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20 Cancer Care facilities receive biannual CoC Outstanding Achievement Award
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
Study eyed zinc for slowing progression of chronic liver disease
BOSTON – Oral zinc supplementation was associated with maintenance of liver function and suppression of hepatocellular carcinoma in a retrospective cohort study of 267 patients with chronic liver disease.
Additional analyses revealed stepwise inverse relationships between serum zinc levels and rates of de novo liver failure, hepatocellular carcinoma, and death, Atsushi Hosui, MD, PhD, said at the annual meeting of the American Association for the Study of Liver Diseases. No patients stopped zinc therapy because of adverse events, and there were no serious adverse events, although some patients experienced nausea, which can occur with zinc supplementation, noted Dr. Hosui of Osaka-Rosai Hospital, Japan.
To begin exploring hepatic correlates of zinc supplementation, Dr. Hosui and his associates retrospectively studied 267 patients in Japan with chronic liver diseases between 2006 and 2015. They had a median of 40 months of data for each patient. No patient had hepatocellular carcinoma at baseline. In all, 196 patients received zinc supplementation (average baseline zinc level, 51 mcg/dL), while 71 patients did not (62 mcg/dL). These two groups resembled each other in terms of etiologies of liver disease, but the zinc group was significantly older (73.2 vs. 66.4 years; P less than .0001), had a significantly higher average baseline bilirubin level (1.2 vs. 0.8 mg/dL; P less than .0001), and a significantly lower average platelet concentration and prothrombin time. (P less than .0001).
Despite having multiple indicators of worse liver disease, only 9.5% of zinc recipients developed hepatocellular carcinoma over 3 years, compared with 25% of patients in the control group (P = .005). Rates of liver failure and death were similar between the two groups, but sequential blood tests did indicate worsening liver disease among patients who did not receive zinc – their prothrombin times and branched-chain amino acid to tyrosine ratios steadily dropped over 3 years, while those in zinc recipients did not.
Next, the researchers stratified zinc recipients according to their serum zinc levels 6 months after starting supplementation. Notably, 3-year rates of mortality, liver failure, and death were significantly higher among patients whose zinc levels were lower than in patients who achieved higher serum zinc levels. For example, 3-year mortality rates were 28% among patients whose zinc level was 70-89 mcg/dL, versus 0% among patients whose zinc level was at least 90 mcg/dL (P = .02). Similarly, 3-year rates of liver failure were 3.6% among patients whose zinc level was 50-69 mcg/dL, versus 0% among patients whose serum zinc level was at least 70 mcg/dL (P = .03). Finally, over 3 years, hepatocellular carcinoma was diagnosed in 17% of patients whose zinc level was 50-69 mcg/dL, versus only 3.8% of patients whose zinc level was 70-89 mcg/dL.
“We suggest that oral zinc supplementation is effective for maintaining liver function and suppressing the development of hepatocellular carcinoma,” Dr. Hosui concluded. The data support a target serum zinc level of at least 70 mcg/dL to suppress liver-related events, including hepatocellular carcinoma, he added. The researchers are exploring clinical trials of zinc for these outcomes in Japan.
The investigators did not report funding for this study. They reported having no conflicts of interest.
BOSTON – Oral zinc supplementation was associated with maintenance of liver function and suppression of hepatocellular carcinoma in a retrospective cohort study of 267 patients with chronic liver disease.
Additional analyses revealed stepwise inverse relationships between serum zinc levels and rates of de novo liver failure, hepatocellular carcinoma, and death, Atsushi Hosui, MD, PhD, said at the annual meeting of the American Association for the Study of Liver Diseases. No patients stopped zinc therapy because of adverse events, and there were no serious adverse events, although some patients experienced nausea, which can occur with zinc supplementation, noted Dr. Hosui of Osaka-Rosai Hospital, Japan.
To begin exploring hepatic correlates of zinc supplementation, Dr. Hosui and his associates retrospectively studied 267 patients in Japan with chronic liver diseases between 2006 and 2015. They had a median of 40 months of data for each patient. No patient had hepatocellular carcinoma at baseline. In all, 196 patients received zinc supplementation (average baseline zinc level, 51 mcg/dL), while 71 patients did not (62 mcg/dL). These two groups resembled each other in terms of etiologies of liver disease, but the zinc group was significantly older (73.2 vs. 66.4 years; P less than .0001), had a significantly higher average baseline bilirubin level (1.2 vs. 0.8 mg/dL; P less than .0001), and a significantly lower average platelet concentration and prothrombin time. (P less than .0001).
Despite having multiple indicators of worse liver disease, only 9.5% of zinc recipients developed hepatocellular carcinoma over 3 years, compared with 25% of patients in the control group (P = .005). Rates of liver failure and death were similar between the two groups, but sequential blood tests did indicate worsening liver disease among patients who did not receive zinc – their prothrombin times and branched-chain amino acid to tyrosine ratios steadily dropped over 3 years, while those in zinc recipients did not.
Next, the researchers stratified zinc recipients according to their serum zinc levels 6 months after starting supplementation. Notably, 3-year rates of mortality, liver failure, and death were significantly higher among patients whose zinc levels were lower than in patients who achieved higher serum zinc levels. For example, 3-year mortality rates were 28% among patients whose zinc level was 70-89 mcg/dL, versus 0% among patients whose zinc level was at least 90 mcg/dL (P = .02). Similarly, 3-year rates of liver failure were 3.6% among patients whose zinc level was 50-69 mcg/dL, versus 0% among patients whose serum zinc level was at least 70 mcg/dL (P = .03). Finally, over 3 years, hepatocellular carcinoma was diagnosed in 17% of patients whose zinc level was 50-69 mcg/dL, versus only 3.8% of patients whose zinc level was 70-89 mcg/dL.
“We suggest that oral zinc supplementation is effective for maintaining liver function and suppressing the development of hepatocellular carcinoma,” Dr. Hosui concluded. The data support a target serum zinc level of at least 70 mcg/dL to suppress liver-related events, including hepatocellular carcinoma, he added. The researchers are exploring clinical trials of zinc for these outcomes in Japan.
The investigators did not report funding for this study. They reported having no conflicts of interest.
BOSTON – Oral zinc supplementation was associated with maintenance of liver function and suppression of hepatocellular carcinoma in a retrospective cohort study of 267 patients with chronic liver disease.
Additional analyses revealed stepwise inverse relationships between serum zinc levels and rates of de novo liver failure, hepatocellular carcinoma, and death, Atsushi Hosui, MD, PhD, said at the annual meeting of the American Association for the Study of Liver Diseases. No patients stopped zinc therapy because of adverse events, and there were no serious adverse events, although some patients experienced nausea, which can occur with zinc supplementation, noted Dr. Hosui of Osaka-Rosai Hospital, Japan.
To begin exploring hepatic correlates of zinc supplementation, Dr. Hosui and his associates retrospectively studied 267 patients in Japan with chronic liver diseases between 2006 and 2015. They had a median of 40 months of data for each patient. No patient had hepatocellular carcinoma at baseline. In all, 196 patients received zinc supplementation (average baseline zinc level, 51 mcg/dL), while 71 patients did not (62 mcg/dL). These two groups resembled each other in terms of etiologies of liver disease, but the zinc group was significantly older (73.2 vs. 66.4 years; P less than .0001), had a significantly higher average baseline bilirubin level (1.2 vs. 0.8 mg/dL; P less than .0001), and a significantly lower average platelet concentration and prothrombin time. (P less than .0001).
Despite having multiple indicators of worse liver disease, only 9.5% of zinc recipients developed hepatocellular carcinoma over 3 years, compared with 25% of patients in the control group (P = .005). Rates of liver failure and death were similar between the two groups, but sequential blood tests did indicate worsening liver disease among patients who did not receive zinc – their prothrombin times and branched-chain amino acid to tyrosine ratios steadily dropped over 3 years, while those in zinc recipients did not.
Next, the researchers stratified zinc recipients according to their serum zinc levels 6 months after starting supplementation. Notably, 3-year rates of mortality, liver failure, and death were significantly higher among patients whose zinc levels were lower than in patients who achieved higher serum zinc levels. For example, 3-year mortality rates were 28% among patients whose zinc level was 70-89 mcg/dL, versus 0% among patients whose zinc level was at least 90 mcg/dL (P = .02). Similarly, 3-year rates of liver failure were 3.6% among patients whose zinc level was 50-69 mcg/dL, versus 0% among patients whose serum zinc level was at least 70 mcg/dL (P = .03). Finally, over 3 years, hepatocellular carcinoma was diagnosed in 17% of patients whose zinc level was 50-69 mcg/dL, versus only 3.8% of patients whose zinc level was 70-89 mcg/dL.
“We suggest that oral zinc supplementation is effective for maintaining liver function and suppressing the development of hepatocellular carcinoma,” Dr. Hosui concluded. The data support a target serum zinc level of at least 70 mcg/dL to suppress liver-related events, including hepatocellular carcinoma, he added. The researchers are exploring clinical trials of zinc for these outcomes in Japan.
The investigators did not report funding for this study. They reported having no conflicts of interest.
AT THE LIVER MEETING 2016
Key clinical point: Oral zinc sulfate supplementation might help prevent the progression of chronic liver disease and associated hepatocellular carcinoma.
