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Self-Management Intervention for Epilepsy Improves Health
The intervention appears to ameliorate mood and quality of life in people with a history of negative health events.
Self-management of epilepsy using a group-format, remote intervention improves mood, quality of life, and health functioning in high-risk individuals, according to a randomized, controlled trial published in the September issue of Epilepsia.
In the six-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related negative health event in the previous six months were randomized to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely during eight to 10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have walked the walk in living with epilepsy,” said Martha Sajatovic, MD, Professor of Psychiatry at Case Western Reserve University in Cleveland, and her colleagues.
During the six-month follow-up period, individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group.
When the authors examined subcategories of negative health event counts (eg, past three-day seizure count or past six‐month emergency department and hospitalization count), the differences between groups were not significant. There was also no difference between groups in seizure severity.
The study showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and physical and mental health functioning, compared with controls. The intervention group also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
Most participants (94.2%) said that the intervention was useful and addressed their most important issues. Approximately 92% said that the benefits of the SMART intervention were worth the effort.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
—Bianca Nogrady
Suggested Reading
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Epilepsia. 2018;59(9):1684-1695.
The intervention appears to ameliorate mood and quality of life in people with a history of negative health events.
The intervention appears to ameliorate mood and quality of life in people with a history of negative health events.
Self-management of epilepsy using a group-format, remote intervention improves mood, quality of life, and health functioning in high-risk individuals, according to a randomized, controlled trial published in the September issue of Epilepsia.
In the six-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related negative health event in the previous six months were randomized to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely during eight to 10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have walked the walk in living with epilepsy,” said Martha Sajatovic, MD, Professor of Psychiatry at Case Western Reserve University in Cleveland, and her colleagues.
During the six-month follow-up period, individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group.
When the authors examined subcategories of negative health event counts (eg, past three-day seizure count or past six‐month emergency department and hospitalization count), the differences between groups were not significant. There was also no difference between groups in seizure severity.
The study showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and physical and mental health functioning, compared with controls. The intervention group also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
Most participants (94.2%) said that the intervention was useful and addressed their most important issues. Approximately 92% said that the benefits of the SMART intervention were worth the effort.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
—Bianca Nogrady
Suggested Reading
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Epilepsia. 2018;59(9):1684-1695.
Self-management of epilepsy using a group-format, remote intervention improves mood, quality of life, and health functioning in high-risk individuals, according to a randomized, controlled trial published in the September issue of Epilepsia.
In the six-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related negative health event in the previous six months were randomized to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely during eight to 10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have walked the walk in living with epilepsy,” said Martha Sajatovic, MD, Professor of Psychiatry at Case Western Reserve University in Cleveland, and her colleagues.
During the six-month follow-up period, individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group.
When the authors examined subcategories of negative health event counts (eg, past three-day seizure count or past six‐month emergency department and hospitalization count), the differences between groups were not significant. There was also no difference between groups in seizure severity.
The study showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and physical and mental health functioning, compared with controls. The intervention group also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
Most participants (94.2%) said that the intervention was useful and addressed their most important issues. Approximately 92% said that the benefits of the SMART intervention were worth the effort.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
—Bianca Nogrady
Suggested Reading
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Epilepsia. 2018;59(9):1684-1695.
Pregnancy registries are a valuable resource
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Clearance rates for some antiepileptic drugs rise during pregnancy
Certain antiepileptic drugs show significant increases in clearance rates during pregnancy, which may be associated with increased seizure rates, research suggests.
Paula E. Voinescu, MD, PhD, of Brigham and Women’s Hospital, Boston, and her coauthors conducted a prospective, observational study of 44 pregnancies in 40 women with epilepsy who were treated with antiepileptic drugs. The women were enrolled preconception or in early pregnancy, then kept daily diaries of medication doses, adherence, and seizures, while antiepileptic drug concentrations were measured every 1-3 months.
The investigators found that levetiracetam reached a mean maximal clearance during the first trimester that was 71% higher than baseline clearance (P = .0001), and its clearance level remained high throughout pregnancy.
“This is important information for clinicians who manage women on levetiracetam as they may opt to begin TDM [therapeutic drug monitoring] as early as possible in pregnancy,” the investigators wrote. The report was published online Sept. 5 in Neurology.
The authors noted that there was significant variability between participants in clearance rates of levetiracetam, ranging from 1.42-fold to 2.02-fold baseline clearance, and they suggested that pharmacogenetic differences may play a role.
“Levetiracetam is mainly excreted unchanged by the kidneys, and the changes in clearance are consistent with the time course of increased glomerular filtration rate during pregnancy,” they wrote. “The pathophysiology of the interparticipant variability in clearance fluctuation during pregnancy and of the race influence observed for levetiracetam are difficult to explain with the known pharmacokinetic data.”
Both oxcarbazepine and topiramate also reached significantly higher mean maximal clearances during the second trimester than at baseline (63% and 39% higher, respectively), and their elevated clearance persisted into the third trimester.
However, there were no significant changes in clearance rates of total or free phenytoin or valproic acid during pregnancy.
