Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: The clinical presentation of exocrine pancreatic insufficiency (EPI) is probably mild in the early postoperative period following gastric resectional surgery. Thus, routine pancreatic supplementation may not be needed after surgery; however, worsening of EPI symptoms should be carefully monitored.

Major finding: During a mean follow-up of 3 months, none of the patients developed clinically significant steatorrhoea or fat malabsorption in postoperative setting. Incidence of EPI (fecal elastase less than 200 μg/g) following gastric resectional surgery was 33.3%.

Study details: This prospective study included 60 patients who received total or subtotal gastrectomy for adenocarcinoma of the stomach. Pre- and postoperative FE testing was done in 27 patients.

Disclosures: This study was funded by the Internal Fluid research Grant, Christian Medical College, Vellore, India. The authors declared no conflicts of interest.

Source: Sridhar RP et al. Indian J Surg Oncol. 2021 Apr 5. doi: 10.1007/s13193-021-01315-7.

Key clinical point: The clinical presentation of exocrine pancreatic insufficiency (EPI) is probably mild in the early postoperative period following gastric resectional surgery. Thus, routine pancreatic supplementation may not be needed after surgery; however, worsening of EPI symptoms should be carefully monitored.

Major finding: During a mean follow-up of 3 months, none of the patients developed clinically significant steatorrhoea or fat malabsorption in postoperative setting. Incidence of EPI (fecal elastase less than 200 μg/g) following gastric resectional surgery was 33.3%.

Study details: This prospective study included 60 patients who received total or subtotal gastrectomy for adenocarcinoma of the stomach. Pre- and postoperative FE testing was done in 27 patients.

Disclosures: This study was funded by the Internal Fluid research Grant, Christian Medical College, Vellore, India. The authors declared no conflicts of interest.

Source: Sridhar RP et al. Indian J Surg Oncol. 2021 Apr 5. doi: 10.1007/s13193-021-01315-7.

Key clinical point: The clinical presentation of exocrine pancreatic insufficiency (EPI) is probably mild in the early postoperative period following gastric resectional surgery. Thus, routine pancreatic supplementation may not be needed after surgery; however, worsening of EPI symptoms should be carefully monitored.

Major finding: During a mean follow-up of 3 months, none of the patients developed clinically significant steatorrhoea or fat malabsorption in postoperative setting. Incidence of EPI (fecal elastase less than 200 μg/g) following gastric resectional surgery was 33.3%.

Study details: This prospective study included 60 patients who received total or subtotal gastrectomy for adenocarcinoma of the stomach. Pre- and postoperative FE testing was done in 27 patients.

Disclosures: This study was funded by the Internal Fluid research Grant, Christian Medical College, Vellore, India. The authors declared no conflicts of interest.

Source: Sridhar RP et al. Indian J Surg Oncol. 2021 Apr 5. doi: 10.1007/s13193-021-01315-7.

Key clinical point: Exogenous digestive enzyme replacement was associated with increased weight gain and head circumference growth in very low birth weight preterm infants with growth failure and signs and symptoms of exocrine pancreatic insufficiency (EPI).

Major finding: Average daily weight gain increased from 14.4 g/kg/day to 17.4 g/kg/day (P = .001) and head circumference growth rate increased from 0.74 cm/week to 0.95 cm/week (P = .028) during 2 weeks following administration of digestive enzyme replacement.

Study details: This was a retrospective study of 132 preterm infants with gestational age below 2 weeks and birth weight below 1250 g who survived for more than 14 days. Growth restriction despite intensified nutrition and poor exocrine pancreatic function was observed in 66 and 38 infants, respectively, of which 33 infants recieved exogenous digestive enzyme replacement.

Disclosures: No specific funding source was identified. Open Access was funded by ProjektDEAL. The authors declared no conflicts of interest.

Source: Münch A et al. Eur J Pediatr. 2021 Apr 10. doi: 10.1007/s00431-021-04069-0.

Key clinical point: Exogenous digestive enzyme replacement was associated with increased weight gain and head circumference growth in very low birth weight preterm infants with growth failure and signs and symptoms of exocrine pancreatic insufficiency (EPI).

Major finding: Average daily weight gain increased from 14.4 g/kg/day to 17.4 g/kg/day (P = .001) and head circumference growth rate increased from 0.74 cm/week to 0.95 cm/week (P = .028) during 2 weeks following administration of digestive enzyme replacement.

