In a study that analyzed Twitter data from 5 American Headache Society (AHS) conferences held from 2014 to 2016 using their respective hashtags, AHS conference discussions featured a small group of accounts creating the bulk of the content, with individual medical professionals and host organizations generating the largest shares of tweets and mentions while host organizations and other individuals produced the most impressions. Researchers gathered data on numbers of tweets, impressions, participants, and mentions during a 10-day period surrounding each conference, as well as samples of Twitter accounts participating. They found:

• 19,936 tweets were generated across the 5 conferences.
• 58% of tweets were created by the top 10 participating accounts in each conference, which were primarily individual medical professionals and host organizations.
• 75% of impressions generated across the 5 conferences came from the top 10 participants in each.
• An average of 331 accounts participated in each conference.
• #migraine usage during conferences showed a significant increase from baseline in number of tweets.

Callister MN, Robbins MS, Callister NR, Vargas BB. Tweeting the headache meetings: Cross-sectional analysis of Twitter activity surrounding American Headache Society conferences. [Published online ahead of print March 20, 2019]. Headache. doi:10.1111/head.13500.

In a study that analyzed Twitter data from 5 American Headache Society (AHS) conferences held from 2014 to 2016 using their respective hashtags, AHS conference discussions featured a small group of accounts creating the bulk of the content, with individual medical professionals and host organizations generating the largest shares of tweets and mentions while host organizations and other individuals produced the most impressions. Researchers gathered data on numbers of tweets, impressions, participants, and mentions during a 10-day period surrounding each conference, as well as samples of Twitter accounts participating. They found:

• 19,936 tweets were generated across the 5 conferences.
• 58% of tweets were created by the top 10 participating accounts in each conference, which were primarily individual medical professionals and host organizations.
• 75% of impressions generated across the 5 conferences came from the top 10 participants in each.
• An average of 331 accounts participated in each conference.
• #migraine usage during conferences showed a significant increase from baseline in number of tweets.

Callister MN, Robbins MS, Callister NR, Vargas BB. Tweeting the headache meetings: Cross-sectional analysis of Twitter activity surrounding American Headache Society conferences. [Published online ahead of print March 20, 2019]. Headache. doi:10.1111/head.13500.

In a study that analyzed Twitter data from 5 American Headache Society (AHS) conferences held from 2014 to 2016 using their respective hashtags, AHS conference discussions featured a small group of accounts creating the bulk of the content, with individual medical professionals and host organizations generating the largest shares of tweets and mentions while host organizations and other individuals produced the most impressions. Researchers gathered data on numbers of tweets, impressions, participants, and mentions during a 10-day period surrounding each conference, as well as samples of Twitter accounts participating. They found:

• 19,936 tweets were generated across the 5 conferences.
• 58% of tweets were created by the top 10 participating accounts in each conference, which were primarily individual medical professionals and host organizations.
• 75% of impressions generated across the 5 conferences came from the top 10 participants in each.
• An average of 331 accounts participated in each conference.
• #migraine usage during conferences showed a significant increase from baseline in number of tweets.

Callister MN, Robbins MS, Callister NR, Vargas BB. Tweeting the headache meetings: Cross-sectional analysis of Twitter activity surrounding American Headache Society conferences. [Published online ahead of print March 20, 2019]. Headache. doi:10.1111/head.13500.

The Migraine Specific Quality-of-Life Questionnaire Version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in episodic migraine (EM) and chronic migraine (CM) clinical trials to assess the functional impact of migraine, a new study suggests. The 7-item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n=851] and CGAH [n=909]) and 1 CM (CGAI [n=1090]) phase 3 clinical trial. Researchers found:

• Cronbach’s alpha values for internal consistency reliability were 0.93, 0.92, and 0.92 for CGAG, CGAH, and CGAI, respectively.
• Test-retest reliability intra-class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients.
• Convergent validity was supported by moderate to strong correlations between the RFR and both the Migraine Disability Assessment (MIDAS) and the Patient Global Impression of Severity (PGI-S).

Speck RM, Shalhoub H, Wyrwich KW, et al. Psychometric validation of the role function restrictive domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 electronic patient-reported outcome in patients with episodic and chronic migraine. [Published online ahead of print March 12, 2019]. Headache. doi:10.1111/head.13497.

The Migraine Specific Quality-of-Life Questionnaire Version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in episodic migraine (EM) and chronic migraine (CM) clinical trials to assess the functional impact of migraine, a new study suggests. The 7-item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n=851] and CGAH [n=909]) and 1 CM (CGAI [n=1090]) phase 3 clinical trial. Researchers found:

• Cronbach’s alpha values for internal consistency reliability were 0.93, 0.92, and 0.92 for CGAG, CGAH, and CGAI, respectively.
• Test-retest reliability intra-class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients.
• Convergent validity was supported by moderate to strong correlations between the RFR and both the Migraine Disability Assessment (MIDAS) and the Patient Global Impression of Severity (PGI-S).