Among the 15 women for whom researchers had complete seizure history and antiepileptic drug concentrations, 40% experienced a worsening of seizure frequency during at least one trimester.
Overall, lower individualized ratio-to-target concentrations of drug were associated with increased seizure frequency in the first and second trimester, but not in the third trimester.
While the study did not compare seizure outcomes between patients who were managed with TDM and those who were not, the authors suggested that their data supported the use of TDM during pregnancy.
“The finding of lower AED RTC [antiepileptic drug ratio to concentration] at different trimesters suggests that in outpatient clinical practice, possible changes in AED dosing varied by trimester may be clinically important for patient care.”
The study was supported by the National Institutes of Health, the American Brain Foundation, the American Epilepsy Society, the Epilepsy Foundation, and the Karger Fund. Four authors declared support, honoraria, and/or other funding from the pharmaceutical industry, and five also declared support from the study funding bodies.
SOURCE: Voinescu P et al. Neurology. 2018 Sep 5. doi: 10.1212/WNL.0000000000006240.
Certain antiepileptic drugs show significant increases in clearance rates during pregnancy, which may be associated with increased seizure rates, research suggests.
Paula E. Voinescu, MD, PhD, of Brigham and Women’s Hospital, Boston, and her coauthors conducted a prospective, observational study of 44 pregnancies in 40 women with epilepsy who were treated with antiepileptic drugs. The women were enrolled preconception or in early pregnancy, then kept daily diaries of medication doses, adherence, and seizures, while antiepileptic drug concentrations were measured every 1-3 months.
The investigators found that levetiracetam reached a mean maximal clearance during the first trimester that was 71% higher than baseline clearance (P = .0001), and its clearance level remained high throughout pregnancy.
“This is important information for clinicians who manage women on levetiracetam as they may opt to begin TDM [therapeutic drug monitoring] as early as possible in pregnancy,” the investigators wrote. The report was published online Sept. 5 in Neurology.
The authors noted that there was significant variability between participants in clearance rates of levetiracetam, ranging from 1.42-fold to 2.02-fold baseline clearance, and they suggested that pharmacogenetic differences may play a role.
“Levetiracetam is mainly excreted unchanged by the kidneys, and the changes in clearance are consistent with the time course of increased glomerular filtration rate during pregnancy,” they wrote. “The pathophysiology of the interparticipant variability in clearance fluctuation during pregnancy and of the race influence observed for levetiracetam are difficult to explain with the known pharmacokinetic data.”
Both oxcarbazepine and topiramate also reached significantly higher mean maximal clearances during the second trimester than at baseline (63% and 39% higher, respectively), and their elevated clearance persisted into the third trimester.
However, there were no significant changes in clearance rates of total or free phenytoin or valproic acid during pregnancy.
Among the 15 women for whom researchers had complete seizure history and antiepileptic drug concentrations, 40% experienced a worsening of seizure frequency during at least one trimester.
Overall, lower individualized ratio-to-target concentrations of drug were associated with increased seizure frequency in the first and second trimester, but not in the third trimester.
While the study did not compare seizure outcomes between patients who were managed with TDM and those who were not, the authors suggested that their data supported the use of TDM during pregnancy.
“The finding of lower AED RTC [antiepileptic drug ratio to concentration] at different trimesters suggests that in outpatient clinical practice, possible changes in AED dosing varied by trimester may be clinically important for patient care.”
The study was supported by the National Institutes of Health, the American Brain Foundation, the American Epilepsy Society, the Epilepsy Foundation, and the Karger Fund. Four authors declared support, honoraria, and/or other funding from the pharmaceutical industry, and five also declared support from the study funding bodies.
SOURCE: Voinescu P et al. Neurology. 2018 Sep 5. doi: 10.1212/WNL.0000000000006240.
Certain antiepileptic drugs show significant increases in clearance rates during pregnancy, which may be associated with increased seizure rates, research suggests.
Paula E. Voinescu, MD, PhD, of Brigham and Women’s Hospital, Boston, and her coauthors conducted a prospective, observational study of 44 pregnancies in 40 women with epilepsy who were treated with antiepileptic drugs. The women were enrolled preconception or in early pregnancy, then kept daily diaries of medication doses, adherence, and seizures, while antiepileptic drug concentrations were measured every 1-3 months.
The investigators found that levetiracetam reached a mean maximal clearance during the first trimester that was 71% higher than baseline clearance (P = .0001), and its clearance level remained high throughout pregnancy.
“This is important information for clinicians who manage women on levetiracetam as they may opt to begin TDM [therapeutic drug monitoring] as early as possible in pregnancy,” the investigators wrote. The report was published online Sept. 5 in Neurology.
The authors noted that there was significant variability between participants in clearance rates of levetiracetam, ranging from 1.42-fold to 2.02-fold baseline clearance, and they suggested that pharmacogenetic differences may play a role.
“Levetiracetam is mainly excreted unchanged by the kidneys, and the changes in clearance are consistent with the time course of increased glomerular filtration rate during pregnancy,” they wrote. “The pathophysiology of the interparticipant variability in clearance fluctuation during pregnancy and of the race influence observed for levetiracetam are difficult to explain with the known pharmacokinetic data.”
