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The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.

The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.

The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The Food and Drug Administration has expanded the approved indication for atezolizumab (Tecentriq) in patients with non–small cell lung cancer (NSCLC).

Atezolizumab is now approved as first-line monotherapy for adults with metastatic NSCLC whose tumors are EGFR and ALK wild-type but have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area).

The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic to identify patients with NSCLC who are eligible for treatment with atezolizumab.

The drug was evaluated in the IMpower110 trial (NCT02409342), which enrolled patients with stage IV, PD-L1–positive (tumor cells [TC] ≥1% or immune cells [IC] ≥1%) NSCLC who had received no prior chemotherapy for metastatic disease.

The patients were randomized to receive atezolizumab at 1,200 mg every 3 weeks (n = 286) or platinum-based chemotherapy (n = 263), which consisted of carboplatin or cisplatin with either pemetrexed or gemcitabine, until disease progression or unacceptable toxicity.

Overall survival was superior in the atezolizumab arm, but only among patients with high PD-L1 expression (TC ≥50% or IC ≥10%). The median overall survival was 20.2 months among PD-L1–high patients in the atezolizumab arm and 13.1 months among PD-L1–high patients in the chemotherapy arm (hazard ratio, 0.59; P = .0106). There was no significant difference in overall survival between the treatment arms for patients in the other two PD-L1 subgroups – TC ≥5% or IC ≥5% and TC ≥1% or IC ≥1%.

Serious adverse events occurred in 28% of patients receiving atezolizumab. The most frequent of these were pneumonia (2.8%), chronic obstructive pulmonary disease (2.1%), and pneumonitis (2.1%). Fatal adverse events in the atezolizumab arm included unexplained death, aspiration, chronic obstructive pulmonary disease, pulmonary embolism, acute myocardial infarction, cardiac arrest, mechanical ileus, sepsis, cerebral infraction, and device occlusion (one patient each).

For more details on atezolizumab, see the full prescribing information.

The FDA has granted the approval of atezolizumab to Genentech and the approval of the VENTANA PD-L1 (SP142) Assay to Ventana Medical Systems.

The Food and Drug Administration has expanded the approved indication for atezolizumab (Tecentriq) in patients with non–small cell lung cancer (NSCLC).

Atezolizumab is now approved as first-line monotherapy for adults with metastatic NSCLC whose tumors are EGFR and ALK wild-type but have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area).

The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic to identify patients with NSCLC who are eligible for treatment with atezolizumab.

The drug was evaluated in the IMpower110 trial (NCT02409342), which enrolled patients with stage IV, PD-L1–positive (tumor cells [TC] ≥1% or immune cells [IC] ≥1%) NSCLC who had received no prior chemotherapy for metastatic disease.

The patients were randomized to receive atezolizumab at 1,200 mg every 3 weeks (n = 286) or platinum-based chemotherapy (n = 263), which consisted of carboplatin or cisplatin with either pemetrexed or gemcitabine, until disease progression or unacceptable toxicity.

Overall survival was superior in the atezolizumab arm, but only among patients with high PD-L1 expression (TC ≥50% or IC ≥10%). The median overall survival was 20.2 months among PD-L1–high patients in the atezolizumab arm and 13.1 months among PD-L1–high patients in the chemotherapy arm (hazard ratio, 0.59; P = .0106). There was no significant difference in overall survival between the treatment arms for patients in the other two PD-L1 subgroups – TC ≥5% or IC ≥5% and TC ≥1% or IC ≥1%.

Serious adverse events occurred in 28% of patients receiving atezolizumab. The most frequent of these were pneumonia (2.8%), chronic obstructive pulmonary disease (2.1%), and pneumonitis (2.1%). Fatal adverse events in the atezolizumab arm included unexplained death, aspiration, chronic obstructive pulmonary disease, pulmonary embolism, acute myocardial infarction, cardiac arrest, mechanical ileus, sepsis, cerebral infraction, and device occlusion (one patient each).

For more details on atezolizumab, see the full prescribing information.

The FDA has granted the approval of atezolizumab to Genentech and the approval of the VENTANA PD-L1 (SP142) Assay to Ventana Medical Systems.

The Food and Drug Administration has expanded the approved indication for atezolizumab (Tecentriq) in patients with non–small cell lung cancer (NSCLC).

Atezolizumab is now approved as first-line monotherapy for adults with metastatic NSCLC whose tumors are EGFR and ALK wild-type but have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area).

The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic to identify patients with NSCLC who are eligible for treatment with atezolizumab.

The drug was evaluated in the IMpower110 trial (NCT02409342), which enrolled patients with stage IV, PD-L1–positive (tumor cells [TC] ≥1% or immune cells [IC] ≥1%) NSCLC who had received no prior chemotherapy for metastatic disease.

The patients were randomized to receive atezolizumab at 1,200 mg every 3 weeks (n = 286) or platinum-based chemotherapy (n = 263), which consisted of carboplatin or cisplatin with either pemetrexed or gemcitabine, until disease progression or unacceptable toxicity.

Overall survival was superior in the atezolizumab arm, but only among patients with high PD-L1 expression (TC ≥50% or IC ≥10%). The median overall survival was 20.2 months among PD-L1–high patients in the atezolizumab arm and 13.1 months among PD-L1–high patients in the chemotherapy arm (hazard ratio, 0.59; P = .0106). There was no significant difference in overall survival between the treatment arms for patients in the other two PD-L1 subgroups – TC ≥5% or IC ≥5% and TC ≥1% or IC ≥1%.