Speck RM, Shalhoub H, Wyrwich KW, et al. Psychometric validation of the role function restrictive domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 electronic patient-reported outcome in patients with episodic and chronic migraine. [Published online ahead of print March 12, 2019]. Headache. doi:10.1111/head.13497.

The Migraine Specific Quality-of-Life Questionnaire Version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in episodic migraine (EM) and chronic migraine (CM) clinical trials to assess the functional impact of migraine, a new study suggests. The 7-item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n=851] and CGAH [n=909]) and 1 CM (CGAI [n=1090]) phase 3 clinical trial. Researchers found:

• Cronbach’s alpha values for internal consistency reliability were 0.93, 0.92, and 0.92 for CGAG, CGAH, and CGAI, respectively.
• Test-retest reliability intra-class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients.
• Convergent validity was supported by moderate to strong correlations between the RFR and both the Migraine Disability Assessment (MIDAS) and the Patient Global Impression of Severity (PGI-S).

Speck RM, Shalhoub H, Wyrwich KW, et al. Psychometric validation of the role function restrictive domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 electronic patient-reported outcome in patients with episodic and chronic migraine. [Published online ahead of print March 12, 2019]. Headache. doi:10.1111/head.13497.

In a recent observational study, the loss of habituation and lower threshold for occipital cortex excitability were demonstrated electrophysiologically in patients with visual snow syndrome (VS). While statistically significant loss of habituation was seen in both VS patients with or without migraine in the right eye, statistically significant loss of habituation in the left eye and decreased threshold of left occipital cortex excitability was seen in patients who had VS with migraine. Researchers investigated the role of neurophysiological assessments of the occipital cortex in VS patients with (VS_m) or without migraine (VS_wom) and in healthy control (HC). They found:

• Twenty-nine volunteers were recruited for the study; the VS_m (n=10), the VS_wom (n=7), and the HC group (n=12) did not differ demographically.
• Flickering and floaters were reported in all VS patients and flickering in the dark was the most distressing symptomology in both VS groups.
• Higher visual analogue scale (VAS) scores for palinopsia, photophobia, and concentration difficulty were more frequent in VS_m patients.
• In the post hoc analysis, the VS patients did not differ according to the presence of migraine from right or left eye stimulations.

Yildiz FG, Turkyilmaz U, Unal-Cevik I. The clinical characteristics and neurophysiological assessments of the occipital cortex in visual snow syndrome with or without migraine. [Published online ahead of print March 8, 2019]. Headache. doi:10.1111/head.13494.

In a recent observational study, the loss of habituation and lower threshold for occipital cortex excitability were demonstrated electrophysiologically in patients with visual snow syndrome (VS). While statistically significant loss of habituation was seen in both VS patients with or without migraine in the right eye, statistically significant loss of habituation in the left eye and decreased threshold of left occipital cortex excitability was seen in patients who had VS with migraine. Researchers investigated the role of neurophysiological assessments of the occipital cortex in VS patients with (VS_m) or without migraine (VS_wom) and in healthy control (HC). They found:

• Twenty-nine volunteers were recruited for the study; the VS_m (n=10), the VS_wom (n=7), and the HC group (n=12) did not differ demographically.
• Flickering and floaters were reported in all VS patients and flickering in the dark was the most distressing symptomology in both VS groups.
• Higher visual analogue scale (VAS) scores for palinopsia, photophobia, and concentration difficulty were more frequent in VS_m patients.
• In the post hoc analysis, the VS patients did not differ according to the presence of migraine from right or left eye stimulations.

Yildiz FG, Turkyilmaz U, Unal-Cevik I. The clinical characteristics and neurophysiological assessments of the occipital cortex in visual snow syndrome with or without migraine. [Published online ahead of print March 8, 2019]. Headache. doi:10.1111/head.13494.

In a recent observational study, the loss of habituation and lower threshold for occipital cortex excitability were demonstrated electrophysiologically in patients with visual snow syndrome (VS). While statistically significant loss of habituation was seen in both VS patients with or without migraine in the right eye, statistically significant loss of habituation in the left eye and decreased threshold of left occipital cortex excitability was seen in patients who had VS with migraine. Researchers investigated the role of neurophysiological assessments of the occipital cortex in VS patients with (VS_m) or without migraine (VS_wom) and in healthy control (HC). They found:

• Twenty-nine volunteers were recruited for the study; the VS_m (n=10), the VS_wom (n=7), and the HC group (n=12) did not differ demographically.
• Flickering and floaters were reported in all VS patients and flickering in the dark was the most distressing symptomology in both VS groups.
• Higher visual analogue scale (VAS) scores for palinopsia, photophobia, and concentration difficulty were more frequent in VS_m patients.
• In the post hoc analysis, the VS patients did not differ according to the presence of migraine from right or left eye stimulations.