Both oxcarbazepine and topiramate also reached significantly higher mean maximal clearances during the second trimester than at baseline (63% and 39% higher, respectively), and their elevated clearance persisted into the third trimester.
However, there were no significant changes in clearance rates of total or free phenytoin or valproic acid during pregnancy.
Among the 15 women for whom researchers had complete seizure history and antiepileptic drug concentrations, 40% experienced a worsening of seizure frequency during at least one trimester.
Overall, lower individualized ratio-to-target concentrations of drug were associated with increased seizure frequency in the first and second trimester, but not in the third trimester.
While the study did not compare seizure outcomes between patients who were managed with TDM and those who were not, the authors suggested that their data supported the use of TDM during pregnancy.
“The finding of lower AED RTC [antiepileptic drug ratio to concentration] at different trimesters suggests that in outpatient clinical practice, possible changes in AED dosing varied by trimester may be clinically important for patient care.”
The study was supported by the National Institutes of Health, the American Brain Foundation, the American Epilepsy Society, the Epilepsy Foundation, and the Karger Fund. Four authors declared support, honoraria, and/or other funding from the pharmaceutical industry, and five also declared support from the study funding bodies.
SOURCE: Voinescu P et al. Neurology. 2018 Sep 5. doi: 10.1212/WNL.0000000000006240.
FROM NEUROLOGY
Key clinical point: Some antiepileptic drugs show higher clearance rates during pregnancy, which could increase seizure risk.
Major finding: The mean maximal clearance rate of levetiracetam in the first trimester is 71% higher than baseline.
Study details: Prospective observational study in 40 women with 44 pregnancies.
Disclosures: The study was supported by the National Institutes of Health, the American Brain Foundation, the American Epilepsy Society, the Epilepsy Foundation, and the Karger Fund. Four authors declared support, honoraria, and/or other funding from the pharmaceutical industry, and five also declared support from the study funding bodies.
Source: Voinescu P et al. Neurology. 2018 Sep 5. doi: 10.1212/WNL.0000000000006240
Multiday seizure cycles may be very common
Multiday epileptic seizure cycles may occur in a substantial number of individuals with epilepsy, results of a retrospective cohort study suggest.
While about 80% of patients in the study showed circadian modulation of their seizure rates, a substantial portion showed strong circaseptan (7 day) rhythms, according to the study’s senior author, Mark J. Cook, MD, of the department of medicine at St. Vincent’s Hospital, Melbourne.
Significant circaseptan cycles were seen in more than 20% of patients in one analysis from the study, which Dr. Cook and his colleagues reported in the Lancet Neurology.
The high prevalence of multiday seizure cycles could present an opportunity to improve treatment through development of patient-specific chronotherapy or the timing of medication to match when seizures would be most likely. “Even without fully understanding the mechanisms of seizure cycles, temporal patterns can be incorporated into patient management plans,” Dr. Cook said in a news release.
The study by Dr. Cook and his colleagues was based on two seizure datasets. One was a U.S. cohort of 1,118 patients who self-reported at least 100 episodes through the SeizureTracker website or mobile app. The other was an Australian cohort of 12 patients with focal epilepsy who had at least 30 recorded seizures in a study of an implanted electrocorticography device that tracked them between 6 months and 3 years.
In the SeizureTracker data, 86% of participants had at least one significant cycle in their seizure times, and 64% had more than one cycle. Most of the cycles (80%) were circadian, while 21% of people had significant 7-day cycles in one analysis using the Hodges-Ajne test, a statistical method used to assess circular data.
“Many patients also showed some evidence of cycles lasting up to a month,” wrote Dr. Cook and his coauthors.
A confirmatory analysis using Monte Carlo simulation found that 7% of people, or 77 individuals, had significant 7-day cycles. “The probability that 77 patients would randomly share a specific cycle [such as a 7-day cycle] is infinitesimal,” the authors wrote.
In the implantable device study, 11 out of 12 patients had strong rhythms at 24 hours, according to the investigators, while 1 had a significant cycle of exactly 1 week, and 2 others had cycles of approximately 1 week.
“Some people had stronger rhythms at time scales longer than 24 hours, which suggests that circadian regulation was not necessarily the strongest modulating factor of epileptic activity,” the investigators wrote.
The cause of longer seizure cycles remains unclear, according to the investigators, though peak seizure times might be linked to behavioral changes such as varying stress levels over the course of the week, seasonal changes in sleep quality, or biologic drivers such as menstruation.
“A better understanding of seizure cycles might provide new targets for treatment,” they wrote.
Funding for the study came from the Australian National Health and Medical Research Council. Dr. Cook declared no competing interests, while his coauthors reported support from sources outside of this study. One study author is a cofounder of SeizureTracker.com.
SOURCE: Cook MJ et al. Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30274-6.
It is “remarkable” that there were such long-lasting cycling alterations in seizure propensity over the course of several weeks in this study, Andreas Schulze-Bonhage, PhD, wrote in a published commentary.
“Ultraslow oscillations in brain excitability are scarcely understood,” he wrote in The Lancet Neurology, adding that emerging evidence suggests slow cycles below well-known circadian rhythms influence both physiological functioning and disease states.
