The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation, Walter M. Stadler, MD, picks the upcoming ASCO presentations he anticipates to be the most interesting in prostate cancer research.

• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.

alexdans/Thinkstock

• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).

• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.

• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.

• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.

• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).

• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.

Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.

The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation, Walter M. Stadler, MD, picks the upcoming ASCO presentations he anticipates to be the most interesting in prostate cancer research.

• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.

alexdans/Thinkstock

• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).

• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.

• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.

• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.

• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).

• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.

Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.

The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation, Walter M. Stadler, MD, picks the upcoming ASCO presentations he anticipates to be the most interesting in prostate cancer research.

• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.

alexdans/Thinkstock

• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).

• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.

• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.

• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.

• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).

• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.

Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.

LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.

Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.

LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.

Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.

LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.

Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.

The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.

“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.

—Erica Tricarico

Suggested Reading

Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].

Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.

The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.

“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.

—Erica Tricarico

Suggested Reading

Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].

Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.

The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.

“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.

—Erica Tricarico

Suggested Reading

Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].

Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.

LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.

Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.

Examining Relative Frequencies

Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.

The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.

In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.

A Range of Symptoms and Conditions

Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).

Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).

The Likelihood of Medication Overuse

Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.

When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities.

The studies were funded by Allergan.

—Jake Remaly

Suggested Reading

Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.

LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.

Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.

Examining Relative Frequencies

Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.

The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.

In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.

A Range of Symptoms and Conditions

Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).

Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).

The Likelihood of Medication Overuse

Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.

When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities.

The studies were funded by Allergan.

—Jake Remaly

Suggested Reading

Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.

LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.

Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.

Examining Relative Frequencies

Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.

The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.

In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.

A Range of Symptoms and Conditions

Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).

Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).

The Likelihood of Medication Overuse

Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.

When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities.

The studies were funded by Allergan.

—Jake Remaly

Suggested Reading

Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.

LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.

ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).

Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.

Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 10³/µL.

As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse rate was 0.16. Treatment significantly reduced the number of gadolinium-enhancing lesions from baseline (mean 1.5) to one year (0.3) among de novo patients.

This study was sponsored by Alkermes and Biogen.

—Glenn S. Williams

LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.

ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).

Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.

Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 10³/µL.

As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse rate was 0.16. Treatment significantly reduced the number of gadolinium-enhancing lesions from baseline (mean 1.5) to one year (0.3) among de novo patients.

This study was sponsored by Alkermes and Biogen.

—Glenn S. Williams

LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.

ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).

Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.

Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 10³/µL.

As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse rate was 0.16. Treatment significantly reduced the number of gadolinium-enhancing lesions from baseline (mean 1.5) to one year (0.3) among de novo patients.

This study was sponsored by Alkermes and Biogen.

—Glenn S. Williams

NEW VISUALIZATION SYSTEMS FROM FUJIFILM

FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.

FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.

FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com

FREEMIE BREAST MILK COLLECTION SYSTEM

Freemie^® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.

The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.

Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.

FOR MORE INFORMATION, VISIT: http://www.freemie.com

PREVENTEZA: EMERGENCY CONTRACEPTIVE

Combe, Inc, the maker of Vagisil^®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.

Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.

FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive

UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY

UpSpring^® says that its patented C-Panty^® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.

C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.

The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.

FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty

NEW VISUALIZATION SYSTEMS FROM FUJIFILM

FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.

FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.

FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com

FREEMIE BREAST MILK COLLECTION SYSTEM

Freemie^® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.

The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.

Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.

FOR MORE INFORMATION, VISIT: http://www.freemie.com

PREVENTEZA: EMERGENCY CONTRACEPTIVE

Combe, Inc, the maker of Vagisil^®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.

Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.

FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive

UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY

UpSpring^® says that its patented C-Panty^® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.

C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.

The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.

FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty

NEW VISUALIZATION SYSTEMS FROM FUJIFILM

FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.

FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.

FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com

FREEMIE BREAST MILK COLLECTION SYSTEM

Freemie^® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.

The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.

Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.

FOR MORE INFORMATION, VISIT: http://www.freemie.com

PREVENTEZA: EMERGENCY CONTRACEPTIVE

Combe, Inc, the maker of Vagisil^®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.

Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.

FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive

UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY

UpSpring^® says that its patented C-Panty^® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.

C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.

The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.

FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.

