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Obesity plays role in sleep-disordered breathing in pregnancy
The relationship between hypertension during pregnancy and sleep-disordered breathing may be partly mediated by obesity, new research suggests.
An article published in the Journal of Sleep Research details the results of a case-control study in 80 pregnant women – 40 normotensive and 40 with either gestational hypertension or preeclampsia – who were matched on body mass index.
Nearly half of the women in the study (45%) met the criteria for sleep-disordered breathing – defined as a respiratory disturbance index of 5 or above. The incidence was higher among women with hypertension (53%) than among women in the normotensive control group (38%), but the difference was not statistically significant.
There were also no significant differences in median respiratory disturbance index or apnea-hypopnea index between the hypertension and control groups.
However, the incidence of more severe sleep-disordered breathing – a respiratory disturbance index of at least 10 – was significantly greater in the hypertensive group (35% vs. 14%; P = .04). The women with pregnancy-related hypertension also had significantly higher respiratory disturbance index during non–rapid eye movement sleep and when they were sleeping on their back.
The severity of hypertensive disease did not affect the prevalence of sleep-disordered breathing.
Danielle L. Wilson of the Institute for Breathing and Sleep at Austin Health in Melbourne and her coauthors wrote that, while previous research has pointed to a link between hypertension in pregnancy and sleep-disordered breathing, this is the first study to explore the potential confounding role of obesity.
“We found SDB [sleep-disordered breathing] to be more common in our control group than in previous studies, confirming that BMI is an important covariate that requires evaluation in future studies exploring the relationship between SDB and HDP [hypertension during pregnancy],” they reported. “SDB may be a mechanism by which obesity and adverse perinatal outcomes are linked, but given the important contribution of obesity to both SDB and HDP, failing to adjust for this covariate will overestimate the strength of association between SDB and HDP.”
However, they acknowledged there was a significant association between moderate to severe sleep-disordered breathing and hypertension in pregnancy. They suggested this might be a means to increase women’s uptake of clinical review with a sleep physician, which was very low in the study despite it being offered to all women.
“Better engagement may be more likely for women with more severe disease if stronger links with adverse pregnancy outcome are demonstrated,” they wrote.
The study was supported by the Austin Medical Research Foundation and the Medical Research Foundation for Women and Babies. One author declared a scholarship from a research funding body, and two declared unrelated research support from private industry. No other conflicts of interest were declared.
SOURCE: Wilson D et al. J Sleep Research. 2018 Oct;27(5):e12656.
The relationship between hypertension during pregnancy and sleep-disordered breathing may be partly mediated by obesity, new research suggests.
An article published in the Journal of Sleep Research details the results of a case-control study in 80 pregnant women – 40 normotensive and 40 with either gestational hypertension or preeclampsia – who were matched on body mass index.
Nearly half of the women in the study (45%) met the criteria for sleep-disordered breathing – defined as a respiratory disturbance index of 5 or above. The incidence was higher among women with hypertension (53%) than among women in the normotensive control group (38%), but the difference was not statistically significant.
There were also no significant differences in median respiratory disturbance index or apnea-hypopnea index between the hypertension and control groups.
However, the incidence of more severe sleep-disordered breathing – a respiratory disturbance index of at least 10 – was significantly greater in the hypertensive group (35% vs. 14%; P = .04). The women with pregnancy-related hypertension also had significantly higher respiratory disturbance index during non–rapid eye movement sleep and when they were sleeping on their back.
The severity of hypertensive disease did not affect the prevalence of sleep-disordered breathing.
Danielle L. Wilson of the Institute for Breathing and Sleep at Austin Health in Melbourne and her coauthors wrote that, while previous research has pointed to a link between hypertension in pregnancy and sleep-disordered breathing, this is the first study to explore the potential confounding role of obesity.