Of note, the study showed that longer cycle durations of several weeks were not limited to women, in whom such cycles might reflect monthly hormonal changes, Dr. Schulze-Bonhage wrote.
The authors of the study acknowledged the inherent limitations of analyzing patient-reported seizure information and long-term assessment of electrocorticography recordings. Some of those limitations might be overcome with technical advances, including seizure trackers that can be worn by large cohorts of patients, according to Dr. Schulze-Bonhage.
“The approach of generating hypotheses in small patient cohorts assessed with high-quality methods and testing them in much larger patient samples from whom only behavioral data can be obtained can be considered seminal for future investigations on big data,” he wrote.
Dr. Schulze-Bonhage is with the Epilepsy Center at University Medical Center, University of Freiburg (Germany). He reported no competing interests related to his editorial (Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30337-5 ).
It is “remarkable” that there were such long-lasting cycling alterations in seizure propensity over the course of several weeks in this study, Andreas Schulze-Bonhage, PhD, wrote in a published commentary.
“Ultraslow oscillations in brain excitability are scarcely understood,” he wrote in The Lancet Neurology, adding that emerging evidence suggests slow cycles below well-known circadian rhythms influence both physiological functioning and disease states.
Of note, the study showed that longer cycle durations of several weeks were not limited to women, in whom such cycles might reflect monthly hormonal changes, Dr. Schulze-Bonhage wrote.
The authors of the study acknowledged the inherent limitations of analyzing patient-reported seizure information and long-term assessment of electrocorticography recordings. Some of those limitations might be overcome with technical advances, including seizure trackers that can be worn by large cohorts of patients, according to Dr. Schulze-Bonhage.
“The approach of generating hypotheses in small patient cohorts assessed with high-quality methods and testing them in much larger patient samples from whom only behavioral data can be obtained can be considered seminal for future investigations on big data,” he wrote.
Dr. Schulze-Bonhage is with the Epilepsy Center at University Medical Center, University of Freiburg (Germany). He reported no competing interests related to his editorial (Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30337-5 ).
It is “remarkable” that there were such long-lasting cycling alterations in seizure propensity over the course of several weeks in this study, Andreas Schulze-Bonhage, PhD, wrote in a published commentary.
“Ultraslow oscillations in brain excitability are scarcely understood,” he wrote in The Lancet Neurology, adding that emerging evidence suggests slow cycles below well-known circadian rhythms influence both physiological functioning and disease states.
Of note, the study showed that longer cycle durations of several weeks were not limited to women, in whom such cycles might reflect monthly hormonal changes, Dr. Schulze-Bonhage wrote.
The authors of the study acknowledged the inherent limitations of analyzing patient-reported seizure information and long-term assessment of electrocorticography recordings. Some of those limitations might be overcome with technical advances, including seizure trackers that can be worn by large cohorts of patients, according to Dr. Schulze-Bonhage.
“The approach of generating hypotheses in small patient cohorts assessed with high-quality methods and testing them in much larger patient samples from whom only behavioral data can be obtained can be considered seminal for future investigations on big data,” he wrote.
Dr. Schulze-Bonhage is with the Epilepsy Center at University Medical Center, University of Freiburg (Germany). He reported no competing interests related to his editorial (Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30337-5 ).
Multiday epileptic seizure cycles may occur in a substantial number of individuals with epilepsy, results of a retrospective cohort study suggest.
While about 80% of patients in the study showed circadian modulation of their seizure rates, a substantial portion showed strong circaseptan (7 day) rhythms, according to the study’s senior author, Mark J. Cook, MD, of the department of medicine at St. Vincent’s Hospital, Melbourne.
Significant circaseptan cycles were seen in more than 20% of patients in one analysis from the study, which Dr. Cook and his colleagues reported in the Lancet Neurology.
The high prevalence of multiday seizure cycles could present an opportunity to improve treatment through development of patient-specific chronotherapy or the timing of medication to match when seizures would be most likely. “Even without fully understanding the mechanisms of seizure cycles, temporal patterns can be incorporated into patient management plans,” Dr. Cook said in a news release.
The study by Dr. Cook and his colleagues was based on two seizure datasets. One was a U.S. cohort of 1,118 patients who self-reported at least 100 episodes through the SeizureTracker website or mobile app. The other was an Australian cohort of 12 patients with focal epilepsy who had at least 30 recorded seizures in a study of an implanted electrocorticography device that tracked them between 6 months and 3 years.
In the SeizureTracker data, 86% of participants had at least one significant cycle in their seizure times, and 64% had more than one cycle. Most of the cycles (80%) were circadian, while 21% of people had significant 7-day cycles in one analysis using the Hodges-Ajne test, a statistical method used to assess circular data.
“Many patients also showed some evidence of cycles lasting up to a month,” wrote Dr. Cook and his coauthors.
A confirmatory analysis using Monte Carlo simulation found that 7% of people, or 77 individuals, had significant 7-day cycles. “The probability that 77 patients would randomly share a specific cycle [such as a 7-day cycle] is infinitesimal,” the authors wrote.