Yildiz FG, Turkyilmaz U, Unal-Cevik I. The clinical characteristics and neurophysiological assessments of the occipital cortex in visual snow syndrome with or without migraine. [Published online ahead of print March 8, 2019]. Headache. doi:10.1111/head.13494.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

NEW ORLEANS – The success of icosapent ethyl in cutting triglyceride levels and reducing cardiovascular disease events in at-risk patients in the REDUCE-IT trial may make clinicians rethink the threshold for an unhealthy triglyceride level that merits intervention.

Mitchel L. Zoler/MDedge News

Study results are also showing that the patients enrolled in REDUCE-IT are common, with apparently millions of Americans who could potentially receive the icosapent ethyl–processed fish oil used in the study if the Food and Drug Administration were to approve new labeling for the drug that the manufacturer filed for in late March 2019. Icosapent ethyl (Vascepa) already has U.S. marketing approval for reducing triglyceride (TG) levels in patients with baseline values of 500 mg/dL or greater, while the REDUCE-IT trial enrolled patients with established cardiovascular disease or diabetes plus at least one more risk factor with a TG level of 150-499 mg/dL. REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial) enrolled only patients already on statin treatment and with a LDL cholesterol level of 41-100 mg/dL.

In reality, the clinicians who enrolled the 8,139 participants at 473 worldwide sites included patients with a TG level as low as 81 mg/dL, and 10% of entered patients had levels below the minimum threshold in the trial’s written design of at least 150 mg/dL. Initial results reported with the primary endpoint finding suggested that the icosapent ethyl treatment benefit extended to these patients who entered with what are currently considered normal TG values, and additional analyses reported by the study’s lead investigator, Deepak L. Bhatt, MD, which used a larger endpoint dataset that included total cardiovascular events rather than just first events, further confirmed that patients with lower baseline TG levels had reductions in their cardiovascular disease events that matched what was seen in patients who entered with substantially higher TG levels.

In the analysis that included total events, the tertile of patients with a baseline TG of 81-190 mg/dL had a statistically significant 26% relative reduction in events during an average 3.5-year follow-up, compared with the tertile of patients with a baseline level of 251 mg/dL or higher, who had a 40% reduction in their events during follow-up, reported Dr. Bhatt, professor of medicine at Harvard Medical School, Boston.


“We had patients [in REDUCE-IT] with lower triglycerides than the inclusion criteria. This shows that the study results apply to a broader range of patients,” he said in a talk at the annual meeting of the American College of Cardiology. “The total-event analysis gives us an appreciation of the large burden of ischemic events that statin-treated patients still have with baseline triglyceride levels of about 100 mg/dL.” Further analysis of the REDUCE-IT data, as well as future studies of TG-lowering drugs like icosapent ethyl, “may help redefine normal TG levels” in a manner similar to what happened over a 2-decade span as serial studies of statins and other drugs that reduced levels of LDL cholesterol led to incremental reductions in goal lipid levels.

In addition to providing greater precision in defining the impact of icosapent ethyl on events in patients with lower baseline TG levels, the total-event analysis “provided a better sense of what is actually going on” with patients clinically as they experience multiple cardiovascular events during follow-up, as well as the impact of treatment on reducing health-related costs. Concurrently with Dr. Bhatt’s report of the total-event analysis at the meeting, some of the new findings he presented also appeared online (J Am Coll Cardiol. 2019 March 18. doi: 10.1016/j.jacc.2019.02.032).

Mitchel L. Zoler/MDedge News

Recent analyses have also begun to assess the scope of patients who could potentially receive icosapent ethyl based on the enrollment criteria of REDUCE-IT. One analysis of more than 1 million people in the U.S. Veterans Affairs Health System during 2010 identified 439,019 people on statin treatment and with an LDL cholesterol of 41-100 mg/dL, the cardiovascular disease history or risk pattern that matched the trial, and not on treatment that could reduce TG levels such as fish oil. Among these people, 30% had a TG level at or above 150 mg/dL that would have qualified them to enter REDUCE-IT, said William E. Boden, MD, professor of medicine at Boston University. Among the 132,203 patients in this group who were on statin treatment and at their target LDL cholesterol level, the 5-year rate of cardiovascular disease events was 8.5% in those with higher TG levels and 6.3% in those with levels below 150 mg/dL, a statistically significant 19% increased risk after adjustment for some potential confounders, Dr. Boden reported in a poster he presented at the meeting. This analysis hinted at the magnitude of patients who are candidates for icosapent ethyl treatment based on REDUCE-IT, and the 19% residual increased risk they displayed showed what this treatment could address.

Analysis of another database identified 16% of more than 24,000 patients with stable coronary artery disease in the CLARIFY registry who would qualify for icosapent ethyl treatment by matching the REDUCE-IT enrollment criteria (J Am Coll Cardiol. 2019 March;73[11];doi: 10.1016/j.jacc.2019.01.016).

