Seated Doctors Better Satisfy Patients, Communication

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Changed
Fri, 08/30/2024 - 12:37

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Statins Linked to Improved Liver Health in MASLD

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Changed
Tue, 09/03/2024 - 05:16

 

TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

  • Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
  • Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
  • Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
  • Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
  • The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

  • Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
  • Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
  • No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

  • Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
  • Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
  • Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
  • Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
  • The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

  • Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
  • Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
  • No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

  • Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
  • Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
  • Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
  • Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
  • The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

  • Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
  • Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
  • No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

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Risk for Giant Cell Arteritis Rises With Air Pollution Levels

Article Type
Changed
Wed, 09/11/2024 - 13:48

 

TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM10) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

  • Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM10 and the risk for giant cell arteritis and its ischemic complications.
  • They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
  • The hourly and daily average concentrations of PM10 were collected from the Italian monitoring network; patients’ exposure to PM10 was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
  • The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

  • Every 10 μg/m3 increase in PM10 exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
  • This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
  • The positive association between incident giant cell arteritis and concentrations of PM10 was seen only when patients were exposed to high concentrations of PM10 (26.9 ± 13.8 μg/m3) but not low concentrations (11.9 ± 7.9 μg/m3).
  • This study did not show any significant association between exposure to PM10 and ischemic complications.

IN PRACTICE:

“Exposure to PM10 in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM10) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

  • Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM10 and the risk for giant cell arteritis and its ischemic complications.
  • They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
  • The hourly and daily average concentrations of PM10 were collected from the Italian monitoring network; patients’ exposure to PM10 was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
  • The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

  • Every 10 μg/m3 increase in PM10 exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
  • This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
  • The positive association between incident giant cell arteritis and concentrations of PM10 was seen only when patients were exposed to high concentrations of PM10 (26.9 ± 13.8 μg/m3) but not low concentrations (11.9 ± 7.9 μg/m3).
  • This study did not show any significant association between exposure to PM10 and ischemic complications.

IN PRACTICE:

“Exposure to PM10 in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM10) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

  • Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM10 and the risk for giant cell arteritis and its ischemic complications.
  • They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
  • The hourly and daily average concentrations of PM10 were collected from the Italian monitoring network; patients’ exposure to PM10 was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
  • The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

  • Every 10 μg/m3 increase in PM10 exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
  • This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
  • The positive association between incident giant cell arteritis and concentrations of PM10 was seen only when patients were exposed to high concentrations of PM10 (26.9 ± 13.8 μg/m3) but not low concentrations (11.9 ± 7.9 μg/m3).
  • This study did not show any significant association between exposure to PM10 and ischemic complications.

IN PRACTICE:

“Exposure to PM10 in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Pooled Trial Data Support Lower Uveitis Rate With Bimekizumab for Axial Spondyloarthritis

Article Type
Changed
Fri, 08/30/2024 - 10:51

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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SBRT vs Surgery in CRC Lung Metastases: Which Is Better?

Article Type
Changed
Mon, 09/09/2024 - 03:37

 

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

  • SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
  • In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
  • A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
  • The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

  • At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
  • Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
  • Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
  • Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

  • SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
  • In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
  • A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
  • The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

  • At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
  • Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
  • Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
  • Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

  • SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
  • In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
  • A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
  • The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

  • At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
  • Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
  • Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
  • Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Inhaled Insulin Aids Patients With Fear of Needles

Article Type
Changed
Fri, 08/30/2024 - 10:30

 

This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

 

 

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

 

 

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.



A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

 

 

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

 

 

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.



A version of this article first appeared on Medscape.com.

 

This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

 

 

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

 

 

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.



A version of this article first appeared on Medscape.com.

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What Are the Best Supplements for Patients With Kidney Disease? A Few Stand Out

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Tue, 09/03/2024 - 13:42

The global dietary supplement industry generates more than $400 billion a year. Supplements are alleged to treat many health concerns, from immune conditions and cognition to sexual dysfunction and premature wrinkles. Although some supplements have been proven to be helpful, others have no scientific basis.