In the implantable device study, 11 out of 12 patients had strong rhythms at 24 hours, according to the investigators, while 1 had a significant cycle of exactly 1 week, and 2 others had cycles of approximately 1 week.
“Some people had stronger rhythms at time scales longer than 24 hours, which suggests that circadian regulation was not necessarily the strongest modulating factor of epileptic activity,” the investigators wrote.
The cause of longer seizure cycles remains unclear, according to the investigators, though peak seizure times might be linked to behavioral changes such as varying stress levels over the course of the week, seasonal changes in sleep quality, or biologic drivers such as menstruation.
“A better understanding of seizure cycles might provide new targets for treatment,” they wrote.
Funding for the study came from the Australian National Health and Medical Research Council. Dr. Cook declared no competing interests, while his coauthors reported support from sources outside of this study. One study author is a cofounder of SeizureTracker.com.
SOURCE: Cook MJ et al. Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30274-6.
Multiday epileptic seizure cycles may occur in a substantial number of individuals with epilepsy, results of a retrospective cohort study suggest.
While about 80% of patients in the study showed circadian modulation of their seizure rates, a substantial portion showed strong circaseptan (7 day) rhythms, according to the study’s senior author, Mark J. Cook, MD, of the department of medicine at St. Vincent’s Hospital, Melbourne.
Significant circaseptan cycles were seen in more than 20% of patients in one analysis from the study, which Dr. Cook and his colleagues reported in the Lancet Neurology.
The high prevalence of multiday seizure cycles could present an opportunity to improve treatment through development of patient-specific chronotherapy or the timing of medication to match when seizures would be most likely. “Even without fully understanding the mechanisms of seizure cycles, temporal patterns can be incorporated into patient management plans,” Dr. Cook said in a news release.
The study by Dr. Cook and his colleagues was based on two seizure datasets. One was a U.S. cohort of 1,118 patients who self-reported at least 100 episodes through the SeizureTracker website or mobile app. The other was an Australian cohort of 12 patients with focal epilepsy who had at least 30 recorded seizures in a study of an implanted electrocorticography device that tracked them between 6 months and 3 years.
In the SeizureTracker data, 86% of participants had at least one significant cycle in their seizure times, and 64% had more than one cycle. Most of the cycles (80%) were circadian, while 21% of people had significant 7-day cycles in one analysis using the Hodges-Ajne test, a statistical method used to assess circular data.
“Many patients also showed some evidence of cycles lasting up to a month,” wrote Dr. Cook and his coauthors.
A confirmatory analysis using Monte Carlo simulation found that 7% of people, or 77 individuals, had significant 7-day cycles. “The probability that 77 patients would randomly share a specific cycle [such as a 7-day cycle] is infinitesimal,” the authors wrote.
In the implantable device study, 11 out of 12 patients had strong rhythms at 24 hours, according to the investigators, while 1 had a significant cycle of exactly 1 week, and 2 others had cycles of approximately 1 week.
“Some people had stronger rhythms at time scales longer than 24 hours, which suggests that circadian regulation was not necessarily the strongest modulating factor of epileptic activity,” the investigators wrote.
The cause of longer seizure cycles remains unclear, according to the investigators, though peak seizure times might be linked to behavioral changes such as varying stress levels over the course of the week, seasonal changes in sleep quality, or biologic drivers such as menstruation.
“A better understanding of seizure cycles might provide new targets for treatment,” they wrote.
Funding for the study came from the Australian National Health and Medical Research Council. Dr. Cook declared no competing interests, while his coauthors reported support from sources outside of this study. One study author is a cofounder of SeizureTracker.com.
SOURCE: Cook MJ et al. Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30274-6.
FROM THE LANCET NEUROLOGY
Key clinical point:
Major finding: Significant 7-day cycles were seen in more than 20% of patients in one analysis from this study.
Study details: A retrospective cohort analysis including 1,118 patients who self-reported episodes online and 12 patients who participated in an electrocorticography device study.
Disclosures: Funding for the study came from the Australian National Health and Medical Research Council. Dr. Cook declared no competing interests, while coauthors reported support from sources outside of this study. One study author is a cofounder of SeizureTracker.com.
Source: Cook MJ et al. Lancet Neurol. 2018 Sep 12. doi: 10.1016/S1474-4422(18)30274-6.
Self-management intervention for epilepsy achieves health improvements
Self-management of epilepsy using a group-format, remote intervention improved mood, quality of life, and health functioning in high-risk individuals in a randomized, controlled trial.
In the 6-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related health event in the previous 6 months were randomized either to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely over 8-10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have ‘walked the walk’ in living with epilepsy,” Martha Sajatovic, MD, of Case Western Reserve University, Cleveland, and her coauthors wrote about their study published in Epilepsia.
Over the 6-month follow-up period, researchers found that individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group (P = .04).
When the authors looked at subcategories of negative health event counts – such as past 3-day seizure count or past 6‐month ED and hospitalization count – the differences were not significant. There was also no difference in seizure severity.
However, the study also showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and health functioning – both physical and mental – compared with controls. Intervention participants also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
The majority of participants (94.2%) said the intervention was useful and that it covered the most important issues for them. A total of 92.3% believed the benefits of the SMART intervention were worth the hassle of taking part.