Our knowledge regarding the benefits and risks of systemic menopausal hormone therapy (HT) has continued to evolve since the 2002 publication of the initial findings of the Women’s Health Initiative (WHI). In late 2017, the US Preventive Services Task Force (USPSTF) issued its recommendation against the use of menopausal HT for the prevention of chronic conditions. In this Menopause Update, Dr. JoAnn Manson, Dr. JoAnn Pinkerton, and I detail why we do not support the Task Force’s recommendation. In a sidebar discussion, Dr. Manson also reviews the results of 2 WHI HT trials, published in September 2017, that analyzed mortality in trial participants over an 18-year follow-up.

In addition, I summarize an observational study that assessed the association of HT and Alzheimer disease (AD) as well as a clinical trial that compared the impact of oral versus transdermal estrogen on sexuality in recently menopausal women.

What's the impact of long-term use of systemic HT on Alzheimer disease risk?

Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88(11):1062-1068.

Data from the WHI HT randomized trials have clarified that initiation of oral HT among women aged 65 and older increases the risk of cognitive decline. By contrast, an analysis of younger WHI participants found that oral HT had no impact on cognitive function. Recently, Imtiaz and colleagues conducted a prospective cohort study of postmenopausal HT and AD in women residing in a Finnish county, with 25 years of follow-up. A diagnosis of AD was based on administrative health records and use of medications prescribed specifically to treat dementia. Use of systemic HT was identified via self-report. Overall, among more than 8,000 women followed, 227 cases of AD (mean age, 72 years) were identified.

In an analysis that controlled for factors including age, body mass index, alcohol use, smoking, physical activity, occupation status, and parity, up to 5 years of HT use was not associated with a risk of being diagnosed with AD. Five to 10 years of HT use was associated with a hazard ratio (HR) of 0.89, an 11% risk reduction that did not achieve statistical significance. By contrast, more than 10 years' use of systemic HT was associated with an HR of 0.53, a statistically significant 47% reduction in risk of AD.¹

Other studies found conflicting results

Three large randomized trials found that HT initiated early in menopause and continued for less than 7 years had no impact on cognitive function.^2-4 The Cache County (Utah) long-term prospective cohort study, however, found that HT started early in menopause and continued for 10 years or longer was associated with a significant reduction in risk of AD.⁵

Of note are results from the 2017 report of 18-year cumulative mortality among WHI participants (see the box on page 30). In that study, mortality from AD and other dementia was lower among participants who were randomly assigned to treatment with estrogen alone versus placebo (HR, 0.74; 95% confidence interval [CI], 0.59-0.94). With estrogen-progestin therapy, the HR was 0.93 (95% CI, 0.77-1.11), and the pooled HR for the 2 trials was 0.85 (95% CI, 0.74-0.98).⁶

NAMS guidance

The North American Menopause Society (NAMS) HT position statement recommends that prevention of dementia should not be considered an indication for HT use since definitive data are not available.⁷ The statement indicates also that estrogen therapy may have positive cognitive benefits when initiated immediately after early surgical menopause and taken until the average age of menopause to prevent health risks seen with early loss of hormones.

Read Dr. Manson’s discussion of 18 years of follow-up data on menopause.

Read how the route of HT may affect sexuality outcomes.

Oral vs transdermal estrogen therapy: Is one preferable regarding sexuality?

Taylor HS, Tal A, Pal L, et al. Effects of oral vs transdermal estrogen therapy on sexual function in early post menopause: ancillary study of the Kronos Early Estrogen Prevention Study (KEEPS). JAMA Intern Med. 2017;177(10):1471-1479.

If route of administration of systemic HT influences sexuality outcomes in menopausal women, this would inform how we counsel our patients regarding HT.

Recently, Taylor and colleagues conducted a randomized clinical trial to examine the effects of HT's route of administration on sexual function.⁸ The 4-year Kronos Early Estrogen Prevention Study (KEEPS) ancillary sexual study randomly assigned 670 recently menopausal women to 0.45 mg of oral conjugated equine estrogens (CEE), an 0.05-mg estradiol transdermal patch, or placebo (with oral micronized progesterone for those on active treatment). The participants were aged 42 to 58 years and were within 36 months from their last menstrual period.

Participants were evaluated using the Female Sexual Function Inventory (FSFI) questionnaire, which assessed desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI is scored using a point range of 0 to 36. A higher FSFI score indicates better sexual function. An FSFI score less than 26.55 depicts low sexual function (LSF). 

Transdermal estrogen improved sexual function scores

Treatment with oral CEE was associated with no significant change in FSFI score compared with placebo, although benefits were seen for lubrication. By contrast, estrogen patch use improved the FSFI score (mean improvement, 2.6). Although improvement in FSFI score with transdermal estrogen was limited to participants with baseline LSF, most participants in fact had LSF at baseline.

