The SVS is now seeking comments on draft Clinical Practice Guidelines on the Management of Visceral Aneurysms. Your comments are essential to strengthen the content of these guidelines, and to ensure relevance in clinical practice and potential for improvements in patient care. Feedback received during the comment period will be shared with the writing committee. Anyone, from SVS members to patients, is welcome to review these draft guidelines and provide comments before April 23.

The SVS is now seeking comments on draft Clinical Practice Guidelines on the Management of Visceral Aneurysms. Your comments are essential to strengthen the content of these guidelines, and to ensure relevance in clinical practice and potential for improvements in patient care. Feedback received during the comment period will be shared with the writing committee. Anyone, from SVS members to patients, is welcome to review these draft guidelines and provide comments before April 23.

The SVS is now seeking comments on draft Clinical Practice Guidelines on the Management of Visceral Aneurysms. Your comments are essential to strengthen the content of these guidelines, and to ensure relevance in clinical practice and potential for improvements in patient care. Feedback received during the comment period will be shared with the writing committee. Anyone, from SVS members to patients, is welcome to review these draft guidelines and provide comments before April 23.

VIENNA – The prevalence of liver steatosis among unselected English young adults was 21% in a study of just over 4,000 people. The prevalence of apparent liver fibrosis was 2.4%, and among the 21% with steatosis, nearly half – 10% of the studied cohort – had severe, S3 steatosis.

Mitchel L. Zoler/MDedge News

The prevalence of steatosis, a marker of nonalcoholic fatty liver disease (NAFLD), seemed to be linked with obesity. Among the 79% of the study group who had no steatosis the obesity prevalence was 6%, compared with a 26% prevalence among those with S1 steatosis, a 33% obesity rate among those with S2 steatosis, and a 57% obesity prevalence among those with S3 steatosis, Kushala Abeysekera, MBBS, said at the meeting sponsored by the European Association for the Study of the Liver.

He and his associates determined these prevalence rates in a population that excluded people who reported consuming what was deemed “excessive” alcohol use.

Another notable finding was that 1,874 of the same people had undergone ultrasound assessment for NAFLD when they were 18 years old, and that assessment found a prevalence of 2.5% (J Clin Endocrinol Metab. 2014 March;99[3]:e410-7), which meant that during the subsequent 6 years prevalence of NAFLD jumped nearly 900%.

Both the 2014 report and the current study used people who had been enrolled in the Avon Longitudinal Study of Parents and Children, a prospective population-based study that began by recruiting a cohort of more than 14,000 pregnant women during 1991-1992, and then followed the more than 13,000 children who resulted from those pregnancies. The study reported by Dr. Abeysekera focused on 4,021 of these children – now young adults – who responded to an invitation to participate in this follow-up, a number that then reduced to 3,600 with informative transient elastography results that quantified fibrosis, and 3,768 with valid Controlled Attenuated Parameter scores from elastography that reflected steatosis extent. Transient elastography is a noninvasive method of measuring liver stiffness using ultrasound and an elastic shear wave (Clin Mol Hepatol. 2012 June;18[2]:163-73).

“To the best of my knowledge, this is the only study that has assessed NAFLD in young adults using transient elastography,” said Dr. Abeysekera, an epidemiologist at the University of Bristol (England).

After subtracting from the study cohort people with excessive alcohol use, the study had transient elastography data from 3,277 24-year-olds that could calculate steatosis severity, and data from 3,128 that could quantify fibrosis.

The analysis also showed a statistically significant link between sex and the presence and severity of steatosis. Among women, 18% had steatosis, including 7% with S3 steatosis, defined as involving at least two-thirds of the liver. Among men, 26% had some degree of steatosis and 14% had the most severe form.

The presence of more severe liver fibrosis also showed a strong link to obesity. The eight people identified with F4 fibrosis (with cirrhosis) had a median body mass index of 32 kg/m2, compared with a median body mass index of 25 kg/m2 or less among those either without fibrosis or with a milder form of F1, F2, or F3 fibrosis.

Dr. Abeysekera reported no disclosures.

[email protected]

VIENNA – The prevalence of liver steatosis among unselected English young adults was 21% in a study of just over 4,000 people. The prevalence of apparent liver fibrosis was 2.4%, and among the 21% with steatosis, nearly half – 10% of the studied cohort – had severe, S3 steatosis.

