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Thursday, July 5, 2018

Senseonics World’s 1st LT Implantable Continuous Glucose Monitor OKd by FDA


Senseonics Holdings, Inc.(NYSE American: SENS) announced the U.S. Food and Drug Administration has approved its Premarket Approval (PMA) application to market the company’s Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes in the United States. The system is the first and only CGM system to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months (see also Senseonics).
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way,” said Tim Goodnow, President and CEO of Senseonics. “More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”
With 70 percent of patients struggling to control blood glucose levels and with hypoglycemia prevalent among insulin users, healthcare professionals believe there are many U.S. patients who could benefit from CGM. Yet the technology is significantly underutilized among the millions of insulin-using patients who could be ideal CGM candidates.
“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & Director of Taking Control of Your Diabetes, and Senseonics Board member. “Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who’ve tried traditional CGM in the past either don’t wear it as often as they should or don’t stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it’s important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user.”
The Eversense System addresses many of the barriers to CGM use. The system consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. The sensor, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems.
The system’s smart transmitter is light, discreet, and comfortable to wear. Interpreting glucose data from the sensor and sending it to the system’s mobile application via Bluetooth, the smart transmitter provides on-body vibratory alerts for discretion and added safety, and is the only CGM transmitter that can be removed and recharged without discarding the sensor.
The Eversense CGM System’s PMA application was based on the previously-reported results of the PRECISE II U.S. pivotal trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the United States. The study clearly demonstrated the system’s safety and effectiveness over 90 days of continuous glucose sensor wear. This March, the FDA’sClinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously, 8 to 0, that the system not only was safe and effective, but also that its benefits outweighed the risks.
Webcast and Conference Call Information
Management will host a conference call today beginning at 4:30 p.m. ET to discuss the PMA approval and commercial activities to support the Eversense product launch in the U.S. Investors interested in listening to the conference call may do so by dialing (877) 883-0383 for domestic callers, or (412) 902-6506 for international callers, using Conference ID: 5389400. To listen to a live webcast, please visit the “Investor Relations” section of the Company’s website at: http://www.senseonics.com. Following the call, a replay will be available on the Investor Relations section of the Company’s website.
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California agency opens third safety probe into Tesla’s Fremont factory


A California agency for occupational safety said on Thursday it opened a third investigation at Tesla Inc’s factory in Fremont, California, following a complaint.
The state’s Occupational Safety and Health Administration (Cal-OSHA) said it opened the latest case on June 21, but did not give details on the investigations beyond confirming that they are active and ongoing.
Online auto news website Jalopnic reported on Thursday that the latest investigation follows a complaint from one of the automaker’s employees at the plant.
Cal-OSHA spokeswoman Erika Monterroza the first investigation opened on April 12 following a serious injury to a millwright employed by Automatic Systems Inc.
The second investigation was launched on April 17, a day after news website Reveal said that Tesla’s omissions in legally mandated reports made its safety record appear better than it was.
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American Well raises $291M, aims for $315M total


  • Virtual care operator American Well is well on its way to raising $315 million, according to an SEC filing. As of June 28, the company had already fetched $291 million.
  • The securities being offered include equity and Series C convertible preferred and common stock.
  • A major backer is multinational technology powerhouse Philips, which partnered with American Well in January to embed telehealth services in a range of products.