I can preach all day that a healthy diet rarely needs supplementation. But even as a dietitian, I find it difficult to consistently eat a diet that is both sufficiently varied and adequate to provide for all my nutrition needs. Our patients with kidney disease, surely, are not immune to this plight. They may even be more inclined to nutrient deficiencies, as poor diet is linked to increased incidence and progression of chronic kidney disease (CKD).

I find that patients with kidney disease often have an interest in dietary supplementation, even those with a well-rounded diet. Though we can discourage the use of supplements, or at the very least encourage patient transparency regarding supplement use, many will continue dietary supplementation at the suggestion of their friends, family, or even their preferred daytime talk show host. 

What these patients truly require is education on using supplements that are most beneficial to them. By recommending supplements that address patients’ pain points like inflammation, dyslipidemia, cardiovascular health, and reduced progression to end-stage renal disease (ESRD), we can improve patient health and, hopefully, decrease use of questionable supplements.
 

Probiotics

Although probiotics have been used in the treatment of digestive issues for many years, the gut-kidney axis is only recently being explored. Studies show that the microbiota of patients with CKD is altered, even in the early stages of disease, producing additional inflammation and metabolic dysfunction. This can be remedied, or at least alleviated, by introducing a probiotic supplement.

Some probiotics have been shown to decrease inflammation, decrease fasting blood glucose, decrease low-density lipoprotein cholesterol, triglycerides, and total cholesterol, increase estimated glomerular filtration rate (eGFR), decrease blood urea nitrogen and urea, and decrease uric acid

Probiotic-rich foods like kimchi or fermented pickles may not be appropriate because of excessive sodium content or simply because of patient preference — kombucha isn’t for everyone. However, adding a probiotic supplement can improve gut microbiota without undermining dietary concerns. 

When recommending probiotics, patients should be educated to ensure that their probiotic has strains that have been proven to be beneficial for kidney health. Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium species, and Streptococcus thermophilus have been shown to have a positive effect on kidney health and decreasing progression of CKD at a dosage of 109 colony-forming units per day.
 

Fish Oil

Though nephrology and cardiology are separate fields, it cannot be overstated that kidney patients are also heart patients. 

Patients with CKD and an eGFR < 60 mL/min per 1.73 m2are most likely to die from cardiovascular causes, and this likelihood increases as eGFR decreases. CKD-associated dyslipidemia results in elevated triglycerides and reduced high-density lipoprotein cholesterol often accompanied by proteinuria, and has been linked to an increase in atherosclerosis.

A simple fish oil supplement can work to decrease oxidative stress, relieve inflammation, and improve serum lipids, leading to improved kidney and cardiovascular health. One meta-analysis found that high-dose fish oil supplementation, though it had no effect on serum creatinine or eGFR, was associated with a lower risk for proteinuria and progression to ESRD. 

Fish oil’s popularity in recent years bodes well for the kidney patient. It is now easily obtained over the counter in high doses to meet the recommended adequate intake of omega-3s, which is 1100 mg/d for women and 1600 mg/d for men. There are also more burpless varieties of these supplements to increase compliance. 
 

 

 

Vitamin D

Patients with renal disease are prone to vitamin D deficiency through inadequate intake and limited sunlight, which is exacerbated by the diseased kidney’s inability to effectively convert calcidiol to calcitriol. Vitamin D deficiency is linked to poor bone health, fatigue, muscle pain, impaired wound healing, and depression. Low vitamin D status has also been linked to poor outcomes in cancer, multiple sclerosis, cardiovascular disease, type 2 diabetes, and weight loss.

A meta-analysis of over 6000 patients with CKD found that high levels of 25-hydroxy vitamin D (25[OH]D) are associated with significantly improved survival rates regardless of CKD or ESRD status. 