Serious adverse events occurred in 28% of patients receiving atezolizumab. The most frequent of these were pneumonia (2.8%), chronic obstructive pulmonary disease (2.1%), and pneumonitis (2.1%). Fatal adverse events in the atezolizumab arm included unexplained death, aspiration, chronic obstructive pulmonary disease, pulmonary embolism, acute myocardial infarction, cardiac arrest, mechanical ileus, sepsis, cerebral infraction, and device occlusion (one patient each).

For more details on atezolizumab, see the full prescribing information.

The FDA has granted the approval of atezolizumab to Genentech and the approval of the VENTANA PD-L1 (SP142) Assay to Ventana Medical Systems.

A new CT scan pulmonary angiography model may help optimize the diagnostic work-up process for patients with suspected pulmonary hypertension (PH), according to a recent study.

The diagnostic and prognostic utility of the model was validated in a tertiary referral population of treatment-naive patients who had a high pretest probability of PH.

“The aim of this study was to (a) build a diagnostic CT model in patients with suspected PH using the current guideline definition of PH (mPAP [mean pulmonary arterial pressure] ≥25 mm Hg) and the recent proposed definition of >20 mm Hg and (b) test its prognostic significance,” wrote Andrew J. Swift, MBChB, PhD, of the University of Sheffield (England) and colleagues in European Radiology.

The study cohort included 491 patients with suspected PH who underwent routine CT pulmonary angiography and right-heart catheterization between April 2012 and March 2016. CT metrics for patients with PH were developed using axial and reconstructed images.

The researchers identified the derivation (n = 247) and validation (n = 244) cohorts using random patient selection. In the derivation cohort, multivariate regression analysis was conducted to develop a model with the ability to predict mPAP ≥25 mm Hg and >20 mm Hg.

In the validation cohort, receiver operating characteristic analysis was performed to establish compromise CT thresholds, as well as sensitivity and specificity. The prognostic utility of the model was evaluated using Kaplan-Meier analysis.
 

Derivation cohort

Among the 247 patients in the derivation cohort, a CT regression model was identified, which included right-ventricle outflow tract thickness, main pulmonary artery diameter, and left ventricular area and interventricular septal angle; the area under the curve (AUC) in this cohort was 0.92.

Validation cohort

Among the 244 patients in the validation cohort, the model demonstrated strong diagnostic utility for the detection of PH, with an AUC of 0.91 and 0.94 for mPAP >20 mm Hg and ≥25 mm Hg, respectively.

With respect to the prognostic utility of the model, the researchers found that the diagnostic thresholds were prognostic in the CT model (all P < .01).

“The diagnostic CT thresholds are also of prognostic value; patients found not to have PH on CT have an excellent outcome,” they explained.

Dr. Swift and colleagues acknowledged that positive and negative predictive values will change based on the diagnostic setting. As a result, the findings from the current study may only be applicable to tertiary referral patient populations.

“This data may be particularly helpful when triaging patients with suspected severe PH for consideration of targeted pulmonary vascular therapies,” they concluded.

The study was supported by Wellcome Trust, the National Institute for Health Research, MRC POLARIS, and Bayer. The authors reported having no conflicts of interest with any companies related to the publication.

SOURCE: Swift AJ et al. Eur Radiol. 2020 Apr 27. doi: 10.1007/s00330-020-06846-1.

A new CT scan pulmonary angiography model may help optimize the diagnostic work-up process for patients with suspected pulmonary hypertension (PH), according to a recent study.

The diagnostic and prognostic utility of the model was validated in a tertiary referral population of treatment-naive patients who had a high pretest probability of PH.

“The aim of this study was to (a) build a diagnostic CT model in patients with suspected PH using the current guideline definition of PH (mPAP [mean pulmonary arterial pressure] ≥25 mm Hg) and the recent proposed definition of >20 mm Hg and (b) test its prognostic significance,” wrote Andrew J. Swift, MBChB, PhD, of the University of Sheffield (England) and colleagues in European Radiology.

The study cohort included 491 patients with suspected PH who underwent routine CT pulmonary angiography and right-heart catheterization between April 2012 and March 2016. CT metrics for patients with PH were developed using axial and reconstructed images.

The researchers identified the derivation (n = 247) and validation (n = 244) cohorts using random patient selection. In the derivation cohort, multivariate regression analysis was conducted to develop a model with the ability to predict mPAP ≥25 mm Hg and >20 mm Hg.

In the validation cohort, receiver operating characteristic analysis was performed to establish compromise CT thresholds, as well as sensitivity and specificity. The prognostic utility of the model was evaluated using Kaplan-Meier analysis.
 

Derivation cohort

Among the 247 patients in the derivation cohort, a CT regression model was identified, which included right-ventricle outflow tract thickness, main pulmonary artery diameter, and left ventricular area and interventricular septal angle; the area under the curve (AUC) in this cohort was 0.92.

Validation cohort

Among the 244 patients in the validation cohort, the model demonstrated strong diagnostic utility for the detection of PH, with an AUC of 0.91 and 0.94 for mPAP >20 mm Hg and ≥25 mm Hg, respectively.

With respect to the prognostic utility of the model, the researchers found that the diagnostic thresholds were prognostic in the CT model (all P < .01).

“The diagnostic CT thresholds are also of prognostic value; patients found not to have PH on CT have an excellent outcome,” they explained.

Dr. Swift and colleagues acknowledged that positive and negative predictive values will change based on the diagnostic setting. As a result, the findings from the current study may only be applicable to tertiary referral patient populations.

“This data may be particularly helpful when triaging patients with suspected severe PH for consideration of targeted pulmonary vascular therapies,” they concluded.

