Wednesday, January 2, 2019
PerkinElmer initiated at Needham
PerkinElmer initiated with a Hold at Needham. Needham analyst Stephen Unger started PerkinElmer with a Hold rating and $79 fair value estimate.
https://thefly.com/landingPageNews.php?id=2842801
Medtronic initiated at Deutsche Bank
Medtronic initiated with a Buy at Deutsche Bank. Deutsche Bank analyst Pito Chickering started Medtronic with a Buy rating and $99 price target. Deutsche had a Buy rating on the shares under analyst Kristen Stewart before going restricted on the name in June of 2018.
https://thefly.com/landingPageNews.php?id=2842829
Edwards Lifesciences initiated at Deutsche Bank
Edwards Lifesciences initiated with a Hold at Deutsche Bank. Deutsche Bank analyst Pito Chickering started Edwards Lifesciences with a Hold rating and $164 price target. Deutsche had a Hold rating on the shares under analyst Kristen Stewart before going restricted on the name in June of 2018.
https://thefly.com/landingPageNews.php?id=2842833
Aspirin May Lessen Long-Term Stroke Risk After Preeclampsia
Long-term risk of stroke was lower in women who took aspirin after experiencing preeclampsia and other hypertensive disorders of pregnancy, a prospective U.S. cohort study found.
Women with preeclampsia and related disorders who did not use aspirin regularly showed 1.5-fold higher risk of stroke before age 60, compared to women not having a history of such conditions, reported Eliza Miller, MD, of Columbia University in New York City, and colleagues in Neurology.
However, the group found, stroke risk was not increased among women with preeclampsia who did use aspirin, compared to the non-preeclampsia group.
Preeclampsia and other hypertensive disorders of pregnancy have been linked to increased rates of chronic hypertension and other cardiovascular risks in prior research, but this is the first prospective U.S. study to look specifically at stroke, Miller said.
“Stroke is now the third leading cause of death in U.S. women, compared to the fifth leading cause in men, so it’s really important that we look at sex-specific risk factors and take those into account in our overall assessment of a woman’s risk of future stroke,” Miller told MedPage Today. “While this is an observational study and isn’t strong enough evidence to change practice, it does raise questions about how aggressively we should be treating women in middle age who have a history of these disorders.”
During pregnancy, aspirin reduces preeclampsia incidence in high-risk women, but it typically is discontinued after pregnancy, she noted. Guidelines for estimating 10-year cardiovascular risk to inform primary prevention do not consider preeclampsia in their risk calculations, Miller added.
The analysis looked at women in the California Teachers Study who were ages ≤60 when they enrolled during 1995-1996, and who were followed up prospectively for validated stroke outcomes through 2015. Median age at enrollment was 53, and women who did not report a prior stroke on a baseline questionnaire were included in the analysis. Of 83,749 women in the sample, 4,070 (4.9%) had a history of preeclampsia, either self-reported in an early questionnaire (n=3,361), hospital-diagnosed (n=972), or both (n=262).
Over a mean follow-up of 18.1 years, there were 123 admissions for stroke in the preeclampsia group (3.0%, event rate 166 per 100,000 woman-years) compared with 1,823 (2.3%, 127 per 100,000 woman-years ) in the non-preeclampsia group (P=0.002). Women with pre-eclampsia history had an increased risk of all stroke, even after adjusting for their increased prevalence of risk factors (adjusted HR 1.3, 95% CI 1.2–1.4).
Overall, the pre-eclampsia group showed no increase in stroke risk before age 60 (adjusted HR 1.2, 95% CI 0.9–1.7). But in stratified analyses, women with preeclampsia history who were regular aspirin users had a lower risk of stroke before age 60 (adjusted HR 0.8, 95% CI 0.4-1.7) than those who did not use aspirin (adjusted HR 1.5, 95% CI 1.0-2.1, P=0.18). This effect was not seen with statins, and aspirin users showed no increased risk for hemorrhagic stroke.
This “is not a definitive study, but rather a first attempt to explore the hypothesis that women who have had hypertensive disorders of pregnancy might benefit from primary preventive therapies directed at stroke,” observed Steven Feske, MD, of Brigham and Women’s Hospital in Boston, and Cheryl Bushnell, MD, MHS, of Wake Forest Baptist Health in Winston-Salem, North Carolina, in an accompanying editorial.
“So, where do we go from here?” they asked. A directed randomized controlled trial is unlikely to detect small effects: “in fact, it required meta-analysis of many trials to establish the benefit of aspirin for secondary stroke prevention,” they wrote.
In prior studies including men and women, aspirin appeared to have no overall benefit for primary prevention, but the Women’s Health Study found a 17% reduction of stroke risk in women ages >45 taking aspirin for primary prevention, Feske and Bushnell noted. While the current findings are too preliminary to drive clinical decision-making, “taking the findings of the Women’s Health Study into consideration, the use of aspirin for primary prevention in women ages >45 years of age is reasonable, increasingly so as they accumulate risk factors,” they wrote.