Kidney Disease: Improving Global Outcomes guidelines recommend supplementing with ergocalciferol or cholecalciferol to correct (OH)D deficiency. This ensures adequate supply for conversion to calcitriol, but it cannot affect bone and mineral metabolism without further intervention in the form of calcitriol supplementation. By supplementing with ergocalciferol or cholecalciferol to meet the recommended daily allowance of 15 µg (600 IU) for adults under 70 years and 20 µg (800 IU) for adults over 70 years, the primary care team can ensure that the body has all the building blocks required for the nephrology team to then address mineral and bone disorder in CKD without the fear of promoting hypercalcemia
 

Safe Purchasing Practices

Patients should be reminded to purchase dietary supplements from reputable dealers, especially when purchasing online. Retailers like Amazon are increasing the barriers required to sell supplements to improve the quality of products sold on the site. But other online retailers may sell products from outside of the United States that fall outside of the Food and Drug Administration’s jurisdiction. 

Patients should also be reminded that “more is not always better” and counseled on appropriate dosages for individual needs. 
 

In Summary

Patients will probably continue to lean on dietary supplements, regardless of our approval. Transparency and education are important when working with patients with CKD, especially in regard to dietary supplements. 

When recommended appropriately, however, the supplements discussed can lead to better outcomes with improvements in kidney health by addressing inflammation, serum lipids, glycemic control, and cardiovascular health.

Ms. Winfree Root is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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The global dietary supplement industry generates more than $400 billion a year. Supplements are alleged to treat many health concerns, from immune conditions and cognition to sexual dysfunction and premature wrinkles. Although some supplements have been proven to be helpful, others have no scientific basis.

I can preach all day that a healthy diet rarely needs supplementation. But even as a dietitian, I find it difficult to consistently eat a diet that is both sufficiently varied and adequate to provide for all my nutrition needs. Our patients with kidney disease, surely, are not immune to this plight. They may even be more inclined to nutrient deficiencies, as poor diet is linked to increased incidence and progression of chronic kidney disease (CKD).

I find that patients with kidney disease often have an interest in dietary supplementation, even those with a well-rounded diet. Though we can discourage the use of supplements, or at the very least encourage patient transparency regarding supplement use, many will continue dietary supplementation at the suggestion of their friends, family, or even their preferred daytime talk show host. 

What these patients truly require is education on using supplements that are most beneficial to them. By recommending supplements that address patients’ pain points like inflammation, dyslipidemia, cardiovascular health, and reduced progression to end-stage renal disease (ESRD), we can improve patient health and, hopefully, decrease use of questionable supplements.
 

Probiotics

Although probiotics have been used in the treatment of digestive issues for many years, the gut-kidney axis is only recently being explored. Studies show that the microbiota of patients with CKD is altered, even in the early stages of disease, producing additional inflammation and metabolic dysfunction. This can be remedied, or at least alleviated, by introducing a probiotic supplement.

Some probiotics have been shown to decrease inflammation, decrease fasting blood glucose, decrease low-density lipoprotein cholesterol, triglycerides, and total cholesterol, increase estimated glomerular filtration rate (eGFR), decrease blood urea nitrogen and urea, and decrease uric acid

Probiotic-rich foods like kimchi or fermented pickles may not be appropriate because of excessive sodium content or simply because of patient preference — kombucha isn’t for everyone. However, adding a probiotic supplement can improve gut microbiota without undermining dietary concerns. 

When recommending probiotics, patients should be educated to ensure that their probiotic has strains that have been proven to be beneficial for kidney health. Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium species, and Streptococcus thermophilus have been shown to have a positive effect on kidney health and decreasing progression of CKD at a dosage of 109 colony-forming units per day.
 

Fish Oil

Though nephrology and cardiology are separate fields, it cannot be overstated that kidney patients are also heart patients. 

Patients with CKD and an eGFR < 60 mL/min per 1.73 m2are most likely to die from cardiovascular causes, and this likelihood increases as eGFR decreases. CKD-associated dyslipidemia results in elevated triglycerides and reduced high-density lipoprotein cholesterol often accompanied by proteinuria, and has been linked to an increase in atherosclerosis.

A simple fish oil supplement can work to decrease oxidative stress, relieve inflammation, and improve serum lipids, leading to improved kidney and cardiovascular health. One meta-analysis found that high-dose fish oil supplementation, though it had no effect on serum creatinine or eGFR, was associated with a lower risk for proteinuria and progression to ESRD. 