The study was supported by Wellcome Trust, the National Institute for Health Research, MRC POLARIS, and Bayer. The authors reported having no conflicts of interest with any companies related to the publication.

SOURCE: Swift AJ et al. Eur Radiol. 2020 Apr 27. doi: 10.1007/s00330-020-06846-1.

A new CT scan pulmonary angiography model may help optimize the diagnostic work-up process for patients with suspected pulmonary hypertension (PH), according to a recent study.

The diagnostic and prognostic utility of the model was validated in a tertiary referral population of treatment-naive patients who had a high pretest probability of PH.

“The aim of this study was to (a) build a diagnostic CT model in patients with suspected PH using the current guideline definition of PH (mPAP [mean pulmonary arterial pressure] ≥25 mm Hg) and the recent proposed definition of >20 mm Hg and (b) test its prognostic significance,” wrote Andrew J. Swift, MBChB, PhD, of the University of Sheffield (England) and colleagues in European Radiology.

The study cohort included 491 patients with suspected PH who underwent routine CT pulmonary angiography and right-heart catheterization between April 2012 and March 2016. CT metrics for patients with PH were developed using axial and reconstructed images.

The researchers identified the derivation (n = 247) and validation (n = 244) cohorts using random patient selection. In the derivation cohort, multivariate regression analysis was conducted to develop a model with the ability to predict mPAP ≥25 mm Hg and >20 mm Hg.

In the validation cohort, receiver operating characteristic analysis was performed to establish compromise CT thresholds, as well as sensitivity and specificity. The prognostic utility of the model was evaluated using Kaplan-Meier analysis.
 

Derivation cohort

Among the 247 patients in the derivation cohort, a CT regression model was identified, which included right-ventricle outflow tract thickness, main pulmonary artery diameter, and left ventricular area and interventricular septal angle; the area under the curve (AUC) in this cohort was 0.92.

Validation cohort

Among the 244 patients in the validation cohort, the model demonstrated strong diagnostic utility for the detection of PH, with an AUC of 0.91 and 0.94 for mPAP >20 mm Hg and ≥25 mm Hg, respectively.

With respect to the prognostic utility of the model, the researchers found that the diagnostic thresholds were prognostic in the CT model (all P < .01).

“The diagnostic CT thresholds are also of prognostic value; patients found not to have PH on CT have an excellent outcome,” they explained.

Dr. Swift and colleagues acknowledged that positive and negative predictive values will change based on the diagnostic setting. As a result, the findings from the current study may only be applicable to tertiary referral patient populations.

“This data may be particularly helpful when triaging patients with suspected severe PH for consideration of targeted pulmonary vascular therapies,” they concluded.

The study was supported by Wellcome Trust, the National Institute for Health Research, MRC POLARIS, and Bayer. The authors reported having no conflicts of interest with any companies related to the publication.

SOURCE: Swift AJ et al. Eur Radiol. 2020 Apr 27. doi: 10.1007/s00330-020-06846-1.

Biomarkers for inflammation and thrombosis may predict deaths from COVID-19 among critically ill patients, researchers say.

Courtesy NIAID

Their prospective cohort study of 1150 patients hospitalized with the disease in New York City also revealed a high proportion of racial and ethnic minorities, and confirmed high rates of critical illness and mortality.

“Of particular interest is the finding that over three quarters of critically ill patients required a ventilator and almost one third required renal dialysis support,” Max O’Donnell, MD, MPH, assistant professor of medicine and epidemiology at Columbia University in New York City, said in a press release.

O’Donnell and colleagues published the results of their study online today in The Lancet. It is the largest prospective cohort study published in the United States, they said.

“Although the clinical spectrum of disease has been characterised in reports from China and Italy, until now, detailed understanding of how the virus is affecting critically ill patients in the US has been limited to reports from a small number of cases,” said Natalie Yip, MD, assistant professor of medicine at Columbia University.

In the cohort, drawn from two NewYork-Presbyterian hospitals, the researchers focused on the 257 (22%) patients who required intensive care. When they estimated inflammation through interleukin-6 (IL-6) concentrations and thrombosis through D-dimer concentrations, they found a 10% increased risk for death with every 10% increase of IL-6 (adjusted hazard ratio [aHR], 1.11; 95% confidence interval [CI], 1.02–1.20) or D-dimer concentration (aHR, 1.10; 95% CI, 1.01–1.19).

“The association of mortality with higher concentrations of IL-6 and d-dimer is particularly relevant for two reasons,” write Giacomo Grasselli, from the Fondazione IRCCS Ca’ Granda Ospediale Maggiore Policlinico, and Alberto Zanella, from the University of Milan, Italy, in an accompanying commentary.

“First, it confirms the key pathogenic role played by the activation of systemic inflammation and endothelial-vascular damage in the development of organ dysfunction,” they write. “Second, it provides the rationale for the design of clinical trials for measuring the efficacy of treatment with immunomodulating and anticoagulant drugs.”

Seventeen percent of patients received interleukin receptor antagonists and 26% received corticosteroids, but the authors did not report any data on the effects of these treatments, or any data about anticoagulant therapies administered.
 

Severe disease common

The study also highlighted a high proportion of ethnic and racial minorities. Sixty-two percent of the critically ill patients were Hispanic or Latinx, 19% Black, 32% White, and 3% Asian.

Their median age was 62 years and 67% were men. Eighty-two percent had at least one chronic illness, most commonly hypertension (63%), followed by diabetes (36%). Forty-six percent were obese.