Major finding: Despite having multiple indicators of worse liver disease, only 9.5% of zinc recipients developed hepatocellular carcinoma over 3 years, compared with 25% of patients in the control group (P = .005).
Data source: A retrospective cohort study of 267 patients with chronic liver disease but no hepatocellular carcinoma at baseline.
Disclosures: The investigators did not report funding for this study. They reported having no conflicts of interest.
SelG1 cut pain crises in sickle cell disease
The humanized antibody SelG1 decreased the frequency of acute pain episodes in people with sickle cell disease, based on results from the multinational, randomized, double-blind, placebo-controlled SUSTAIN study that will be presented at the annual meeting of the American Society of Hematology in San Diego.
In other sickle cell disease research to be presented at the meeting, researchers will be presenting new findings from two studies conducted in Africa. One study examines a team approach to reduce mortality in pregnant women with sickle cell disease in Ghana. The other study, called SPIN, is a safety and feasibility study conducted in advance of a randomized trial in Nigerian children at risk for stroke.
After 1 year, the annual rate of sickle cell–related pain crises resulting in a visit to a medical facility was 1.6 in the group receiving the 5 mg/kg dose, compared with 3 in the placebo group. The 47% difference was statistically significant (P = .01).
Also, time to first pain crisis was a median of 4 months in those who received the 5 mg/kg dose and 1.4 months for those in the placebo group (P = .001).
Infections were not seen increased in either of the groups randomized to SelG1, and no treatment-related deaths occurred during the course of the study. The first-in-class agent “appears to be safe and well tolerated,” as well as effective in reducing pain episodes, Dr. Ataga and his colleagues wrote in their abstract.
In the Nigerian trial, led by Najibah Aliyu Galadanci, MD, MPH, of Bayero University in Kano, Nigeria, the goal was to determine whether families of children with sickle cell disease and transcranial Doppler measurements indicative of increased risk for stroke could be recruited and retained in a large clinical trial, and whether they could adhere to the medication regimen. The trial also obtained preliminary evidence for hydroxyurea’s safety in this clinical setting, where transfusion therapy is not an option for most children.
Dr. Galadanci and her colleagues approached 375 families for transcranial Doppler screening, and 90% accepted. Among families of children found to have elevated measures of risk on transcranial Doppler, 92% participated in the study and received a moderate dose of hydroxyurea (20 mg/kg) for 2 years. A comparison group included 210 children without elevated measures on transcranial Doppler. These children underwent regular monitoring but were not offered medication unless transcranial Doppler measures were found to be elevated.
Study adherence was exceptionally high: the families missed no monthly research visits, and no participants in the active treatment group dropped out voluntarily.
Also, at 2 years, the children treated with hydroxyurea did not have evidence of excessive toxicity, compared with the children who did not receive the drug. “Our results provide strong preliminary evidence supporting the current multicenter randomized controlled trial comparing hydroxyurea therapy (20 mg/kg per day vs. 10 mg/kg per day) for preventing primary strokes in children with sickle cell anemia living in Nigeria,” Dr. Galadanci and her colleagues wrote in their abstract.
In the third study, a multidisciplinary team decreased mortality in pregnant women who had sickle cell disease and lived in low and middle income settings, according to Eugenia Vicky Naa Kwarley Asare, MD, of the Ghana Institute of Clinical Genetics and the Korle-Bu Teaching Hospital in Accra.
In a prospective trial in Ghana, where maternal mortality among women with sickle cell disease is estimated to be 8,300 per 100,000 live births, compared with 690 for women without sickle cell disease, Dr. Asare and her colleagues’ multidisciplinary team included obstetricians, hematologists, pulmonologists, and nurses, and the planned intervention protocols included a number of changes to make management more consistent and intensive. A total of 154 pregnancies were evaluated before the intervention, and 91 after. Median gestational age was 24 weeks at enrollment, and median maternal age was 29 years for both pre- and post-intervention cohorts.
Maternal mortality before the intervention was 9.7% (15 of 154) and after the intervention was 1.1% (1 of 91) of total deliveries.
Dr. Ataga’s study was sponsored by Selexys Pharmaceuticals, the drug’s manufacturer, and included coinvestigators who are employees of Selexys Pharmaceuticals or who disclosed relationships with other drug manufacturers. Dr. Galadanci’s and Dr. Asare’s groups disclosed no conflicts of interest.
The humanized antibody SelG1 decreased the frequency of acute pain episodes in people with sickle cell disease, based on results from the multinational, randomized, double-blind, placebo-controlled SUSTAIN study that will be presented at the annual meeting of the American Society of Hematology in San Diego.
In other sickle cell disease research to be presented at the meeting, researchers will be presenting new findings from two studies conducted in Africa. One study examines a team approach to reduce mortality in pregnant women with sickle cell disease in Ghana. The other study, called SPIN, is a safety and feasibility study conducted in advance of a randomized trial in Nigerian children at risk for stroke.
After 1 year, the annual rate of sickle cell–related pain crises resulting in a visit to a medical facility was 1.6 in the group receiving the 5 mg/kg dose, compared with 3 in the placebo group. The 47% difference was statistically significant (P = .01).
Also, time to first pain crisis was a median of 4 months in those who received the 5 mg/kg dose and 1.4 months for those in the placebo group (P = .001).
Infections were not seen increased in either of the groups randomized to SelG1, and no treatment-related deaths occurred during the course of the study. The first-in-class agent “appears to be safe and well tolerated,” as well as effective in reducing pain episodes, Dr. Ataga and his colleagues wrote in their abstract.
In the Nigerian trial, led by Najibah Aliyu Galadanci, MD, MPH, of Bayero University in Kano, Nigeria, the goal was to determine whether families of children with sickle cell disease and transcranial Doppler measurements indicative of increased risk for stroke could be recruited and retained in a large clinical trial, and whether they could adhere to the medication regimen. The trial also obtained preliminary evidence for hydroxyurea’s safety in this clinical setting, where transfusion therapy is not an option for most children.
Dr. Galadanci and her colleagues approached 375 families for transcranial Doppler screening, and 90% accepted. Among families of children found to have elevated measures of risk on transcranial Doppler, 92% participated in the study and received a moderate dose of hydroxyurea (20 mg/kg) for 2 years. A comparison group included 210 children without elevated measures on transcranial Doppler. These children underwent regular monitoring but were not offered medication unless transcranial Doppler measures were found to be elevated.
Study adherence was exceptionally high: the families missed no monthly research visits, and no participants in the active treatment group dropped out voluntarily.
Also, at 2 years, the children treated with hydroxyurea did not have evidence of excessive toxicity, compared with the children who did not receive the drug. “Our results provide strong preliminary evidence supporting the current multicenter randomized controlled trial comparing hydroxyurea therapy (20 mg/kg per day vs. 10 mg/kg per day) for preventing primary strokes in children with sickle cell anemia living in Nigeria,” Dr. Galadanci and her colleagues wrote in their abstract.
In the third study, a multidisciplinary team decreased mortality in pregnant women who had sickle cell disease and lived in low and middle income settings, according to Eugenia Vicky Naa Kwarley Asare, MD, of the Ghana Institute of Clinical Genetics and the Korle-Bu Teaching Hospital in Accra.
In a prospective trial in Ghana, where maternal mortality among women with sickle cell disease is estimated to be 8,300 per 100,000 live births, compared with 690 for women without sickle cell disease, Dr. Asare and her colleagues’ multidisciplinary team included obstetricians, hematologists, pulmonologists, and nurses, and the planned intervention protocols included a number of changes to make management more consistent and intensive. A total of 154 pregnancies were evaluated before the intervention, and 91 after. Median gestational age was 24 weeks at enrollment, and median maternal age was 29 years for both pre- and post-intervention cohorts.
Maternal mortality before the intervention was 9.7% (15 of 154) and after the intervention was 1.1% (1 of 91) of total deliveries.
Dr. Ataga’s study was sponsored by Selexys Pharmaceuticals, the drug’s manufacturer, and included coinvestigators who are employees of Selexys Pharmaceuticals or who disclosed relationships with other drug manufacturers. Dr. Galadanci’s and Dr. Asare’s groups disclosed no conflicts of interest.
The humanized antibody SelG1 decreased the frequency of acute pain episodes in people with sickle cell disease, based on results from the multinational, randomized, double-blind, placebo-controlled SUSTAIN study that will be presented at the annual meeting of the American Society of Hematology in San Diego.
In other sickle cell disease research to be presented at the meeting, researchers will be presenting new findings from two studies conducted in Africa. One study examines a team approach to reduce mortality in pregnant women with sickle cell disease in Ghana. The other study, called SPIN, is a safety and feasibility study conducted in advance of a randomized trial in Nigerian children at risk for stroke.
After 1 year, the annual rate of sickle cell–related pain crises resulting in a visit to a medical facility was 1.6 in the group receiving the 5 mg/kg dose, compared with 3 in the placebo group. The 47% difference was statistically significant (P = .01).
Also, time to first pain crisis was a median of 4 months in those who received the 5 mg/kg dose and 1.4 months for those in the placebo group (P = .001).
Infections were not seen increased in either of the groups randomized to SelG1, and no treatment-related deaths occurred during the course of the study. The first-in-class agent “appears to be safe and well tolerated,” as well as effective in reducing pain episodes, Dr. Ataga and his colleagues wrote in their abstract.