Enthusiasm for telehealth has been steadily mounting with major health systems like Mayo Clinic, Intermountain Healthcare and Kaiser Permanenteinvesting heavily in the technology.
Investors are also betting big on the modality. During the first half of 2018, telemedicine landed 21% of total digital health funding with 32 deals worth $714.6 million, a new Rock Health report shows. Behavioral health was also a big winner, with 16 deals across 15 companies valued at $273 million. More than half of those startups include virtual or on-demand services, the report notes.
Still, telehealth has struggled at times to show clear ROI, and adoption has been slowed by lack of consumer awareness and regulatory barriers that prevent doctors from providing virtual care across state lines in some areas.
Telehealth was vital to delivering care during last year’s Hurricanes Harvey and Irma and again during the last winter’s flu outbreak. But not everyone is convinced telehealth is headed for large-scale care delivery. “I remember when Segway came out and there were all these articles about how it was going to help people get around, and ultimately it found its niche in tourism and cities,” Jay Parkinson, founder and CEO of virtual primary care company Sherpaa, told Healthcare Dive earlier this year. “It feels like that’s what telehealth is … [I]t’s going to revolutionize a niche.”
Boston-based American Well continues to forge new partnerships and roll out products. In May, the company signed a definitive agreement to acquire acute care telehealth vendor Avizia for an undisclosed amount. The deal — set to close in the second quarter — would create a “single, end-to-end offering for telehealth customers,” American Well CEO Ido Schoenberg said at the time.
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Inova joins shift in hospitals investing in inpatient behavioral health


The hallways of Inova Health System’s newest inpatient mental health unit gleam white and new.
With all private patient rooms, they look very much the style of patient rooms popping up in brand new hospital towers around this region of the country.  And despite safety design features—such as hidden sensors to help monitor patients at risk for self-harm and doors that are built to be barricade-proof—that is what Inova hopes patients will see in the newly renovated unit.
“Three years ago, we embarked on this journey to increase behavioral health beds with the knowledge that we really needed to find more specialized care for our patients outside of a general psychiatric population. We do that with any other type of illness,” said Michelle Mullany, Inova’s assistant vice president of behavioral health.
Later this month, the hospital will open that behavioral health inpatient unit with one floor dedicated to adolescents and another for adults.
They join a growing number of hospitals around the country that are adding or growing such units after years of efforts to deinstitutionalize mental health care led to shortages of inpatient behavioral health beds.
Children’s Hospital of Richmond at Virginia Commonwealth University recently redesigned its behavioral health center, boosting its inpatient bed count from 24 to 32 beds. San Francisco just opened a 54-bed inpatient facility, Mercy Medical Center recently announced plans to build a proposed 100-bed psychiatric hospital in Iowa and multiple psychiatric hospital projects have already been built or are underway in Massachusetts and New Jersey.

The creation of these specialized units makes sense because many of the patients with severe and persistent mental illness have co-occurring health conditions or present suicide risks that are landing them in inpatient units anyway, said Doug Tynan, the director for the American Psychological Association Center for Psychology and Health.
“I think some of the hospitals are finally realizing let’s just create the units that best suit these patients,” Tynan said. “They are looking at the patient population, more people have insurance now, there is now health parity and I think hospitals in a particular location look at their catchment and say, ‘What is our best setup for the patients we’re going to have coming in the front door?”
The creation of the Inova unit driven by a growth in needs with reports of increases in suicides and other “deaths of despair” related to drugs and alcohol, as well as poor outcomes for patients with mental health concerns, Mullany said.
“We get the meds wrong, we don’t necessarily give enough time to see how the trajectory of the improvement is on those medications, we discharge folks,” Mullany said about mental health care in general in the U.S. “Having an increase in beds will help us prevent the readmissions and really get that treatment right from the beginning.”
An inpatient room in the new behavioral
health unit. (Inova Health System)
Inova’s unit, which will have all private patient rooms, will offer patients individual bathrooms, large windows that allow natural light and open areas such as shared dining space and group therapy rooms. In all, they will have 15 adolescent inpatient beds, 14 mood disorder unit beds, 12 medical and geriatric psychiatry unit beds and 12 acute care psychiatry beds. It will also have 25 Comprehensive Addiction Treatment Services beds. They are careful to point out this is part of a comprehensive suite of services that include outpatient services.
Inova said it will accept all appropriate patients regardless of which insurance they have. Mullany said she expects Medicaid expansion in Virginia will significantly help provide patients better access and improve Inova’s financial considerations when it comes to providing care to all comers.
But there are still significant reimbursement challenges Inova and other hospitals have to overcome to provide specialized inpatient behavioral health care as part of their overall mental health services continuum.
“Many hospitals will negotiate contracts with companies that provide higher reimbursement for high ticket items. Cancer. Transplant. Heart attacks. And they will take a lower rate for behavioral health in favor of bigger reimbursement for those other diagnoses,” Mullany said. “That’s not a criticism of the health system. That’s good fiduciary responsibility. But as a result, we sometimes see the rates of reimbursement are lagging behind.”
Further, to meet the demand among patients, she said health systems need to be able to make better use of midlevel providers such as social workers and counselors because the Centers for Medicare and Medicaid Services doesn’t reimburse for them in a hospital setting.
“If a patient comes into the hospital, the only person who can bill for services is a doctor and a psychologist,” Mullany said. “But 90% of mental health treatment is done by social workers and counselors who are billable and reimbursable—it’s just in the hospital they are not allowed to do that.
She ultimately wants to see a shift where mental health care is viewed—and paid for—the same as other health services.
“Essentially, what we’re saying to patients is ‘You’re different. This is a different diagnosis. It may or may not need the treatment that we think you need,'” Mullany said. “If you’re having a heart attack, no one is sitting around saying that. I think we have a lot of work to do there.”
Investments in inpatient units, such as Inova’s, are a step toward changing that, she said.
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Biotech catalysts coming up in 2H 2018