As of April 28, 2020, 101 (39%) of the critically ill patients had died following a median of 9 days (interquartile range (IQR), 5–15) in the hospital and 94 (37%) remained hospitalized. Of the 203 patients who received invasive mechanical ventilation, 84 (41%) had died.

The poor prognosis of patients requiring ventilation is consistent with data from a report on patients treated in National Health Service intensive care units in England, Wales, and Northern Ireland through May 15. Overall, 11,292 patients with COVID-19 required critical care, and 4855 needed advanced respiratory support. Approximately half of the patients receiving mechanical ventilation had died 30 days after starting critical care.

In the New York study, patients spent an average of 18 days on a ventilator (IQR, 9–28 days). This is a longer period than reported in smaller studies of cases from Washington state, but corresponds with a recent report from Italy, the researchers said.

Remarkably, O’Donnell and colleagues report that almost a third (31%) of critically ill patients developed severe kidney damage and required dialysis.

Mortality was associated with several baseline factors, including older age (aHR, 1.31 [95% CI, 1.09–1.57] per 10-year increase), chronic cardiac disease (aHR, 1.76; 95% CI, 1.08–2·86), and chronic pulmonary disease (aHR, 2.94; 95% CI, 1.48–5.84).

Authors of the New York study reported financial relationships to ICE Neurosystems, ALung Technologies, Baxter, BREETHE, Xenios, Hemovent, Gilead Sciences, Amazon, and Karyopharm Therapeutics. Grasselli reports personal fees from Biotest, Draeger, Fisher & Paykel, Maquet, Merck Sharp & Dohme, and Pfizer, all outside the area of work commented on here. Zanella has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Biomarkers for inflammation and thrombosis may predict deaths from COVID-19 among critically ill patients, researchers say.

Courtesy NIAID

Their prospective cohort study of 1150 patients hospitalized with the disease in New York City also revealed a high proportion of racial and ethnic minorities, and confirmed high rates of critical illness and mortality.

“Of particular interest is the finding that over three quarters of critically ill patients required a ventilator and almost one third required renal dialysis support,” Max O’Donnell, MD, MPH, assistant professor of medicine and epidemiology at Columbia University in New York City, said in a press release.

O’Donnell and colleagues published the results of their study online today in The Lancet. It is the largest prospective cohort study published in the United States, they said.

“Although the clinical spectrum of disease has been characterised in reports from China and Italy, until now, detailed understanding of how the virus is affecting critically ill patients in the US has been limited to reports from a small number of cases,” said Natalie Yip, MD, assistant professor of medicine at Columbia University.

In the cohort, drawn from two NewYork-Presbyterian hospitals, the researchers focused on the 257 (22%) patients who required intensive care. When they estimated inflammation through interleukin-6 (IL-6) concentrations and thrombosis through D-dimer concentrations, they found a 10% increased risk for death with every 10% increase of IL-6 (adjusted hazard ratio [aHR], 1.11; 95% confidence interval [CI], 1.02–1.20) or D-dimer concentration (aHR, 1.10; 95% CI, 1.01–1.19).

“The association of mortality with higher concentrations of IL-6 and d-dimer is particularly relevant for two reasons,” write Giacomo Grasselli, from the Fondazione IRCCS Ca’ Granda Ospediale Maggiore Policlinico, and Alberto Zanella, from the University of Milan, Italy, in an accompanying commentary.

“First, it confirms the key pathogenic role played by the activation of systemic inflammation and endothelial-vascular damage in the development of organ dysfunction,” they write. “Second, it provides the rationale for the design of clinical trials for measuring the efficacy of treatment with immunomodulating and anticoagulant drugs.”

Seventeen percent of patients received interleukin receptor antagonists and 26% received corticosteroids, but the authors did not report any data on the effects of these treatments, or any data about anticoagulant therapies administered.
 

Severe disease common

The study also highlighted a high proportion of ethnic and racial minorities. Sixty-two percent of the critically ill patients were Hispanic or Latinx, 19% Black, 32% White, and 3% Asian.

Their median age was 62 years and 67% were men. Eighty-two percent had at least one chronic illness, most commonly hypertension (63%), followed by diabetes (36%). Forty-six percent were obese.

As of April 28, 2020, 101 (39%) of the critically ill patients had died following a median of 9 days (interquartile range (IQR), 5–15) in the hospital and 94 (37%) remained hospitalized. Of the 203 patients who received invasive mechanical ventilation, 84 (41%) had died.

The poor prognosis of patients requiring ventilation is consistent with data from a report on patients treated in National Health Service intensive care units in England, Wales, and Northern Ireland through May 15. Overall, 11,292 patients with COVID-19 required critical care, and 4855 needed advanced respiratory support. Approximately half of the patients receiving mechanical ventilation had died 30 days after starting critical care.

In the New York study, patients spent an average of 18 days on a ventilator (IQR, 9–28 days). This is a longer period than reported in smaller studies of cases from Washington state, but corresponds with a recent report from Italy, the researchers said.

Remarkably, O’Donnell and colleagues report that almost a third (31%) of critically ill patients developed severe kidney damage and required dialysis.

Mortality was associated with several baseline factors, including older age (aHR, 1.31 [95% CI, 1.09–1.57] per 10-year increase), chronic cardiac disease (aHR, 1.76; 95% CI, 1.08–2·86), and chronic pulmonary disease (aHR, 2.94; 95% CI, 1.48–5.84).

Authors of the New York study reported financial relationships to ICE Neurosystems, ALung Technologies, Baxter, BREETHE, Xenios, Hemovent, Gilead Sciences, Amazon, and Karyopharm Therapeutics. Grasselli reports personal fees from Biotest, Draeger, Fisher & Paykel, Maquet, Merck Sharp & Dohme, and Pfizer, all outside the area of work commented on here. Zanella has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Biomarkers for inflammation and thrombosis may predict deaths from COVID-19 among critically ill patients, researchers say.

