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Premeal Stomach-Filling Capsule Effective for Weight Loss
TOPLINE:
Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.
METHODOLOGY:
- Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
- This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
- One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
- Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
- Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).
TAKEAWAY:
- At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
- The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
- Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
- Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.
IN PRACTICE:
“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.
SOURCE:
Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.
DISCLOSURES:
This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.
METHODOLOGY:
- Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
- This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
- One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
- Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
- Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).
TAKEAWAY:
- At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
- The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
- Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
- Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.
IN PRACTICE:
“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.
SOURCE:
Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.
DISCLOSURES:
This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.
METHODOLOGY:
- Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
- This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
- One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
- Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
- Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).
TAKEAWAY:
- At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
- The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
- Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
- Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.
IN PRACTICE:
“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.
SOURCE:
Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.
DISCLOSURES:
This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.
A version of this article appeared on Medscape.com.
Younger Age at Diabetes Onset Raises Cancer Risk
TOPLINE:
A diagnosis of type 2 diabetes (T2D) at a younger age is associated with an increased cancer risk, while the risk drops for T2D diagnosed at age 75 and older.
METHODOLOGY:
- A T2D diagnosis at a younger age is associated with a greater risk for complications and comorbidities, such as cardiovascular and kidney diseases, retinopathy, and dementia than that occurring at an older age.
- The study evaluated the association between the age at T2D diagnosis and subsequent risk for overall and 14 site-specific cancers in a Shanghai, China, cohort of 428,568 patients newly diagnosed with T2D (about half women) from 2011 to 2018.
- New cases of cancer from the T2D diagnosis to 2018 were identified through a tumor registry.
- Patients were categorized into six groups based on their age at T2D diagnosis: 20-54, 55-59, 60-64, 65-69, 70-74, and ≥ 75 years.
- The incidence rates of overall and 14 site-specific cancers were compared between patients with T2D and the general Shanghai population (older than 20 years).
TAKEAWAY:
- Compared to the general population, T2D increased the relative risk for all-cause cancer by 10% (standardized incidence ratios [SIRs], 1.10; 95% CI, 1.09-1.12).
- :
- 20-54 years: 1.48 (95% CI, 1.41-1.54)
- 55-59 years: 1.30 (95% CI, 1.25-1.35)
- 60-64 years: 1.19 (95% CI, 1.15-1.23)
- 65-69 years: 1.16 (95% CI, 1.12-1.20)
- 70-74 years: 1.06 (95% CI, 1.02-1.10)
- The overall cancer incidence risk in patients diagnosed with T2D at age ≥ 75 years was even lower than that in the general population (SIR, 0.86; 95% CI, 0.84-0.89).
- The risk (SIR) for most site-specific cancers (including respiratory, colorectal, stomach, liver, pancreatic, bladder, central nervous system, kidney, and gallbladder cancers and lymphoma) decreased with increasing age at T2D diagnosis.
IN PRACTICE:
“Our findings suggest that the carcinogenicity of T2D differs markedly by age at diagnosis and highlights the necessity of stratifying patients according to diagnosis age in management, screening, and preventative strategies,” wrote the authors.
SOURCE:
The study, led by Yanyun Li, Division of Chronic Non-Communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China, was published online in Diabetes Care.
LIMITATIONS:
Data on smoking history, alcohol consumption, and physical activity were available for nearly 60% of patients with T2D. The findings might only apply to patients with T2D who survive longer than the average and are therefore less applicable to the general population with diabetes. Patients with young-onset T2D had not reached the age where cancers are more prevalent despite as many as 8 years of follow-up.
DISCLOSURES:
This work was supported by the Foundation of National Facility for Translational Medicine, National Natural Science Foundation of China, Shanghai Municipal Health Commission, and Three-Year Action Plan of Shanghai Public Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
A diagnosis of type 2 diabetes (T2D) at a younger age is associated with an increased cancer risk, while the risk drops for T2D diagnosed at age 75 and older.
METHODOLOGY:
- A T2D diagnosis at a younger age is associated with a greater risk for complications and comorbidities, such as cardiovascular and kidney diseases, retinopathy, and dementia than that occurring at an older age.
- The study evaluated the association between the age at T2D diagnosis and subsequent risk for overall and 14 site-specific cancers in a Shanghai, China, cohort of 428,568 patients newly diagnosed with T2D (about half women) from 2011 to 2018.
- New cases of cancer from the T2D diagnosis to 2018 were identified through a tumor registry.
- Patients were categorized into six groups based on their age at T2D diagnosis: 20-54, 55-59, 60-64, 65-69, 70-74, and ≥ 75 years.
- The incidence rates of overall and 14 site-specific cancers were compared between patients with T2D and the general Shanghai population (older than 20 years).