Biotech stocks carved out modest gains in the first half of 2018 and outperformed the broader market, although their gains paled before those of the tech-weighted Nasdaq Composite Index. From the fundamental perspective, there was no lack of catalytic events such as FDA decisions, clinical trial results announcements and mergers and acquisitions.
Here’s a listing of some individual biotechs that moved notably in either direction in the first half of the year.

Stocks That More Than Doubled

The 5 Worst Declines

IBB Vs. S&P 500 Vs Nasdaq Composite Index

IBB Chart
Source: YCharts

NME Approvals

New molecular entities are products that contain active moieties that haven’t been previously approved by the FDA, either as a single ingredient drug or as part of a combination product. The number of NME approvals are usually considered a measure of innovation in drug research. So far in 2018, the number of NME approvals totaled 17 — a big number, though smaller than the 23 approvals made in the same period last year. Click here to learn about FDA’s NME approvals for the first half.

Launches With Blockbuster Potential

A handful of drugs with blockbuster potential were launched in the first half:
Gilead Sciences, Inc. GILD 1.89%‘s AIDS cocktail Biktarvy, a concoction of bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg. A once-daily single tablet regimen for HIV-1 infection was approved by the FDA Feb. 7. Biktarvy’s sales could touch $6.1 billion by 2024, Evaluate Pharma said in its World Preview 2018.
Novo Nordisk A/S (ADR) NVO 1.48% launched its Ozempic injection, chemically semaglutide, 0.5 mg or 1 mg as well as Fiasp 100 Units/mL across the U.S. in February. The FDA had approved Ozempic, a glucagon-like peptide 1 agonist, in December. EvaluatePharma estimates Ozempic sales of about $4.41 billion by 2024.

Major Heartaches

On the flipside, some biotechs did experience setbacks in the first half of the year.
Incyte Corporation INCY 0.98% had to halt trials of its lead immunotherapy candidateepacadostat — which was evaluated in combination with Merck & Co., Inc. MRK 1.42%‘s Keytruda for melanoma — after it failed to meet the primary endpoint in a pivotal Phase 3 study. The news triggered a 23-percent downward move in Incyte shares in a single day on April 6.
AbbVie Inc ABBV 1.21% had its share of bad news, as its rovalpituzumab tesirine, or Rova-T, produced disappointing results. The therapy was evaluated in a Phase 2 trial dubbed TRINITY as a third-line treatment for patients with relapsed or refractory small-cell lung cancer demonstrating high DLL3 expression. The company said it would not pursue accelerated approval for Rova-T. The stock fell about 13 percent on the March 22 announcement and is still off from levels reached before the announcement.
Celgene Corporation CELG 1.56% was in for a shock after the FDA issued a “refuse-to-file” letter in response to its NDA filing for ozanimod in patients with relapsing forms of multiple sclerosis.