Miller and colleagues noted several study limitations. A small number of strokes occurred in both groups. The researchers used a threshold of P<0.2 for significance for a statistical interaction; this approach may have resulted in increased type 1 errors. Transient ischemic attacks (TIA) and survivor bias may have affected results, and self-reports of preeclampsia history may have introduced misclassification. And women who enrolled in the California Teachers Study were predominantly white and likely to have delayed childbearing to a later age; they may not be representative of all women.
Miller disclosed support from the NIH National Institute of Neurological Disorders and Stroke, the StrokeNet Training Core, and the NIH National Center for Advancing Translational Science. Co-authors disclosed relevant relationships with BMS-Pfizer Alliance for Eliquis, Merck/Organon, and Auxilium.
Feske and Bushnell disclosed no relevant relationships with industry.
Primary Source
Neurology
Secondary Source
Neurology
College Attendance: New Risk Factor for Meningitis B?
College students faced increased risk of contracting serogroup B meningococcal disease (MenB) compared to non-college students, surveillance data from 2014-2016 indicated.
During this period there was a higher risk for sporadic and outbreak-associated MenB disease in college students versus non-college students (RR 3.54, 95% CI 2.21-5.41), reported Sarah A. Mbaeyi, MD, and colleagues at the CDC.
But there was no similar risk observed for serogroups A, C, W, and Y combined in college students versus non-college students (RR 0.56, 95% CI 0.27-1.14), the authors wrote in Pediatrics.
They highlighted the contrast in recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) — that quadrivalent meningococcal conjugate vaccine (MenACWY) is currently recommended for all adolescents, but vaccines against meningococcal serogroup B are not “routinely recommended” for all adolescents or college students.
The MenB vaccine may be given “on the basis of clinical decision making,” although the authors said that preliminary data suggests coverage estimates for ≥1 dose of MenB vaccine among youth ages 16-18 was <10% by the end of 2017.
They also noted that both MenACWY and MenB vaccines are recommended for groups “at an increased risk of meningococcal disease,” including during an outbreak. However, the authors added that previous evaluations of epidemiology and risks for meningococcal disease among college students were conducted “when rates of disease were higher, serogroup C was the predominant cause of disease” and the MenACWY and MenB vaccines had not yet become available.
Researchers examined data from the National Notifiable Diseases Surveillance System, and enhanced meningococcal disease surveillance activities from 45 states, representing 98% of the population. College students were defined as individuals ages 18-24 identifying themselves as enrolled at 4-year, 2-year, or technical institutions. “Non-college students” were anyone else in this age group.
Overall, 1,174 confirmed or probable cases of meningococcal disease were reported from 2014 to 2016 in adults ages 18-24, though analyses were conducted on the 163 cases in this age group with known information on college student status. This included 83 college students and 80 non-college students.
The overall incidence of meningococcal disease among adults ages 18-24 was 0.17 cases per 100,000, with the greatest incidence among persons ages 18-20.
In the entire 18-24 cohort, 58.3% of cases were serogroup B. Among college students, 76.9% of cases were serogroup B vs 38.4% of cases in non-college students. About 13% of cases were serogroup C and 10% serogroup Y.
Compared to non-college students, college students with meningococcal disease were more likely to be younger (ages 18-20), and to have received ≥1 dose of MenACWY vaccine.
Six MenB disease outbreaks occurred on college campuses during this time period; about one-third of serogroup B cases were associated with outbreaks. Mbaeyi and colleagues also noted that “no outbreaks due to non-B serogroups were known to have occurred among college students.”
In an accompanying editorial, Lucila Marquez, MD, and Sheldon L. Kaplan, MD, both of Baylor College of Medicine in Houston, wrote that the findings “modify the current understanding of the epidemiology of meningococcal disease.”
They added that when the ACIP deliberated MenB vaccines in June 2015, “college attendance” was not identified as a risk factor for the disease, which was part of the reason that MenB vaccines were given a Category B recommendation.
The editorialists also cited “consequences” for Category B recommendations, including a recent survey that found providers are less likely to recommend a vaccine if it’s not in Category A. Though they added that findings from this study “are unlikely to change” the current recommendation, they argued that these results now give providers “an even more compelling reason” to recommend the MenB vaccine for patients attending college.
“At a minimum, pediatricians should educate students and families regarding the increased risk of MenB infections in college students in the United States and inform them that two vaccines are available that can potentially protect college students from this infection,” Marquez and Kaplan wrote.
One limitation to the data, said Mbaeyi and colleagues, is that they were unable to assess the expected strain coverage of MenB vaccines in this population “because we did not evaluate levels of gene expression and isolate susceptibility to antibodies induced by vaccine antigens.”