“We found SDB [sleep-disordered breathing] to be more common in our control group than in previous studies, confirming that BMI is an important covariate that requires evaluation in future studies exploring the relationship between SDB and HDP [hypertension during pregnancy],” they reported. “SDB may be a mechanism by which obesity and adverse perinatal outcomes are linked, but given the important contribution of obesity to both SDB and HDP, failing to adjust for this covariate will overestimate the strength of association between SDB and HDP.”
However, they acknowledged there was a significant association between moderate to severe sleep-disordered breathing and hypertension in pregnancy. They suggested this might be a means to increase women’s uptake of clinical review with a sleep physician, which was very low in the study despite it being offered to all women.
“Better engagement may be more likely for women with more severe disease if stronger links with adverse pregnancy outcome are demonstrated,” they wrote.
The study was supported by the Austin Medical Research Foundation and the Medical Research Foundation for Women and Babies. One author declared a scholarship from a research funding body, and two declared unrelated research support from private industry. No other conflicts of interest were declared.
SOURCE: Wilson D et al. J Sleep Research. 2018 Oct;27(5):e12656.
The relationship between hypertension during pregnancy and sleep-disordered breathing may be partly mediated by obesity, new research suggests.
An article published in the Journal of Sleep Research details the results of a case-control study in 80 pregnant women – 40 normotensive and 40 with either gestational hypertension or preeclampsia – who were matched on body mass index.
Nearly half of the women in the study (45%) met the criteria for sleep-disordered breathing – defined as a respiratory disturbance index of 5 or above. The incidence was higher among women with hypertension (53%) than among women in the normotensive control group (38%), but the difference was not statistically significant.
There were also no significant differences in median respiratory disturbance index or apnea-hypopnea index between the hypertension and control groups.
However, the incidence of more severe sleep-disordered breathing – a respiratory disturbance index of at least 10 – was significantly greater in the hypertensive group (35% vs. 14%; P = .04). The women with pregnancy-related hypertension also had significantly higher respiratory disturbance index during non–rapid eye movement sleep and when they were sleeping on their back.
The severity of hypertensive disease did not affect the prevalence of sleep-disordered breathing.
Danielle L. Wilson of the Institute for Breathing and Sleep at Austin Health in Melbourne and her coauthors wrote that, while previous research has pointed to a link between hypertension in pregnancy and sleep-disordered breathing, this is the first study to explore the potential confounding role of obesity.
“We found SDB [sleep-disordered breathing] to be more common in our control group than in previous studies, confirming that BMI is an important covariate that requires evaluation in future studies exploring the relationship between SDB and HDP [hypertension during pregnancy],” they reported. “SDB may be a mechanism by which obesity and adverse perinatal outcomes are linked, but given the important contribution of obesity to both SDB and HDP, failing to adjust for this covariate will overestimate the strength of association between SDB and HDP.”
However, they acknowledged there was a significant association between moderate to severe sleep-disordered breathing and hypertension in pregnancy. They suggested this might be a means to increase women’s uptake of clinical review with a sleep physician, which was very low in the study despite it being offered to all women.
“Better engagement may be more likely for women with more severe disease if stronger links with adverse pregnancy outcome are demonstrated,” they wrote.
The study was supported by the Austin Medical Research Foundation and the Medical Research Foundation for Women and Babies. One author declared a scholarship from a research funding body, and two declared unrelated research support from private industry. No other conflicts of interest were declared.
SOURCE: Wilson D et al. J Sleep Research. 2018 Oct;27(5):e12656.
FROM JOURNAL OF SLEEP RESEARCH
Key clinical point:
Major finding: The relationship between hypertension in pregnancy and sleep-disordered breathing is only significant for more severe sleep-disordered breathing.
Study details: Prospective case-control study in 80 pregnant women.
Disclosures: The study was supported by the Austin Medical Research Foundation and the Medical Research Foundation for Women and Babies. One author declared a scholarship from a research funding body, and two declared unrelated research support from private industry. No other conflicts of interest were declared.
Source: Wilson D et al. J Sleep Research. 2018 Oct;27(5):e12656.
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
Two red flags spell trouble ahead in spontaneous coronary artery dissection
MUNICH –
Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.
CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.
SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.
CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.
In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.
Of note, one-third of patients had no cardiovascular risk factors.
The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.
Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.
The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.
Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.
“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.
Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”
“Are you doing that in your practice?” asked Dr. Serruys.
“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”
Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.
“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.
MUNICH –
Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.
CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.
SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.
CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.
In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.
Of note, one-third of patients had no cardiovascular risk factors.
The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.
Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.
The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.
Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.
“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.
Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”
“Are you doing that in your practice?” asked Dr. Serruys.
“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”
Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.
“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.
MUNICH –
Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.
CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.
SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.
CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.
In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.
Of note, one-third of patients had no cardiovascular risk factors.
The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.
Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.
The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.
Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.
“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.
Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”
“Are you doing that in your practice?” asked Dr. Serruys.
“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”
Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.
“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: SCAD occurring during the peripartum period or in patients with connective tissue disease identifies subgroups at high risk for major adverse cardiovascular events within 30 days.
Major finding: Patients with spontaneous coronary artery dissection and comorbid connective tissue disease were at 8.7-fold increased risk of major adverse cardiovascular events within 30 days.
Study details: CanSCAD is an ongoing, prospective, multicenter, observational study in 750 patients with confirmed spontaneous coronary artery dissection.
Disclosures: CanSCAD is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier.
One-step gestational diabetes screening doesn’t improve outcomes
according to data from a before-and-after cohort study of women in the state of Washington.
The one-step test, a 75-g 2-hour oral glucose tolerance test (OGTT), was recommended for all pregnant women in 2010, although the traditional two-step test – a 50-g screening glucose challenge test followed by a 100-g 3-hour OGTT – remains widely used, wrote Gaia Pocobelli, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues. “No randomized trial has been published comparing outcomes of the two approaches.”
In a study published in Obstetrics & Gynecology, the researchers compared data from 23,257 women who received prenatal care in Washington State between January 2009 and December 2014, including 8,363 women who received care before the guideline change, 4,103 who received care during a transition period, and 10,791 after the guideline change. Approximately 60% of the women received care from clinicians internal to Kaiser Permanente; 40% received care from external providers. Most (87%) of the internal clinicians switched to the one-step approach, the researchers said. Only 5% of external providers did so.
Overall, adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes, the researchers noted.
The incidence of GDM increased from 7% before the guideline change to 11% afterward for women seen by internal providers. For women seen by external providers, gestational diabetes incidence increased from 10% to 11%.
For women seen by internal providers, the use of insulin increased from 1% before the guideline change to 4% afterward; for women seen by external providers, use of insulin increased from 1.3% to 1.4% (change between the groups P less than .001).
In addition, women seen by internal providers were more likely to undergo induction of labor after the guideline change (25% to 29%), while labor induction decreased for women seen by external providers (31% to 29%) for a relative risk of 1.2.
Neonatal hypoglycemia increased from 1% to 2% among women seen by internal providers, but decreased slightly from 2.4% to 2.1% for women seen by external providers, for a relative risk of 1.77.
There were no significant differences between the women seen by internal and external providers in risk of primary cesarean section, large for gestational age, small for gestational age, or neonatal ICU admission.
The main limitation of the study was the potential confounding variables including maternal diet and exercise, and possible underreporting of risk factors such as smoking, the researchers noted. However, the results were strengthened by the large study population, and the results “do not suggest a benefit of adopting the one-step over the two-step approach.
“Kaiser Permanente Washington has revised [its] guidelines to return to a two-step process. We recommend that any health care system considering switching to the one-step approach incorporate a rigorous evaluation of changes in maternal and neonatal outcomes,” Dr. Pocobelli and her associates added.
Dr. Pocobelli disclosed funding from Jazz Pharmaceuticals for work unrelated to this study. The study was supported in part by a grant from the Group Health Foundation Momentum Fund.