It’s Raining Deals

M&A in the biotech space picked up momentum after a lull in 2017, with a few multibillion-dollar deals announced in the space. Tax reform freed up free cash flow, and the urge to bolster pipelines prompted companies to explore the M&A route in a bid to reinvigorate sagging top and bottom lines. Some of the noteworthy deals that were announced include:
Japan’s Takeda agreeing to buy Shire PLC (ADR) SHPG 1.35% for $62 billion.
Sanofi SA (ADR) SNY 3.74% acquiring Bioverativ, which develops hemophilia and blood disorder drugs, for $11.6 billion, as well as Belgian biotech company Ablnyx for $4.8 billion.
Celgene buying Juno Therapeutics for $9 billion — and in the process gaining a foothold in the immuno-oncology market through its access to JCAR071, a CD-19 targeted CAR-T therapy in pivotal late-stage trials for relapsed and/or refractory diffuse large B-cell lymphoma. Celgene also bought Impact Biomedicines for up to $7 billion, including potential milestone payments.

A Second Half Preview

Here’s a sneak peek into potential biotech catalysts coming in the second half of 2018.

FDA Approvals

Johnson & Johnson JNJ 1.74%‘s sNDA for its Xarelto vascular dose to reduce the risk of major cardiovascular events in patients with chronic coronary and/or peripheral artery disease, as well as for reducing the risk of acute limb ischemia in patients with peripheral artery disease, is pending before the FDA. The application was submitted in mid-December.
Teva Pharmaceutical Industries Ltd (ADR) ADR TEVA 3.04%‘s BLA for its migraine treatment candidate fremanezumab will come before the FDA, with the agency scheduled to rule on the drug Sept. 16.
Abbvie and Neurocrine Biosciences, Inc. NBIX 0.79% are awaiting the FDA verdict on their NDA for elagolix in endometriosis-associated pain. The PDUFA date is set for the third quarter following a three-month extension of the review period.
Insys Therapeutics Inc INSY 2.09% has a July 28 FDA date and is set to receive the verdict on the company’s sublingual spray formulation of buprenorphine to treat moderate-to-severe acute pain.
DURECT Corporation DRRX 8.28%, which has licensed its schizophrenia candidate RBP-7000 to U.K.-based Indivior, comes under the FDA scanner, with the agency set to rule July 28 on the pipeline candidate. DURECT will yet again be in the spotlight, as Remoxy ER, a drug it licensed to Pain Therapeutics, Inc. PTIE 16.74% has a PDUFA action date of Aug. 7. The odds of the drug clearing the FDA hurdle have worsened after a FDA panel voted against the approval.
SIGA Technologies, Inc. SIGA 2.65%‘s small pox antiviral therapy Tpoxx in an oral formulation faces an FDA decision Aug. 8.
AstraZeneca plc (ADR) AZN 0.27%‘s BLA for moxetumomab pasudotox for treating hairy cell leukemia has a PDUFA date in the third quarter.
Bristol-Myers Squibb Co BMY 1.18%‘s sBLA for Opdivo for treating small-cell lung cancer that has progressed following two or more lines of therapy was granted priority review in mid-April. The application was submitted based on the CheckMate-032 trial.
Eli Lilly And Co LLY 0.13% and Merck await the FDA’s decision on the Keytruda-Alimta combo along with platinum chemotherapy as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer. The PUDFA action date is set for Sept. 23.
Pfizer Inc. PFE 1.14%‘s dacomitinib, evaluated as a first-line treatment for squamous non-small cell lung cancer with epidermal growth factor receptor-activating mutations, awaits the FDA’s verdict in September.
The FDA is set to rule on Verastem Inc VSTM 1.64%‘s lead product candidate duvelisib Oct. 5. The pipeline candidate is being tested for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Clinical Trials