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Bhatt is an adviser to Cardax, PhaseBio, and Regado Biosciences, he is on the board of TobeSoft, and he has received research funding from several companies. Dr. Boden reported no disclosures.

[email protected]

NEW ORLEANS – The success of icosapent ethyl in cutting triglyceride levels and reducing cardiovascular disease events in at-risk patients in the REDUCE-IT trial may make clinicians rethink the threshold for an unhealthy triglyceride level that merits intervention.

Mitchel L. Zoler/MDedge News

Study results are also showing that the patients enrolled in REDUCE-IT are common, with apparently millions of Americans who could potentially receive the icosapent ethyl–processed fish oil used in the study if the Food and Drug Administration were to approve new labeling for the drug that the manufacturer filed for in late March 2019. Icosapent ethyl (Vascepa) already has U.S. marketing approval for reducing triglyceride (TG) levels in patients with baseline values of 500 mg/dL or greater, while the REDUCE-IT trial enrolled patients with established cardiovascular disease or diabetes plus at least one more risk factor with a TG level of 150-499 mg/dL. REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial) enrolled only patients already on statin treatment and with a LDL cholesterol level of 41-100 mg/dL.

In reality, the clinicians who enrolled the 8,139 participants at 473 worldwide sites included patients with a TG level as low as 81 mg/dL, and 10% of entered patients had levels below the minimum threshold in the trial’s written design of at least 150 mg/dL. Initial results reported with the primary endpoint finding suggested that the icosapent ethyl treatment benefit extended to these patients who entered with what are currently considered normal TG values, and additional analyses reported by the study’s lead investigator, Deepak L. Bhatt, MD, which used a larger endpoint dataset that included total cardiovascular events rather than just first events, further confirmed that patients with lower baseline TG levels had reductions in their cardiovascular disease events that matched what was seen in patients who entered with substantially higher TG levels.

In the analysis that included total events, the tertile of patients with a baseline TG of 81-190 mg/dL had a statistically significant 26% relative reduction in events during an average 3.5-year follow-up, compared with the tertile of patients with a baseline level of 251 mg/dL or higher, who had a 40% reduction in their events during follow-up, reported Dr. Bhatt, professor of medicine at Harvard Medical School, Boston.


“We had patients [in REDUCE-IT] with lower triglycerides than the inclusion criteria. This shows that the study results apply to a broader range of patients,” he said in a talk at the annual meeting of the American College of Cardiology. “The total-event analysis gives us an appreciation of the large burden of ischemic events that statin-treated patients still have with baseline triglyceride levels of about 100 mg/dL.” Further analysis of the REDUCE-IT data, as well as future studies of TG-lowering drugs like icosapent ethyl, “may help redefine normal TG levels” in a manner similar to what happened over a 2-decade span as serial studies of statins and other drugs that reduced levels of LDL cholesterol led to incremental reductions in goal lipid levels.

In addition to providing greater precision in defining the impact of icosapent ethyl on events in patients with lower baseline TG levels, the total-event analysis “provided a better sense of what is actually going on” with patients clinically as they experience multiple cardiovascular events during follow-up, as well as the impact of treatment on reducing health-related costs. Concurrently with Dr. Bhatt’s report of the total-event analysis at the meeting, some of the new findings he presented also appeared online (J Am Coll Cardiol. 2019 March 18. doi: 10.1016/j.jacc.2019.02.032).

Mitchel L. Zoler/MDedge News

Recent analyses have also begun to assess the scope of patients who could potentially receive icosapent ethyl based on the enrollment criteria of REDUCE-IT. One analysis of more than 1 million people in the U.S. Veterans Affairs Health System during 2010 identified 439,019 people on statin treatment and with an LDL cholesterol of 41-100 mg/dL, the cardiovascular disease history or risk pattern that matched the trial, and not on treatment that could reduce TG levels such as fish oil. Among these people, 30% had a TG level at or above 150 mg/dL that would have qualified them to enter REDUCE-IT, said William E. Boden, MD, professor of medicine at Boston University. Among the 132,203 patients in this group who were on statin treatment and at their target LDL cholesterol level, the 5-year rate of cardiovascular disease events was 8.5% in those with higher TG levels and 6.3% in those with levels below 150 mg/dL, a statistically significant 19% increased risk after adjustment for some potential confounders, Dr. Boden reported in a poster he presented at the meeting. This analysis hinted at the magnitude of patients who are candidates for icosapent ethyl treatment based on REDUCE-IT, and the 19% residual increased risk they displayed showed what this treatment could address.

Analysis of another database identified 16% of more than 24,000 patients with stable coronary artery disease in the CLARIFY registry who would qualify for icosapent ethyl treatment by matching the REDUCE-IT enrollment criteria (J Am Coll Cardiol. 2019 March;73[11];doi: 10.1016/j.jacc.2019.01.016).