Fish oil’s popularity in recent years bodes well for the kidney patient. It is now easily obtained over the counter in high doses to meet the recommended adequate intake of omega-3s, which is 1100 mg/d for women and 1600 mg/d for men. There are also more burpless varieties of these supplements to increase compliance. 
 

 

 

Vitamin D

Patients with renal disease are prone to vitamin D deficiency through inadequate intake and limited sunlight, which is exacerbated by the diseased kidney’s inability to effectively convert calcidiol to calcitriol. Vitamin D deficiency is linked to poor bone health, fatigue, muscle pain, impaired wound healing, and depression. Low vitamin D status has also been linked to poor outcomes in cancer, multiple sclerosis, cardiovascular disease, type 2 diabetes, and weight loss.

A meta-analysis of over 6000 patients with CKD found that high levels of 25-hydroxy vitamin D (25[OH]D) are associated with significantly improved survival rates regardless of CKD or ESRD status. 

Kidney Disease: Improving Global Outcomes guidelines recommend supplementing with ergocalciferol or cholecalciferol to correct (OH)D deficiency. This ensures adequate supply for conversion to calcitriol, but it cannot affect bone and mineral metabolism without further intervention in the form of calcitriol supplementation. By supplementing with ergocalciferol or cholecalciferol to meet the recommended daily allowance of 15 µg (600 IU) for adults under 70 years and 20 µg (800 IU) for adults over 70 years, the primary care team can ensure that the body has all the building blocks required for the nephrology team to then address mineral and bone disorder in CKD without the fear of promoting hypercalcemia
 

Safe Purchasing Practices

Patients should be reminded to purchase dietary supplements from reputable dealers, especially when purchasing online. Retailers like Amazon are increasing the barriers required to sell supplements to improve the quality of products sold on the site. But other online retailers may sell products from outside of the United States that fall outside of the Food and Drug Administration’s jurisdiction. 

Patients should also be reminded that “more is not always better” and counseled on appropriate dosages for individual needs. 
 

In Summary

Patients will probably continue to lean on dietary supplements, regardless of our approval. Transparency and education are important when working with patients with CKD, especially in regard to dietary supplements. 

When recommended appropriately, however, the supplements discussed can lead to better outcomes with improvements in kidney health by addressing inflammation, serum lipids, glycemic control, and cardiovascular health.

Ms. Winfree Root is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

The global dietary supplement industry generates more than $400 billion a year. Supplements are alleged to treat many health concerns, from immune conditions and cognition to sexual dysfunction and premature wrinkles. Although some supplements have been proven to be helpful, others have no scientific basis.

I can preach all day that a healthy diet rarely needs supplementation. But even as a dietitian, I find it difficult to consistently eat a diet that is both sufficiently varied and adequate to provide for all my nutrition needs. Our patients with kidney disease, surely, are not immune to this plight. They may even be more inclined to nutrient deficiencies, as poor diet is linked to increased incidence and progression of chronic kidney disease (CKD).

I find that patients with kidney disease often have an interest in dietary supplementation, even those with a well-rounded diet. Though we can discourage the use of supplements, or at the very least encourage patient transparency regarding supplement use, many will continue dietary supplementation at the suggestion of their friends, family, or even their preferred daytime talk show host. 

What these patients truly require is education on using supplements that are most beneficial to them. By recommending supplements that address patients’ pain points like inflammation, dyslipidemia, cardiovascular health, and reduced progression to end-stage renal disease (ESRD), we can improve patient health and, hopefully, decrease use of questionable supplements.
 

Probiotics

Although probiotics have been used in the treatment of digestive issues for many years, the gut-kidney axis is only recently being explored. Studies show that the microbiota of patients with CKD is altered, even in the early stages of disease, producing additional inflammation and metabolic dysfunction. This can be remedied, or at least alleviated, by introducing a probiotic supplement.