Alkermes Plc ALKS 0.58% expects to release top-line results from the ENLIGHTEN-2 study, the second of two key Phase 3 studies for ALKS 3831 for schizophrenia, in the fourth quarter. The company plans to use clinical data from the study for the NDA submission if the study is successful, along with the previously reported data for the ENLIGHTEN-1 study.
Foamix Pharmaceuticals Ltd FOMX 0.79% plans to release top-line results from two Phase 3 pivotal studies for its FMX103 trial of 1.5-percent topical minocycline foam in rosacea early in the fourth quarter. The company will also release top-line data for its FMX-101 Phase 3 acne study in the third quarter.
FibroGen Inc FGEN 1.62% expects to release top-line results from Phase 3 studies supporting its NDA submission for roxadustat in anemia-associated with chronic kidney disease by the end of 2018. The company expects to submit the NDA in the first half of 2019.
Regulus Therapeutics Inc RGLS 1.37% plans to release data from the Phase 1 renal biopsy study of RG-012 to treat Alport syndrome by the end of the year.
OncoSec Medical Inc ONCS will complete enrollment of 23 patients in the first stage of the PISCES/KEYNOTE-695 study evaluating its intratumoral Tavo plus electroporation in combination with intravenous Keytruda in patients with stage III/IV melanoma who are progressing on either Keytruda or Opdivo in the third quarter. The company expects to present top-line results from this study before the end of the year.

Regulatory Submissions

AbbVie announced positive Phase 3 top-line results for its oral JAK1-selective inhibitor upadacitinib in early June. The candidate is being evaluated as a monotherapy in adults with moderate-to-severe rheumatoid arthritis. The company expects the SECLECT-EARLY study, the fifth pivotal study, to -produce results supporting a regulatory filing in the second half of 2018.
Intra-Cellular Therapies Inc ITCI 5.06%, which initiated a rolling submission of its NDA for lumateperone for treating schizophrenia in June, expects to complete the NDA submission by mid-2018. Rolling submission allows a company to submit sections of the NDA when they are complete, rather than waiting until the entire application is finalized.
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Oral Meds Relieve Acute Migraine Attacks