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Bhatt is an adviser to Cardax, PhaseBio, and Regado Biosciences, he is on the board of TobeSoft, and he has received research funding from several companies. Dr. Boden reported no disclosures.

[email protected]

NEW ORLEANS – The success of icosapent ethyl in cutting triglyceride levels and reducing cardiovascular disease events in at-risk patients in the REDUCE-IT trial may make clinicians rethink the threshold for an unhealthy triglyceride level that merits intervention.

Mitchel L. Zoler/MDedge News

Study results are also showing that the patients enrolled in REDUCE-IT are common, with apparently millions of Americans who could potentially receive the icosapent ethyl–processed fish oil used in the study if the Food and Drug Administration were to approve new labeling for the drug that the manufacturer filed for in late March 2019. Icosapent ethyl (Vascepa) already has U.S. marketing approval for reducing triglyceride (TG) levels in patients with baseline values of 500 mg/dL or greater, while the REDUCE-IT trial enrolled patients with established cardiovascular disease or diabetes plus at least one more risk factor with a TG level of 150-499 mg/dL. REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial) enrolled only patients already on statin treatment and with a LDL cholesterol level of 41-100 mg/dL.

In reality, the clinicians who enrolled the 8,139 participants at 473 worldwide sites included patients with a TG level as low as 81 mg/dL, and 10% of entered patients had levels below the minimum threshold in the trial’s written design of at least 150 mg/dL. Initial results reported with the primary endpoint finding suggested that the icosapent ethyl treatment benefit extended to these patients who entered with what are currently considered normal TG values, and additional analyses reported by the study’s lead investigator, Deepak L. Bhatt, MD, which used a larger endpoint dataset that included total cardiovascular events rather than just first events, further confirmed that patients with lower baseline TG levels had reductions in their cardiovascular disease events that matched what was seen in patients who entered with substantially higher TG levels.

In the analysis that included total events, the tertile of patients with a baseline TG of 81-190 mg/dL had a statistically significant 26% relative reduction in events during an average 3.5-year follow-up, compared with the tertile of patients with a baseline level of 251 mg/dL or higher, who had a 40% reduction in their events during follow-up, reported Dr. Bhatt, professor of medicine at Harvard Medical School, Boston.


“We had patients [in REDUCE-IT] with lower triglycerides than the inclusion criteria. This shows that the study results apply to a broader range of patients,” he said in a talk at the annual meeting of the American College of Cardiology. “The total-event analysis gives us an appreciation of the large burden of ischemic events that statin-treated patients still have with baseline triglyceride levels of about 100 mg/dL.” Further analysis of the REDUCE-IT data, as well as future studies of TG-lowering drugs like icosapent ethyl, “may help redefine normal TG levels” in a manner similar to what happened over a 2-decade span as serial studies of statins and other drugs that reduced levels of LDL cholesterol led to incremental reductions in goal lipid levels.

In addition to providing greater precision in defining the impact of icosapent ethyl on events in patients with lower baseline TG levels, the total-event analysis “provided a better sense of what is actually going on” with patients clinically as they experience multiple cardiovascular events during follow-up, as well as the impact of treatment on reducing health-related costs. Concurrently with Dr. Bhatt’s report of the total-event analysis at the meeting, some of the new findings he presented also appeared online (J Am Coll Cardiol. 2019 March 18. doi: 10.1016/j.jacc.2019.02.032).

Mitchel L. Zoler/MDedge News

Recent analyses have also begun to assess the scope of patients who could potentially receive icosapent ethyl based on the enrollment criteria of REDUCE-IT. One analysis of more than 1 million people in the U.S. Veterans Affairs Health System during 2010 identified 439,019 people on statin treatment and with an LDL cholesterol of 41-100 mg/dL, the cardiovascular disease history or risk pattern that matched the trial, and not on treatment that could reduce TG levels such as fish oil. Among these people, 30% had a TG level at or above 150 mg/dL that would have qualified them to enter REDUCE-IT, said William E. Boden, MD, professor of medicine at Boston University. Among the 132,203 patients in this group who were on statin treatment and at their target LDL cholesterol level, the 5-year rate of cardiovascular disease events was 8.5% in those with higher TG levels and 6.3% in those with levels below 150 mg/dL, a statistically significant 19% increased risk after adjustment for some potential confounders, Dr. Boden reported in a poster he presented at the meeting. This analysis hinted at the magnitude of patients who are candidates for icosapent ethyl treatment based on REDUCE-IT, and the 19% residual increased risk they displayed showed what this treatment could address.

Analysis of another database identified 16% of more than 24,000 patients with stable coronary artery disease in the CLARIFY registry who would qualify for icosapent ethyl treatment by matching the REDUCE-IT enrollment criteria (J Am Coll Cardiol. 2019 March;73[11];doi: 10.1016/j.jacc.2019.01.016).