Some probiotics have been shown to decrease inflammation, decrease fasting blood glucose, decrease low-density lipoprotein cholesterol, triglycerides, and total cholesterol, increase estimated glomerular filtration rate (eGFR), decrease blood urea nitrogen and urea, and decrease uric acid

Probiotic-rich foods like kimchi or fermented pickles may not be appropriate because of excessive sodium content or simply because of patient preference — kombucha isn’t for everyone. However, adding a probiotic supplement can improve gut microbiota without undermining dietary concerns. 

When recommending probiotics, patients should be educated to ensure that their probiotic has strains that have been proven to be beneficial for kidney health. Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium species, and Streptococcus thermophilus have been shown to have a positive effect on kidney health and decreasing progression of CKD at a dosage of 109 colony-forming units per day.
 

Fish Oil

Though nephrology and cardiology are separate fields, it cannot be overstated that kidney patients are also heart patients. 

Patients with CKD and an eGFR < 60 mL/min per 1.73 m2are most likely to die from cardiovascular causes, and this likelihood increases as eGFR decreases. CKD-associated dyslipidemia results in elevated triglycerides and reduced high-density lipoprotein cholesterol often accompanied by proteinuria, and has been linked to an increase in atherosclerosis.

A simple fish oil supplement can work to decrease oxidative stress, relieve inflammation, and improve serum lipids, leading to improved kidney and cardiovascular health. One meta-analysis found that high-dose fish oil supplementation, though it had no effect on serum creatinine or eGFR, was associated with a lower risk for proteinuria and progression to ESRD. 

Fish oil’s popularity in recent years bodes well for the kidney patient. It is now easily obtained over the counter in high doses to meet the recommended adequate intake of omega-3s, which is 1100 mg/d for women and 1600 mg/d for men. There are also more burpless varieties of these supplements to increase compliance. 
 

 

 

Vitamin D

Patients with renal disease are prone to vitamin D deficiency through inadequate intake and limited sunlight, which is exacerbated by the diseased kidney’s inability to effectively convert calcidiol to calcitriol. Vitamin D deficiency is linked to poor bone health, fatigue, muscle pain, impaired wound healing, and depression. Low vitamin D status has also been linked to poor outcomes in cancer, multiple sclerosis, cardiovascular disease, type 2 diabetes, and weight loss.

A meta-analysis of over 6000 patients with CKD found that high levels of 25-hydroxy vitamin D (25[OH]D) are associated with significantly improved survival rates regardless of CKD or ESRD status. 

Kidney Disease: Improving Global Outcomes guidelines recommend supplementing with ergocalciferol or cholecalciferol to correct (OH)D deficiency. This ensures adequate supply for conversion to calcitriol, but it cannot affect bone and mineral metabolism without further intervention in the form of calcitriol supplementation. By supplementing with ergocalciferol or cholecalciferol to meet the recommended daily allowance of 15 µg (600 IU) for adults under 70 years and 20 µg (800 IU) for adults over 70 years, the primary care team can ensure that the body has all the building blocks required for the nephrology team to then address mineral and bone disorder in CKD without the fear of promoting hypercalcemia
 

Safe Purchasing Practices

Patients should be reminded to purchase dietary supplements from reputable dealers, especially when purchasing online. Retailers like Amazon are increasing the barriers required to sell supplements to improve the quality of products sold on the site. But other online retailers may sell products from outside of the United States that fall outside of the Food and Drug Administration’s jurisdiction. 

Patients should also be reminded that “more is not always better” and counseled on appropriate dosages for individual needs. 
 

In Summary

Patients will probably continue to lean on dietary supplements, regardless of our approval. Transparency and education are important when working with patients with CKD, especially in regard to dietary supplements. 

When recommended appropriately, however, the supplements discussed can lead to better outcomes with improvements in kidney health by addressing inflammation, serum lipids, glycemic control, and cardiovascular health.

Ms. Winfree Root is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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Part of Taking a Good (Human) Patient History Includes Asking About Pet Vaccinations

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Tue, 09/03/2024 - 05:08

 

This transcript has been edited for clarity.