Study details: This was a retrospective study of 132 preterm infants with gestational age below 2 weeks and birth weight below 1250 g who survived for more than 14 days. Growth restriction despite intensified nutrition and poor exocrine pancreatic function was observed in 66 and 38 infants, respectively, of which 33 infants recieved exogenous digestive enzyme replacement.

Disclosures: No specific funding source was identified. Open Access was funded by ProjektDEAL. The authors declared no conflicts of interest.

Source: Münch A et al. Eur J Pediatr. 2021 Apr 10. doi: 10.1007/s00431-021-04069-0.

Key clinical point: Exogenous digestive enzyme replacement was associated with increased weight gain and head circumference growth in very low birth weight preterm infants with growth failure and signs and symptoms of exocrine pancreatic insufficiency (EPI).

Major finding: Average daily weight gain increased from 14.4 g/kg/day to 17.4 g/kg/day (P = .001) and head circumference growth rate increased from 0.74 cm/week to 0.95 cm/week (P = .028) during 2 weeks following administration of digestive enzyme replacement.

Study details: This was a retrospective study of 132 preterm infants with gestational age below 2 weeks and birth weight below 1250 g who survived for more than 14 days. Growth restriction despite intensified nutrition and poor exocrine pancreatic function was observed in 66 and 38 infants, respectively, of which 33 infants recieved exogenous digestive enzyme replacement.

Disclosures: No specific funding source was identified. Open Access was funded by ProjektDEAL. The authors declared no conflicts of interest.

Source: Münch A et al. Eur J Pediatr. 2021 Apr 10. doi: 10.1007/s00431-021-04069-0.

The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.

Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.

The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.

Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.

He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”

The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
 

FDA breakthrough designation

SEP-363856 has a completely different mechanism of action from currently available antipsychotics.

In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.

Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.

In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.

They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.

Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.

The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.

Significant improvement

The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).

Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).

In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.

During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.

PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.

When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.

Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.

In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
 

Still in development

Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.

Courtesy Mount Sinai Health System

Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. “The proof of the pudding is phase 3, and we have to wait and see,” he added.

“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”

He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.

“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.

“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.

Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.

However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.

The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.

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

The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.

Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.

The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.

Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.

He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”

The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
 

FDA breakthrough designation

SEP-363856 has a completely different mechanism of action from currently available antipsychotics.

In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.

Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.

In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.

They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.

Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.

The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.

Significant improvement

The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).

Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).

In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.

During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.

PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.

When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.

Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.

In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
 

Still in development

Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.

Courtesy Mount Sinai Health System

Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. “The proof of the pudding is phase 3, and we have to wait and see,” he added.

“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”

He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.

“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.

“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.

Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.

However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.

The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.

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

The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.

Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.

The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.

Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.

He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”

The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
 

FDA breakthrough designation

SEP-363856 has a completely different mechanism of action from currently available antipsychotics.

In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.

Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.

In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.

They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.

Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.

The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.

Significant improvement

The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).

Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).

In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.

During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.

PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.

When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.

Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.

In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
 

Still in development

Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.

Courtesy Mount Sinai Health System

Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. “The proof of the pudding is phase 3, and we have to wait and see,” he added.

“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”

He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.

“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.

“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.

Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.

However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.

The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.

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

Key clinical point: Exocrine pancreatic function appeared normal in critically ill children during the first week of admission to the pediatric intensive care unit (PICU).

Major finding: Fecal elastase-1 concentrations were normal (1-2 μg/g; n=10). Mean amylase levels on admission and PICU discharge were 13 (interquartile range [IQR], 6.5-41.5) U/L and 15.5 (IQR, 7-44) U/L, respectively. Mean lipase levels on admission and at PICU discharge were 11 (IQR, 6.8-19.5) U/L and 16.5 (IQR, 12.3-36.8) U/L, respectively.

Study details: Findings are from a prospective observational study that included 15 critically ill children (median age, 5 months) admitted to PICU (median stay, 15 days) at a tertiary hospital in Madrid, Spain.

Disclosures: No specific funding source was identified. The authors did not report any disclosures.

Source: Solana Garcia MJ et al. Pedia Crit Care Med. 2021 Mar doi: 10.1097/01.pcc.0000738960.34833.ce.