Diabetes is a significant global public health concern, but is especially problematic for women of reproductive age because diabetes in pregnancy can cause significant health complications for the mother and baby. Gestational diabetes mellitus (GDM) affects up to 10% of pregnancies in the United States annually, and is associated with perinatal loss, operative delivery, macrosomia, hypoglycemia, respiratory distress syndrome, and metabolic derangements for the offspring. For the mother, GDM is associated with hypertensive disorders, infections, hydramnios, and increased risk for developing type 2 diabetes later in life. As the incidence of GDM continues to rise, studies examining how to reduce, manage or prevent this condition become increasingly important.
The authors’ conclusions, that adopting the one-step approach increased the number of women with diagnosed GDM but did not significantly improve maternal or neonatal outcomes, are not surprising. Since the initial publication of the Hyperglycemia and Adverse Pregnancy Outcome Study, upon which the International Association of the Diabetes in Pregnancy Study Groups based its recommendations to go to a one-step approach, much debate has ensued about the best method to diagnose GDM. Indeed, the National Institutes of Health convened a consensus panel to review the literature and determine whether the one-step approach should be universally adopted (the panel concluded that more information was needed, and that the current two-step approach should continue to be used).
As the authors concede, studies have shown conflicting results, and no large-scale randomized controlled trial has been conducted to date. However, the literature does not bear out the idea that the one-step approach is truly better. The current study, although including a significant number of women and a reasonable control group, only serves as yet another study to reinforce what has previously been published.
I would agree with the researchers’ conclusions that the one-step approach is not necessarily beneficial. Although the one-step approach may identify a subset of patients who might not otherwise be diagnosed with GDM, it still remains unclear whether the outcomes for these patients will be improved. Furthermore, additional testing, need for insulin or other oral antidiabetic medications, etc., would result in additional stress to the patient and the health care system. Based on the authors’ findings, and results of other studies, it remains to be determined if the effort (diagnosing additional patients with GDM) is justified medically, economically, or otherwise.
As ob.gyns., we must continually ask ourselves: “By not doing something, are we causing harm to our patients?” If we change the diagnostic criteria for GDM, thereby increasing the number of women with the condition who would then require additional care, medications, and, potentially, more complex decisions around timing and mode of delivery, we need to be certain that we are not doing harm. This, and other studies examining the use of the one- versus two-step approach have yet to demonstrate, unequivocally, that changing the criteria reduces harm, and, perhaps, might – unintentionally – cause more.
As the study authors and the NIH consensus panel concluded, more rigorous evaluation is needed; that is, a large, multicenter randomized controlled trial that examines not only the benefits during pregnancy but also the long-term benefits to women and their children.
E. Albert Reece, MD, PhD, MBA, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He provided commentary on the study by Pocobelli et al. Dr. Reece said he had no relevant financial disclosures.
Diabetes is a significant global public health concern, but is especially problematic for women of reproductive age because diabetes in pregnancy can cause significant health complications for the mother and baby. Gestational diabetes mellitus (GDM) affects up to 10% of pregnancies in the United States annually, and is associated with perinatal loss, operative delivery, macrosomia, hypoglycemia, respiratory distress syndrome, and metabolic derangements for the offspring. For the mother, GDM is associated with hypertensive disorders, infections, hydramnios, and increased risk for developing type 2 diabetes later in life. As the incidence of GDM continues to rise, studies examining how to reduce, manage or prevent this condition become increasingly important.
The authors’ conclusions, that adopting the one-step approach increased the number of women with diagnosed GDM but did not significantly improve maternal or neonatal outcomes, are not surprising. Since the initial publication of the Hyperglycemia and Adverse Pregnancy Outcome Study, upon which the International Association of the Diabetes in Pregnancy Study Groups based its recommendations to go to a one-step approach, much debate has ensued about the best method to diagnose GDM. Indeed, the National Institutes of Health convened a consensus panel to review the literature and determine whether the one-step approach should be universally adopted (the panel concluded that more information was needed, and that the current two-step approach should continue to be used).
As the authors concede, studies have shown conflicting results, and no large-scale randomized controlled trial has been conducted to date. However, the literature does not bear out the idea that the one-step approach is truly better. The current study, although including a significant number of women and a reasonable control group, only serves as yet another study to reinforce what has previously been published.