In the Nigerian trial, led by Najibah Aliyu Galadanci, MD, MPH, of Bayero University in Kano, Nigeria, the goal was to determine whether families of children with sickle cell disease and transcranial Doppler measurements indicative of increased risk for stroke could be recruited and retained in a large clinical trial, and whether they could adhere to the medication regimen. The trial also obtained preliminary evidence for hydroxyurea’s safety in this clinical setting, where transfusion therapy is not an option for most children.
Dr. Galadanci and her colleagues approached 375 families for transcranial Doppler screening, and 90% accepted. Among families of children found to have elevated measures of risk on transcranial Doppler, 92% participated in the study and received a moderate dose of hydroxyurea (20 mg/kg) for 2 years. A comparison group included 210 children without elevated measures on transcranial Doppler. These children underwent regular monitoring but were not offered medication unless transcranial Doppler measures were found to be elevated.
Study adherence was exceptionally high: the families missed no monthly research visits, and no participants in the active treatment group dropped out voluntarily.
Also, at 2 years, the children treated with hydroxyurea did not have evidence of excessive toxicity, compared with the children who did not receive the drug. “Our results provide strong preliminary evidence supporting the current multicenter randomized controlled trial comparing hydroxyurea therapy (20 mg/kg per day vs. 10 mg/kg per day) for preventing primary strokes in children with sickle cell anemia living in Nigeria,” Dr. Galadanci and her colleagues wrote in their abstract.
In the third study, a multidisciplinary team decreased mortality in pregnant women who had sickle cell disease and lived in low and middle income settings, according to Eugenia Vicky Naa Kwarley Asare, MD, of the Ghana Institute of Clinical Genetics and the Korle-Bu Teaching Hospital in Accra.
In a prospective trial in Ghana, where maternal mortality among women with sickle cell disease is estimated to be 8,300 per 100,000 live births, compared with 690 for women without sickle cell disease, Dr. Asare and her colleagues’ multidisciplinary team included obstetricians, hematologists, pulmonologists, and nurses, and the planned intervention protocols included a number of changes to make management more consistent and intensive. A total of 154 pregnancies were evaluated before the intervention, and 91 after. Median gestational age was 24 weeks at enrollment, and median maternal age was 29 years for both pre- and post-intervention cohorts.
Maternal mortality before the intervention was 9.7% (15 of 154) and after the intervention was 1.1% (1 of 91) of total deliveries.
Dr. Ataga’s study was sponsored by Selexys Pharmaceuticals, the drug’s manufacturer, and included coinvestigators who are employees of Selexys Pharmaceuticals or who disclosed relationships with other drug manufacturers. Dr. Galadanci’s and Dr. Asare’s groups disclosed no conflicts of interest.
FROM ASH 2016
Nivolumab’s safety profile further clarified
In patients taking nivolumab for advanced melanoma, most immunologic adverse effects are mild to moderate in intensity and resolve when existing management guidelines are followed, investigators report.
Nivolumab, a programmed death-1 (PD-1) checkpoint inhibitor antibody, is effective in several tumor types, including melanoma, but its safety profile has not been well characterized to date. Researchers pooled data from two phase I exploratory and two phase III comparative clinical trials of advanced melanoma to better examine safety outcomes, in what they described as “the largest and most comprehensive analysis to date of ... anti-PD-1 monotherapy.”
The study included 576 patients (median age, 61 years) taking nivolumab. Slightly more than half had received ipilimumab, another immune checkpoint inhibitor, previously. Twelve percent had brain metastases. The median duration of nivolumab therapy was 3.7 months, reflecting a median of nine doses of the agent per patient. Median follow-up was 7.2 months (range, 0.3-62.5 months), said Jeffrey S. Weber, MD, PhD, of Dana-Farber Cancer Institute, Boston, and his associates.
The overall rate of adverse events likely to have an immunologic etiology was 49%, and most of these were mild to moderate; severe immunologic adverse effects occurred in less than 4% of patients. Prior ipilimumab therapy did not influence the number or severity of adverse reactions to nivolumab. Most immunologic adverse effects involved the skin and GI tract, and most of them, including the few severe effects, resolved when treated according to safety management guidelines.
The types of immunologic adverse events in this study were similar to those previously reported for this class of drug. However, pneumonitis developed less frequently (less than 2% of patients) in this study population than has been reported previously and also was less severe. Rare and unusual immunologic adverse events remain a possibility with PD-1 checkpoint inhibitor antibodies. In particular, five of these study participants developed grade 3 neurologic toxicities. Further information on such effects and on optimal management is needed, the investigators wrote (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.66.1389).
Immune modulators – chiefly systemic, topical, or inhaled corticosteroids – were frequently used to treat immunologic adverse effects. “Although there is a theoretic concern that [this] might interfere with an anticancer immune response, the results of our analysis suggest that immune modulators do not negatively affect the rate or quality of antitumor responses [to] nivolumab therapy,” Dr. Weber and his associates said.
In patients taking nivolumab for advanced melanoma, most immunologic adverse effects are mild to moderate in intensity and resolve when existing management guidelines are followed, investigators report.
Nivolumab, a programmed death-1 (PD-1) checkpoint inhibitor antibody, is effective in several tumor types, including melanoma, but its safety profile has not been well characterized to date. Researchers pooled data from two phase I exploratory and two phase III comparative clinical trials of advanced melanoma to better examine safety outcomes, in what they described as “the largest and most comprehensive analysis to date of ... anti-PD-1 monotherapy.”
The study included 576 patients (median age, 61 years) taking nivolumab. Slightly more than half had received ipilimumab, another immune checkpoint inhibitor, previously. Twelve percent had brain metastases. The median duration of nivolumab therapy was 3.7 months, reflecting a median of nine doses of the agent per patient. Median follow-up was 7.2 months (range, 0.3-62.5 months), said Jeffrey S. Weber, MD, PhD, of Dana-Farber Cancer Institute, Boston, and his associates.
The overall rate of adverse events likely to have an immunologic etiology was 49%, and most of these were mild to moderate; severe immunologic adverse effects occurred in less than 4% of patients. Prior ipilimumab therapy did not influence the number or severity of adverse reactions to nivolumab. Most immunologic adverse effects involved the skin and GI tract, and most of them, including the few severe effects, resolved when treated according to safety management guidelines.
The types of immunologic adverse events in this study were similar to those previously reported for this class of drug. However, pneumonitis developed less frequently (less than 2% of patients) in this study population than has been reported previously and also was less severe. Rare and unusual immunologic adverse events remain a possibility with PD-1 checkpoint inhibitor antibodies. In particular, five of these study participants developed grade 3 neurologic toxicities. Further information on such effects and on optimal management is needed, the investigators wrote (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.66.1389).
Immune modulators – chiefly systemic, topical, or inhaled corticosteroids – were frequently used to treat immunologic adverse effects. “Although there is a theoretic concern that [this] might interfere with an anticancer immune response, the results of our analysis suggest that immune modulators do not negatively affect the rate or quality of antitumor responses [to] nivolumab therapy,” Dr. Weber and his associates said.
In patients taking nivolumab for advanced melanoma, most immunologic adverse effects are mild to moderate in intensity and resolve when existing management guidelines are followed, investigators report.
Nivolumab, a programmed death-1 (PD-1) checkpoint inhibitor antibody, is effective in several tumor types, including melanoma, but its safety profile has not been well characterized to date. Researchers pooled data from two phase I exploratory and two phase III comparative clinical trials of advanced melanoma to better examine safety outcomes, in what they described as “the largest and most comprehensive analysis to date of ... anti-PD-1 monotherapy.”
The study included 576 patients (median age, 61 years) taking nivolumab. Slightly more than half had received ipilimumab, another immune checkpoint inhibitor, previously. Twelve percent had brain metastases. The median duration of nivolumab therapy was 3.7 months, reflecting a median of nine doses of the agent per patient. Median follow-up was 7.2 months (range, 0.3-62.5 months), said Jeffrey S. Weber, MD, PhD, of Dana-Farber Cancer Institute, Boston, and his associates.
The overall rate of adverse events likely to have an immunologic etiology was 49%, and most of these were mild to moderate; severe immunologic adverse effects occurred in less than 4% of patients. Prior ipilimumab therapy did not influence the number or severity of adverse reactions to nivolumab. Most immunologic adverse effects involved the skin and GI tract, and most of them, including the few severe effects, resolved when treated according to safety management guidelines.
The types of immunologic adverse events in this study were similar to those previously reported for this class of drug. However, pneumonitis developed less frequently (less than 2% of patients) in this study population than has been reported previously and also was less severe. Rare and unusual immunologic adverse events remain a possibility with PD-1 checkpoint inhibitor antibodies. In particular, five of these study participants developed grade 3 neurologic toxicities. Further information on such effects and on optimal management is needed, the investigators wrote (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.66.1389).
Immune modulators – chiefly systemic, topical, or inhaled corticosteroids – were frequently used to treat immunologic adverse effects. “Although there is a theoretic concern that [this] might interfere with an anticancer immune response, the results of our analysis suggest that immune modulators do not negatively affect the rate or quality of antitumor responses [to] nivolumab therapy,” Dr. Weber and his associates said.
Key clinical point: In patients taking nivolumab for advanced melanoma, most immunologic adverse effects are mild to moderate in intensity and resolve when existing management guidelines are followed.
