroidism, although this is not confirmed in all studies.”
Weight gain after hyperthyroid treatment drives concerns
The findings are important because weight gain associated with hyperthyroidism treatment is no small matter for many patients, even prompting a lack of adherence to therapy for some, despite its importance, Dr. Boelaert noted.
“Since the majority of patients lose weight as a consequence of being hyperthyroid, it can be expected that they will at least regain the lost weight and possibly even have a weight overshoot,” she explained. “Indeed, many patients are reluctant to accept definitive treatment with surgery or radioiodine out of fear of weight gain.”
“This may cause difficulties to some patients who occasionally may even stop taking antithyroid drugs to prevent this weight regain. Such lack of adherence may have dire consequences and is likely a contributing factor to the increased mortality in these patients,” she observed.
In a previous study of 1,373 patients, Dr. Boelaert and colleagues found that men treated for hyperthyroidism gained an average of 8.0 kg (17.6 lb), and women gained an average of 5.5 kg (12.1 lb).
Compared with the background population, men were significantly more likely to gain weight over the study period (odds ratio, 1.7; P < .001) as were women (OR, 1.3; P < .001). Also in that study, radioiodine was associated with greater weight gain (0.6 kg; P < .001), compared with antithyroid drug treatment alone.
Dr. Russell added that even when weight gain does occur, the payoff of having treated the potentially serious state of hyperthyroidism is a highly beneficial trade-off.
Ultimately, “the goal of treating any patient with Graves’ should be to get them to become hypothyroid as quickly as possible,” he said. “Patients have options, and all of these options can be safe in the right situation.”
“It is unrealistic to think that going from a hyperthyroid state to a low thyroid state will not result in weight gain for many patients,” Dr. Russell added. “But the key point is that overall health is better despite this weight gain.”
Dr. Boelaert has disclosed consulting fees paid to the University of Birmingham by Lilly and Eisai. Dr. Russell has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MONTREAL – Amid common patient concerns about weight gain in the treatment of hyperthyroidism, findings from a large study suggest the therapy with the most favorable survival rate – radioiodine – is not associated with an increased risk of weight gain or obesity.
“EGRET is the first large study using population-based linked community and hospital data to elucidate the long-term consequences of treatment modalities for hyperthyroidism,” said co-author Kristien Boelaert, MD, PhD, while presenting the research at the American Thyroid Association annual meeting.
“The administration of [radioiodine] for hyperthyroidism is associated with a survival benefit for patients with hyperthyroidism and is not associated with increased risks of becoming obese,” Dr. Boelaert, a professor of endocrinology and consultant endocrinologist with the Institute of Applied Health Research, University of Birmingham, England, told this news organization.
However, “overall, there was a nearly 10% risk of major adverse cardiac events [MACE] in patients with hyperthyroidism regardless of the treatment modality used,” she noted.
Commenting on the findings, Jonathon O. Russell, MD, said the study offers surprising – but encouraging – results.
The discovery that radioiodine shows no increase in weight gain “contradicts numerous previous studies which have consistently demonstrated weight gain following definitive radioiodine,” Dr. Russell told this news organization.
Overall, however, “these findings reinforce our knowledge that definitive treatment of an overactive thyroid leads to a longer life – even if there is some weight gain,” added Dr. Russell, who is chief of the Division of Head and Neck Endocrine Surgery at Johns Hopkins, Baltimore.
Hyperthyroidism associated with serious long-term cardiometabolic issues
Hyperthyroidism is associated with serious long-term cardiovascular and metabolic morbidity and mortality, and treatment is therefore essential. However, the swing to hypothyroidism that often occurs afterward commonly results in regaining the weight lost due to the hyperthyroidism, if not more, potentially leading to obesity and its attendant health risks.
To investigate those risks in relation to the three key hyperthyroidism treatments, the authors conducted the EGRET trial. They identified 62,474 patients in the United Kingdom population-based electronic health record database who had newly diagnosed hyperthyroidism and were treated with antithyroid drugs (73.4%), radioiodine (19.5%), or thyroidectomy (7.1%) between April 1997 and December 2015.
Exclusion criteria included those with less than 6 months of antithyroid drugs as the only form of treatment, thyroid cancer, or pregnancy during the first episode.
With a median follow-up of about 8 years, those who were treated with thyroidectomy had a significantly increased risk of gaining weight, compared with the general population (P < .001), and of developing obesity (body mass index > 30 kg/m2; P = .003), while the corresponding increases with antithyroid drugs and radioiodine were not significantly different, compared with the general population over the same period.
In terms of survival, with an average follow-up of about 11 years per person, about 14% of the cohort died, with rates of 14.4% in the antithyroid drug group, 15.8% in the radioiodine group, and 9.2% in the thyroidectomy group.