Study authors were CDC employees and reported no conflicts of interest.
Marquez disclosed no conflicts of interest. Kaplan disclosed support from Pfizer.
Primary Source
Pediatrics
Secondary Source
Pediatrics
Smoking Cessation Key Component of Cancer Moonshot Program
Quitting smoking after a cancer diagnosis is now recognized as a highly effective strategy for improving outcomes and survival in a large percentage of patients, but smoking cessation treatment remains uncommon in cancer care.
That may soon change, thanks to an initiative of the National Cancer Institute’s “Cancer Moonshot” program, designed to jump-start smoking cessation treatment at NCI-designated cancer centers.
Late in 2017, 22 such centers received funding from the program to begin or expand their smoking cessation-treatment programs, and in 2018 an additional 20 centers received the funds, amounting to $500,000 over two years for each center.
The program, known as the Cancer Center Cessation Initiative, integrates evidence-based tobacco-dependence treatment into cancer treatment using electronic health record (EHR) technology to facilitate the integration, three experts wrote in an editorial published Jan. 2 in New England Journal of Medicine.
“The initiative has the potential to transform clinical cancer care so that evidence-based smoking-cessation treatment is an integral component of care for every person with cancer who smokes,” wrote Robert T. Croyle, PhD, and Glen Morgan, PhD, both of the NCI, and Michael C. Fiore, MD, of the University of Wisconsin School of Medicine and Public Health’s National Center for Tobacco Research and Intervention.
In an interview with MedPage Today, Fiore said the initiative is particularly timely given what is now known about the impact of smoking cessation on cancer treatment and survival.
“We have some powerful new data that tell us patients who continue smoking during cancer treatment tend to have more side effects,” he said. “And we also know that the likelihood of developing a second cancer is markedly increased among people who continue to smoke after being cured of a cancer. We are sharing this data with oncologists to emphasize that smoking cessation should be a core part of cancer care.”
Fiore, Croyle, and Morgan wrote that while smoking causes roughly a third of all cancer deaths, “clinicians may not appreciate the harms caused by continued smoking among patients with cancer.”
“Some clinicians believe that they are inadequately trained to deliver effective treatment for tobacco use and that their patients will resist such treatment or that it will not be effective,” they wrote. “Some clinicians may also fear that focusing attention on smoking will exacerbate the guilt and shame that smokers often feel after the development of cancer. Such factors, along with resource limitations, have hindered the delivery of effective smoking-cessation treatments in cancer patients for too many years.”
As part of the initiative, all patients who smoke receiving treatment at one of the 42 centers should be urged to quit, offered evidence-based cessation treatment, and tracked “in order to assess treatment outcomes.”
Each of the centers is also required to have a plan in place to continue its program for an additional two years after NCI funding ends, Fiore said.
“In many ways this is really a manifestation of the promise of ‘Moonshot,’ which is designed to accelerate the ways we can help more cancer patients and prevent more cancers,” he said.
Allowing individual centers some autonomy in their organizational approaches to delivering smoking cessation treatments will allow them to serve as laboratories for researching how to best incorporate such treatments into clinical practice, Fiore said.
“The idea is that the lessons learned over the next few years can be disseminated to other cancer clinics,” he said. “Ideally, every patient who comes into a cancer clinic who smokes should be offered effective treatment.”
Ironwood, Allergan reach settlement with Mylan over LINZESS patent litigation
Ironwood Pharmaceuticals (IRWD) and Allergan (AGN) announced that the companies have reached an agreement with Mylan Pharmaceuticals, Inc. (MYL) resolving patent litigations brought in response to Mylan’s abbreviated new drug applications seeking approval to market generic versions of LINZESS prior to the expiration of the companies’ applicable patents. The settlement with Mylan is the third patent infringement settlement the companies have reached with respect to LINZESS. Pursuant to the terms of the settlement, Ironwood and Allergan will grant Mylan a license to market its generic version of LINZESS 145 mcg and 290 mcg in the United States beginning February 5, 2030, and its generic version of LINZESS 72 mcg in the United States beginning August 5, 2030, unless certain limited circumstances, customary for settlement agreements of this nature, occur. As a result of the settlement, all ongoing Hatch-Waxman litigations between the companies and Mylan regarding LINZESS patents pending in the U.S. District Court for the Northern District of West Virginia will be dismissed. Additional details regarding the settlement were not disclosed. As required by law, the companies will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Patent infringement litigations brought by Allergan and Ironwood against other parties who have submitted ANDAs to the U.S. FDA seeking approval to market generic versions of LINZESS remain pending in the U.S. District Court for the District of Delaware, where the earliest scheduled trial date is June 17, 2019.
https://thefly.com/landingPageNews.php?id=2842759
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