Major finding: The overall rate of adverse events likely to have an immunologic etiology was 49%, while the rate of severe immunologic adverse effects was less than 4%.
Data source: A pooled analysis of data from four clinical trials involving 576 patients who took nivolumab for a median of 4 months and were followed for a median of 7 months.
Disclosures: This study was supported in part by Bristol-Myers Squibb and the Royal Marsden/Institute of Cancer Research Biomedical Research Centre. Dr. Weber and his associates reported ties to numerous industry sources.
Cabozantinib bests sunitinib against metastatic RCC
Cabozantinib showed significant improvements in progression-free survival and objective response rate over standard-of-care sunitinib in a phase II clinical trial of adults with metastatic renal cell carcinoma, according to a report published in the Journal of Clinical Oncology.
As a first-line therapy for patients with poor- to intermediate-risk renal cell carcinoma (RCC), cabozantinib improved progression-free survival by approximately 3 months, corresponding to a 34% reduction in the rate of disease progression or death. This is the first study in this patient population in which another agent demonstrated “notable and clinically meaningful” superiority over sunitinib, which has been an established standard of care for more than 10 years, wrote Toni K. Choueiri, MD, director of the Kidney Cancer Center, Dana-Farber Cancer Institute, Boston, and his associates.
In the open-label study, participants were randomly assigned to receive daily oral cabozantinib (79 patients) or daily oral sunitinib (78 patients) in 6-week cycles until disease progressed, intolerance developed, or patients withdrew from treatment. A total of 36% had bone metastases at baseline, an indicator of poor prognosis.
The primary endpoint – median duration of progression-free survival or time to death from any cause – was 8.2 months with cabozantinib and 5.6 months with sunitinib (adjusted hazard ratio, 0.66). Analyses of patient subgroups defined by disease severity consistently favored cabozantinib. Reductions in target lesion size, as measured by CT or MRI, were observed in 87% of the cabozantinib group, compared with 44% of the sunitinib group, the investigators reported (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.2016.70.7398).
Preliminary data showed that overall survival was 30.3 months with cabozantinib and 21.8 months with sunitinib. This represents a 20% decrease in mortality with cabozantinib.
The median number of treatment cycles was greater in the cabozantinib group (five cycles) than in the sunitinib group (two cycles), and corresponded to median treatment durations of 6.9 months and 2.8 months, respectively. Rates of treatment discontinuation due to adverse events were similar between the two study groups, as were the rates of adverse events of any grade, adverse events of grade 3 or 4, and adverse events of grade 5.
These findings indicate that cabozantinib may represent a new treatment option for previously untreated poor- or intermediate-risk metastatic RCC, Dr. Choueiri and his associates wrote.
The study was supported by the National Institutes of Health and Exelixis, which provided the cabozantinib. Dr. Choueiri and many of his associates reported ties to numerous industry sources.
Cabozantinib showed significant improvements in progression-free survival and objective response rate over standard-of-care sunitinib in a phase II clinical trial of adults with metastatic renal cell carcinoma, according to a report published in the Journal of Clinical Oncology.
As a first-line therapy for patients with poor- to intermediate-risk renal cell carcinoma (RCC), cabozantinib improved progression-free survival by approximately 3 months, corresponding to a 34% reduction in the rate of disease progression or death. This is the first study in this patient population in which another agent demonstrated “notable and clinically meaningful” superiority over sunitinib, which has been an established standard of care for more than 10 years, wrote Toni K. Choueiri, MD, director of the Kidney Cancer Center, Dana-Farber Cancer Institute, Boston, and his associates.
In the open-label study, participants were randomly assigned to receive daily oral cabozantinib (79 patients) or daily oral sunitinib (78 patients) in 6-week cycles until disease progressed, intolerance developed, or patients withdrew from treatment. A total of 36% had bone metastases at baseline, an indicator of poor prognosis.
The primary endpoint – median duration of progression-free survival or time to death from any cause – was 8.2 months with cabozantinib and 5.6 months with sunitinib (adjusted hazard ratio, 0.66). Analyses of patient subgroups defined by disease severity consistently favored cabozantinib. Reductions in target lesion size, as measured by CT or MRI, were observed in 87% of the cabozantinib group, compared with 44% of the sunitinib group, the investigators reported (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.2016.70.7398).
Preliminary data showed that overall survival was 30.3 months with cabozantinib and 21.8 months with sunitinib. This represents a 20% decrease in mortality with cabozantinib.
The median number of treatment cycles was greater in the cabozantinib group (five cycles) than in the sunitinib group (two cycles), and corresponded to median treatment durations of 6.9 months and 2.8 months, respectively. Rates of treatment discontinuation due to adverse events were similar between the two study groups, as were the rates of adverse events of any grade, adverse events of grade 3 or 4, and adverse events of grade 5.
These findings indicate that cabozantinib may represent a new treatment option for previously untreated poor- or intermediate-risk metastatic RCC, Dr. Choueiri and his associates wrote.
The study was supported by the National Institutes of Health and Exelixis, which provided the cabozantinib. Dr. Choueiri and many of his associates reported ties to numerous industry sources.
Cabozantinib showed significant improvements in progression-free survival and objective response rate over standard-of-care sunitinib in a phase II clinical trial of adults with metastatic renal cell carcinoma, according to a report published in the Journal of Clinical Oncology.
As a first-line therapy for patients with poor- to intermediate-risk renal cell carcinoma (RCC), cabozantinib improved progression-free survival by approximately 3 months, corresponding to a 34% reduction in the rate of disease progression or death. This is the first study in this patient population in which another agent demonstrated “notable and clinically meaningful” superiority over sunitinib, which has been an established standard of care for more than 10 years, wrote Toni K. Choueiri, MD, director of the Kidney Cancer Center, Dana-Farber Cancer Institute, Boston, and his associates.
In the open-label study, participants were randomly assigned to receive daily oral cabozantinib (79 patients) or daily oral sunitinib (78 patients) in 6-week cycles until disease progressed, intolerance developed, or patients withdrew from treatment. A total of 36% had bone metastases at baseline, an indicator of poor prognosis.
The primary endpoint – median duration of progression-free survival or time to death from any cause – was 8.2 months with cabozantinib and 5.6 months with sunitinib (adjusted hazard ratio, 0.66). Analyses of patient subgroups defined by disease severity consistently favored cabozantinib. Reductions in target lesion size, as measured by CT or MRI, were observed in 87% of the cabozantinib group, compared with 44% of the sunitinib group, the investigators reported (J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.2016.70.7398).
Preliminary data showed that overall survival was 30.3 months with cabozantinib and 21.8 months with sunitinib. This represents a 20% decrease in mortality with cabozantinib.
The median number of treatment cycles was greater in the cabozantinib group (five cycles) than in the sunitinib group (two cycles), and corresponded to median treatment durations of 6.9 months and 2.8 months, respectively. Rates of treatment discontinuation due to adverse events were similar between the two study groups, as were the rates of adverse events of any grade, adverse events of grade 3 or 4, and adverse events of grade 5.
These findings indicate that cabozantinib may represent a new treatment option for previously untreated poor- or intermediate-risk metastatic RCC, Dr. Choueiri and his associates wrote.
The study was supported by the National Institutes of Health and Exelixis, which provided the cabozantinib. Dr. Choueiri and many of his associates reported ties to numerous industry sources.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: The primary end point – median duration of progression-free survival or time to death from any cause – was 8.2 months with cabozantinib and 5.6 months with sunitinib (adjusted HR, 0.66).
Data source: A randomized, open-label phase II clinical trial of first-line treatment for 157 adults.
Disclosures: The study was supported by the National Institutes of Health and Exelixis, which provided the cabozantinib. Dr. Choueiri and many of his associates reported ties to numerous industry sources.
Calcipotriene-Betamethasone Dipropionate Foam in the Management of Psioriasis: A Panoramic View of Available Studies with Emphasis on Clinical Relevance
In this supplement you will learn about:
- The formulation characteristics of calcipotriene-betamethasone dipropionate aerosol foam (Cal/BD-AF)
- The efficacy and safety of Cal/BD-AF
- The results of Phase III clinical trials completed with Cal/BD-AF
James Q. Del Rosso, DO, FAOCD, FAAD
Adjunct Clinical Professor (Dermatology), Touro University Nevada, Henderson, Nevada
Lakes Dermatology and Del Rosso Dermatology Research Center, Las Vegas, Nevada
Dr. Del Rosso discloses that he is a consultant, speaker, and researcher for LEO Pharma Inc. Related to this subject area he is also a consultant, speaker, and/or researcher for Aqua Pharmaceuticals/Almirall, S.A.; Bayer AG; Celgene Corporation; Galderma Laboratories, L.P.; Genentech, Inc.; Novan, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc. /Anacor Pharmaceuticals, Inc.; PharmaDerm; Promius Pharma, LLC; Sun Pharmaceutical Industries, Ltd.; and Valeant Pharmaceuticals International, Inc.