Mortality rates were further assessed based on an average treatment effects analysis in which the average change was estimated, compared with the index of antithyroid drugs – for instance, if all were treated instead with radioiodine. In that extension of life analysis, those treated with radioiodine could be expected to die, on average, 1.2 years later than those taking antithyroid drugs (P < .001), while those treated with thyroidectomy would be expected to die 0.6 years later, which was not statistically significant.
Using the same average treatment effects analysis, Dr. Boelaert noted, “we found a slightly increased risk of major adverse cardiovascular events following radioiodine, compared with antithyroid drugs; [however], the risk was very small and may not be clinically relevant.”
“Previous data from our and other groups have shown reduced risks of mortality and cardiovascular death following radioiodine-induced hypothyroidism, although this is not confirmed in all studies.”
Weight gain after hyperthyroid treatment drives concerns
The findings are important because weight gain associated with hyperthyroidism treatment is no small matter for many patients, even prompting a lack of adherence to therapy for some, despite its importance, Dr. Boelaert noted.
“Since the majority of patients lose weight as a consequence of being hyperthyroid, it can be expected that they will at least regain the lost weight and possibly even have a weight overshoot,” she explained. “Indeed, many patients are reluctant to accept definitive treatment with surgery or radioiodine out of fear of weight gain.”
“This may cause difficulties to some patients who occasionally may even stop taking antithyroid drugs to prevent this weight regain. Such lack of adherence may have dire consequences and is likely a contributing factor to the increased mortality in these patients,” she observed.
In a previous study of 1,373 patients, Dr. Boelaert and colleagues found that men treated for hyperthyroidism gained an average of 8.0 kg (17.6 lb), and women gained an average of 5.5 kg (12.1 lb).
Compared with the background population, men were significantly more likely to gain weight over the study period (odds ratio, 1.7; P < .001) as were women (OR, 1.3; P < .001). Also in that study, radioiodine was associated with greater weight gain (0.6 kg; P < .001), compared with antithyroid drug treatment alone.
Dr. Russell added that even when weight gain does occur, the payoff of having treated the potentially serious state of hyperthyroidism is a highly beneficial trade-off.
Ultimately, “the goal of treating any patient with Graves’ should be to get them to become hypothyroid as quickly as possible,” he said. “Patients have options, and all of these options can be safe in the right situation.”
“It is unrealistic to think that going from a hyperthyroid state to a low thyroid state will not result in weight gain for many patients,” Dr. Russell added. “But the key point is that overall health is better despite this weight gain.”
Dr. Boelaert has disclosed consulting fees paid to the University of Birmingham by Lilly and Eisai. Dr. Russell has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ATA 2022
Updated Moderna booster shows greater activity against COVID in adults
WASHINGTON –
The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.
Additionally, no new safety concerns emerged.
Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.
In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.
The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.
In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.
Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.
“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.
In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.
Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.
Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
Separate study of causes of severe breakthrough infections in early vaccine formulations
Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.
In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.
Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.
The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.
Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.
The strongest risk factor for severe disease despite vaccination was age, the researchers found.
Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”
To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”
Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.
Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.
“We also found that receipt of an additional booster dose of vaccine was associated with a 50% reduction in adjusted odds of severe disease,” noted Dr. Branch-Elliman.
Dr. Nori emphasized that, given these data, emphatic messaging is needed to encourage uptake of the updated Omicron-targeted vaccines for these high-risk age groups.
The study by Dr. Chalkias and colleagues was funded by Moderna. Dr. Chalkias and several coauthors are employed by Moderna. One coauthor has relationships with DLA Piper/Medtronic, and Gilead Pharmaceuticals, and one has relationships with Celgene/Bristol-Myers Squibb, ChemoCentryx, Gilead, and Kiniksa. Dr. Nori has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.
Additionally, no new safety concerns emerged.
Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.
In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.
The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.
In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.
Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.
“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.
In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.
Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.
Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
Separate study of causes of severe breakthrough infections in early vaccine formulations
Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.
In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.
Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.
The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.
Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.
The strongest risk factor for severe disease despite vaccination was age, the researchers found.
Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”
To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”
Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.
Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.
“We also found that receipt of an additional booster dose of vaccine was associated with a 50% reduction in adjusted odds of severe disease,” noted Dr. Branch-Elliman.
Dr. Nori emphasized that, given these data, emphatic messaging is needed to encourage uptake of the updated Omicron-targeted vaccines for these high-risk age groups.
The study by Dr. Chalkias and colleagues was funded by Moderna. Dr. Chalkias and several coauthors are employed by Moderna. One coauthor has relationships with DLA Piper/Medtronic, and Gilead Pharmaceuticals, and one has relationships with Celgene/Bristol-Myers Squibb, ChemoCentryx, Gilead, and Kiniksa. Dr. Nori has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.