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Bhatt is an adviser to Cardax, PhaseBio, and Regado Biosciences, he is on the board of TobeSoft, and he has received research funding from several companies. Dr. Boden reported no disclosures.

[email protected]

Key clinical point: Patients who discontinued disease-modifying therapy after a period of disease inactivity had a similar time to next event, compared with patients who remained on treatment.

Major finding: Compared with patients aged 45 years and younger, older patients who discontinued disease-modifying therapy had significantly favorable disease course in terms of time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005).

Study details: A single-center study of 140 patients with relapsing remitting multiple sclerosis.

Disclosures: Dr. Yano reported that he has received a research grant from the Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

Citation: Yano H et al. ACTRIMS Forum 2019, Poster 061.

Key clinical point: Patients who discontinued disease-modifying therapy after a period of disease inactivity had a similar time to next event, compared with patients who remained on treatment.

Major finding: Compared with patients aged 45 years and younger, older patients who discontinued disease-modifying therapy had significantly favorable disease course in terms of time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005).

Study details: A single-center study of 140 patients with relapsing remitting multiple sclerosis.

Disclosures: Dr. Yano reported that he has received a research grant from the Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

Citation: Yano H et al. ACTRIMS Forum 2019, Poster 061.

Key clinical point: Patients who discontinued disease-modifying therapy after a period of disease inactivity had a similar time to next event, compared with patients who remained on treatment.

Major finding: Compared with patients aged 45 years and younger, older patients who discontinued disease-modifying therapy had significantly favorable disease course in terms of time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005).

Study details: A single-center study of 140 patients with relapsing remitting multiple sclerosis.

Disclosures: Dr. Yano reported that he has received a research grant from the Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

Citation: Yano H et al. ACTRIMS Forum 2019, Poster 061.

NEW ORLEANS – In STEMI patients who aren’t able to undergo primary PCI, ticagrelor after fibrinolytic therapy offered no advantages over clopidogrel – a less potent and less costly antiplatelet agent – in rates of cardiovascular events or bleeding though 12 months of follow-up in the TREAT trial.

Bruce Jancin/MDedge News

“In terms of efficacy, it is appropriate to interpret TREAT statistically as a neutral trial,” Otavio Berwanger, MD, PhD, advised at the annual meeting of the American College of Cardiology.

TREAT (Ticagrelor in patients with ST-elevation myocardial infarction treated with pharmacological thrombolysis) was a 10-country, 152-site, randomized, open-label clinical trial of 3,799 STEMI (ST-elevation MI) patients treated with fibrinolytic therapy followed an average of 11 hours later by a loading dose of either ticagrelor (Brilinta) or clopidogrel, then 12 months of standard-dose maintenance therapy of their designated potent antiplatelet drug. The adherence rate was 90% at 12 months. Participating countries included Russia, China, Brazil, Australia, and Canada, but not the United States.

The primary efficacy endpoint was the 12-month composite of death from a vascular cause, MI, stroke, severe recurrent ischemia, TIA, or another arterial thrombotic event. The rate was 8% in the ticagrelor group and 9.1% with clopidogrel, a 12% relative risk reduction in favor of ticagrelor that was not statistically significant. But then, TREAT was underpowered to show a difference in efficacy. However, the 12% relative risk reduction mirrors that seen in the earlier PLATO trial of 18,624 patients with acute coronary syndrome who were randomized to ticagrelor or clopidogrel in conjunction with primary PCI, a difference that was statistically significant because of PLATO’s much larger size (N Engl J Med. 2009 Sep 10;361[11]:1045-57).

TREAT was sufficiently powered to assess safety. There was no significant between-group difference in TIMI major bleeding, the primary safety endpoint. However, the rate of total bleeding events was significantly higher in the ticagrelor arm, by a margin of 10.25% versus 6.15%. Moreover, the rate of TIMI clinically significant bleeding requiring medical attention was also higher in the ticagrelor group – 5.2% versus 3.8% – and the TIMI minimal bleeding rate of 5.85% in the ticagrelor group was more than double that in the clopidogrel arm, reported Dr. Berwanger of the Heart Hospital Research Institute in São Paolo.

These 12-month outcomes echo those previously reported at the 30-day mark in TREAT (JAMA Cardiol. 2018 May 1;3[5]:391-9).

Discussant C. Michael Gibson, MD, put TREAT in perspective: “Here we’re looking to see if there are differences between two thienopyridine inhibitors. There’s nothing really that important on the efficacy side, although there was 1.5% missingness in the study. And there was a higher number of total bleeds with ticagrelor.

“Some of the junior members of the audience may not be all that familiar with fibrinolysis. In the era where it was more prominent, reocclusion occurred in 5%-8% of patients. When it did occur, it led to a tripling of mortality. It’s important to note that the first study of a thienopyridine inhibitor added to lytics was CLARITY, almost 15 years ago, showing a reduction in death, MI, or reocclusion down from about 15% to 7% [N Engl J Med 2005; 352:1179-89]. So it should be very clear to the audience that reocclusion is a problem and the addition of a thienopyridine inhibitor improves that,” explained Dr. Gibson, professor of medicine at Harvard Medical School, Boston.