Courtesy NIAID

Their prospective cohort study of 1150 patients hospitalized with the disease in New York City also revealed a high proportion of racial and ethnic minorities, and confirmed high rates of critical illness and mortality.

“Of particular interest is the finding that over three quarters of critically ill patients required a ventilator and almost one third required renal dialysis support,” Max O’Donnell, MD, MPH, assistant professor of medicine and epidemiology at Columbia University in New York City, said in a press release.

O’Donnell and colleagues published the results of their study online today in The Lancet. It is the largest prospective cohort study published in the United States, they said.

“Although the clinical spectrum of disease has been characterised in reports from China and Italy, until now, detailed understanding of how the virus is affecting critically ill patients in the US has been limited to reports from a small number of cases,” said Natalie Yip, MD, assistant professor of medicine at Columbia University.

In the cohort, drawn from two NewYork-Presbyterian hospitals, the researchers focused on the 257 (22%) patients who required intensive care. When they estimated inflammation through interleukin-6 (IL-6) concentrations and thrombosis through D-dimer concentrations, they found a 10% increased risk for death with every 10% increase of IL-6 (adjusted hazard ratio [aHR], 1.11; 95% confidence interval [CI], 1.02–1.20) or D-dimer concentration (aHR, 1.10; 95% CI, 1.01–1.19).

“The association of mortality with higher concentrations of IL-6 and d-dimer is particularly relevant for two reasons,” write Giacomo Grasselli, from the Fondazione IRCCS Ca’ Granda Ospediale Maggiore Policlinico, and Alberto Zanella, from the University of Milan, Italy, in an accompanying commentary.

“First, it confirms the key pathogenic role played by the activation of systemic inflammation and endothelial-vascular damage in the development of organ dysfunction,” they write. “Second, it provides the rationale for the design of clinical trials for measuring the efficacy of treatment with immunomodulating and anticoagulant drugs.”

Seventeen percent of patients received interleukin receptor antagonists and 26% received corticosteroids, but the authors did not report any data on the effects of these treatments, or any data about anticoagulant therapies administered.
 

Severe disease common

The study also highlighted a high proportion of ethnic and racial minorities. Sixty-two percent of the critically ill patients were Hispanic or Latinx, 19% Black, 32% White, and 3% Asian.

Their median age was 62 years and 67% were men. Eighty-two percent had at least one chronic illness, most commonly hypertension (63%), followed by diabetes (36%). Forty-six percent were obese.

As of April 28, 2020, 101 (39%) of the critically ill patients had died following a median of 9 days (interquartile range (IQR), 5–15) in the hospital and 94 (37%) remained hospitalized. Of the 203 patients who received invasive mechanical ventilation, 84 (41%) had died.

The poor prognosis of patients requiring ventilation is consistent with data from a report on patients treated in National Health Service intensive care units in England, Wales, and Northern Ireland through May 15. Overall, 11,292 patients with COVID-19 required critical care, and 4855 needed advanced respiratory support. Approximately half of the patients receiving mechanical ventilation had died 30 days after starting critical care.

In the New York study, patients spent an average of 18 days on a ventilator (IQR, 9–28 days). This is a longer period than reported in smaller studies of cases from Washington state, but corresponds with a recent report from Italy, the researchers said.

Remarkably, O’Donnell and colleagues report that almost a third (31%) of critically ill patients developed severe kidney damage and required dialysis.

Mortality was associated with several baseline factors, including older age (aHR, 1.31 [95% CI, 1.09–1.57] per 10-year increase), chronic cardiac disease (aHR, 1.76; 95% CI, 1.08–2·86), and chronic pulmonary disease (aHR, 2.94; 95% CI, 1.48–5.84).

Authors of the New York study reported financial relationships to ICE Neurosystems, ALung Technologies, Baxter, BREETHE, Xenios, Hemovent, Gilead Sciences, Amazon, and Karyopharm Therapeutics. Grasselli reports personal fees from Biotest, Draeger, Fisher & Paykel, Maquet, Merck Sharp & Dohme, and Pfizer, all outside the area of work commented on here. Zanella has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

Among patients with atrial fibrillation, use of direct oral anticoagulants is linked to lower osteoporotic fracture risk versus warfarin, results of a recent population-based cohort study show.

iStock/Thinkstock

The choice of direct oral anticoagulant (DOAC) didn’t appear to have an impact, as each individual agent yielded a substantially lower risk of fracture versus the vitamin K antagonist, with risk reductions ranging from 38% to 48%, according to the study authors.

This is one of the latest reports to suggest DOACs could have an edge over warfarin for preventing fractures, providing new evidence that “may help inform the benefit risk assessment” when it comes to choosing an anticoagulant for a patient with atrial fibrillation (AFib) in the clinic, wrote the authors, led by Wallis C.Y. Lau, PhD, with the University College London.

“There exists a compelling case for evaluating whether the risk for osteoporotic fractures should be considered at the point of prescribing an oral anticoagulant to minimize fracture risk,” Dr. Lau and coauthors wrote in a report on the study that appears in Annals of Internal Medicine.

The case is especially compelling since fracture risk is “often neglected” when choosing an anticoagulant, the authors wrote. Surgeries to treat fracture are difficult because of the need for perioperative management of anticoagulation as “a balance between the risk for stroke and excessive bleeding must be achieved,” they added.