Read about the authors’ concern over new USPSTF guidance.

The USPSTF recommendation against menopausal HT use for prevention of chronic conditions: Guidance that may confuse--and mislead

US Preventive Services Task Force; Grossman DC, CurrySJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

In late 2017, the USPSTF issued its recommendation against the use of menopausal HT for prevention of chronic conditions.⁹ We are concerned that this recommendation will be misconstrued as suggesting that the use of HT is not appropriate for any indication, including treatment of bothersome menopausal symptoms.

Although the Task Force's report briefly indicated that the guidance does not refer to HT use for treatment of symptoms, this important disclaimer likely will be overlooked or ignored by many readers. The result may be increased uncertainty and anxiety in decision making regarding HT use. Thus, we might see a further decline in the proportion of menopausal women who are prescribed appropriate treatment for symptoms that impair quality of life.

HT use improves menopausal symptoms

According to the 2017 NAMS Position Statement, for symptomatic women in early menopause (that is, younger than age 60 or within 10 years of menopause onset) and free of contraindications to treatment, use of systemic HT is appropriate.⁷ Currently, clinicians are reluctant to prescribe HT, and women are apprehensive regarding its use.¹⁰ Unfortunately, the USPSTF guidance may further discourage appropriate treatment of menopausal symptoms.

Findings from randomized clinical trials, as well as preclinical, clinical, and epidemiologic studies, clarify the favorable benefit-risk profile for HT use by recently menopausal women with bothersome vasomotor and related menopausal symptoms.^7,10-12

Notably, the USPSTF guidance does not address women with premature or early menopause, those with persistent (long-duration) vasomotor symptoms, or women at increased risk for osteoporosis and related fractures. Furthermore, the prevalent and undertreated condition, genitourinary syndrome of menopause, deserves but does not receive attention.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Our knowledge regarding the benefits and risks of systemic menopausal hormone therapy (HT) has continued to evolve since the 2002 publication of the initial findings of the Women’s Health Initiative (WHI). In late 2017, the US Preventive Services Task Force (USPSTF) issued its recommendation against the use of menopausal HT for the prevention of chronic conditions. In this Menopause Update, Dr. JoAnn Manson, Dr. JoAnn Pinkerton, and I detail why we do not support the Task Force’s recommendation. In a sidebar discussion, Dr. Manson also reviews the results of 2 WHI HT trials, published in September 2017, that analyzed mortality in trial participants over an 18-year follow-up.

In addition, I summarize an observational study that assessed the association of HT and Alzheimer disease (AD) as well as a clinical trial that compared the impact of oral versus transdermal estrogen on sexuality in recently menopausal women.

What's the impact of long-term use of systemic HT on Alzheimer disease risk?

Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88(11):1062-1068.

Data from the WHI HT randomized trials have clarified that initiation of oral HT among women aged 65 and older increases the risk of cognitive decline. By contrast, an analysis of younger WHI participants found that oral HT had no impact on cognitive function. Recently, Imtiaz and colleagues conducted a prospective cohort study of postmenopausal HT and AD in women residing in a Finnish county, with 25 years of follow-up. A diagnosis of AD was based on administrative health records and use of medications prescribed specifically to treat dementia. Use of systemic HT was identified via self-report. Overall, among more than 8,000 women followed, 227 cases of AD (mean age, 72 years) were identified.

In an analysis that controlled for factors including age, body mass index, alcohol use, smoking, physical activity, occupation status, and parity, up to 5 years of HT use was not associated with a risk of being diagnosed with AD. Five to 10 years of HT use was associated with a hazard ratio (HR) of 0.89, an 11% risk reduction that did not achieve statistical significance. By contrast, more than 10 years' use of systemic HT was associated with an HR of 0.53, a statistically significant 47% reduction in risk of AD.¹

Other studies found conflicting results

Three large randomized trials found that HT initiated early in menopause and continued for less than 7 years had no impact on cognitive function.^2-4 The Cache County (Utah) long-term prospective cohort study, however, found that HT started early in menopause and continued for 10 years or longer was associated with a significant reduction in risk of AD.⁵

Of note are results from the 2017 report of 18-year cumulative mortality among WHI participants (see the box on page 30). In that study, mortality from AD and other dementia was lower among participants who were randomly assigned to treatment with estrogen alone versus placebo (HR, 0.74; 95% confidence interval [CI], 0.59-0.94). With estrogen-progestin therapy, the HR was 0.93 (95% CI, 0.77-1.11), and the pooled HR for the 2 trials was 0.85 (95% CI, 0.74-0.98).⁶

NAMS guidance

The North American Menopause Society (NAMS) HT position statement recommends that prevention of dementia should not be considered an indication for HT use since definitive data are not available.⁷ The statement indicates also that estrogen therapy may have positive cognitive benefits when initiated immediately after early surgical menopause and taken until the average age of menopause to prevent health risks seen with early loss of hormones.