Additionally, no new safety concerns emerged.
Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.
In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.
The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.
In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.
Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.
“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.
In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.
Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.
Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
Separate study of causes of severe breakthrough infections in early vaccine formulations
Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.
In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.
Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.
The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.
Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.
The strongest risk factor for severe disease despite vaccination was age, the researchers found.
Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”
To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”
Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.
Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.
“We also found that receipt of an additional booster dose of vaccine was associated with a 50% reduction in adjusted odds of severe disease,” noted Dr. Branch-Elliman.
Dr. Nori emphasized that, given these data, emphatic messaging is needed to encourage uptake of the updated Omicron-targeted vaccines for these high-risk age groups.
The study by Dr. Chalkias and colleagues was funded by Moderna. Dr. Chalkias and several coauthors are employed by Moderna. One coauthor has relationships with DLA Piper/Medtronic, and Gilead Pharmaceuticals, and one has relationships with Celgene/Bristol-Myers Squibb, ChemoCentryx, Gilead, and Kiniksa. Dr. Nori has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IDWEEK 2022
25 years of chickenpox vaccine: 91 million cases prevented
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IDWEEK 2022
Lower serum bile acid levels independently predict adverse renal outcomes in T2DM and DKD
Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.
Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).
Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.
Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.
Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995 (Oct 7). Doi: 10.3389/fendo.2022.1026995.
Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.
Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).
Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.
Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.
Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995 (Oct 7). Doi: 10.3389/fendo.2022.1026995.
Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.
Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).
Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.
Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.
Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995 (Oct 7). Doi: 10.3389/fendo.2022.1026995.
No increase in risk for major adverse limb events with SGLT-2i vs. GLP-1RA in T2DM
Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).
Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).
Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).
Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804 (Sep 13). Doi: 10.3389/fphar.2022.869804
Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).
Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).
Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).
Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804 (Sep 13). Doi: 10.3389/fphar.2022.869804
Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).
Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).
Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).
Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804 (Sep 13). Doi: 10.3389/fphar.2022.869804
Adding antihypertensive to standard diabetes therapy improves glycemic control in T2DM
Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes (T2D) compared with standard diabetes therapy alone.
Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.
Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).
Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.
Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561 (Sep 9). Doi: 10.3389/fendo.2022.935561.
Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes (T2D) compared with standard diabetes therapy alone.
Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.
Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).
Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.
Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561 (Sep 9). Doi: 10.3389/fendo.2022.935561.
Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes (T2D) compared with standard diabetes therapy alone.
Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.
Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).
Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.
Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561 (Sep 9). Doi: 10.3389/fendo.2022.935561.
Metformin ups gastrointestinal adverse event risk in T2D
Key clinical point: Patients with type 2 diabetes mellitus (T2D) receiving metformin vs other antidiabetic drugs or placebo had a higher risk for gastrointestinal (GI) adverse events (AE) such as abdominal pain, nausea, and diarrhea, with the risk for bloating and diarrhea being higher with metformin immediate release (IR) vs extended release (XR).
Major finding: Patients treated with metformin vs. placebo or any other antidiabetic drug were at a significantly higher risk for abdominal pain (risk ratio [RR] 1.491; P = .0001), diarrhea (RR 2.445; P = .0001), and nausea (RR 1.641; P = .0004). The risks for bloating (coefficient −0.89; P = .76) and diarrhea (coefficient −0.344; P = .0437) were higher with metformin IR vs XR.
Study details: The data come from a meta-analysis of 71 randomized controlled trials including 55,042 patients with T2D who were randomly assigned to receive metformin or comparators.
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Nabrdalik K et al. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:975912 (Sep 14). Doi: 10.3389/fendo.2022.975912
Key clinical point: Patients with type 2 diabetes mellitus (T2D) receiving metformin vs other antidiabetic drugs or placebo had a higher risk for gastrointestinal (GI) adverse events (AE) such as abdominal pain, nausea, and diarrhea, with the risk for bloating and diarrhea being higher with metformin immediate release (IR) vs extended release (XR).
Major finding: Patients treated with metformin vs. placebo or any other antidiabetic drug were at a significantly higher risk for abdominal pain (risk ratio [RR] 1.491; P = .0001), diarrhea (RR 2.445; P = .0001), and nausea (RR 1.641; P = .0004). The risks for bloating (coefficient −0.89; P = .76) and diarrhea (coefficient −0.344; P = .0437) were higher with metformin IR vs XR.
Study details: The data come from a meta-analysis of 71 randomized controlled trials including 55,042 patients with T2D who were randomly assigned to receive metformin or comparators.