Key clinical point: Exocrine pancreatic function appeared normal in critically ill children during the first week of admission to the pediatric intensive care unit (PICU).

Major finding: Fecal elastase-1 concentrations were normal (1-2 μg/g; n=10). Mean amylase levels on admission and PICU discharge were 13 (interquartile range [IQR], 6.5-41.5) U/L and 15.5 (IQR, 7-44) U/L, respectively. Mean lipase levels on admission and at PICU discharge were 11 (IQR, 6.8-19.5) U/L and 16.5 (IQR, 12.3-36.8) U/L, respectively.

Study details: Findings are from a prospective observational study that included 15 critically ill children (median age, 5 months) admitted to PICU (median stay, 15 days) at a tertiary hospital in Madrid, Spain.

Disclosures: No specific funding source was identified. The authors did not report any disclosures.

Source: Solana Garcia MJ et al. Pedia Crit Care Med. 2021 Mar doi: 10.1097/01.pcc.0000738960.34833.ce.

Key clinical point: Exocrine pancreatic function appeared normal in critically ill children during the first week of admission to the pediatric intensive care unit (PICU).

Major finding: Fecal elastase-1 concentrations were normal (1-2 μg/g; n=10). Mean amylase levels on admission and PICU discharge were 13 (interquartile range [IQR], 6.5-41.5) U/L and 15.5 (IQR, 7-44) U/L, respectively. Mean lipase levels on admission and at PICU discharge were 11 (IQR, 6.8-19.5) U/L and 16.5 (IQR, 12.3-36.8) U/L, respectively.

Study details: Findings are from a prospective observational study that included 15 critically ill children (median age, 5 months) admitted to PICU (median stay, 15 days) at a tertiary hospital in Madrid, Spain.

Disclosures: No specific funding source was identified. The authors did not report any disclosures.

Source: Solana Garcia MJ et al. Pedia Crit Care Med. 2021 Mar doi: 10.1097/01.pcc.0000738960.34833.ce.

Key clinical point: Lipomatous pseudohypertrophy (LPH) of the pancreas is a rare disease with varied clinical presentation and different signs and symptoms. It could be a cause of exocrine pancreatic insufficiency (EPI) and thus requires patient follow-up and appropriate treatment.

Major finding: LPH of pancreas was diagnosed in a 26-year-old man under evaluation. Computed tomography scan and magnetic resonance imaging showed a diffusely enlarged pancreas with scattered remnants of pancreatic parenchyma. Pancreatic exocrine and endocrine functions were maintained as pockets of pancreatic parenchyma were preserved. The patient was discharged with an advice for regular follow-ups.

Study details: Findings are from analysis of a 26-year-old man admitted to hospital with loss of appetite for 6 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Luu VD et al. Radiology Case Reports. 2021 Apr 9. doi: 10.1016/j.radcr.2021.03.045.

Key clinical point: Lipomatous pseudohypertrophy (LPH) of the pancreas is a rare disease with varied clinical presentation and different signs and symptoms. It could be a cause of exocrine pancreatic insufficiency (EPI) and thus requires patient follow-up and appropriate treatment.

Major finding: LPH of pancreas was diagnosed in a 26-year-old man under evaluation. Computed tomography scan and magnetic resonance imaging showed a diffusely enlarged pancreas with scattered remnants of pancreatic parenchyma. Pancreatic exocrine and endocrine functions were maintained as pockets of pancreatic parenchyma were preserved. The patient was discharged with an advice for regular follow-ups.

Study details: Findings are from analysis of a 26-year-old man admitted to hospital with loss of appetite for 6 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Luu VD et al. Radiology Case Reports. 2021 Apr 9. doi: 10.1016/j.radcr.2021.03.045.

Key clinical point: Lipomatous pseudohypertrophy (LPH) of the pancreas is a rare disease with varied clinical presentation and different signs and symptoms. It could be a cause of exocrine pancreatic insufficiency (EPI) and thus requires patient follow-up and appropriate treatment.

Major finding: LPH of pancreas was diagnosed in a 26-year-old man under evaluation. Computed tomography scan and magnetic resonance imaging showed a diffusely enlarged pancreas with scattered remnants of pancreatic parenchyma. Pancreatic exocrine and endocrine functions were maintained as pockets of pancreatic parenchyma were preserved. The patient was discharged with an advice for regular follow-ups.