Based on these data, physicians should strongly consider DOACs as an alternative to vitamin K antagonists to reduce the risk of osteoporosis over the long term in patients with AFib, according to Victor Lawrence Roberts, MD, a Florida endocrinologist.

“Osteoporosis takes years, sometimes decades to develop, and if you then overlay warfarin on top of a readily evolving metabolic bone disease, you probably accelerate that process, said Dr. Roberts, professor of internal medicine at the University of Central Florida, Orlando, and editorial advisory board member of Internal Medicine News.

There’s a considerable amount of concerning preclinical data that warfarin could increase osteoporotic fracture risk. Of note, vitamin K antagonists modulate osteocalcin, a calcium-binding bone matrix protein, Dr. Roberts said.

“Osteocalcin is important for bone metabolism and health, and inhibiting osteocalcin will inhibit the ability to have a healthy bone matrix,” he explained.

The impact of anticoagulants on fracture risk is particularly relevant to patients with AFib, according to Dr. Lau and colleagues, who referenced one 2017 report showing a higher incidence of hip fracture among AFib patients versus those without AFib.

In their more recent study, Dr. Lau and colleagues reviewed electronic health records in a Hong Kong database for 23,515 older adults with a new diagnosis of AFib who received a new prescription of warfarin or DOACs including apixaban, dabigatran, or rivaroxaban.

DOAC use was consistently associated with a lower risk of osteoporotic fractures versus warfarin, regardless of the DOAC considered. The hazard ratios were 0.62 (95% confidence interval, 0.41-0.94) for apixaban, 0.65 (95% CI, 0.49-0.86) for dabigatran, and 0.52 (95% CI, 0.37-0.73) for rivaroxaban versus warfarin, the report showed.

Head-to-head comparisons between DOACS didn’t yield any statistically significant differences, though the analyses were underpowered in this respect, according to the investigators.

“This study can only rule out more than a twofold higher or a 50% lower relative risk for osteoporotic fractures between individual DOACs,” they wrote. “However, any absolute risk differences were small and would likely be of minor clinical significance.”

The reduced risk of fracture for DOACs versus warfarin was consistent in men and women with AFib, suggesting that women may particularly benefit from DOACs, given that they have a higher risk of fracture than men, the investigators added.

The results of this study suggest yet another benefit of DOACs over warfarin in patients with AFib, according to internist Noel Deep, MD, who is the chief medical officer of Aspirus Langlade Hospital in Antigo, Wisconsin.

“The lower risk of osteoporotic fractures with DOACS, in addition to other advantages such as lower risk of intracranial bleeding, once- or twice-daily consistent dosing, no dietary restrictions, and no blood tests to regulate the dose might be another reason that physicians may favor them over warfarin in older individuals requiring anticoagulation,” Dr. Deep said in an interview.

Results of this and several other recent studies may help in recommending DOACs to internal medicine patients who have a diagnosis of AFib requiring anticoagulation, according to Dr. Deep, who is also a physician at Aspirus Antigo Clinic and a member of Internal Medicine News’ editorial advisory board. These include a 2019 U.S.-based study of more than 167,000 patients with AFib (JAMA Intern Med. 2019;180[2]:245‐253) showing that use of DOACs, particularly apixaban, were linked to lower fracture risk versus warfarin use. Similarly, a Danish national registry study also published in 2019 showed that the absolute risk of osteoporotic fractures was low overall and significantly lower in patients who received DOACs (J Am Coll Cardiol. 2019;74[17]:2150-2158).

Funding for the study came from the University of Hong Kong and University College London Strategic Planning Fund. The study authors reported disclosures related to Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, IQVIA, and others.

SOURCE: Lau WCY et al. Ann Intern Med. 2020 May 18. doi: 10.7326/M19-3671.

When a mass trauma or disaster hit, mental health clinicians often focus on encouraging resilience. In the middle of the COVID-19 pandemic, however, interventions that maintain calm, build community, and sustain hope may take priority, according to a working group of clinical experts from the International College of Obsessive Compulsive Spectrum Disorders and the Obsessive-Compulsive and Related Disorders Research Network of the European College of Neuropsychopharmacology.

While the COVID-19 pandemic has tested everyone, “[p]erhaps no group of individuals with mental illness is as directly affected by the worsening outbreak of COVID-19 as people living with obsessive-compulsive disorder (OCD),” say the group members, who include clinicians from Stanford University, University of California, and VAHCS in Palo Alto. “Paradoxically, they are ‘experts by experience’ in attempting to avert dangers through enacting compulsive behaviors.”

Consequently, coronavirus may become all these patients think about. Some who have contamination-related OCD may express doubts about the rationality of their therapies, while other  patients have told their clinicians they were “right all along.” Moreover, people with OCD can be inflexible at “unlearning” danger responses and are thus conditioned to prolonged virus-induced distress and anxiety.

In response to the emerging crisis and growing calls from patients and clinicians, the working group produced a consensus statement with the aim of delivering “pragmatic guidance” for the treatment of OCD under COVID-19 conditions. Their report covers the issues they judged currently most relevant for clinicians.