In this supplement you will learn about:
- The formulation characteristics of calcipotriene-betamethasone dipropionate aerosol foam (Cal/BD-AF)
- The efficacy and safety of Cal/BD-AF
- The results of Phase III clinical trials completed with Cal/BD-AF
James Q. Del Rosso, DO, FAOCD, FAAD
Adjunct Clinical Professor (Dermatology), Touro University Nevada, Henderson, Nevada
Lakes Dermatology and Del Rosso Dermatology Research Center, Las Vegas, Nevada
Dr. Del Rosso discloses that he is a consultant, speaker, and researcher for LEO Pharma Inc. Related to this subject area he is also a consultant, speaker, and/or researcher for Aqua Pharmaceuticals/Almirall, S.A.; Bayer AG; Celgene Corporation; Galderma Laboratories, L.P.; Genentech, Inc.; Novan, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc. /Anacor Pharmaceuticals, Inc.; PharmaDerm; Promius Pharma, LLC; Sun Pharmaceutical Industries, Ltd.; and Valeant Pharmaceuticals International, Inc.
In this supplement you will learn about:
- The formulation characteristics of calcipotriene-betamethasone dipropionate aerosol foam (Cal/BD-AF)
- The efficacy and safety of Cal/BD-AF
- The results of Phase III clinical trials completed with Cal/BD-AF
James Q. Del Rosso, DO, FAOCD, FAAD
Adjunct Clinical Professor (Dermatology), Touro University Nevada, Henderson, Nevada
Lakes Dermatology and Del Rosso Dermatology Research Center, Las Vegas, Nevada
Dr. Del Rosso discloses that he is a consultant, speaker, and researcher for LEO Pharma Inc. Related to this subject area he is also a consultant, speaker, and/or researcher for Aqua Pharmaceuticals/Almirall, S.A.; Bayer AG; Celgene Corporation; Galderma Laboratories, L.P.; Genentech, Inc.; Novan, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc. /Anacor Pharmaceuticals, Inc.; PharmaDerm; Promius Pharma, LLC; Sun Pharmaceutical Industries, Ltd.; and Valeant Pharmaceuticals International, Inc.
USPSTF: Expand statin use beyond lipids to CVD risk
Use of statins for the primary prevention of cardiovascular disease should be based on overall cardiovascular disease risk, not necessarily blood lipid levels, according to new recommendations from the United States Preventive Services Task Force.
Despite widespread use in the elderly, USPSTF also said there’s insufficient evidence to recommend starting statins for cardiovascular disease (CVD) prevention in patients 76 years or older (JAMA. 2016 Nov;316[19]:1997-2007).
USPSTF now recommends low- to moderate-dose statins for primary prevention in adults 40-75 years old who have at least one CVD risk factor – dyslipidemia, diabetes, hypertension, or smoking – and a 10-year CVD event risk of at least 10% (B grade). It also recommended “selectively” offering low- to moderate-dose statins if patients have a 7.5%-10% risk (C grade). The task force recommends using the online American College of Cardiology/American Heart Association risk calculator.
A B grade denotes that USPSTF recommends the service as one where there is “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” With a C grade, the task force recommends that the service be provided subject to professional judgment and patient preferences.
The new advices from USPSTF is consistent with the task force’s 2015 draft proposals, and is based on a pooled analysis of 19 randomized trials in 71,344 adults at risk for CVD but without prior events; 17 of the studies were sponsored at least in part by the companies that make statins. The median duration of follow-up was 3 years. Trials included atorvastatin (Lipitor) and six other statins from 1994-2016.
Few of the 19 trials enrolled patients older than 75 years, so “the balance of benefits and harms of initiating statin use for” primary prevention in elderly adults “cannot be determined.” The task force did not make a recommendation either way, and called for further investigation.
For younger patients, the scales tipped toward benefit when the group found no overall increased risk of cancer, liver damage, diabetes, or cognitive problems with statins for primary prevention. “Although muscle pain, soreness, or weakness are commonly reported with statin use, there were no statistically significant differences between the intervention and control groups for myalgia, myopathy, or rhabdomyolysis,” according to the task force.
Across the 19 trials, statin therapy was associated with a statistically significant 14% reduction in all-cause mortality; 31% reduction in cardiovascular mortality; 29% reduction in stroke; and a 36% reduction in myocardial infarction; 250 patients needed to be treated to prevent one death from any cause after 1-6 years, and 233 to prevent one cardiovascular death after 2-6 years.
The recommendations call for low to moderate doses because that’s what most of the studies used, and there were no clear benefits when trials stratified patients by dose.
USPSTF cautioned that “reliance on a risk calculator ... alone as a basis for prevention may be problematic, given its possible overestimation of risk in some populations” and noted that the benefits “of statin use may be linear according to a patient’s absolute risk level, and any cut points used are only population estimates of benefits.”
The recommendations do not pertain to adults with very high CVD risk, such as those with familial hypercholesterolemia or an LDL level greater than 190mg/dL, since they were excluded from primary prevention trials.
While the USPSTF was careful in its evidence review, “ the limitations of the evidence were not considered sufficiently, given the serious concerns about the harms of statins for primary prevention,” Rita Redberg, MD, and Mitchell Katz, MD, wrote in an editorial accompanying the recommendations.
“USPSTF also did not have access to patient-level data; they had to rely on peer-reviewed published reports,” according to the editorialists. “The actual trial data are largely held by the Cholesterol Treatment Trialists’ Collaboration on behalf of industry sponsors and have not been made available to other researchers, despite multiple requests over many years.” Further, many of the trials were industry sponsored.
Using the USPSTF data, only 2% of patients who take statins for 5 years will avoid a myocardial infarction; virtually all (98%) will not experience any benefit. At the same time, 5%-20% will experience side effects including rhabdomyolysis, cognitive dysfunction, and increased risk of diabetes (JAMA. 2016 Nov;316[19]:1979-81).
There are unintended consequences of widespread statin use in healthy persons, Dr. Redberg and Dr. Katz wrote. People taking statins are more likely to become obese and more sedentary over time, likely because they mistakenly think they do not need to eat a healthy diet and exercise.
The USPSTF analysis was funded by the Agency for Healthcare Research and Quality. Task force lead Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, has advised the Institute for Clinical and Economic Review, which is partly funded by industry, on the cost-effectiveness of lipid-lowering drugs. Another member reported comparing how well they worked. The other 15 task force members had no disclosures.
Dare cardiovascular experts consider a future in which there are near-universal statin recommendations for middle-aged adults?
[USPSTF analysis suggests] that statin recommendations could be based primarily on a patient’s underlying CVD risk rather than on his or her cholesterol level. Disseminating a treatment strategy based largely on CVD risk alone has been a difficult message for the clinical community to accept and implement.
Nearly a generation of physicians has considered high-cholesterol levels, rather than generalized CVD risk, the target for statin treatment. Only a minority of physicians consistently use complex, risk-based probabilistic calculations to determine therapy.
Several key questions deserve careful consideration. Should LDL be considered in treatment recommendations beyond CVD risk? The decision to use absolute risk to guide statin recommendations is based on the finding that the relative risk reduction seen with statin therapy is independent of baseline risk; thus, those with the highest absolute baseline CVD risk experience the greatest reduction in CVD events.
However, the relative risk reduction of lipid-lowering therapy is also proportional to mmol/dL reduction in LDL level. This supports the contention that those with the highest baseline LDL levels should benefit the most from treatment because they have the most potential decline in LDL with intervention. One way to reconcile these findings is to incorporate both LDL levels and CVD risk into treatment recommendations, as has been done in the European guidelines. This approach recognizes that the relative benefit of statins is proportional to LDL lowering but that the absolute treatment benefit is largely driven by baseline risk.
From the resource perspective, the vast majority of statins are now available as generic products and require limited monitoring, leading to quite modest therapeutic costs. For patients in the gray area not covered by the guidelines, clinicians should be cautioned against adopting either a “treat none” or a “treat all” strategy. Rather, gaps in the evidence provide opportunities for clinicians to practice the art of medicine and engage with patients in shared decision-making regarding strategies for CVD prevention.
Ann Marie Navar, MD, PhD, and Eric Peterson, MD, MPH, are both at the Duke Clinical Research Institute in Durham, N.C. Dr. Navar reported funding from Regeneron and Sanofi. Dr. Peterson reported funding from Merck, Sanofi, Regeneron, and AstraZeneca. They made their comments in an editorial to the USPSTF report (JAMA. 2016 Nov;316[19]:1981-3).
Dare cardiovascular experts consider a future in which there are near-universal statin recommendations for middle-aged adults?
[USPSTF analysis suggests] that statin recommendations could be based primarily on a patient’s underlying CVD risk rather than on his or her cholesterol level. Disseminating a treatment strategy based largely on CVD risk alone has been a difficult message for the clinical community to accept and implement.
Nearly a generation of physicians has considered high-cholesterol levels, rather than generalized CVD risk, the target for statin treatment. Only a minority of physicians consistently use complex, risk-based probabilistic calculations to determine therapy.
Several key questions deserve careful consideration. Should LDL be considered in treatment recommendations beyond CVD risk? The decision to use absolute risk to guide statin recommendations is based on the finding that the relative risk reduction seen with statin therapy is independent of baseline risk; thus, those with the highest absolute baseline CVD risk experience the greatest reduction in CVD events.
However, the relative risk reduction of lipid-lowering therapy is also proportional to mmol/dL reduction in LDL level. This supports the contention that those with the highest baseline LDL levels should benefit the most from treatment because they have the most potential decline in LDL with intervention. One way to reconcile these findings is to incorporate both LDL levels and CVD risk into treatment recommendations, as has been done in the European guidelines. This approach recognizes that the relative benefit of statins is proportional to LDL lowering but that the absolute treatment benefit is largely driven by baseline risk.