Study details: Findings are from analysis of a 26-year-old man admitted to hospital with loss of appetite for 6 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Luu VD et al. Radiology Case Reports. 2021 Apr 9. doi: 10.1016/j.radcr.2021.03.045.

Key clinical point: Over a 10-year period, an unexpected high prevalence of vitamin D overdosing was observed in patients with cystic fibrosis with odds of overdose higher in patients suffering from exocrine pancreatic insufficiency (EPI).

Major finding: Severe vitamin D overdose was observed in 5.3% of patients, with 2 patients developing clinical toxicity and presenting with severe hypercalcemia, hypercalciuria, and acute kidney injury necessitating hospitalization and monitoring. Patients experiencing vitamin D overdose were more likely to suffer from EPI or were homozygous for F508del.

Study details: Findings are from a retrospective review of 244 patients with a diagnosis of cystic fibrosis and at least 1 measure of serum 25(OH)D.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Planté-Bordeneuve T et al. Sci Rep. 2021 Apr 8. doi: 10.1038/s41598-021-87099-w.

Key clinical point: Over a 10-year period, an unexpected high prevalence of vitamin D overdosing was observed in patients with cystic fibrosis with odds of overdose higher in patients suffering from exocrine pancreatic insufficiency (EPI).

Major finding: Severe vitamin D overdose was observed in 5.3% of patients, with 2 patients developing clinical toxicity and presenting with severe hypercalcemia, hypercalciuria, and acute kidney injury necessitating hospitalization and monitoring. Patients experiencing vitamin D overdose were more likely to suffer from EPI or were homozygous for F508del.

Study details: Findings are from a retrospective review of 244 patients with a diagnosis of cystic fibrosis and at least 1 measure of serum 25(OH)D.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Planté-Bordeneuve T et al. Sci Rep. 2021 Apr 8. doi: 10.1038/s41598-021-87099-w.

Key clinical point: Over a 10-year period, an unexpected high prevalence of vitamin D overdosing was observed in patients with cystic fibrosis with odds of overdose higher in patients suffering from exocrine pancreatic insufficiency (EPI).

Major finding: Severe vitamin D overdose was observed in 5.3% of patients, with 2 patients developing clinical toxicity and presenting with severe hypercalcemia, hypercalciuria, and acute kidney injury necessitating hospitalization and monitoring. Patients experiencing vitamin D overdose were more likely to suffer from EPI or were homozygous for F508del.

Study details: Findings are from a retrospective review of 244 patients with a diagnosis of cystic fibrosis and at least 1 measure of serum 25(OH)D.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Planté-Bordeneuve T et al. Sci Rep. 2021 Apr 8. doi: 10.1038/s41598-021-87099-w.

Key clinical point: Overt exocrine insufficiency is rare in patients with pancreatic trauma but some asymptomatic patients may show biochemical exocrine insufficiencies on specific investigations, particularly after pancreatic resection.

Major finding: Severe pancreatic exocrine insufficiency (PEI) was seen in 4 patients (20%), of which 3 had undergone pancreatic resection (P = .7). Only 1 patient complained of steatorrhea. Patients undergoing pancreatic resection had lower fecal elastase than those who did not (median, 113 μg/g vs. 162.5 μg/g), although difference was not significant statistically (P = .7).

Study details: Findings are from analysis of 20 patients with grade 2-5 pancreatic injury (age, 18-65 years) who were admitted and managed at the division of Trauma Surgery and Critical Care. Patients either underwent partial pancreatic resection (n=12) or nonoperative management or operation without resection (n=8).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: Overt exocrine insufficiency is rare in patients with pancreatic trauma but some asymptomatic patients may show biochemical exocrine insufficiencies on specific investigations, particularly after pancreatic resection.

Major finding: Severe pancreatic exocrine insufficiency (PEI) was seen in 4 patients (20%), of which 3 had undergone pancreatic resection (P = .7). Only 1 patient complained of steatorrhea. Patients undergoing pancreatic resection had lower fecal elastase than those who did not (median, 113 μg/g vs. 162.5 μg/g), although difference was not significant statistically (P = .7).