Mitchel L. Zoler/MDedge News

The prevalence of steatosis, a marker of nonalcoholic fatty liver disease (NAFLD), seemed to be linked with obesity. Among the 79% of the study group who had no steatosis the obesity prevalence was 6%, compared with a 26% prevalence among those with S1 steatosis, a 33% obesity rate among those with S2 steatosis, and a 57% obesity prevalence among those with S3 steatosis, Kushala Abeysekera, MBBS, said at the meeting sponsored by the European Association for the Study of the Liver.

He and his associates determined these prevalence rates in a population that excluded people who reported consuming what was deemed “excessive” alcohol use.

Another notable finding was that 1,874 of the same people had undergone ultrasound assessment for NAFLD when they were 18 years old, and that assessment found a prevalence of 2.5% (J Clin Endocrinol Metab. 2014 March;99[3]:e410-7), which meant that during the subsequent 6 years prevalence of NAFLD jumped nearly 900%.

Both the 2014 report and the current study used people who had been enrolled in the Avon Longitudinal Study of Parents and Children, a prospective population-based study that began by recruiting a cohort of more than 14,000 pregnant women during 1991-1992, and then followed the more than 13,000 children who resulted from those pregnancies. The study reported by Dr. Abeysekera focused on 4,021 of these children – now young adults – who responded to an invitation to participate in this follow-up, a number that then reduced to 3,600 with informative transient elastography results that quantified fibrosis, and 3,768 with valid Controlled Attenuated Parameter scores from elastography that reflected steatosis extent. Transient elastography is a noninvasive method of measuring liver stiffness using ultrasound and an elastic shear wave (Clin Mol Hepatol. 2012 June;18[2]:163-73).

“To the best of my knowledge, this is the only study that has assessed NAFLD in young adults using transient elastography,” said Dr. Abeysekera, an epidemiologist at the University of Bristol (England).

After subtracting from the study cohort people with excessive alcohol use, the study had transient elastography data from 3,277 24-year-olds that could calculate steatosis severity, and data from 3,128 that could quantify fibrosis.

The analysis also showed a statistically significant link between sex and the presence and severity of steatosis. Among women, 18% had steatosis, including 7% with S3 steatosis, defined as involving at least two-thirds of the liver. Among men, 26% had some degree of steatosis and 14% had the most severe form.

The presence of more severe liver fibrosis also showed a strong link to obesity. The eight people identified with F4 fibrosis (with cirrhosis) had a median body mass index of 32 kg/m2, compared with a median body mass index of 25 kg/m2 or less among those either without fibrosis or with a milder form of F1, F2, or F3 fibrosis.

Dr. Abeysekera reported no disclosures.

[email protected]

VIENNA – The prevalence of liver steatosis among unselected English young adults was 21% in a study of just over 4,000 people. The prevalence of apparent liver fibrosis was 2.4%, and among the 21% with steatosis, nearly half – 10% of the studied cohort – had severe, S3 steatosis.

Mitchel L. Zoler/MDedge News

The prevalence of steatosis, a marker of nonalcoholic fatty liver disease (NAFLD), seemed to be linked with obesity. Among the 79% of the study group who had no steatosis the obesity prevalence was 6%, compared with a 26% prevalence among those with S1 steatosis, a 33% obesity rate among those with S2 steatosis, and a 57% obesity prevalence among those with S3 steatosis, Kushala Abeysekera, MBBS, said at the meeting sponsored by the European Association for the Study of the Liver.

He and his associates determined these prevalence rates in a population that excluded people who reported consuming what was deemed “excessive” alcohol use.

Another notable finding was that 1,874 of the same people had undergone ultrasound assessment for NAFLD when they were 18 years old, and that assessment found a prevalence of 2.5% (J Clin Endocrinol Metab. 2014 March;99[3]:e410-7), which meant that during the subsequent 6 years prevalence of NAFLD jumped nearly 900%.

Both the 2014 report and the current study used people who had been enrolled in the Avon Longitudinal Study of Parents and Children, a prospective population-based study that began by recruiting a cohort of more than 14,000 pregnant women during 1991-1992, and then followed the more than 13,000 children who resulted from those pregnancies. The study reported by Dr. Abeysekera focused on 4,021 of these children – now young adults – who responded to an invitation to participate in this follow-up, a number that then reduced to 3,600 with informative transient elastography results that quantified fibrosis, and 3,768 with valid Controlled Attenuated Parameter scores from elastography that reflected steatosis extent. Transient elastography is a noninvasive method of measuring liver stiffness using ultrasound and an elastic shear wave (Clin Mol Hepatol. 2012 June;18[2]:163-73).