From the resource perspective, the vast majority of statins are now available as generic products and require limited monitoring, leading to quite modest therapeutic costs. For patients in the gray area not covered by the guidelines, clinicians should be cautioned against adopting either a “treat none” or a “treat all” strategy. Rather, gaps in the evidence provide opportunities for clinicians to practice the art of medicine and engage with patients in shared decision-making regarding strategies for CVD prevention.
Ann Marie Navar, MD, PhD, and Eric Peterson, MD, MPH, are both at the Duke Clinical Research Institute in Durham, N.C. Dr. Navar reported funding from Regeneron and Sanofi. Dr. Peterson reported funding from Merck, Sanofi, Regeneron, and AstraZeneca. They made their comments in an editorial to the USPSTF report (JAMA. 2016 Nov;316[19]:1981-3).
Dare cardiovascular experts consider a future in which there are near-universal statin recommendations for middle-aged adults?
[USPSTF analysis suggests] that statin recommendations could be based primarily on a patient’s underlying CVD risk rather than on his or her cholesterol level. Disseminating a treatment strategy based largely on CVD risk alone has been a difficult message for the clinical community to accept and implement.
Nearly a generation of physicians has considered high-cholesterol levels, rather than generalized CVD risk, the target for statin treatment. Only a minority of physicians consistently use complex, risk-based probabilistic calculations to determine therapy.
Several key questions deserve careful consideration. Should LDL be considered in treatment recommendations beyond CVD risk? The decision to use absolute risk to guide statin recommendations is based on the finding that the relative risk reduction seen with statin therapy is independent of baseline risk; thus, those with the highest absolute baseline CVD risk experience the greatest reduction in CVD events.
However, the relative risk reduction of lipid-lowering therapy is also proportional to mmol/dL reduction in LDL level. This supports the contention that those with the highest baseline LDL levels should benefit the most from treatment because they have the most potential decline in LDL with intervention. One way to reconcile these findings is to incorporate both LDL levels and CVD risk into treatment recommendations, as has been done in the European guidelines. This approach recognizes that the relative benefit of statins is proportional to LDL lowering but that the absolute treatment benefit is largely driven by baseline risk.
From the resource perspective, the vast majority of statins are now available as generic products and require limited monitoring, leading to quite modest therapeutic costs. For patients in the gray area not covered by the guidelines, clinicians should be cautioned against adopting either a “treat none” or a “treat all” strategy. Rather, gaps in the evidence provide opportunities for clinicians to practice the art of medicine and engage with patients in shared decision-making regarding strategies for CVD prevention.
Ann Marie Navar, MD, PhD, and Eric Peterson, MD, MPH, are both at the Duke Clinical Research Institute in Durham, N.C. Dr. Navar reported funding from Regeneron and Sanofi. Dr. Peterson reported funding from Merck, Sanofi, Regeneron, and AstraZeneca. They made their comments in an editorial to the USPSTF report (JAMA. 2016 Nov;316[19]:1981-3).
Use of statins for the primary prevention of cardiovascular disease should be based on overall cardiovascular disease risk, not necessarily blood lipid levels, according to new recommendations from the United States Preventive Services Task Force.
Despite widespread use in the elderly, USPSTF also said there’s insufficient evidence to recommend starting statins for cardiovascular disease (CVD) prevention in patients 76 years or older (JAMA. 2016 Nov;316[19]:1997-2007).
USPSTF now recommends low- to moderate-dose statins for primary prevention in adults 40-75 years old who have at least one CVD risk factor – dyslipidemia, diabetes, hypertension, or smoking – and a 10-year CVD event risk of at least 10% (B grade). It also recommended “selectively” offering low- to moderate-dose statins if patients have a 7.5%-10% risk (C grade). The task force recommends using the online American College of Cardiology/American Heart Association risk calculator.
A B grade denotes that USPSTF recommends the service as one where there is “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” With a C grade, the task force recommends that the service be provided subject to professional judgment and patient preferences.
The new advices from USPSTF is consistent with the task force’s 2015 draft proposals, and is based on a pooled analysis of 19 randomized trials in 71,344 adults at risk for CVD but without prior events; 17 of the studies were sponsored at least in part by the companies that make statins. The median duration of follow-up was 3 years. Trials included atorvastatin (Lipitor) and six other statins from 1994-2016.
Few of the 19 trials enrolled patients older than 75 years, so “the balance of benefits and harms of initiating statin use for” primary prevention in elderly adults “cannot be determined.” The task force did not make a recommendation either way, and called for further investigation.
For younger patients, the scales tipped toward benefit when the group found no overall increased risk of cancer, liver damage, diabetes, or cognitive problems with statins for primary prevention. “Although muscle pain, soreness, or weakness are commonly reported with statin use, there were no statistically significant differences between the intervention and control groups for myalgia, myopathy, or rhabdomyolysis,” according to the task force.
Across the 19 trials, statin therapy was associated with a statistically significant 14% reduction in all-cause mortality; 31% reduction in cardiovascular mortality; 29% reduction in stroke; and a 36% reduction in myocardial infarction; 250 patients needed to be treated to prevent one death from any cause after 1-6 years, and 233 to prevent one cardiovascular death after 2-6 years.
The recommendations call for low to moderate doses because that’s what most of the studies used, and there were no clear benefits when trials stratified patients by dose.
USPSTF cautioned that “reliance on a risk calculator ... alone as a basis for prevention may be problematic, given its possible overestimation of risk in some populations” and noted that the benefits “of statin use may be linear according to a patient’s absolute risk level, and any cut points used are only population estimates of benefits.”
The recommendations do not pertain to adults with very high CVD risk, such as those with familial hypercholesterolemia or an LDL level greater than 190mg/dL, since they were excluded from primary prevention trials.
While the USPSTF was careful in its evidence review, “ the limitations of the evidence were not considered sufficiently, given the serious concerns about the harms of statins for primary prevention,” Rita Redberg, MD, and Mitchell Katz, MD, wrote in an editorial accompanying the recommendations.
“USPSTF also did not have access to patient-level data; they had to rely on peer-reviewed published reports,” according to the editorialists. “The actual trial data are largely held by the Cholesterol Treatment Trialists’ Collaboration on behalf of industry sponsors and have not been made available to other researchers, despite multiple requests over many years.” Further, many of the trials were industry sponsored.
Using the USPSTF data, only 2% of patients who take statins for 5 years will avoid a myocardial infarction; virtually all (98%) will not experience any benefit. At the same time, 5%-20% will experience side effects including rhabdomyolysis, cognitive dysfunction, and increased risk of diabetes (JAMA. 2016 Nov;316[19]:1979-81).
There are unintended consequences of widespread statin use in healthy persons, Dr. Redberg and Dr. Katz wrote. People taking statins are more likely to become obese and more sedentary over time, likely because they mistakenly think they do not need to eat a healthy diet and exercise.
The USPSTF analysis was funded by the Agency for Healthcare Research and Quality. Task force lead Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, has advised the Institute for Clinical and Economic Review, which is partly funded by industry, on the cost-effectiveness of lipid-lowering drugs. Another member reported comparing how well they worked. The other 15 task force members had no disclosures.
Use of statins for the primary prevention of cardiovascular disease should be based on overall cardiovascular disease risk, not necessarily blood lipid levels, according to new recommendations from the United States Preventive Services Task Force.
Despite widespread use in the elderly, USPSTF also said there’s insufficient evidence to recommend starting statins for cardiovascular disease (CVD) prevention in patients 76 years or older (JAMA. 2016 Nov;316[19]:1997-2007).
USPSTF now recommends low- to moderate-dose statins for primary prevention in adults 40-75 years old who have at least one CVD risk factor – dyslipidemia, diabetes, hypertension, or smoking – and a 10-year CVD event risk of at least 10% (B grade). It also recommended “selectively” offering low- to moderate-dose statins if patients have a 7.5%-10% risk (C grade). The task force recommends using the online American College of Cardiology/American Heart Association risk calculator.
A B grade denotes that USPSTF recommends the service as one where there is “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” With a C grade, the task force recommends that the service be provided subject to professional judgment and patient preferences.
The new advices from USPSTF is consistent with the task force’s 2015 draft proposals, and is based on a pooled analysis of 19 randomized trials in 71,344 adults at risk for CVD but without prior events; 17 of the studies were sponsored at least in part by the companies that make statins. The median duration of follow-up was 3 years. Trials included atorvastatin (Lipitor) and six other statins from 1994-2016.
Few of the 19 trials enrolled patients older than 75 years, so “the balance of benefits and harms of initiating statin use for” primary prevention in elderly adults “cannot be determined.” The task force did not make a recommendation either way, and called for further investigation.
For younger patients, the scales tipped toward benefit when the group found no overall increased risk of cancer, liver damage, diabetes, or cognitive problems with statins for primary prevention. “Although muscle pain, soreness, or weakness are commonly reported with statin use, there were no statistically significant differences between the intervention and control groups for myalgia, myopathy, or rhabdomyolysis,” according to the task force.