Read Dr. Manson’s discussion of 18 years of follow-up data on menopause.

Read how the route of HT may affect sexuality outcomes.

Oral vs transdermal estrogen therapy: Is one preferable regarding sexuality?

Taylor HS, Tal A, Pal L, et al. Effects of oral vs transdermal estrogen therapy on sexual function in early post menopause: ancillary study of the Kronos Early Estrogen Prevention Study (KEEPS). JAMA Intern Med. 2017;177(10):1471-1479.

If route of administration of systemic HT influences sexuality outcomes in menopausal women, this would inform how we counsel our patients regarding HT.

Recently, Taylor and colleagues conducted a randomized clinical trial to examine the effects of HT's route of administration on sexual function.⁸ The 4-year Kronos Early Estrogen Prevention Study (KEEPS) ancillary sexual study randomly assigned 670 recently menopausal women to 0.45 mg of oral conjugated equine estrogens (CEE), an 0.05-mg estradiol transdermal patch, or placebo (with oral micronized progesterone for those on active treatment). The participants were aged 42 to 58 years and were within 36 months from their last menstrual period.

Participants were evaluated using the Female Sexual Function Inventory (FSFI) questionnaire, which assessed desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI is scored using a point range of 0 to 36. A higher FSFI score indicates better sexual function. An FSFI score less than 26.55 depicts low sexual function (LSF). 

Transdermal estrogen improved sexual function scores

Treatment with oral CEE was associated with no significant change in FSFI score compared with placebo, although benefits were seen for lubrication. By contrast, estrogen patch use improved the FSFI score (mean improvement, 2.6). Although improvement in FSFI score with transdermal estrogen was limited to participants with baseline LSF, most participants in fact had LSF at baseline.

Read about the authors’ concern over new USPSTF guidance.

The USPSTF recommendation against menopausal HT use for prevention of chronic conditions: Guidance that may confuse--and mislead

US Preventive Services Task Force; Grossman DC, CurrySJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

In late 2017, the USPSTF issued its recommendation against the use of menopausal HT for prevention of chronic conditions.⁹ We are concerned that this recommendation will be misconstrued as suggesting that the use of HT is not appropriate for any indication, including treatment of bothersome menopausal symptoms.

Although the Task Force's report briefly indicated that the guidance does not refer to HT use for treatment of symptoms, this important disclaimer likely will be overlooked or ignored by many readers. The result may be increased uncertainty and anxiety in decision making regarding HT use. Thus, we might see a further decline in the proportion of menopausal women who are prescribed appropriate treatment for symptoms that impair quality of life.

HT use improves menopausal symptoms

According to the 2017 NAMS Position Statement, for symptomatic women in early menopause (that is, younger than age 60 or within 10 years of menopause onset) and free of contraindications to treatment, use of systemic HT is appropriate.⁷ Currently, clinicians are reluctant to prescribe HT, and women are apprehensive regarding its use.¹⁰ Unfortunately, the USPSTF guidance may further discourage appropriate treatment of menopausal symptoms.

Findings from randomized clinical trials, as well as preclinical, clinical, and epidemiologic studies, clarify the favorable benefit-risk profile for HT use by recently menopausal women with bothersome vasomotor and related menopausal symptoms.^7,10-12

Notably, the USPSTF guidance does not address women with premature or early menopause, those with persistent (long-duration) vasomotor symptoms, or women at increased risk for osteoporosis and related fractures. Furthermore, the prevalent and undertreated condition, genitourinary syndrome of menopause, deserves but does not receive attention.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Our knowledge regarding the benefits and risks of systemic menopausal hormone therapy (HT) has continued to evolve since the 2002 publication of the initial findings of the Women’s Health Initiative (WHI). In late 2017, the US Preventive Services Task Force (USPSTF) issued its recommendation against the use of menopausal HT for the prevention of chronic conditions. In this Menopause Update, Dr. JoAnn Manson, Dr. JoAnn Pinkerton, and I detail why we do not support the Task Force’s recommendation. In a sidebar discussion, Dr. Manson also reviews the results of 2 WHI HT trials, published in September 2017, that analyzed mortality in trial participants over an 18-year follow-up.