“To the best of my knowledge, this is the only study that has assessed NAFLD in young adults using transient elastography,” said Dr. Abeysekera, an epidemiologist at the University of Bristol (England).

After subtracting from the study cohort people with excessive alcohol use, the study had transient elastography data from 3,277 24-year-olds that could calculate steatosis severity, and data from 3,128 that could quantify fibrosis.

The analysis also showed a statistically significant link between sex and the presence and severity of steatosis. Among women, 18% had steatosis, including 7% with S3 steatosis, defined as involving at least two-thirds of the liver. Among men, 26% had some degree of steatosis and 14% had the most severe form.

The presence of more severe liver fibrosis also showed a strong link to obesity. The eight people identified with F4 fibrosis (with cirrhosis) had a median body mass index of 32 kg/m2, compared with a median body mass index of 25 kg/m2 or less among those either without fibrosis or with a milder form of F1, F2, or F3 fibrosis.

Dr. Abeysekera reported no disclosures.

[email protected]

The Society for Vascular Surgery will provide complimentary meeting registration to a lucky attendee. To be eligible, all you must do is register for the meeting before 5 p.m. CDT Wednesday, April 24. The winner will be selected at random. This year’s meeting will be June 12 to 15 at the Gaylord National Resort & Convention Center in National Harbor, Md., just outside Washington D.C. Read more about the VAM contest, and more, in the latest SVS VAMail.

The Society for Vascular Surgery will provide complimentary meeting registration to a lucky attendee. To be eligible, all you must do is register for the meeting before 5 p.m. CDT Wednesday, April 24. The winner will be selected at random. This year’s meeting will be June 12 to 15 at the Gaylord National Resort & Convention Center in National Harbor, Md., just outside Washington D.C. Read more about the VAM contest, and more, in the latest SVS VAMail.

The Society for Vascular Surgery will provide complimentary meeting registration to a lucky attendee. To be eligible, all you must do is register for the meeting before 5 p.m. CDT Wednesday, April 24. The winner will be selected at random. This year’s meeting will be June 12 to 15 at the Gaylord National Resort & Convention Center in National Harbor, Md., just outside Washington D.C. Read more about the VAM contest, and more, in the latest SVS VAMail.

GENEVA – The TRK inhibitor larotrectinib is highly active in lung cancer patients with NTRK gene fusions, supporting routine screening for such fusions in cases of lung cancer, according to investigators.

Will Pass/MDedge News

Although NTRK fusions are relatively infrequent in lung cancer, lead author Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, suggested that their low frequency should not preclude testing in the current diagnostic setting.

“The frequency of TRK fusions in lung cancers in a prospective series that we put together was at the order of 0.23%, recognizing that the paradigm now for molecular profiling in lung cancer screens for many different drivers together, and not just single-gene testing,” Dr. Drilon said at the European Lung Cancer Conference. Dr. Drilon noted that larotrectinib is now approved by the Food and Drug Administration for the treatment of adult and pediatric patients with TRK fusion-positive cancers.

The present analysis involved 11 patients with metastatic lung adenocarcinoma and NTRK gene fusions from two previous clinical trials (NCT02122913 and NCT02576431); of these patients, 8 had NTRK1 fusions and 3 had NTRK3 fusions. Patients were given larotrectinib 100 mg twice daily on a continuous 28-day schedule until disease progression, unacceptable toxicity, or withdrawal. Almost all patients (10 out of 11) had a prior systemic therapy, and 5 patients had three or more prior therapies. The best response to previous therapies included four stable disease and one partial response. Out of 11 patients, 4 were ineligible for response analysis because of a treatment period of less than 1 month, leaving 7 evaluable patients; of these, 2 patients had stable disease, 4 had a partial response, and 1 had a complete response, translating to an overall response rate of 71%. On average, patients responded in just 1.8 months, with responses ranging from 7.4 months to 17.6 months, with the caveat that median duration of response has yet to be met. Treatment was generally well tolerated, with most adverse events being grade 1 or 2. Dr. Drilon cited a historical dose reduction rate of 9% and a discontinuation rate of less than 1% (out of 122 patients across cancer types).