The TREAT trial was funded by AstraZeneca. Dr. Berwanger reported receiving research grants from and serving as a consultant to that company and half a dozen others.

Simultaneously with the presentation, the TREAT study was published online (J Am Coll Cardiol. 2019 Mar 12. doi: 10.1016/j.jacc.2019.03.011).

[email protected]

NEW ORLEANS – In STEMI patients who aren’t able to undergo primary PCI, ticagrelor after fibrinolytic therapy offered no advantages over clopidogrel – a less potent and less costly antiplatelet agent – in rates of cardiovascular events or bleeding though 12 months of follow-up in the TREAT trial.

Bruce Jancin/MDedge News

“In terms of efficacy, it is appropriate to interpret TREAT statistically as a neutral trial,” Otavio Berwanger, MD, PhD, advised at the annual meeting of the American College of Cardiology.

TREAT (Ticagrelor in patients with ST-elevation myocardial infarction treated with pharmacological thrombolysis) was a 10-country, 152-site, randomized, open-label clinical trial of 3,799 STEMI (ST-elevation MI) patients treated with fibrinolytic therapy followed an average of 11 hours later by a loading dose of either ticagrelor (Brilinta) or clopidogrel, then 12 months of standard-dose maintenance therapy of their designated potent antiplatelet drug. The adherence rate was 90% at 12 months. Participating countries included Russia, China, Brazil, Australia, and Canada, but not the United States.

The primary efficacy endpoint was the 12-month composite of death from a vascular cause, MI, stroke, severe recurrent ischemia, TIA, or another arterial thrombotic event. The rate was 8% in the ticagrelor group and 9.1% with clopidogrel, a 12% relative risk reduction in favor of ticagrelor that was not statistically significant. But then, TREAT was underpowered to show a difference in efficacy. However, the 12% relative risk reduction mirrors that seen in the earlier PLATO trial of 18,624 patients with acute coronary syndrome who were randomized to ticagrelor or clopidogrel in conjunction with primary PCI, a difference that was statistically significant because of PLATO’s much larger size (N Engl J Med. 2009 Sep 10;361[11]:1045-57).

TREAT was sufficiently powered to assess safety. There was no significant between-group difference in TIMI major bleeding, the primary safety endpoint. However, the rate of total bleeding events was significantly higher in the ticagrelor arm, by a margin of 10.25% versus 6.15%. Moreover, the rate of TIMI clinically significant bleeding requiring medical attention was also higher in the ticagrelor group – 5.2% versus 3.8% – and the TIMI minimal bleeding rate of 5.85% in the ticagrelor group was more than double that in the clopidogrel arm, reported Dr. Berwanger of the Heart Hospital Research Institute in São Paolo.

These 12-month outcomes echo those previously reported at the 30-day mark in TREAT (JAMA Cardiol. 2018 May 1;3[5]:391-9).

Discussant C. Michael Gibson, MD, put TREAT in perspective: “Here we’re looking to see if there are differences between two thienopyridine inhibitors. There’s nothing really that important on the efficacy side, although there was 1.5% missingness in the study. And there was a higher number of total bleeds with ticagrelor.

“Some of the junior members of the audience may not be all that familiar with fibrinolysis. In the era where it was more prominent, reocclusion occurred in 5%-8% of patients. When it did occur, it led to a tripling of mortality. It’s important to note that the first study of a thienopyridine inhibitor added to lytics was CLARITY, almost 15 years ago, showing a reduction in death, MI, or reocclusion down from about 15% to 7% [N Engl J Med 2005; 352:1179-89]. So it should be very clear to the audience that reocclusion is a problem and the addition of a thienopyridine inhibitor improves that,” explained Dr. Gibson, professor of medicine at Harvard Medical School, Boston.

The TREAT trial was funded by AstraZeneca. Dr. Berwanger reported receiving research grants from and serving as a consultant to that company and half a dozen others.

Simultaneously with the presentation, the TREAT study was published online (J Am Coll Cardiol. 2019 Mar 12. doi: 10.1016/j.jacc.2019.03.011).

[email protected]

NEW ORLEANS – In STEMI patients who aren’t able to undergo primary PCI, ticagrelor after fibrinolytic therapy offered no advantages over clopidogrel – a less potent and less costly antiplatelet agent – in rates of cardiovascular events or bleeding though 12 months of follow-up in the TREAT trial.

Bruce Jancin/MDedge News

“In terms of efficacy, it is appropriate to interpret TREAT statistically as a neutral trial,” Otavio Berwanger, MD, PhD, advised at the annual meeting of the American College of Cardiology.