Across the 19 trials, statin therapy was associated with a statistically significant 14% reduction in all-cause mortality; 31% reduction in cardiovascular mortality; 29% reduction in stroke; and a 36% reduction in myocardial infarction; 250 patients needed to be treated to prevent one death from any cause after 1-6 years, and 233 to prevent one cardiovascular death after 2-6 years.
The recommendations call for low to moderate doses because that’s what most of the studies used, and there were no clear benefits when trials stratified patients by dose.
USPSTF cautioned that “reliance on a risk calculator ... alone as a basis for prevention may be problematic, given its possible overestimation of risk in some populations” and noted that the benefits “of statin use may be linear according to a patient’s absolute risk level, and any cut points used are only population estimates of benefits.”
The recommendations do not pertain to adults with very high CVD risk, such as those with familial hypercholesterolemia or an LDL level greater than 190mg/dL, since they were excluded from primary prevention trials.
While the USPSTF was careful in its evidence review, “ the limitations of the evidence were not considered sufficiently, given the serious concerns about the harms of statins for primary prevention,” Rita Redberg, MD, and Mitchell Katz, MD, wrote in an editorial accompanying the recommendations.
“USPSTF also did not have access to patient-level data; they had to rely on peer-reviewed published reports,” according to the editorialists. “The actual trial data are largely held by the Cholesterol Treatment Trialists’ Collaboration on behalf of industry sponsors and have not been made available to other researchers, despite multiple requests over many years.” Further, many of the trials were industry sponsored.
Using the USPSTF data, only 2% of patients who take statins for 5 years will avoid a myocardial infarction; virtually all (98%) will not experience any benefit. At the same time, 5%-20% will experience side effects including rhabdomyolysis, cognitive dysfunction, and increased risk of diabetes (JAMA. 2016 Nov;316[19]:1979-81).
There are unintended consequences of widespread statin use in healthy persons, Dr. Redberg and Dr. Katz wrote. People taking statins are more likely to become obese and more sedentary over time, likely because they mistakenly think they do not need to eat a healthy diet and exercise.
The USPSTF analysis was funded by the Agency for Healthcare Research and Quality. Task force lead Kirsten Bibbins-Domingo, MD, PhD, of the University of California, San Francisco, has advised the Institute for Clinical and Economic Review, which is partly funded by industry, on the cost-effectiveness of lipid-lowering drugs. Another member reported comparing how well they worked. The other 15 task force members had no disclosures.
It’s not easy to identify clinical depression in menopause
The notion that women in midlife are moody is so pervasive that entire Pinterest boards and Facebook pages are dedicated to menopause jokes. For physicians, however, it’s not always so easy to sort out when a patient who says she’s down, or short tempered, might really have major depressive disorder or another serious psychiatric diagnosis.
“The key point is that depressive symptoms are not the same as clinical depression,” said Hadine Joffe, MD, in an interview that recapped her recent presentation at the annual meeting of the North American Menopause Society (NAMS). “The causal factors and contributions to depressive symptoms and major depression are different.”
Practically speaking, this means two things. The first message is that treating common menopausal symptoms can have a positive impact on mood. However, it’s also true that clinicians must be educated and vigilant about more serious mood symptoms, and not expect major depression to lift when a patient starts hormone therapy, according to Dr. Joffe, a psychiatrist and director of the women’s hormone and aging research program at Brigham and Women’s Hospital, Boston.
Using a novel experimental model, Dr. Joffe and her coinvestigators recently completed work that examined the relationship among daytime and nighttime hot flashes, sleep disturbance, and mood changes. In a small study of 29 healthy premenopausal women, they tracked mood, hormone levels, and sleep fragmentation both before and after suppressing ovarian function with a gonadotropin-releasing hormone agonist. The study found independent and significant effects on mood for nighttime (but not daytime) hot flashes, as well as subjective sleep disturbance (J Clin Endocrinol Metab. 2016;101[10]:3847-55).
“We were struck by the fact that the nighttime hot flashes, separate from the sleep problems, contributed to mood symptoms,” Dr. Joffe said.
This study, though small, validates and extends the notion that multiple symptoms of the menopausal transition contribute to the mild mood symptoms that are common during this phase of a woman’s life, said Dr. Joffe. To date, most of the studies have been large epidemiologic studies, which while important, tend to assess people at one cross-sectional time point annually, and can’t always capture a nuanced and precise view of symptoms and how they relate to hormone levels, she said.
“Perimenopausal hormone changes are dynamic,” said Dr. Joffe, and have wide interindividual variation during the menopausal transition. Overall, though, she said, “clinical studies show that mood is better as ovarian activity is more normalized in perimenopausal women. Conversely, the more abnormal the hormonal profile, the worse the mood.”
Major depression is another story, said Dr. Joffe. “Menopause-specific factors have not, for the most part, been linked,” she said, noting that the best predictors for clinical depression in midlife that have been identified to date are a previous history of clinical depression or anxiety, as well as other traditional psychiatric risk factors such as low socioeconomic status and a low level of social support.
“People often present with all these symptoms all at once; they have mood disturbances, they have hot flashes, they have sleep disturbances. For the people experiencing these symptoms, it matters a lot to be able to have an explanation that’s credible, and defendable, and evidence based,” Dr. Joffe said. “And it also has implications for treatment, of course.”
This real world complexity inevitably intrudes during a clinical encounter, and it’s not an easy task, or a quick one, to tease apart the extent to which the menopausal transition is contributing to depressive symptoms when women have so many other potential stressors.
While acknowledging that it’s very difficult to unpack this in a brief clinic visit, Dr. Shifren also emphasized that it’s critically important. For patients with mild depressive symptoms, hormone therapy or other treatment to address vasomotor symptoms, along with evidence-based treatment of sleep problems, can be of real help.
“That’s very different from women who come in with real depression,” Dr. Shifren said in an interview. “It’s very important not to say, ‘Oh, that’s just a little bit of perimenopause.’ ”
“There is not enough education of general providers about the nuances of mood changes and mental health of women in midlife,” Dr. Montgomery said in an interview. “These are nicely dealt with in publications of the North American Menopause Society,” he said, also noting that the ob.gyn. residency curriculum at Drexel University includes specific modules to address the menopausal transition and menopause. “If you are going to be caring for women in transition, you probably should do a little deeper dive,” he said.
“My advice for clinicians is don’t do this alone,” Dr. Shifren said. If clinicians feel they lack expertise in diagnosing and managing mood disorders, they should establish collaborative relationships with colleagues in mental health. “We can still help with hormone management, sleep management, and keeping in touch with the patient,” she said.
One trick of the trade is to use your nursing staff to follow up with patients, Dr. Shifren said. She will ask a nurse to make a follow-up phone call 2-6 weeks after a patient visit to assess how the woman is faring with symptoms and any treatments that have been initiated or modified. The interval and intensity of follow-up can be modified based on feedback from this call, she said.
The bottom line for Dr. Montgomery is twofold: “Being menopausal does not make you depressed,” he said. “True clinical depression is a rare event, but one that should not be missed.”
Dr. Joffe reported consulting agreements with several pharmaceutical companies, and grant support from Merck for research related to vasomotor symptoms and insomnia. Dr. Montgomery reported no relevant financial disclosures. Dr. Shifren reported that she has a consulting agreement with the New England Research Institutes.
[email protected]
On Twitter @karioakes
The notion that women in midlife are moody is so pervasive that entire Pinterest boards and Facebook pages are dedicated to menopause jokes. For physicians, however, it’s not always so easy to sort out when a patient who says she’s down, or short tempered, might really have major depressive disorder or another serious psychiatric diagnosis.
“The key point is that depressive symptoms are not the same as clinical depression,” said Hadine Joffe, MD, in an interview that recapped her recent presentation at the annual meeting of the North American Menopause Society (NAMS). “The causal factors and contributions to depressive symptoms and major depression are different.”
Practically speaking, this means two things. The first message is that treating common menopausal symptoms can have a positive impact on mood. However, it’s also true that clinicians must be educated and vigilant about more serious mood symptoms, and not expect major depression to lift when a patient starts hormone therapy, according to Dr. Joffe, a psychiatrist and director of the women’s hormone and aging research program at Brigham and Women’s Hospital, Boston.
Using a novel experimental model, Dr. Joffe and her coinvestigators recently completed work that examined the relationship among daytime and nighttime hot flashes, sleep disturbance, and mood changes. In a small study of 29 healthy premenopausal women, they tracked mood, hormone levels, and sleep fragmentation both before and after suppressing ovarian function with a gonadotropin-releasing hormone agonist. The study found independent and significant effects on mood for nighttime (but not daytime) hot flashes, as well as subjective sleep disturbance (J Clin Endocrinol Metab. 2016;101[10]:3847-55).
“We were struck by the fact that the nighttime hot flashes, separate from the sleep problems, contributed to mood symptoms,” Dr. Joffe said.
This study, though small, validates and extends the notion that multiple symptoms of the menopausal transition contribute to the mild mood symptoms that are common during this phase of a woman’s life, said Dr. Joffe. To date, most of the studies have been large epidemiologic studies, which while important, tend to assess people at one cross-sectional time point annually, and can’t always capture a nuanced and precise view of symptoms and how they relate to hormone levels, she said.
“Perimenopausal hormone changes are dynamic,” said Dr. Joffe, and have wide interindividual variation during the menopausal transition. Overall, though, she said, “clinical studies show that mood is better as ovarian activity is more normalized in perimenopausal women. Conversely, the more abnormal the hormonal profile, the worse the mood.”