Study details: Findings are from analysis of 20 patients with grade 2-5 pancreatic injury (age, 18-65 years) who were admitted and managed at the division of Trauma Surgery and Critical Care. Patients either underwent partial pancreatic resection (n=12) or nonoperative management or operation without resection (n=8).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: Overt exocrine insufficiency is rare in patients with pancreatic trauma but some asymptomatic patients may show biochemical exocrine insufficiencies on specific investigations, particularly after pancreatic resection.

Major finding: Severe pancreatic exocrine insufficiency (PEI) was seen in 4 patients (20%), of which 3 had undergone pancreatic resection (P = .7). Only 1 patient complained of steatorrhea. Patients undergoing pancreatic resection had lower fecal elastase than those who did not (median, 113 μg/g vs. 162.5 μg/g), although difference was not significant statistically (P = .7).

Study details: Findings are from analysis of 20 patients with grade 2-5 pancreatic injury (age, 18-65 years) who were admitted and managed at the division of Trauma Surgery and Critical Care. Patients either underwent partial pancreatic resection (n=12) or nonoperative management or operation without resection (n=8).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Colney L et al. Eur J Trauma Emerg Surg. 2021 Mar 14. doi: 10.1007/s00068-021-01638-8.

Key clinical point: During long-term follow-up, exocrine pancreatic insufficiency (EPI) was observed in more than half of the patients who underwent curative gastrectomy and had completed oncological treatment for gastric adenocarcinoma. Postoperative radiotherapy as an adjunct to adjuvant chemotherapy was a serious risk factor for EPI development.

Major finding: Fecal elastase-1 (FE-1) less than 200 μg/g, considered a measure of EPI, was present in 63.8% of patients. A higher proportion of patients with low FE-1 (less than 100 μg/g) received adjuvant chemoradiotherapy vs. those with moderate FE-1 (100-200 μg/g; P = .012) and normal FE-1 (less than 200 μg/g; P less than .001).

Study details: This study included 69 patients with gastric cancer who underwent total or subtotal curative gastrectomy with D2 lymphadenectomy and had long-term disease-free survival success. Patients were followed up for 16-120 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Surmelioglu A et al. Pancreatology. 2021 Apr 1. doi: 10.1016/j.pan.2021.03.019.

Key clinical point: During long-term follow-up, exocrine pancreatic insufficiency (EPI) was observed in more than half of the patients who underwent curative gastrectomy and had completed oncological treatment for gastric adenocarcinoma. Postoperative radiotherapy as an adjunct to adjuvant chemotherapy was a serious risk factor for EPI development.

Major finding: Fecal elastase-1 (FE-1) less than 200 μg/g, considered a measure of EPI, was present in 63.8% of patients. A higher proportion of patients with low FE-1 (less than 100 μg/g) received adjuvant chemoradiotherapy vs. those with moderate FE-1 (100-200 μg/g; P = .012) and normal FE-1 (less than 200 μg/g; P less than .001).

Study details: This study included 69 patients with gastric cancer who underwent total or subtotal curative gastrectomy with D2 lymphadenectomy and had long-term disease-free survival success. Patients were followed up for 16-120 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Surmelioglu A et al. Pancreatology. 2021 Apr 1. doi: 10.1016/j.pan.2021.03.019.

Key clinical point: During long-term follow-up, exocrine pancreatic insufficiency (EPI) was observed in more than half of the patients who underwent curative gastrectomy and had completed oncological treatment for gastric adenocarcinoma. Postoperative radiotherapy as an adjunct to adjuvant chemotherapy was a serious risk factor for EPI development.

Major finding: Fecal elastase-1 (FE-1) less than 200 μg/g, considered a measure of EPI, was present in 63.8% of patients. A higher proportion of patients with low FE-1 (less than 100 μg/g) received adjuvant chemoradiotherapy vs. those with moderate FE-1 (100-200 μg/g; P = .012) and normal FE-1 (less than 200 μg/g; P less than .001).

Study details: This study included 69 patients with gastric cancer who underwent total or subtotal curative gastrectomy with D2 lymphadenectomy and had long-term disease-free survival success. Patients were followed up for 16-120 months.

Disclosures: No specific funding source was identified. The authors declared no conflicts of interest.

Source: Surmelioglu A et al. Pancreatology. 2021 Apr 1. doi: 10.1016/j.pan.2021.03.019.

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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