Although most patients were heavily pretreated, Dr. Drilon highlighted one patient, a 76-year-old woman with non–small cell lung cancer, who had an NTRK1 gene fusion and multiple metastases to the brain and contralateral lung. This patient received larotrectinib as first-line therapy after refusing standard platinum doublet chemotherapy. The woman had a partial response, including “a near complete intracranial response with 95% volumetric shrinkage,” Dr. Drilon said at the meeting, presented by the European Society for Medical Oncology. “She remains on therapy as of six and a half months per the last data cutoff and is still doing well without any substantial toxicities from this drug.”

“In conclusion, larotrectinib is active in advanced lung cancers that harbor a TRK fusion,” Dr. Drilon said. “Of course, these [findings] underscore the utility of molecular profiling for TRK fusions when we look for drivers in patients with non–small cell lung cancer.”

When asked by the invited discussant if NTRK fusions should be tested up-front in all cases of non–small cell lung cancer, Dr. Drilon said, “I think the answer is absolutely yes.” He highlighted the fact that this study and other existing research has shown an overall response rate of about 70%, “which certainly beats the outcomes that we see with other systemic therapies, including, arguably, chemoimmunotherapy for this population. So I think that the paradigm here should be similar to the paradigm for EGFR and ALK, where we have an active target therapeutic that we can use up front, which would likely really improve outcomes for patients.”

Loxo Oncology Inc. and Bayer AG funded the study. The investigators reported financial relationships with Ignyta, Loxo, TP Therapeutics, AstraZeneca, Pfizer, and others.

SOURCE: Drilon et al. ELCC 2019. Abstract 111O.

GENEVA – The TRK inhibitor larotrectinib is highly active in lung cancer patients with NTRK gene fusions, supporting routine screening for such fusions in cases of lung cancer, according to investigators.

Will Pass/MDedge News

Although NTRK fusions are relatively infrequent in lung cancer, lead author Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, suggested that their low frequency should not preclude testing in the current diagnostic setting.

“The frequency of TRK fusions in lung cancers in a prospective series that we put together was at the order of 0.23%, recognizing that the paradigm now for molecular profiling in lung cancer screens for many different drivers together, and not just single-gene testing,” Dr. Drilon said at the European Lung Cancer Conference. Dr. Drilon noted that larotrectinib is now approved by the Food and Drug Administration for the treatment of adult and pediatric patients with TRK fusion-positive cancers.

The present analysis involved 11 patients with metastatic lung adenocarcinoma and NTRK gene fusions from two previous clinical trials (NCT02122913 and NCT02576431); of these patients, 8 had NTRK1 fusions and 3 had NTRK3 fusions. Patients were given larotrectinib 100 mg twice daily on a continuous 28-day schedule until disease progression, unacceptable toxicity, or withdrawal. Almost all patients (10 out of 11) had a prior systemic therapy, and 5 patients had three or more prior therapies. The best response to previous therapies included four stable disease and one partial response. Out of 11 patients, 4 were ineligible for response analysis because of a treatment period of less than 1 month, leaving 7 evaluable patients; of these, 2 patients had stable disease, 4 had a partial response, and 1 had a complete response, translating to an overall response rate of 71%. On average, patients responded in just 1.8 months, with responses ranging from 7.4 months to 17.6 months, with the caveat that median duration of response has yet to be met. Treatment was generally well tolerated, with most adverse events being grade 1 or 2. Dr. Drilon cited a historical dose reduction rate of 9% and a discontinuation rate of less than 1% (out of 122 patients across cancer types).

Although most patients were heavily pretreated, Dr. Drilon highlighted one patient, a 76-year-old woman with non–small cell lung cancer, who had an NTRK1 gene fusion and multiple metastases to the brain and contralateral lung. This patient received larotrectinib as first-line therapy after refusing standard platinum doublet chemotherapy. The woman had a partial response, including “a near complete intracranial response with 95% volumetric shrinkage,” Dr. Drilon said at the meeting, presented by the European Society for Medical Oncology. “She remains on therapy as of six and a half months per the last data cutoff and is still doing well without any substantial toxicities from this drug.”

“In conclusion, larotrectinib is active in advanced lung cancers that harbor a TRK fusion,” Dr. Drilon said. “Of course, these [findings] underscore the utility of molecular profiling for TRK fusions when we look for drivers in patients with non–small cell lung cancer.”