Stipulating that the best available treatments for most patients are likely to include evidence-based pharmacotherapy and modifying or pausing cognitive behavioral therapy (CBT) in conjunction with enhanced supportive therapies, the panel also recommends:

• Using telemedicine, including telephone or video calls, but be aware of the patient’s circumstances: For some, poverty makes it hard to stay home. Regularly check on patients who are likely to engage in particularly harmful decontamination rituals or behaviors. The added benefit of video calling is that it helps the therapist perform a visual risk evaluation—which is especially valuable for patients living alone—to determine the condition of the patient's hands, presence of food in the fridge or cupboard, etc.
• Taking a careful history, clarifying the extent to which the symptoms represent a rational or exaggerated reaction to recent highly stressful events, or a worsening of the OCD. Don’t assume that every patient with contamination fears related to germs and illness will necessarily be excessively concerned about COVID-19.
• Assessing suicide risk. Factors such as a recent increase in OCD severity, experiencing a family member found positive for COVID-19, or finding the effects of quarantine or isolation distressing have anecdotally been shown to raise suicide risk.
• Providing balanced information about the known risks and impact of COVID-19 on physical and mental health. This includes the difficulties managing uncertainty associated with the virus, which might be particularly challenging for some people with OCD, hypochondriasis or anxiety. Patients need to understand that this health crisis may persist for some time, and they will need to manage their stress levels over that time (eg, by putting into play long-term routines of mindfulness techniques, exercise and structure).
• Inquiring about Internet usage and news consumption. Some patients spend hours a day watching television and online media sources, which may significantly exacerbate OCD and anxiety symptoms. Offer a balanced approach (eg, individuals should not spend more than a half-hour in the morning and at night to stay informed about the pandemic, to minimize the triggering of symptoms). Suggest trusted sources to avoid myths, rumors and misinformation.
• Identifying and discouraging high-risk obsessive-compulsive behaviors, such as washing in water that is too hot or bleach, or total fasting. Some patients, as a result of doubt or uncertainty about whether food in the house is contaminated, respond by throwing everything away and consequently have little or nothing to eat. Encourage eating and drinking to maintain health.

Keeping people calm and reducing the risk of depression using supportive techniques are an essential element of care. Nevertheless, the group says, clinicians should still try to find ways to help patients foster resilience towards obsessional thinking and compulsive acts.

“We are aware this guidance marks a change in practice for many clinicians treating OCD,” they note. “Temporarily modifying or pausing in vivo CBT with ERP [exposure response prevention] for contamination-related OCD, … is a difficult decision to make, but as with any treatment, the benefits and risks need to be balanced up and clear messages that take public health into account need to be given at this time of heightened risk of infection, to avoid confusion. On the other hand, many forms of CBT can be continued with modification for safety as needed.”

Understanding the impact of a pandemic like COVID-19 on patients with mental health disorders can provide important insights into the environmental determinants, the panel says. They urge research-active groups to investigate the effects of such changes on health outcomes—as well as exploring ways to address the expected rise in incidence of OCD once the pandemic is over.

When a mass trauma or disaster hit, mental health clinicians often focus on encouraging resilience. In the middle of the COVID-19 pandemic, however, interventions that maintain calm, build community, and sustain hope may take priority, according to a working group of clinical experts from the International College of Obsessive Compulsive Spectrum Disorders and the Obsessive-Compulsive and Related Disorders Research Network of the European College of Neuropsychopharmacology.

While the COVID-19 pandemic has tested everyone, “[p]erhaps no group of individuals with mental illness is as directly affected by the worsening outbreak of COVID-19 as people living with obsessive-compulsive disorder (OCD),” say the group members, who include clinicians from Stanford University, University of California, and VAHCS in Palo Alto. “Paradoxically, they are ‘experts by experience’ in attempting to avert dangers through enacting compulsive behaviors.”

Consequently, coronavirus may become all these patients think about. Some who have contamination-related OCD may express doubts about the rationality of their therapies, while other  patients have told their clinicians they were “right all along.” Moreover, people with OCD can be inflexible at “unlearning” danger responses and are thus conditioned to prolonged virus-induced distress and anxiety.

In response to the emerging crisis and growing calls from patients and clinicians, the working group produced a consensus statement with the aim of delivering “pragmatic guidance” for the treatment of OCD under COVID-19 conditions. Their report covers the issues they judged currently most relevant for clinicians.

Stipulating that the best available treatments for most patients are likely to include evidence-based pharmacotherapy and modifying or pausing cognitive behavioral therapy (CBT) in conjunction with enhanced supportive therapies, the panel also recommends:

• Using telemedicine, including telephone or video calls, but be aware of the patient’s circumstances: For some, poverty makes it hard to stay home. Regularly check on patients who are likely to engage in particularly harmful decontamination rituals or behaviors. The added benefit of video calling is that it helps the therapist perform a visual risk evaluation—which is especially valuable for patients living alone—to determine the condition of the patient's hands, presence of food in the fridge or cupboard, etc.
• Taking a careful history, clarifying the extent to which the symptoms represent a rational or exaggerated reaction to recent highly stressful events, or a worsening of the OCD. Don’t assume that every patient with contamination fears related to germs and illness will necessarily be excessively concerned about COVID-19.
• Assessing suicide risk. Factors such as a recent increase in OCD severity, experiencing a family member found positive for COVID-19, or finding the effects of quarantine or isolation distressing have anecdotally been shown to raise suicide risk.
• Providing balanced information about the known risks and impact of COVID-19 on physical and mental health. This includes the difficulties managing uncertainty associated with the virus, which might be particularly challenging for some people with OCD, hypochondriasis or anxiety. Patients need to understand that this health crisis may persist for some time, and they will need to manage their stress levels over that time (eg, by putting into play long-term routines of mindfulness techniques, exercise and structure).
• Inquiring about Internet usage and news consumption. Some patients spend hours a day watching television and online media sources, which may significantly exacerbate OCD and anxiety symptoms. Offer a balanced approach (eg, individuals should not spend more than a half-hour in the morning and at night to stay informed about the pandemic, to minimize the triggering of symptoms). Suggest trusted sources to avoid myths, rumors and misinformation.
• Identifying and discouraging high-risk obsessive-compulsive behaviors, such as washing in water that is too hot or bleach, or total fasting. Some patients, as a result of doubt or uncertainty about whether food in the house is contaminated, respond by throwing everything away and consequently have little or nothing to eat. Encourage eating and drinking to maintain health.