I would agree with the researchers’ conclusions that the one-step approach is not necessarily beneficial. Although the one-step approach may identify a subset of patients who might not otherwise be diagnosed with GDM, it still remains unclear whether the outcomes for these patients will be improved. Furthermore, additional testing, need for insulin or other oral antidiabetic medications, etc., would result in additional stress to the patient and the health care system. Based on the authors’ findings, and results of other studies, it remains to be determined if the effort (diagnosing additional patients with GDM) is justified medically, economically, or otherwise.
As ob.gyns., we must continually ask ourselves: “By not doing something, are we causing harm to our patients?” If we change the diagnostic criteria for GDM, thereby increasing the number of women with the condition who would then require additional care, medications, and, potentially, more complex decisions around timing and mode of delivery, we need to be certain that we are not doing harm. This, and other studies examining the use of the one- versus two-step approach have yet to demonstrate, unequivocally, that changing the criteria reduces harm, and, perhaps, might – unintentionally – cause more.
As the study authors and the NIH consensus panel concluded, more rigorous evaluation is needed; that is, a large, multicenter randomized controlled trial that examines not only the benefits during pregnancy but also the long-term benefits to women and their children.
E. Albert Reece, MD, PhD, MBA, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He provided commentary on the study by Pocobelli et al. Dr. Reece said he had no relevant financial disclosures.
Diabetes is a significant global public health concern, but is especially problematic for women of reproductive age because diabetes in pregnancy can cause significant health complications for the mother and baby. Gestational diabetes mellitus (GDM) affects up to 10% of pregnancies in the United States annually, and is associated with perinatal loss, operative delivery, macrosomia, hypoglycemia, respiratory distress syndrome, and metabolic derangements for the offspring. For the mother, GDM is associated with hypertensive disorders, infections, hydramnios, and increased risk for developing type 2 diabetes later in life. As the incidence of GDM continues to rise, studies examining how to reduce, manage or prevent this condition become increasingly important.
The authors’ conclusions, that adopting the one-step approach increased the number of women with diagnosed GDM but did not significantly improve maternal or neonatal outcomes, are not surprising. Since the initial publication of the Hyperglycemia and Adverse Pregnancy Outcome Study, upon which the International Association of the Diabetes in Pregnancy Study Groups based its recommendations to go to a one-step approach, much debate has ensued about the best method to diagnose GDM. Indeed, the National Institutes of Health convened a consensus panel to review the literature and determine whether the one-step approach should be universally adopted (the panel concluded that more information was needed, and that the current two-step approach should continue to be used).
As the authors concede, studies have shown conflicting results, and no large-scale randomized controlled trial has been conducted to date. However, the literature does not bear out the idea that the one-step approach is truly better. The current study, although including a significant number of women and a reasonable control group, only serves as yet another study to reinforce what has previously been published.
I would agree with the researchers’ conclusions that the one-step approach is not necessarily beneficial. Although the one-step approach may identify a subset of patients who might not otherwise be diagnosed with GDM, it still remains unclear whether the outcomes for these patients will be improved. Furthermore, additional testing, need for insulin or other oral antidiabetic medications, etc., would result in additional stress to the patient and the health care system. Based on the authors’ findings, and results of other studies, it remains to be determined if the effort (diagnosing additional patients with GDM) is justified medically, economically, or otherwise.
As ob.gyns., we must continually ask ourselves: “By not doing something, are we causing harm to our patients?” If we change the diagnostic criteria for GDM, thereby increasing the number of women with the condition who would then require additional care, medications, and, potentially, more complex decisions around timing and mode of delivery, we need to be certain that we are not doing harm. This, and other studies examining the use of the one- versus two-step approach have yet to demonstrate, unequivocally, that changing the criteria reduces harm, and, perhaps, might – unintentionally – cause more.