Two oral calcitonin gene-related peptide (CGRP) inhibitors offer rapid relief from acute headache pain and associated migraine symptoms for about 20% of patients, researchers reported here.
One in five people treated with rimegepant in a phase III study reported freedom from pain at 2 hours after a single dose, and nearly 40% reported relief from their most bothersome symptom, usually photophobia. Similar proportions of patients reported improvement after taking ubrogepant.
The findings were presented at the American Headache Society (AHS) annual meeting.
Vascular dysfunction is thought to play a key role in migraine. CGRP is a potent vasodilator, and blocking the peptide or its receptors can prevent or treat migraine without the cardiovascular side effects often seen with triptans. Monoclonal antibodies are being developed for migraine prophylaxis, while small-molecule oral agents are under study for the treatment of acute attacks.
“This morning we’ve heard about seven new molecular entities that are effective in acute or preventive treatment of migraine and a couple novel ways of delivering older drugs. This is truly a remarkable time in our field,” said Richard Lipton, MD, of Albert Einstein College of Medicine in New York City.
For decades triptans have been the most widely prescribed drugs for the acute treatment of migraine, but many patients cannot use them because of cardiovascular contraindications.
“Perhaps a third of people with migraine don’t respond to triptans, 30% to 40% have recurrent attacks, and according to our estimate 3.5 million people have absolute or relative contraindications for triptans among the 40 million people who get migraines,” Lipton said. “Clearly there are unmet needs, and the hope is that ‘gepants’ will address some of those needs.”
Study 302 of Rimegepant
Lipton presented findings from Study 302, a double-blind phase III trial comparing rimegepant, an oral CGRP receptor antagonist, versus placebo for the acute treatment of migraine.
The study included 1,072 patients; nearly 90% were women, and median age was 41. Participants had at least a 1-year history of migraine and had two to eight attacks of moderate to severe intensity per month (median 4.6 attacks); those with chronic migraine (more than 15 headache days per month) were excluded. Patients were allowed to be on stable migraine prevention medication. They reported their most bothersome symptom to be photophobia (58%), nausea (16%), and phonophobia (27%).
Participants were randomly assigned to receive 75 mg rimegepant or placebo to treat a single migraine attack. A total of 543 people were treated in each group (some enrolled patients did not experience attacks during the follow-up period). Rescue medication was permitted at 2 hours if needed.
At 2 hours after treatment, 19.6% of patients in the rimegepant group reported pain freedom, compared with 12.0% in the placebo group (P=0.0006). At the same time point, 37.6% and 25.2%, respectively, reported freedom from their most bothersome symptom (P=0.0001).
Looking at secondary endpoints, the researchers found that more people in the rimegepant arm reported being free of photophobia and phonophobia at 2 hours post-treatment. The proportions reporting pain relief at 2 hours were 58.1% in the rimegepant arm and 42.8% in the placebo arm; 32.6% and 23.4%, respectively, were able to function normally. Fewer patients required rescue medication in the rimegepant arm compared with the placebo arm (21.0% versus 37.0%).
The proportion of patients receiving rimegepant reporting freedom from pain after a single dose with no rescue medication rose over time, from 20% at 2 hours to 48% at 8 hours. Significantly more people in the rimegepant arm reported continued pain freedom, pain relief, and ability to function through 48 hours.
Treatment was generally safe and well tolerated, Lipton said. One patient in the rimegepant arm and two in the placebo arm had serious adverse events — 1.8 and 0.6%, respectively, had treatment-related adverse events. There were no adverse events leading to treatment discontinuation in either group. Elevated liver enzymes are a potential concern with this class of drugs, but no patients had alanine aminotransferase or aspartate transaminase levels that were more than three times the upper limit of normal or bilirubin more than twice the upper limit.
The researchers concluded that rimegepant offers broad and clinically important benefit with a single dose, with an excellent safety profile similar to that of the placebo. Lipton noted that a parallel trial, Study 301, also showed consistent results.
ACHIEVE I Trial of Ubrogepant
David Dodick, MD, of the Mayo Clinic in Phoenix, presented results from ACHIEVE I, a phase III trial evaluating another oral CGRP receptor agonist, ubrogepant.
As previously reported at the American Academy of Neurology annual meeting in April, 19.2% of patients treated with a single 50 mg dose of ubrogepant and 21.2% of those who received 100 mg reported freedom from pain at 2 hours post-treatment, compared with 11.8% of placebo recipients. About 38% in both dose groups were free of their most bothersome symptom at 2 hours, the study found.
Various secondary endpoints also favored ubrogepant over placebo. A third of patients reported satisfaction with ubrogepant at 2 hours, rising to more than 60% at 24 hours. Like rimegepant, ubrogepant was generally safe and well tolerated. Dodick said that “nearly identical” results were seen in the related ACHIEVE II trial.
These pivotal results support the approval of rimegepant and ubrogepant for the acute treatment of migraine, he said. Biohaven Pharmaceuticals and Allergan have indicated that they plan to file New Drug Applications for the agents in 2019.
Commenting on these two drugs and others described at the same session, moderator Andrew Charles, MD, of the David Geffen School of Medicine at UCLA, told MedPage Today, “How they sort out in comparison remains to be seen, but it shows that the target [CGRP] is an important one and the medications that are going after this target are all working.”
The rimegepant study was funded by Biohaven Pharmaceuticals.
The ubrogepant study was funded by Allergan.
Lipton and Dodick both reported relationships with numerous companies active in migraine drug development.
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Migraine Patterns Often Change During Menopause