When asked by the invited discussant if NTRK fusions should be tested up-front in all cases of non–small cell lung cancer, Dr. Drilon said, “I think the answer is absolutely yes.” He highlighted the fact that this study and other existing research has shown an overall response rate of about 70%, “which certainly beats the outcomes that we see with other systemic therapies, including, arguably, chemoimmunotherapy for this population. So I think that the paradigm here should be similar to the paradigm for EGFR and ALK, where we have an active target therapeutic that we can use up front, which would likely really improve outcomes for patients.”

Loxo Oncology Inc. and Bayer AG funded the study. The investigators reported financial relationships with Ignyta, Loxo, TP Therapeutics, AstraZeneca, Pfizer, and others.

SOURCE: Drilon et al. ELCC 2019. Abstract 111O.

GENEVA – The TRK inhibitor larotrectinib is highly active in lung cancer patients with NTRK gene fusions, supporting routine screening for such fusions in cases of lung cancer, according to investigators.

Will Pass/MDedge News

Although NTRK fusions are relatively infrequent in lung cancer, lead author Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, suggested that their low frequency should not preclude testing in the current diagnostic setting.

“The frequency of TRK fusions in lung cancers in a prospective series that we put together was at the order of 0.23%, recognizing that the paradigm now for molecular profiling in lung cancer screens for many different drivers together, and not just single-gene testing,” Dr. Drilon said at the European Lung Cancer Conference. Dr. Drilon noted that larotrectinib is now approved by the Food and Drug Administration for the treatment of adult and pediatric patients with TRK fusion-positive cancers.

The present analysis involved 11 patients with metastatic lung adenocarcinoma and NTRK gene fusions from two previous clinical trials (NCT02122913 and NCT02576431); of these patients, 8 had NTRK1 fusions and 3 had NTRK3 fusions. Patients were given larotrectinib 100 mg twice daily on a continuous 28-day schedule until disease progression, unacceptable toxicity, or withdrawal. Almost all patients (10 out of 11) had a prior systemic therapy, and 5 patients had three or more prior therapies. The best response to previous therapies included four stable disease and one partial response. Out of 11 patients, 4 were ineligible for response analysis because of a treatment period of less than 1 month, leaving 7 evaluable patients; of these, 2 patients had stable disease, 4 had a partial response, and 1 had a complete response, translating to an overall response rate of 71%. On average, patients responded in just 1.8 months, with responses ranging from 7.4 months to 17.6 months, with the caveat that median duration of response has yet to be met. Treatment was generally well tolerated, with most adverse events being grade 1 or 2. Dr. Drilon cited a historical dose reduction rate of 9% and a discontinuation rate of less than 1% (out of 122 patients across cancer types).

Although most patients were heavily pretreated, Dr. Drilon highlighted one patient, a 76-year-old woman with non–small cell lung cancer, who had an NTRK1 gene fusion and multiple metastases to the brain and contralateral lung. This patient received larotrectinib as first-line therapy after refusing standard platinum doublet chemotherapy. The woman had a partial response, including “a near complete intracranial response with 95% volumetric shrinkage,” Dr. Drilon said at the meeting, presented by the European Society for Medical Oncology. “She remains on therapy as of six and a half months per the last data cutoff and is still doing well without any substantial toxicities from this drug.”

“In conclusion, larotrectinib is active in advanced lung cancers that harbor a TRK fusion,” Dr. Drilon said. “Of course, these [findings] underscore the utility of molecular profiling for TRK fusions when we look for drivers in patients with non–small cell lung cancer.”

When asked by the invited discussant if NTRK fusions should be tested up-front in all cases of non–small cell lung cancer, Dr. Drilon said, “I think the answer is absolutely yes.” He highlighted the fact that this study and other existing research has shown an overall response rate of about 70%, “which certainly beats the outcomes that we see with other systemic therapies, including, arguably, chemoimmunotherapy for this population. So I think that the paradigm here should be similar to the paradigm for EGFR and ALK, where we have an active target therapeutic that we can use up front, which would likely really improve outcomes for patients.”

Loxo Oncology Inc. and Bayer AG funded the study. The investigators reported financial relationships with Ignyta, Loxo, TP Therapeutics, AstraZeneca, Pfizer, and others.

SOURCE: Drilon et al. ELCC 2019. Abstract 111O.

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.