“SMART’s strengths are its foundation based on participatory research methods and an evidence‐based intervention, its use of peer educators facilitating empowerment and training, multimode delivery using traditional group format and telehealth approaches to eliminate barriers to care, and efficacy even in people who have long‐standing epilepsy,” the authors wrote.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
The study was supported by the Centers for Disease Control and Prevention. Three authors declared research grants, consultancies, royalties, or speaking positions with the private sector.
SOURCE: Sajatovic M et al. Epilepsia. 2018 Aug 10. doi: 10.1111/epi.14527.
Self-management of epilepsy using a group-format, remote intervention improved mood, quality of life, and health functioning in high-risk individuals in a randomized, controlled trial.
In the 6-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related health event in the previous 6 months were randomized either to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely over 8-10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have ‘walked the walk’ in living with epilepsy,” Martha Sajatovic, MD, of Case Western Reserve University, Cleveland, and her coauthors wrote about their study published in Epilepsia.
Over the 6-month follow-up period, researchers found that individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group (P = .04).
When the authors looked at subcategories of negative health event counts – such as past 3-day seizure count or past 6‐month ED and hospitalization count – the differences were not significant. There was also no difference in seizure severity.
However, the study also showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and health functioning – both physical and mental – compared with controls. Intervention participants also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
The majority of participants (94.2%) said the intervention was useful and that it covered the most important issues for them. A total of 92.3% believed the benefits of the SMART intervention were worth the hassle of taking part.
“SMART’s strengths are its foundation based on participatory research methods and an evidence‐based intervention, its use of peer educators facilitating empowerment and training, multimode delivery using traditional group format and telehealth approaches to eliminate barriers to care, and efficacy even in people who have long‐standing epilepsy,” the authors wrote.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
The study was supported by the Centers for Disease Control and Prevention. Three authors declared research grants, consultancies, royalties, or speaking positions with the private sector.
SOURCE: Sajatovic M et al. Epilepsia. 2018 Aug 10. doi: 10.1111/epi.14527.
Self-management of epilepsy using a group-format, remote intervention improved mood, quality of life, and health functioning in high-risk individuals in a randomized, controlled trial.
In the 6-month trial, 120 individuals with epilepsy who had experienced at least one epilepsy-related health event in the previous 6 months were randomized either to a wait-list control group or a novel self‐management intervention.
The eight-session intervention, known as SMART, focused on modifiable factors that can be addressed with self-management, such as stress, substance abuse, routine, nutrition, and social support. It was delivered remotely over 8-10 weeks, either by telephone or online, after an initial in-person session.
“SMART combines the portability and low cost of a Web‐based intervention with the personally salient components of behavior modeling obtained by interacting with individuals who have ‘walked the walk’ in living with epilepsy,” Martha Sajatovic, MD, of Case Western Reserve University, Cleveland, and her coauthors wrote about their study published in Epilepsia.
Over the 6-month follow-up period, researchers found that individuals randomized to the intervention had a mean of 10.16 fewer negative health events, compared with a mean of 1.93 fewer events in the control group (P = .04).
When the authors looked at subcategories of negative health event counts – such as past 3-day seizure count or past 6‐month ED and hospitalization count – the differences were not significant. There was also no difference in seizure severity.
However, the study also showed significant improvements in participants’ self-rated depressive symptom severity, observer-rated depressive symptom severity, quality of life, and health functioning – both physical and mental – compared with controls. Intervention participants also reported significant improvements on the Epilepsy Self-Efficacy and Epilepsy Self-Management scales.
The majority of participants (94.2%) said the intervention was useful and that it covered the most important issues for them. A total of 92.3% believed the benefits of the SMART intervention were worth the hassle of taking part.
“SMART’s strengths are its foundation based on participatory research methods and an evidence‐based intervention, its use of peer educators facilitating empowerment and training, multimode delivery using traditional group format and telehealth approaches to eliminate barriers to care, and efficacy even in people who have long‐standing epilepsy,” the authors wrote.
“It is possible that SMART, which uses people with epilepsy as guides to help others learn to cope with the challenges of living with this common chronic neurologic condition, may help to alleviate some of the factors that prevent people with epilepsy from optimizing their quality of life.”
The study was supported by the Centers for Disease Control and Prevention. Three authors declared research grants, consultancies, royalties, or speaking positions with the private sector.
SOURCE: Sajatovic M et al. Epilepsia. 2018 Aug 10. doi: 10.1111/epi.14527.
FROM EPILEPSIA
Key clinical point:
Major finding: A remote, self-management intervention for epilepsy was associated with significantly fewer negative health events, compared with being in a wait-list control group.
Study details: A randomized, controlled trial in 120 individuals with epilepsy.
Disclosures: The study was supported by the Centers for Disease Control and Prevention. Three authors declared research grants, consultancies, royalties, or speaking positions with the private sector.
Source: Sajatovic M et al. Epilepsia. 2018 Aug 10. doi: 10.1111/epi.14527.
Epilepsy often accompanies congenital Zika infections
Epilepsy occurred in approximately two-thirds of infants with congenital Zika virus infection in a study of 141 children.