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Nabrdalik K et al. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:975912 (Sep 14). Doi: 10.3389/fendo.2022.975912
Key clinical point: Patients with type 2 diabetes mellitus (T2D) receiving metformin vs other antidiabetic drugs or placebo had a higher risk for gastrointestinal (GI) adverse events (AE) such as abdominal pain, nausea, and diarrhea, with the risk for bloating and diarrhea being higher with metformin immediate release (IR) vs extended release (XR).
Major finding: Patients treated with metformin vs. placebo or any other antidiabetic drug were at a significantly higher risk for abdominal pain (risk ratio [RR] 1.491; P = .0001), diarrhea (RR 2.445; P = .0001), and nausea (RR 1.641; P = .0004). The risks for bloating (coefficient −0.89; P = .76) and diarrhea (coefficient −0.344; P = .0437) were higher with metformin IR vs XR.
Study details: The data come from a meta-analysis of 71 randomized controlled trials including 55,042 patients with T2D who were randomly assigned to receive metformin or comparators.
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Nabrdalik K et al. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:975912 (Sep 14). Doi: 10.3389/fendo.2022.975912
Metformin may offer more neuroprotection for dementia than sulfonylurea in T2D
Key clinical point: Patients with type 2 diabetes (T2D) who used metformin vs. sulfonylurea were at a significantly lower risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VD), but not Parkinson’s disease (PD) or mild cognitive impairment (MCI).
Major finding: The risk for all-cause dementia (hazard ratio [HR] 0.80; 95% CI 0.73-0.88), AD (HR 0.81; 95% CI 0.70-0.94), and VD (HR 0.79; 95% CI 0.63-1.00) was significantly lower in metformin vs sulfonylurea users, with no significant difference in the risk for PD and MCI.
Study details: Findings are from a new user active comparator study including 112,591 patients with T2D, of which 96,140 were new metformin users and 16,451 were new sulfonylurea users.
Disclosures: This study was supported by Janssen Pharmaceuticals. AJ Nevado-Holgado declared receiving funding from Janssen Pharmaceuticals and others. QS Li declared being an employee of Janssen Research & Development, Johnson & Johnson, or holding equity in Johnson & Johnson.
Source: Newby D et al. Comparative effect of metformin versus sulfonylureas with dementia and Parkinson's disease risk in US patients over 50 with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2022;10(5):e003036 (Sep 15). Doi: 10.1136/bmjdrc-2022-003036
Key clinical point: Patients with type 2 diabetes (T2D) who used metformin vs. sulfonylurea were at a significantly lower risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VD), but not Parkinson’s disease (PD) or mild cognitive impairment (MCI).
Major finding: The risk for all-cause dementia (hazard ratio [HR] 0.80; 95% CI 0.73-0.88), AD (HR 0.81; 95% CI 0.70-0.94), and VD (HR 0.79; 95% CI 0.63-1.00) was significantly lower in metformin vs sulfonylurea users, with no significant difference in the risk for PD and MCI.
Study details: Findings are from a new user active comparator study including 112,591 patients with T2D, of which 96,140 were new metformin users and 16,451 were new sulfonylurea users.
Disclosures: This study was supported by Janssen Pharmaceuticals. AJ Nevado-Holgado declared receiving funding from Janssen Pharmaceuticals and others. QS Li declared being an employee of Janssen Research & Development, Johnson & Johnson, or holding equity in Johnson & Johnson.
Source: Newby D et al. Comparative effect of metformin versus sulfonylureas with dementia and Parkinson's disease risk in US patients over 50 with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2022;10(5):e003036 (Sep 15). Doi: 10.1136/bmjdrc-2022-003036
Key clinical point: Patients with type 2 diabetes (T2D) who used metformin vs. sulfonylurea were at a significantly lower risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VD), but not Parkinson’s disease (PD) or mild cognitive impairment (MCI).
Major finding: The risk for all-cause dementia (hazard ratio [HR] 0.80; 95% CI 0.73-0.88), AD (HR 0.81; 95% CI 0.70-0.94), and VD (HR 0.79; 95% CI 0.63-1.00) was significantly lower in metformin vs sulfonylurea users, with no significant difference in the risk for PD and MCI.
Study details: Findings are from a new user active comparator study including 112,591 patients with T2D, of which 96,140 were new metformin users and 16,451 were new sulfonylurea users.
Disclosures: This study was supported by Janssen Pharmaceuticals. AJ Nevado-Holgado declared receiving funding from Janssen Pharmaceuticals and others. QS Li declared being an employee of Janssen Research & Development, Johnson & Johnson, or holding equity in Johnson & Johnson.
Source: Newby D et al. Comparative effect of metformin versus sulfonylureas with dementia and Parkinson's disease risk in US patients over 50 with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2022;10(5):e003036 (Sep 15). Doi: 10.1136/bmjdrc-2022-003036