Major depression is another story, said Dr. Joffe. “Menopause-specific factors have not, for the most part, been linked,” she said, noting that the best predictors for clinical depression in midlife that have been identified to date are a previous history of clinical depression or anxiety, as well as other traditional psychiatric risk factors such as low socioeconomic status and a low level of social support.
“People often present with all these symptoms all at once; they have mood disturbances, they have hot flashes, they have sleep disturbances. For the people experiencing these symptoms, it matters a lot to be able to have an explanation that’s credible, and defendable, and evidence based,” Dr. Joffe said. “And it also has implications for treatment, of course.”
This real world complexity inevitably intrudes during a clinical encounter, and it’s not an easy task, or a quick one, to tease apart the extent to which the menopausal transition is contributing to depressive symptoms when women have so many other potential stressors.
While acknowledging that it’s very difficult to unpack this in a brief clinic visit, Dr. Shifren also emphasized that it’s critically important. For patients with mild depressive symptoms, hormone therapy or other treatment to address vasomotor symptoms, along with evidence-based treatment of sleep problems, can be of real help.
“That’s very different from women who come in with real depression,” Dr. Shifren said in an interview. “It’s very important not to say, ‘Oh, that’s just a little bit of perimenopause.’ ”
“There is not enough education of general providers about the nuances of mood changes and mental health of women in midlife,” Dr. Montgomery said in an interview. “These are nicely dealt with in publications of the North American Menopause Society,” he said, also noting that the ob.gyn. residency curriculum at Drexel University includes specific modules to address the menopausal transition and menopause. “If you are going to be caring for women in transition, you probably should do a little deeper dive,” he said.
“My advice for clinicians is don’t do this alone,” Dr. Shifren said. If clinicians feel they lack expertise in diagnosing and managing mood disorders, they should establish collaborative relationships with colleagues in mental health. “We can still help with hormone management, sleep management, and keeping in touch with the patient,” she said.
One trick of the trade is to use your nursing staff to follow up with patients, Dr. Shifren said. She will ask a nurse to make a follow-up phone call 2-6 weeks after a patient visit to assess how the woman is faring with symptoms and any treatments that have been initiated or modified. The interval and intensity of follow-up can be modified based on feedback from this call, she said.
The bottom line for Dr. Montgomery is twofold: “Being menopausal does not make you depressed,” he said. “True clinical depression is a rare event, but one that should not be missed.”
Dr. Joffe reported consulting agreements with several pharmaceutical companies, and grant support from Merck for research related to vasomotor symptoms and insomnia. Dr. Montgomery reported no relevant financial disclosures. Dr. Shifren reported that she has a consulting agreement with the New England Research Institutes.
[email protected]
On Twitter @karioakes
The notion that women in midlife are moody is so pervasive that entire Pinterest boards and Facebook pages are dedicated to menopause jokes. For physicians, however, it’s not always so easy to sort out when a patient who says she’s down, or short tempered, might really have major depressive disorder or another serious psychiatric diagnosis.
“The key point is that depressive symptoms are not the same as clinical depression,” said Hadine Joffe, MD, in an interview that recapped her recent presentation at the annual meeting of the North American Menopause Society (NAMS). “The causal factors and contributions to depressive symptoms and major depression are different.”
Practically speaking, this means two things. The first message is that treating common menopausal symptoms can have a positive impact on mood. However, it’s also true that clinicians must be educated and vigilant about more serious mood symptoms, and not expect major depression to lift when a patient starts hormone therapy, according to Dr. Joffe, a psychiatrist and director of the women’s hormone and aging research program at Brigham and Women’s Hospital, Boston.
Using a novel experimental model, Dr. Joffe and her coinvestigators recently completed work that examined the relationship among daytime and nighttime hot flashes, sleep disturbance, and mood changes. In a small study of 29 healthy premenopausal women, they tracked mood, hormone levels, and sleep fragmentation both before and after suppressing ovarian function with a gonadotropin-releasing hormone agonist. The study found independent and significant effects on mood for nighttime (but not daytime) hot flashes, as well as subjective sleep disturbance (J Clin Endocrinol Metab. 2016;101[10]:3847-55).
“We were struck by the fact that the nighttime hot flashes, separate from the sleep problems, contributed to mood symptoms,” Dr. Joffe said.
This study, though small, validates and extends the notion that multiple symptoms of the menopausal transition contribute to the mild mood symptoms that are common during this phase of a woman’s life, said Dr. Joffe. To date, most of the studies have been large epidemiologic studies, which while important, tend to assess people at one cross-sectional time point annually, and can’t always capture a nuanced and precise view of symptoms and how they relate to hormone levels, she said.
“Perimenopausal hormone changes are dynamic,” said Dr. Joffe, and have wide interindividual variation during the menopausal transition. Overall, though, she said, “clinical studies show that mood is better as ovarian activity is more normalized in perimenopausal women. Conversely, the more abnormal the hormonal profile, the worse the mood.”
Major depression is another story, said Dr. Joffe. “Menopause-specific factors have not, for the most part, been linked,” she said, noting that the best predictors for clinical depression in midlife that have been identified to date are a previous history of clinical depression or anxiety, as well as other traditional psychiatric risk factors such as low socioeconomic status and a low level of social support.
“People often present with all these symptoms all at once; they have mood disturbances, they have hot flashes, they have sleep disturbances. For the people experiencing these symptoms, it matters a lot to be able to have an explanation that’s credible, and defendable, and evidence based,” Dr. Joffe said. “And it also has implications for treatment, of course.”
This real world complexity inevitably intrudes during a clinical encounter, and it’s not an easy task, or a quick one, to tease apart the extent to which the menopausal transition is contributing to depressive symptoms when women have so many other potential stressors.
While acknowledging that it’s very difficult to unpack this in a brief clinic visit, Dr. Shifren also emphasized that it’s critically important. For patients with mild depressive symptoms, hormone therapy or other treatment to address vasomotor symptoms, along with evidence-based treatment of sleep problems, can be of real help.
“That’s very different from women who come in with real depression,” Dr. Shifren said in an interview. “It’s very important not to say, ‘Oh, that’s just a little bit of perimenopause.’ ”
“There is not enough education of general providers about the nuances of mood changes and mental health of women in midlife,” Dr. Montgomery said in an interview. “These are nicely dealt with in publications of the North American Menopause Society,” he said, also noting that the ob.gyn. residency curriculum at Drexel University includes specific modules to address the menopausal transition and menopause. “If you are going to be caring for women in transition, you probably should do a little deeper dive,” he said.
“My advice for clinicians is don’t do this alone,” Dr. Shifren said. If clinicians feel they lack expertise in diagnosing and managing mood disorders, they should establish collaborative relationships with colleagues in mental health. “We can still help with hormone management, sleep management, and keeping in touch with the patient,” she said.
One trick of the trade is to use your nursing staff to follow up with patients, Dr. Shifren said. She will ask a nurse to make a follow-up phone call 2-6 weeks after a patient visit to assess how the woman is faring with symptoms and any treatments that have been initiated or modified. The interval and intensity of follow-up can be modified based on feedback from this call, she said.
The bottom line for Dr. Montgomery is twofold: “Being menopausal does not make you depressed,” he said. “True clinical depression is a rare event, but one that should not be missed.”
Dr. Joffe reported consulting agreements with several pharmaceutical companies, and grant support from Merck for research related to vasomotor symptoms and insomnia. Dr. Montgomery reported no relevant financial disclosures. Dr. Shifren reported that she has a consulting agreement with the New England Research Institutes.
[email protected]
On Twitter @karioakes
VIDEO: Choosing Your Path: Academic or Community Hospital Medicine?
Choosing hospital medicine as a specialty means choosing between practicing community HM or academic HM. Or does it? Elizabeth Cook, MD, of Hospital Medicine Associates in Lynchburg VA; Stella Fitzgibbon, MD, FACP, FHM, with Memorial Hermann Hospital in The Woodlands, TX; and Chris Moriates, MD, of Dell Medical School at UT Austin, talk about the options available in community and academic HM, and moving between them during an HM career.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Choosing hospital medicine as a specialty means choosing between practicing community HM or academic HM. Or does it? Elizabeth Cook, MD, of Hospital Medicine Associates in Lynchburg VA; Stella Fitzgibbon, MD, FACP, FHM, with Memorial Hermann Hospital in The Woodlands, TX; and Chris Moriates, MD, of Dell Medical School at UT Austin, talk about the options available in community and academic HM, and moving between them during an HM career.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Choosing hospital medicine as a specialty means choosing between practicing community HM or academic HM. Or does it? Elizabeth Cook, MD, of Hospital Medicine Associates in Lynchburg VA; Stella Fitzgibbon, MD, FACP, FHM, with Memorial Hermann Hospital in The Woodlands, TX; and Chris Moriates, MD, of Dell Medical School at UT Austin, talk about the options available in community and academic HM, and moving between them during an HM career.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Travel barriers can impede patient choice for pancreatectomy
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
Key clinical point:
Major finding: About 60% of patients who didn’t travel had surgery at a low-volume hospital with a higher mortality rate and longer length of stay.
Data source: The 10-year California database review comprised 13,000 patients.
Disclosures: Dr. Fong had no financial disclosures.