About 60% of women with migraine experience changing headache patterns around the menopause transition, with a majority of those reporting greater frequency or worsening intensity, according to research presented here.
Migraine changes were most likely during the post-menopausal period — reported by 43% of study participants — and were associated with greater changes in hormone levels.
The results were presented at the American Headache Society annual meeting.
Women make up three-quarters of all patients with migraine. Past research has shown that migraine patterns may change over the course of the normal menstrual cycle, as well as during pregnancy or after giving birth, suggesting that hormonal levels and patterns play a role. Although some prior studies have reported an increase in headaches during peri-menopause, there are few data about the changing course of headaches in women with pre-existing migraine as they go through the menopause transition.
“The evolution and character of migraine during the peri-menopause has not received as much attention as it deserves, so it’s nice to see this study. The study results are consistent with the common clinical impression that the peri-menopausal transition is a time when migraine headaches often change in character,” Elizabeth Loder, MD, MPH, chief of neurology at Brigham and Women’s Hospital in Boston, told MedPage Today.
Yu-Chen Cheng of Massachusetts General Hospital in Boston presented findings from a retrospective study of changing migraine patterns among women of peri-menopausal and menopausal age, 40 to 60 years.
The study used data from the Research Patient Database Registry of Partners HealthCare, a not-for-profit system in the Boston area that includes a managed care organization, hospitals, community health centers, and home care.
The analysis included 60 women with data on pre-existing migraines prior to menopause who had available MRI reports and medical records with information on estradiol and follicle-stimulating hormone (FSH) levels. Most (80%) were white, the median age at menopause was approximately 47 years, and two thirds used estrogen-based hormone replacement therapy (HRT). There were no notable demographic differences between the group with migraine changes and the group without changes, Cheng said.
Of these women, 35 (58.3%) reported migraine changes while 25 (41.7%) said they did not have changes. Within the first group, 60.0% reported greater frequency or intensity, 28.6% said the characteristics of their headaches changed, and 2.8% reported both.
Migraine changes were most likely to occur post-menopause, or after the final menstrual period (42.9%). This was followed by changes during peri-menopause, defined as either clinical indications such as irregular periods or climacteric symptoms, or 1 year before the final menstrual period (31.4%). Changes were least likely to occur pre-menopause, defined as having regular periods (14.3%).
Women who experienced migraine changes experienced greater hormonal changes than those who did not. Women with migraine changes started with higher levels of estradiol before menopause (median 52.6 versus 29.0 pg/mL) and saw a larger drop, as well as having lower pre-menopause FSH levels (median 13.53 versus 38.58 U/L) and a greater rise. Most of these differences, however, did not reach statistical significance.
Brain imaging showed that a majority of women with and without migraine changes had normal MRI findings (68.6% and 56.0%, respectively). Women without migraine changes were numerically more likely to have pituitary abnormalities and white matter lesions, but again the differences were not statistically significant.
While the underlying mechanism for migraine change during menopause remains unclear, Cheng said, previous research indicates that declining estrogen levels stimulate migraine attacks in the late luteal phase, and migraineurs have a faster decrease in estrogen than women without migraine. The steep decline in estrogen may trigger migraine changes during the menopause transition, she suggested.
“This is an important but underestimated and undermanaged issue, and more awareness and better treatment are needed,” Cheng and colleagues concluded.
Asked about the potential of HRT for managing migraines during the menopause transition, Cheng noted that women with and without migraine changes in this analysis had similar rates of HRT use, and said that studies have produced mixed results about whether HRT triggers migraine or is beneficial.
“It could be beneficial in the future to use hormone therapy for these patients,” Cheng told MedPage Today.
Loder cautioned that the women in this study may not be representative of all peri-menopausal women with migraine.
“It is possible that some of the testing and imaging may have been done in response to changes in migraine status; thus, requiring the presence of tests and imaging in order to include patients in the study may have inadvertently selected a group in whom pituitary abnormalities or clinical worsening are more likely. Further prospective studies would be needed to verify this observation,” said Loder, who was not involved in the study.
Lauren Green, DO, RD, of the Keck School of Medicine at the University of Southern California, said that brain imaging may be a useful tool for managing women with headaches during the menopause transition.
“In neurology, we are always concerned about secondary headaches versus the more common primary headache such as migraine,” Green told MedPage Today. “This study supports performing MRI imaging on peri-menopausal and menopausal women with a distinctive change in their typical headache presentation.”
Cheng, Loder, and Green made no relevant disclosures.
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