In my job, I spend 99% of my time thinking about ethical issues that arise in the care of human beings. That is the focus of our medical school, and that’s what we do. 

However, there are behaviors that are emerging with respect to pets that bear on human health and require the attention of doctors and nurses who deal with people who are pet owners.

Recently, there has been a great increase in the number of pet owners who are saying, “I’m not going to vaccinate my pets.” As horrible as this sounds, what’s happening is vaccine hesitancy about vaccines used in humans is extending through some people to their pets. 

The number of people who say they don’t trust things like rabies vaccine to be effective or safe for their pet animals is 40%, at least in surveys, and the American Veterinary Medical Association reports that 15%-18% of pet owners are not, in fact, vaccinating their pets against rabies.

Rabies, as I hope everybody knows, is one horrible disease. Even the treatment of it, should you get bitten by a rabid animal, is no fun, expensive, and hopefully something that can be administered quickly. It’s not always the case. Worldwide, at least 70,000 people die from rabies every year.

Obviously, there are many countries that are so terrified of rabies, they won’t let you bring pets in without quarantining them, say, England, for at least 6 months to a year, I believe, because they don’t want rabies getting into their country. They’re very strict about the movement of pets.

It is inexcusable for people, first, not to give their pets vaccines that prevent them getting distemper, parvovirus, or many other diseases that harm the pet. It’s also inexcusable to shorten your pet’s life or ask your patients to care for pets who get sick from many of these diseases that are vaccine preventable.

Worst of all, it’s inexcusable for any pet owner not to give a rabies vaccine to their pets. Were it up to me, I’d say you have to license your pet, and as part of that, you must mandate rabies vaccines for your dogs, cats, and other pets. 

We know what happens when people encounter wild animals like raccoons and rabbits. It is not a good situation. Your pets can easily encounter a rabid animal and then put themselves in a position where they can harm their human owners. 

We have an efficacious, safe treatment. If you’re dealing with someone, it might make sense to ask them, “Do you own a pet? Are you vaccinating?” It may not be something you’d ever thought about, but what we don’t need is rabies back in a bigger way in the United States than it’s been in the past.

I think, as a matter of prudence and public health, maybe firing up that question, “Got a pet in the house and are you vaccinating,” could be part of taking a good history.

 

Dr. Caplan is director of the division of medical ethics at New York University Langone Medical Center, New York City. He disclosed conflicts of interest with Johnson & Johnson and Medscape.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity.

In my job, I spend 99% of my time thinking about ethical issues that arise in the care of human beings. That is the focus of our medical school, and that’s what we do. 

However, there are behaviors that are emerging with respect to pets that bear on human health and require the attention of doctors and nurses who deal with people who are pet owners.

Recently, there has been a great increase in the number of pet owners who are saying, “I’m not going to vaccinate my pets.” As horrible as this sounds, what’s happening is vaccine hesitancy about vaccines used in humans is extending through some people to their pets. 

The number of people who say they don’t trust things like rabies vaccine to be effective or safe for their pet animals is 40%, at least in surveys, and the American Veterinary Medical Association reports that 15%-18% of pet owners are not, in fact, vaccinating their pets against rabies.

Rabies, as I hope everybody knows, is one horrible disease. Even the treatment of it, should you get bitten by a rabid animal, is no fun, expensive, and hopefully something that can be administered quickly. It’s not always the case. Worldwide, at least 70,000 people die from rabies every year.

Obviously, there are many countries that are so terrified of rabies, they won’t let you bring pets in without quarantining them, say, England, for at least 6 months to a year, I believe, because they don’t want rabies getting into their country. They’re very strict about the movement of pets.

It is inexcusable for people, first, not to give their pets vaccines that prevent them getting distemper, parvovirus, or many other diseases that harm the pet. It’s also inexcusable to shorten your pet’s life or ask your patients to care for pets who get sick from many of these diseases that are vaccine preventable.