TREAT (Ticagrelor in patients with ST-elevation myocardial infarction treated with pharmacological thrombolysis) was a 10-country, 152-site, randomized, open-label clinical trial of 3,799 STEMI (ST-elevation MI) patients treated with fibrinolytic therapy followed an average of 11 hours later by a loading dose of either ticagrelor (Brilinta) or clopidogrel, then 12 months of standard-dose maintenance therapy of their designated potent antiplatelet drug. The adherence rate was 90% at 12 months. Participating countries included Russia, China, Brazil, Australia, and Canada, but not the United States.

The primary efficacy endpoint was the 12-month composite of death from a vascular cause, MI, stroke, severe recurrent ischemia, TIA, or another arterial thrombotic event. The rate was 8% in the ticagrelor group and 9.1% with clopidogrel, a 12% relative risk reduction in favor of ticagrelor that was not statistically significant. But then, TREAT was underpowered to show a difference in efficacy. However, the 12% relative risk reduction mirrors that seen in the earlier PLATO trial of 18,624 patients with acute coronary syndrome who were randomized to ticagrelor or clopidogrel in conjunction with primary PCI, a difference that was statistically significant because of PLATO’s much larger size (N Engl J Med. 2009 Sep 10;361[11]:1045-57).

TREAT was sufficiently powered to assess safety. There was no significant between-group difference in TIMI major bleeding, the primary safety endpoint. However, the rate of total bleeding events was significantly higher in the ticagrelor arm, by a margin of 10.25% versus 6.15%. Moreover, the rate of TIMI clinically significant bleeding requiring medical attention was also higher in the ticagrelor group – 5.2% versus 3.8% – and the TIMI minimal bleeding rate of 5.85% in the ticagrelor group was more than double that in the clopidogrel arm, reported Dr. Berwanger of the Heart Hospital Research Institute in São Paolo.

These 12-month outcomes echo those previously reported at the 30-day mark in TREAT (JAMA Cardiol. 2018 May 1;3[5]:391-9).

Discussant C. Michael Gibson, MD, put TREAT in perspective: “Here we’re looking to see if there are differences between two thienopyridine inhibitors. There’s nothing really that important on the efficacy side, although there was 1.5% missingness in the study. And there was a higher number of total bleeds with ticagrelor.

“Some of the junior members of the audience may not be all that familiar with fibrinolysis. In the era where it was more prominent, reocclusion occurred in 5%-8% of patients. When it did occur, it led to a tripling of mortality. It’s important to note that the first study of a thienopyridine inhibitor added to lytics was CLARITY, almost 15 years ago, showing a reduction in death, MI, or reocclusion down from about 15% to 7% [N Engl J Med 2005; 352:1179-89]. So it should be very clear to the audience that reocclusion is a problem and the addition of a thienopyridine inhibitor improves that,” explained Dr. Gibson, professor of medicine at Harvard Medical School, Boston.

The TREAT trial was funded by AstraZeneca. Dr. Berwanger reported receiving research grants from and serving as a consultant to that company and half a dozen others.

Simultaneously with the presentation, the TREAT study was published online (J Am Coll Cardiol. 2019 Mar 12. doi: 10.1016/j.jacc.2019.03.011).

[email protected]

Key clinical point: A higher number of comorbidities was associated with lower quality of life.

Major finding: All comorbidities accounted for 18.09% of the variance of overall health-related quality of life.

Study details: A longitudinal study of 902 patients with MS.

Disclosures: This study was supported by Multiple Sclerosis Research Australia.

Citation: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.

Key clinical point: A higher number of comorbidities was associated with lower quality of life.

Major finding: All comorbidities accounted for 18.09% of the variance of overall health-related quality of life.

Study details: A longitudinal study of 902 patients with MS.

Disclosures: This study was supported by Multiple Sclerosis Research Australia.

Citation: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.

Key clinical point: A higher number of comorbidities was associated with lower quality of life.

Major finding: All comorbidities accounted for 18.09% of the variance of overall health-related quality of life.

Study details: A longitudinal study of 902 patients with MS.

Disclosures: This study was supported by Multiple Sclerosis Research Australia.

Citation: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.

Key clinical point: In patients with relapsing-remitting MS, cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test.

Major finding: Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months (Beta = –0.172).

Study details: A retrospective analysis of MRI data from 838 patients in the phase 3 CombiRx trial.

Disclosures: The researchers had no disclosures.

Citation: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.

Key clinical point: In patients with relapsing-remitting MS, cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test.

Major finding: Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months (Beta = –0.172).

Study details: A retrospective analysis of MRI data from 838 patients in the phase 3 CombiRx trial.

Disclosures: The researchers had no disclosures.

Citation: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.

Key clinical point: In patients with relapsing-remitting MS, cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test.

Major finding: Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months (Beta = –0.172).

Study details: A retrospective analysis of MRI data from 838 patients in the phase 3 CombiRx trial.

Disclosures: The researchers had no disclosures.

Citation: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

[email protected]

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

[email protected]

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

[email protected]