In addition, I summarize an observational study that assessed the association of HT and Alzheimer disease (AD) as well as a clinical trial that compared the impact of oral versus transdermal estrogen on sexuality in recently menopausal women.

What's the impact of long-term use of systemic HT on Alzheimer disease risk?

Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88(11):1062-1068.

Data from the WHI HT randomized trials have clarified that initiation of oral HT among women aged 65 and older increases the risk of cognitive decline. By contrast, an analysis of younger WHI participants found that oral HT had no impact on cognitive function. Recently, Imtiaz and colleagues conducted a prospective cohort study of postmenopausal HT and AD in women residing in a Finnish county, with 25 years of follow-up. A diagnosis of AD was based on administrative health records and use of medications prescribed specifically to treat dementia. Use of systemic HT was identified via self-report. Overall, among more than 8,000 women followed, 227 cases of AD (mean age, 72 years) were identified.

In an analysis that controlled for factors including age, body mass index, alcohol use, smoking, physical activity, occupation status, and parity, up to 5 years of HT use was not associated with a risk of being diagnosed with AD. Five to 10 years of HT use was associated with a hazard ratio (HR) of 0.89, an 11% risk reduction that did not achieve statistical significance. By contrast, more than 10 years' use of systemic HT was associated with an HR of 0.53, a statistically significant 47% reduction in risk of AD.¹

Other studies found conflicting results

Three large randomized trials found that HT initiated early in menopause and continued for less than 7 years had no impact on cognitive function.^2-4 The Cache County (Utah) long-term prospective cohort study, however, found that HT started early in menopause and continued for 10 years or longer was associated with a significant reduction in risk of AD.⁵

Of note are results from the 2017 report of 18-year cumulative mortality among WHI participants (see the box on page 30). In that study, mortality from AD and other dementia was lower among participants who were randomly assigned to treatment with estrogen alone versus placebo (HR, 0.74; 95% confidence interval [CI], 0.59-0.94). With estrogen-progestin therapy, the HR was 0.93 (95% CI, 0.77-1.11), and the pooled HR for the 2 trials was 0.85 (95% CI, 0.74-0.98).⁶

NAMS guidance

The North American Menopause Society (NAMS) HT position statement recommends that prevention of dementia should not be considered an indication for HT use since definitive data are not available.⁷ The statement indicates also that estrogen therapy may have positive cognitive benefits when initiated immediately after early surgical menopause and taken until the average age of menopause to prevent health risks seen with early loss of hormones.

Read Dr. Manson’s discussion of 18 years of follow-up data on menopause.

Read how the route of HT may affect sexuality outcomes.

Oral vs transdermal estrogen therapy: Is one preferable regarding sexuality?

Taylor HS, Tal A, Pal L, et al. Effects of oral vs transdermal estrogen therapy on sexual function in early post menopause: ancillary study of the Kronos Early Estrogen Prevention Study (KEEPS). JAMA Intern Med. 2017;177(10):1471-1479.

If route of administration of systemic HT influences sexuality outcomes in menopausal women, this would inform how we counsel our patients regarding HT.

Recently, Taylor and colleagues conducted a randomized clinical trial to examine the effects of HT's route of administration on sexual function.⁸ The 4-year Kronos Early Estrogen Prevention Study (KEEPS) ancillary sexual study randomly assigned 670 recently menopausal women to 0.45 mg of oral conjugated equine estrogens (CEE), an 0.05-mg estradiol transdermal patch, or placebo (with oral micronized progesterone for those on active treatment). The participants were aged 42 to 58 years and were within 36 months from their last menstrual period.

Participants were evaluated using the Female Sexual Function Inventory (FSFI) questionnaire, which assessed desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI is scored using a point range of 0 to 36. A higher FSFI score indicates better sexual function. An FSFI score less than 26.55 depicts low sexual function (LSF). 

Transdermal estrogen improved sexual function scores

Treatment with oral CEE was associated with no significant change in FSFI score compared with placebo, although benefits were seen for lubrication. By contrast, estrogen patch use improved the FSFI score (mean improvement, 2.6). Although improvement in FSFI score with transdermal estrogen was limited to participants with baseline LSF, most participants in fact had LSF at baseline.