Keeping people calm and reducing the risk of depression using supportive techniques are an essential element of care. Nevertheless, the group says, clinicians should still try to find ways to help patients foster resilience towards obsessional thinking and compulsive acts.

“We are aware this guidance marks a change in practice for many clinicians treating OCD,” they note. “Temporarily modifying or pausing in vivo CBT with ERP [exposure response prevention] for contamination-related OCD, … is a difficult decision to make, but as with any treatment, the benefits and risks need to be balanced up and clear messages that take public health into account need to be given at this time of heightened risk of infection, to avoid confusion. On the other hand, many forms of CBT can be continued with modification for safety as needed.”

Understanding the impact of a pandemic like COVID-19 on patients with mental health disorders can provide important insights into the environmental determinants, the panel says. They urge research-active groups to investigate the effects of such changes on health outcomes—as well as exploring ways to address the expected rise in incidence of OCD once the pandemic is over.

When a mass trauma or disaster hit, mental health clinicians often focus on encouraging resilience. In the middle of the COVID-19 pandemic, however, interventions that maintain calm, build community, and sustain hope may take priority, according to a working group of clinical experts from the International College of Obsessive Compulsive Spectrum Disorders and the Obsessive-Compulsive and Related Disorders Research Network of the European College of Neuropsychopharmacology.

While the COVID-19 pandemic has tested everyone, “[p]erhaps no group of individuals with mental illness is as directly affected by the worsening outbreak of COVID-19 as people living with obsessive-compulsive disorder (OCD),” say the group members, who include clinicians from Stanford University, University of California, and VAHCS in Palo Alto. “Paradoxically, they are ‘experts by experience’ in attempting to avert dangers through enacting compulsive behaviors.”

Consequently, coronavirus may become all these patients think about. Some who have contamination-related OCD may express doubts about the rationality of their therapies, while other  patients have told their clinicians they were “right all along.” Moreover, people with OCD can be inflexible at “unlearning” danger responses and are thus conditioned to prolonged virus-induced distress and anxiety.

In response to the emerging crisis and growing calls from patients and clinicians, the working group produced a consensus statement with the aim of delivering “pragmatic guidance” for the treatment of OCD under COVID-19 conditions. Their report covers the issues they judged currently most relevant for clinicians.

Stipulating that the best available treatments for most patients are likely to include evidence-based pharmacotherapy and modifying or pausing cognitive behavioral therapy (CBT) in conjunction with enhanced supportive therapies, the panel also recommends:

• Using telemedicine, including telephone or video calls, but be aware of the patient’s circumstances: For some, poverty makes it hard to stay home. Regularly check on patients who are likely to engage in particularly harmful decontamination rituals or behaviors. The added benefit of video calling is that it helps the therapist perform a visual risk evaluation—which is especially valuable for patients living alone—to determine the condition of the patient's hands, presence of food in the fridge or cupboard, etc.
• Taking a careful history, clarifying the extent to which the symptoms represent a rational or exaggerated reaction to recent highly stressful events, or a worsening of the OCD. Don’t assume that every patient with contamination fears related to germs and illness will necessarily be excessively concerned about COVID-19.
• Assessing suicide risk. Factors such as a recent increase in OCD severity, experiencing a family member found positive for COVID-19, or finding the effects of quarantine or isolation distressing have anecdotally been shown to raise suicide risk.
• Providing balanced information about the known risks and impact of COVID-19 on physical and mental health. This includes the difficulties managing uncertainty associated with the virus, which might be particularly challenging for some people with OCD, hypochondriasis or anxiety. Patients need to understand that this health crisis may persist for some time, and they will need to manage their stress levels over that time (eg, by putting into play long-term routines of mindfulness techniques, exercise and structure).
• Inquiring about Internet usage and news consumption. Some patients spend hours a day watching television and online media sources, which may significantly exacerbate OCD and anxiety symptoms. Offer a balanced approach (eg, individuals should not spend more than a half-hour in the morning and at night to stay informed about the pandemic, to minimize the triggering of symptoms). Suggest trusted sources to avoid myths, rumors and misinformation.
• Identifying and discouraging high-risk obsessive-compulsive behaviors, such as washing in water that is too hot or bleach, or total fasting. Some patients, as a result of doubt or uncertainty about whether food in the house is contaminated, respond by throwing everything away and consequently have little or nothing to eat. Encourage eating and drinking to maintain health.

Keeping people calm and reducing the risk of depression using supportive techniques are an essential element of care. Nevertheless, the group says, clinicians should still try to find ways to help patients foster resilience towards obsessional thinking and compulsive acts.

“We are aware this guidance marks a change in practice for many clinicians treating OCD,” they note. “Temporarily modifying or pausing in vivo CBT with ERP [exposure response prevention] for contamination-related OCD, … is a difficult decision to make, but as with any treatment, the benefits and risks need to be balanced up and clear messages that take public health into account need to be given at this time of heightened risk of infection, to avoid confusion. On the other hand, many forms of CBT can be continued with modification for safety as needed.”

Understanding the impact of a pandemic like COVID-19 on patients with mental health disorders can provide important insights into the environmental determinants, the panel says. They urge research-active groups to investigate the effects of such changes on health outcomes—as well as exploring ways to address the expected rise in incidence of OCD once the pandemic is over.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.