TAKEAWAY:
- Compared to the general population, T2D increased the relative risk for all-cause cancer by 10% (standardized incidence ratios [SIRs], 1.10; 95% CI, 1.09-1.12).
- :
- 20-54 years: 1.48 (95% CI, 1.41-1.54)
- 55-59 years: 1.30 (95% CI, 1.25-1.35)
- 60-64 years: 1.19 (95% CI, 1.15-1.23)
- 65-69 years: 1.16 (95% CI, 1.12-1.20)
- 70-74 years: 1.06 (95% CI, 1.02-1.10)
- The overall cancer incidence risk in patients diagnosed with T2D at age ≥ 75 years was even lower than that in the general population (SIR, 0.86; 95% CI, 0.84-0.89).
- The risk (SIR) for most site-specific cancers (including respiratory, colorectal, stomach, liver, pancreatic, bladder, central nervous system, kidney, and gallbladder cancers and lymphoma) decreased with increasing age at T2D diagnosis.
IN PRACTICE:
“Our findings suggest that the carcinogenicity of T2D differs markedly by age at diagnosis and highlights the necessity of stratifying patients according to diagnosis age in management, screening, and preventative strategies,” wrote the authors.
SOURCE:
The study, led by Yanyun Li, Division of Chronic Non-Communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China, was published online in Diabetes Care.
LIMITATIONS:
Data on smoking history, alcohol consumption, and physical activity were available for nearly 60% of patients with T2D. The findings might only apply to patients with T2D who survive longer than the average and are therefore less applicable to the general population with diabetes. Patients with young-onset T2D had not reached the age where cancers are more prevalent despite as many as 8 years of follow-up.
DISCLOSURES:
This work was supported by the Foundation of National Facility for Translational Medicine, National Natural Science Foundation of China, Shanghai Municipal Health Commission, and Three-Year Action Plan of Shanghai Public Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
A diagnosis of type 2 diabetes (T2D) at a younger age is associated with an increased cancer risk, while the risk drops for T2D diagnosed at age 75 and older.
METHODOLOGY:
- A T2D diagnosis at a younger age is associated with a greater risk for complications and comorbidities, such as cardiovascular and kidney diseases, retinopathy, and dementia than that occurring at an older age.
- The study evaluated the association between the age at T2D diagnosis and subsequent risk for overall and 14 site-specific cancers in a Shanghai, China, cohort of 428,568 patients newly diagnosed with T2D (about half women) from 2011 to 2018.
- New cases of cancer from the T2D diagnosis to 2018 were identified through a tumor registry.
- Patients were categorized into six groups based on their age at T2D diagnosis: 20-54, 55-59, 60-64, 65-69, 70-74, and ≥ 75 years.
- The incidence rates of overall and 14 site-specific cancers were compared between patients with T2D and the general Shanghai population (older than 20 years).
TAKEAWAY:
- Compared to the general population, T2D increased the relative risk for all-cause cancer by 10% (standardized incidence ratios [SIRs], 1.10; 95% CI, 1.09-1.12).
- :
- 20-54 years: 1.48 (95% CI, 1.41-1.54)
- 55-59 years: 1.30 (95% CI, 1.25-1.35)
- 60-64 years: 1.19 (95% CI, 1.15-1.23)
- 65-69 years: 1.16 (95% CI, 1.12-1.20)
- 70-74 years: 1.06 (95% CI, 1.02-1.10)
- The overall cancer incidence risk in patients diagnosed with T2D at age ≥ 75 years was even lower than that in the general population (SIR, 0.86; 95% CI, 0.84-0.89).
- The risk (SIR) for most site-specific cancers (including respiratory, colorectal, stomach, liver, pancreatic, bladder, central nervous system, kidney, and gallbladder cancers and lymphoma) decreased with increasing age at T2D diagnosis.
IN PRACTICE:
“Our findings suggest that the carcinogenicity of T2D differs markedly by age at diagnosis and highlights the necessity of stratifying patients according to diagnosis age in management, screening, and preventative strategies,” wrote the authors.
SOURCE:
The study, led by Yanyun Li, Division of Chronic Non-Communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China, was published online in Diabetes Care.
LIMITATIONS:
Data on smoking history, alcohol consumption, and physical activity were available for nearly 60% of patients with T2D. The findings might only apply to patients with T2D who survive longer than the average and are therefore less applicable to the general population with diabetes. Patients with young-onset T2D had not reached the age where cancers are more prevalent despite as many as 8 years of follow-up.
DISCLOSURES:
This work was supported by the Foundation of National Facility for Translational Medicine, National Natural Science Foundation of China, Shanghai Municipal Health Commission, and Three-Year Action Plan of Shanghai Public Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.