Read about the authors’ concern over new USPSTF guidance.

The USPSTF recommendation against menopausal HT use for prevention of chronic conditions: Guidance that may confuse--and mislead

US Preventive Services Task Force; Grossman DC, CurrySJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

In late 2017, the USPSTF issued its recommendation against the use of menopausal HT for prevention of chronic conditions.⁹ We are concerned that this recommendation will be misconstrued as suggesting that the use of HT is not appropriate for any indication, including treatment of bothersome menopausal symptoms.

Although the Task Force's report briefly indicated that the guidance does not refer to HT use for treatment of symptoms, this important disclaimer likely will be overlooked or ignored by many readers. The result may be increased uncertainty and anxiety in decision making regarding HT use. Thus, we might see a further decline in the proportion of menopausal women who are prescribed appropriate treatment for symptoms that impair quality of life.

HT use improves menopausal symptoms

According to the 2017 NAMS Position Statement, for symptomatic women in early menopause (that is, younger than age 60 or within 10 years of menopause onset) and free of contraindications to treatment, use of systemic HT is appropriate.⁷ Currently, clinicians are reluctant to prescribe HT, and women are apprehensive regarding its use.¹⁰ Unfortunately, the USPSTF guidance may further discourage appropriate treatment of menopausal symptoms.

Findings from randomized clinical trials, as well as preclinical, clinical, and epidemiologic studies, clarify the favorable benefit-risk profile for HT use by recently menopausal women with bothersome vasomotor and related menopausal symptoms.^7,10-12

Notably, the USPSTF guidance does not address women with premature or early menopause, those with persistent (long-duration) vasomotor symptoms, or women at increased risk for osteoporosis and related fractures. Furthermore, the prevalent and undertreated condition, genitourinary syndrome of menopause, deserves but does not receive attention.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Correct answer: C

Rationale

This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.

References

1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.

Correct answer: C

Rationale

This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.

References

1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.

Correct answer: C

Rationale

This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.

References

1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.

Among military veterans, mild traumatic brain injury (TBI) is associated with a 56% increased risk of developing Parkinson’s disease over 12 years of follow-up, according to data published online ahead of print April 18 in Neurology. Prior TBI also is associated with a diagnosis of Parkinson’s disease two years earlier than among controls.

“Our findings highlight the critical importance of unraveling mechanisms subserving the association between TBI and Parkinson’s disease to inform treatment and prevention of post-TBI Parkinson’s disease,” said Raquel C. Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco.

A Longitudinal Cohort Study

Every year, mild TBI affects an estimated 42 million people worldwide. It is especially common among athletes and military personnel and is a growing epidemic among the elderly. In 2008, the Institute of Medicine found sufficient evidence to suggest an association between moderate to severe TBI and a clinical diagnosis of Parkinson’s disease, but limited evidence for an association between mild TBI with loss of consciousness and a clinical diagnosis of Parkinson’s disease. One small case–control study assessed the risk of Parkinson’s disease following mild TBI among military veterans, but the results were inconclusive, said the authors.

Dr. Gardner and colleagues conducted a longitudinal cohort study to evaluate the risk of Parkinson’s disease following TBI, including mild TBI, among patients in the Veterans Health Administration (VHA). They analyzed data from three nationwide VHA health care system databases and identified patients with a diagnosis of TBI from October 2002 to September 2014. Participants were age 18 or older without Parkinson’s disease or dementia at baseline and were age-matched 1:1 to a random sample of patients without TBI.

Researchers defined moderate to severe TBI as a loss of consciousness for more than 30 minutes, alteration of consciousness for more than 24 hours, or amnesia for more than 24 hours. They defined mild TBI as loss of consciousness for zero to 30 minutes, alteration of consciousness for a moment to 24 hours, or amnesia for zero to 24 hours.

TBI exposure and severity were determined via detailed clinical assessments or ICD-9 codes using Department of Defense and Defense and Veterans Brain Injury Center criteria. Baseline comorbidities and incident Parkinson’s disease at more than one year post TBI were identified using ICD-9 codes. In addition, investigators used Cox proportional hazard models adjusted for demographics and medical and psychiatric comorbidities to assess risk of Parkinson’s disease after TBI.

Prior TBI Was Associated With Minority Status

A total of 325,870 patients were included in the study with an average age of 47.9 and an average follow-up of 4.6 years. In all, 1,462 patients were diagnosed with Parkinson’s disease during follow-up. After adjusting for age, sex, race, education, and other health conditions, the researchers found that patients with any severity of TBI had a 71% increased risk of Parkinson’s disease; participants with moderate to severe TBI had an 83% increased risk.