“When ZIKV [Zika virus] infection is acquired in utero, it may be associated with epilepsy, and we characterized aspects of this complication in a study performed at our referral center,” wrote Hélio van der Linden Jr., MD, of Dr. Henrique Santillo Rehabilitation and Readaptation Center in Goiânia, Brazil, and colleagues in a letter to the editor published in the New England Journal of Medicine.
The researchers reviewed data from 141 infants aged 1-14 months with a median age of 9 months and Zika virus infection confirmed by laboratory analysis; 55% were girls.
The prevalence of epilepsy was 67%, with a mean age at onset of 4.9 months. Based on data provided by parents, 74% of the children experienced seizures at 6 months of age or younger.
Overall, 77% of the infants experienced a single type of seizure. Epileptic spasms, the most common type, occurred in 72% of infants, followed by focal motor seizure (21%) and tonic seizures (4%).
All 95 epileptic infants were treated with antiepileptic medications and 62 (65%) achieved remission. Of those in remission, 24 (39%) received monotherapy and 38 (61%) received polytherapy. The drugs most associated with seizure control were vigabatrin, levetiracetam, valproate, and phenobarbital.
The prevalence of epilepsy in this study was higher than that seen in previous studies, and most patients had early-onset, drug-resistant epilepsy, the researchers noted. However, burst-suppression patterns and hypsarrhythmia on EEG predicted more severe disease and suggest that epilepsy might complicate cases of congenital Zika infection, they said.
The researchers had no financial conflicts to disclose.
SOURCE: van der Linden H et al. N Engl J Med. 2018 Aug 30. doi: 10.1056/NEJMc1716070.
Epilepsy occurred in approximately two-thirds of infants with congenital Zika virus infection in a study of 141 children.
“When ZIKV [Zika virus] infection is acquired in utero, it may be associated with epilepsy, and we characterized aspects of this complication in a study performed at our referral center,” wrote Hélio van der Linden Jr., MD, of Dr. Henrique Santillo Rehabilitation and Readaptation Center in Goiânia, Brazil, and colleagues in a letter to the editor published in the New England Journal of Medicine.
The researchers reviewed data from 141 infants aged 1-14 months with a median age of 9 months and Zika virus infection confirmed by laboratory analysis; 55% were girls.
The prevalence of epilepsy was 67%, with a mean age at onset of 4.9 months. Based on data provided by parents, 74% of the children experienced seizures at 6 months of age or younger.
Overall, 77% of the infants experienced a single type of seizure. Epileptic spasms, the most common type, occurred in 72% of infants, followed by focal motor seizure (21%) and tonic seizures (4%).
All 95 epileptic infants were treated with antiepileptic medications and 62 (65%) achieved remission. Of those in remission, 24 (39%) received monotherapy and 38 (61%) received polytherapy. The drugs most associated with seizure control were vigabatrin, levetiracetam, valproate, and phenobarbital.
The prevalence of epilepsy in this study was higher than that seen in previous studies, and most patients had early-onset, drug-resistant epilepsy, the researchers noted. However, burst-suppression patterns and hypsarrhythmia on EEG predicted more severe disease and suggest that epilepsy might complicate cases of congenital Zika infection, they said.
The researchers had no financial conflicts to disclose.
SOURCE: van der Linden H et al. N Engl J Med. 2018 Aug 30. doi: 10.1056/NEJMc1716070.
Epilepsy occurred in approximately two-thirds of infants with congenital Zika virus infection in a study of 141 children.
“When ZIKV [Zika virus] infection is acquired in utero, it may be associated with epilepsy, and we characterized aspects of this complication in a study performed at our referral center,” wrote Hélio van der Linden Jr., MD, of Dr. Henrique Santillo Rehabilitation and Readaptation Center in Goiânia, Brazil, and colleagues in a letter to the editor published in the New England Journal of Medicine.
The researchers reviewed data from 141 infants aged 1-14 months with a median age of 9 months and Zika virus infection confirmed by laboratory analysis; 55% were girls.
The prevalence of epilepsy was 67%, with a mean age at onset of 4.9 months. Based on data provided by parents, 74% of the children experienced seizures at 6 months of age or younger.
Overall, 77% of the infants experienced a single type of seizure. Epileptic spasms, the most common type, occurred in 72% of infants, followed by focal motor seizure (21%) and tonic seizures (4%).
All 95 epileptic infants were treated with antiepileptic medications and 62 (65%) achieved remission. Of those in remission, 24 (39%) received monotherapy and 38 (61%) received polytherapy. The drugs most associated with seizure control were vigabatrin, levetiracetam, valproate, and phenobarbital.
The prevalence of epilepsy in this study was higher than that seen in previous studies, and most patients had early-onset, drug-resistant epilepsy, the researchers noted. However, burst-suppression patterns and hypsarrhythmia on EEG predicted more severe disease and suggest that epilepsy might complicate cases of congenital Zika infection, they said.
The researchers had no financial conflicts to disclose.
SOURCE: van der Linden H et al. N Engl J Med. 2018 Aug 30. doi: 10.1056/NEJMc1716070.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Epilepsy occurred in 67% of 141 infants with congenital Zika infections.