Worst of all, it’s inexcusable for any pet owner not to give a rabies vaccine to their pets. Were it up to me, I’d say you have to license your pet, and as part of that, you must mandate rabies vaccines for your dogs, cats, and other pets. 

We know what happens when people encounter wild animals like raccoons and rabbits. It is not a good situation. Your pets can easily encounter a rabid animal and then put themselves in a position where they can harm their human owners. 

We have an efficacious, safe treatment. If you’re dealing with someone, it might make sense to ask them, “Do you own a pet? Are you vaccinating?” It may not be something you’d ever thought about, but what we don’t need is rabies back in a bigger way in the United States than it’s been in the past.

I think, as a matter of prudence and public health, maybe firing up that question, “Got a pet in the house and are you vaccinating,” could be part of taking a good history.

 

Dr. Caplan is director of the division of medical ethics at New York University Langone Medical Center, New York City. He disclosed conflicts of interest with Johnson & Johnson and Medscape.

A version of this article first appeared on Medscape.com.

 

This transcript has been edited for clarity.

In my job, I spend 99% of my time thinking about ethical issues that arise in the care of human beings. That is the focus of our medical school, and that’s what we do. 

However, there are behaviors that are emerging with respect to pets that bear on human health and require the attention of doctors and nurses who deal with people who are pet owners.

Recently, there has been a great increase in the number of pet owners who are saying, “I’m not going to vaccinate my pets.” As horrible as this sounds, what’s happening is vaccine hesitancy about vaccines used in humans is extending through some people to their pets. 

The number of people who say they don’t trust things like rabies vaccine to be effective or safe for their pet animals is 40%, at least in surveys, and the American Veterinary Medical Association reports that 15%-18% of pet owners are not, in fact, vaccinating their pets against rabies.

Rabies, as I hope everybody knows, is one horrible disease. Even the treatment of it, should you get bitten by a rabid animal, is no fun, expensive, and hopefully something that can be administered quickly. It’s not always the case. Worldwide, at least 70,000 people die from rabies every year.

Obviously, there are many countries that are so terrified of rabies, they won’t let you bring pets in without quarantining them, say, England, for at least 6 months to a year, I believe, because they don’t want rabies getting into their country. They’re very strict about the movement of pets.

It is inexcusable for people, first, not to give their pets vaccines that prevent them getting distemper, parvovirus, or many other diseases that harm the pet. It’s also inexcusable to shorten your pet’s life or ask your patients to care for pets who get sick from many of these diseases that are vaccine preventable.

Worst of all, it’s inexcusable for any pet owner not to give a rabies vaccine to their pets. Were it up to me, I’d say you have to license your pet, and as part of that, you must mandate rabies vaccines for your dogs, cats, and other pets. 

We know what happens when people encounter wild animals like raccoons and rabbits. It is not a good situation. Your pets can easily encounter a rabid animal and then put themselves in a position where they can harm their human owners. 

We have an efficacious, safe treatment. If you’re dealing with someone, it might make sense to ask them, “Do you own a pet? Are you vaccinating?” It may not be something you’d ever thought about, but what we don’t need is rabies back in a bigger way in the United States than it’s been in the past.

I think, as a matter of prudence and public health, maybe firing up that question, “Got a pet in the house and are you vaccinating,” could be part of taking a good history.

 

Dr. Caplan is director of the division of medical ethics at New York University Langone Medical Center, New York City. He disclosed conflicts of interest with Johnson & Johnson and Medscape.

A version of this article first appeared on Medscape.com.

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Men, Women, & Exercise: How Metabolism Differs

Article Type
Changed
Fri, 08/30/2024 - 09:50

 

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

  • By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
  • This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
  • Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
  • Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
  • The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

  • At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
  • Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
  • The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
  • The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

  • By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
  • This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
  • Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
  • Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
  • The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

  • At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
  • Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
  • The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
  • The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

  • By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
  • This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
  • Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
  • Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
  • The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

  • At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
  • Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
  • The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
  • The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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High-Dose Psilocybin Shows Promising Results for Depression

Article Type
Changed
Tue, 09/03/2024 - 10:31

 

TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Topics
Sections

 

TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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