Overall, patients with prior TBI were diagnosed with Parkinson’s disease at a significantly younger age, had significantly higher prevalence of non-Hispanic black and Hispanic race or ethnicity, and had significantly higher prevalence of all medical and psychiatric comorbidities, compared with those without prior TBI.

“Given the growing evidence for several potentially modifiable risk factors for Parkinson’s disease, an important area for future research will be to determine whether improved management of specific highly prevalent comorbidities among TBI-exposed veterans may reduce risk of subsequent Parkinson’s disease,” said the researchers.

Strengths of this study include the use of physicians’ diagnosis of TBI and Parkinson’s disease, a longitudinal cohort design, and a large sample size. One of the study’s limitations was the use of ICD-9 codes for the diagnosis of TBI and Parkinson’s disease, which may have overlooked some cases, such as TBI with polytrauma or mild TBI sustained in combat, said the authors. NR

—Erica Tricarico

Suggested Reading

Gardner RC, Byers AL, Barnes DE, et al. Mild TBI and risk of Parkinson disease: a chronic effects of neurotrauma consortium study. Neurology. 2018 Apr 18 [Epub ahead of print].

Among military veterans, mild traumatic brain injury (TBI) is associated with a 56% increased risk of developing Parkinson’s disease over 12 years of follow-up, according to data published online ahead of print April 18 in Neurology. Prior TBI also is associated with a diagnosis of Parkinson’s disease two years earlier than among controls.

“Our findings highlight the critical importance of unraveling mechanisms subserving the association between TBI and Parkinson’s disease to inform treatment and prevention of post-TBI Parkinson’s disease,” said Raquel C. Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco.

A Longitudinal Cohort Study

Every year, mild TBI affects an estimated 42 million people worldwide. It is especially common among athletes and military personnel and is a growing epidemic among the elderly. In 2008, the Institute of Medicine found sufficient evidence to suggest an association between moderate to severe TBI and a clinical diagnosis of Parkinson’s disease, but limited evidence for an association between mild TBI with loss of consciousness and a clinical diagnosis of Parkinson’s disease. One small case–control study assessed the risk of Parkinson’s disease following mild TBI among military veterans, but the results were inconclusive, said the authors.

Dr. Gardner and colleagues conducted a longitudinal cohort study to evaluate the risk of Parkinson’s disease following TBI, including mild TBI, among patients in the Veterans Health Administration (VHA). They analyzed data from three nationwide VHA health care system databases and identified patients with a diagnosis of TBI from October 2002 to September 2014. Participants were age 18 or older without Parkinson’s disease or dementia at baseline and were age-matched 1:1 to a random sample of patients without TBI.

Researchers defined moderate to severe TBI as a loss of consciousness for more than 30 minutes, alteration of consciousness for more than 24 hours, or amnesia for more than 24 hours. They defined mild TBI as loss of consciousness for zero to 30 minutes, alteration of consciousness for a moment to 24 hours, or amnesia for zero to 24 hours.

TBI exposure and severity were determined via detailed clinical assessments or ICD-9 codes using Department of Defense and Defense and Veterans Brain Injury Center criteria. Baseline comorbidities and incident Parkinson’s disease at more than one year post TBI were identified using ICD-9 codes. In addition, investigators used Cox proportional hazard models adjusted for demographics and medical and psychiatric comorbidities to assess risk of Parkinson’s disease after TBI.

Prior TBI Was Associated With Minority Status

A total of 325,870 patients were included in the study with an average age of 47.9 and an average follow-up of 4.6 years. In all, 1,462 patients were diagnosed with Parkinson’s disease during follow-up. After adjusting for age, sex, race, education, and other health conditions, the researchers found that patients with any severity of TBI had a 71% increased risk of Parkinson’s disease; participants with moderate to severe TBI had an 83% increased risk.

Overall, patients with prior TBI were diagnosed with Parkinson’s disease at a significantly younger age, had significantly higher prevalence of non-Hispanic black and Hispanic race or ethnicity, and had significantly higher prevalence of all medical and psychiatric comorbidities, compared with those without prior TBI.

“Given the growing evidence for several potentially modifiable risk factors for Parkinson’s disease, an important area for future research will be to determine whether improved management of specific highly prevalent comorbidities among TBI-exposed veterans may reduce risk of subsequent Parkinson’s disease,” said the researchers.