Study details: The data come from 141 infants aged 1-14 months with congenital Zika infections.
Disclosures: The researchers had no financial conflicts to disclose.
Source: van der Linden H et al. N Engl J Med. 2018 Aug 30. doi: 10.1056/NEJMc1716070.
FDA approves Diacomit for Dravet syndrome
The Food and Drug Administration has approved stiripentol (Diacomit) for the treatment of Dravet syndrome in patients aged 2 years and older who are taking clobazam.
Dravet syndrome is a rare form of epilepsy that presents within the first year as febrile seizures and then with other types of seizure later in life. Status epilepticus, a potentially life-threatening medical emergency, is a known risk. Also, developmental and interpersonal difficulties have been associated with this syndrome.
Because there are no clinical data for using stiripentol as monotherapy, it is indicated for use only in conjunction with clobazam. The recommended dosage for stiripentol is 50 mg/kg per day divided into either two or three doses, although the maximum recommended daily dose is 3,000 mg. It is available as either capsules or powder for oral solution, both of which come in either 250-mg or 500-mg forms.
Adverse reactions include somnolence, decreased appetite and weight, neutropenia and thrombocytopenia, tremor, nausea, and suicidal behavior and ideation. Because of the risk of neutropenia and thrombocytopenia, blood counts should be obtained via hematologic testing before starting stiripentol and again every 6 months. Also, as with most antiepileptic drugs, there is a risk of withdrawal symptoms, such as risk of increased seizure frequency and status epilepticus; as such, patients should not discontinue stiripentol without first consulting their health care professional.
Full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved stiripentol (Diacomit) for the treatment of Dravet syndrome in patients aged 2 years and older who are taking clobazam.
Dravet syndrome is a rare form of epilepsy that presents within the first year as febrile seizures and then with other types of seizure later in life. Status epilepticus, a potentially life-threatening medical emergency, is a known risk. Also, developmental and interpersonal difficulties have been associated with this syndrome.
Because there are no clinical data for using stiripentol as monotherapy, it is indicated for use only in conjunction with clobazam. The recommended dosage for stiripentol is 50 mg/kg per day divided into either two or three doses, although the maximum recommended daily dose is 3,000 mg. It is available as either capsules or powder for oral solution, both of which come in either 250-mg or 500-mg forms.
Adverse reactions include somnolence, decreased appetite and weight, neutropenia and thrombocytopenia, tremor, nausea, and suicidal behavior and ideation. Because of the risk of neutropenia and thrombocytopenia, blood counts should be obtained via hematologic testing before starting stiripentol and again every 6 months. Also, as with most antiepileptic drugs, there is a risk of withdrawal symptoms, such as risk of increased seizure frequency and status epilepticus; as such, patients should not discontinue stiripentol without first consulting their health care professional.
Full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved stiripentol (Diacomit) for the treatment of Dravet syndrome in patients aged 2 years and older who are taking clobazam.
Dravet syndrome is a rare form of epilepsy that presents within the first year as febrile seizures and then with other types of seizure later in life. Status epilepticus, a potentially life-threatening medical emergency, is a known risk. Also, developmental and interpersonal difficulties have been associated with this syndrome.
Because there are no clinical data for using stiripentol as monotherapy, it is indicated for use only in conjunction with clobazam. The recommended dosage for stiripentol is 50 mg/kg per day divided into either two or three doses, although the maximum recommended daily dose is 3,000 mg. It is available as either capsules or powder for oral solution, both of which come in either 250-mg or 500-mg forms.
Adverse reactions include somnolence, decreased appetite and weight, neutropenia and thrombocytopenia, tremor, nausea, and suicidal behavior and ideation. Because of the risk of neutropenia and thrombocytopenia, blood counts should be obtained via hematologic testing before starting stiripentol and again every 6 months. Also, as with most antiepileptic drugs, there is a risk of withdrawal symptoms, such as risk of increased seizure frequency and status epilepticus; as such, patients should not discontinue stiripentol without first consulting their health care professional.
Full prescribing information can be found on the FDA website.
SMART Self-Management Program Enhances Epilepsy Care
A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.
- A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
- The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
- The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
- Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
- SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.
A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.
- A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
- The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
- The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
- Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
- SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.
A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.
- A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
- The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
- The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
- Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
- SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.
Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.
Don’t Ignore Sleep Complaints in PNES Patients
Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.
- 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
- By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
- The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.
Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.
Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.
- 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
- By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
- The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.
Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.
Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.
- 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
- By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
- The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.
Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.
Analysis of Epilepsy Self-Management Skills
Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.
- Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
- The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
- Self-management behavioral skills were stronger in females and among patients with less education.
- The same skills were weaker in patients with depression and in those who reported a lower quality of life.
Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.
Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.
- Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
- The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
- Self-management behavioral skills were stronger in females and among patients with less education.
- The same skills were weaker in patients with depression and in those who reported a lower quality of life.
Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.
Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.
- Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
- The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
- Self-management behavioral skills were stronger in females and among patients with less education.
- The same skills were weaker in patients with depression and in those who reported a lower quality of life.
Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.