Strengths of this study include the use of physicians’ diagnosis of TBI and Parkinson’s disease, a longitudinal cohort design, and a large sample size. One of the study’s limitations was the use of ICD-9 codes for the diagnosis of TBI and Parkinson’s disease, which may have overlooked some cases, such as TBI with polytrauma or mild TBI sustained in combat, said the authors. NR

—Erica Tricarico

Suggested Reading

Gardner RC, Byers AL, Barnes DE, et al. Mild TBI and risk of Parkinson disease: a chronic effects of neurotrauma consortium study. Neurology. 2018 Apr 18 [Epub ahead of print].

Among military veterans, mild traumatic brain injury (TBI) is associated with a 56% increased risk of developing Parkinson’s disease over 12 years of follow-up, according to data published online ahead of print April 18 in Neurology. Prior TBI also is associated with a diagnosis of Parkinson’s disease two years earlier than among controls.

“Our findings highlight the critical importance of unraveling mechanisms subserving the association between TBI and Parkinson’s disease to inform treatment and prevention of post-TBI Parkinson’s disease,” said Raquel C. Gardner, MD, Assistant Professor of Neurology at the University of California, San Francisco.

A Longitudinal Cohort Study

Every year, mild TBI affects an estimated 42 million people worldwide. It is especially common among athletes and military personnel and is a growing epidemic among the elderly. In 2008, the Institute of Medicine found sufficient evidence to suggest an association between moderate to severe TBI and a clinical diagnosis of Parkinson’s disease, but limited evidence for an association between mild TBI with loss of consciousness and a clinical diagnosis of Parkinson’s disease. One small case–control study assessed the risk of Parkinson’s disease following mild TBI among military veterans, but the results were inconclusive, said the authors.

Dr. Gardner and colleagues conducted a longitudinal cohort study to evaluate the risk of Parkinson’s disease following TBI, including mild TBI, among patients in the Veterans Health Administration (VHA). They analyzed data from three nationwide VHA health care system databases and identified patients with a diagnosis of TBI from October 2002 to September 2014. Participants were age 18 or older without Parkinson’s disease or dementia at baseline and were age-matched 1:1 to a random sample of patients without TBI.

Researchers defined moderate to severe TBI as a loss of consciousness for more than 30 minutes, alteration of consciousness for more than 24 hours, or amnesia for more than 24 hours. They defined mild TBI as loss of consciousness for zero to 30 minutes, alteration of consciousness for a moment to 24 hours, or amnesia for zero to 24 hours.

TBI exposure and severity were determined via detailed clinical assessments or ICD-9 codes using Department of Defense and Defense and Veterans Brain Injury Center criteria. Baseline comorbidities and incident Parkinson’s disease at more than one year post TBI were identified using ICD-9 codes. In addition, investigators used Cox proportional hazard models adjusted for demographics and medical and psychiatric comorbidities to assess risk of Parkinson’s disease after TBI.

Prior TBI Was Associated With Minority Status

A total of 325,870 patients were included in the study with an average age of 47.9 and an average follow-up of 4.6 years. In all, 1,462 patients were diagnosed with Parkinson’s disease during follow-up. After adjusting for age, sex, race, education, and other health conditions, the researchers found that patients with any severity of TBI had a 71% increased risk of Parkinson’s disease; participants with moderate to severe TBI had an 83% increased risk.

Overall, patients with prior TBI were diagnosed with Parkinson’s disease at a significantly younger age, had significantly higher prevalence of non-Hispanic black and Hispanic race or ethnicity, and had significantly higher prevalence of all medical and psychiatric comorbidities, compared with those without prior TBI.

“Given the growing evidence for several potentially modifiable risk factors for Parkinson’s disease, an important area for future research will be to determine whether improved management of specific highly prevalent comorbidities among TBI-exposed veterans may reduce risk of subsequent Parkinson’s disease,” said the researchers.

Strengths of this study include the use of physicians’ diagnosis of TBI and Parkinson’s disease, a longitudinal cohort design, and a large sample size. One of the study’s limitations was the use of ICD-9 codes for the diagnosis of TBI and Parkinson’s disease, which may have overlooked some cases, such as TBI with polytrauma or mild TBI sustained in combat, said the authors. NR

—Erica Tricarico

Suggested Reading

Gardner RC, Byers AL, Barnes DE, et al. Mild TBI and risk of Parkinson disease: a chronic effects of neurotrauma consortium study. Neurology. 2018 Apr 18 [Epub ahead of print].