As the study authors and the NIH consensus panel concluded, more rigorous evaluation is needed; that is, a large, multicenter randomized controlled trial that examines not only the benefits during pregnancy but also the long-term benefits to women and their children.
E. Albert Reece, MD, PhD, MBA, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He provided commentary on the study by Pocobelli et al. Dr. Reece said he had no relevant financial disclosures.
according to data from a before-and-after cohort study of women in the state of Washington.
The one-step test, a 75-g 2-hour oral glucose tolerance test (OGTT), was recommended for all pregnant women in 2010, although the traditional two-step test – a 50-g screening glucose challenge test followed by a 100-g 3-hour OGTT – remains widely used, wrote Gaia Pocobelli, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues. “No randomized trial has been published comparing outcomes of the two approaches.”
In a study published in Obstetrics & Gynecology, the researchers compared data from 23,257 women who received prenatal care in Washington State between January 2009 and December 2014, including 8,363 women who received care before the guideline change, 4,103 who received care during a transition period, and 10,791 after the guideline change. Approximately 60% of the women received care from clinicians internal to Kaiser Permanente; 40% received care from external providers. Most (87%) of the internal clinicians switched to the one-step approach, the researchers said. Only 5% of external providers did so.
Overall, adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes, the researchers noted.
The incidence of GDM increased from 7% before the guideline change to 11% afterward for women seen by internal providers. For women seen by external providers, gestational diabetes incidence increased from 10% to 11%.
For women seen by internal providers, the use of insulin increased from 1% before the guideline change to 4% afterward; for women seen by external providers, use of insulin increased from 1.3% to 1.4% (change between the groups P less than .001).
In addition, women seen by internal providers were more likely to undergo induction of labor after the guideline change (25% to 29%), while labor induction decreased for women seen by external providers (31% to 29%) for a relative risk of 1.2.
Neonatal hypoglycemia increased from 1% to 2% among women seen by internal providers, but decreased slightly from 2.4% to 2.1% for women seen by external providers, for a relative risk of 1.77.
There were no significant differences between the women seen by internal and external providers in risk of primary cesarean section, large for gestational age, small for gestational age, or neonatal ICU admission.
The main limitation of the study was the potential confounding variables including maternal diet and exercise, and possible underreporting of risk factors such as smoking, the researchers noted. However, the results were strengthened by the large study population, and the results “do not suggest a benefit of adopting the one-step over the two-step approach.
“Kaiser Permanente Washington has revised [its] guidelines to return to a two-step process. We recommend that any health care system considering switching to the one-step approach incorporate a rigorous evaluation of changes in maternal and neonatal outcomes,” Dr. Pocobelli and her associates added.
Dr. Pocobelli disclosed funding from Jazz Pharmaceuticals for work unrelated to this study. The study was supported in part by a grant from the Group Health Foundation Momentum Fund.
according to data from a before-and-after cohort study of women in the state of Washington.
The one-step test, a 75-g 2-hour oral glucose tolerance test (OGTT), was recommended for all pregnant women in 2010, although the traditional two-step test – a 50-g screening glucose challenge test followed by a 100-g 3-hour OGTT – remains widely used, wrote Gaia Pocobelli, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues. “No randomized trial has been published comparing outcomes of the two approaches.”
In a study published in Obstetrics & Gynecology, the researchers compared data from 23,257 women who received prenatal care in Washington State between January 2009 and December 2014, including 8,363 women who received care before the guideline change, 4,103 who received care during a transition period, and 10,791 after the guideline change. Approximately 60% of the women received care from clinicians internal to Kaiser Permanente; 40% received care from external providers. Most (87%) of the internal clinicians switched to the one-step approach, the researchers said. Only 5% of external providers did so.
Overall, adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes, the researchers noted.
The incidence of GDM increased from 7% before the guideline change to 11% afterward for women seen by internal providers. For women seen by external providers, gestational diabetes incidence increased from 10% to 11%.
For women seen by internal providers, the use of insulin increased from 1% before the guideline change to 4% afterward; for women seen by external providers, use of insulin increased from 1.3% to 1.4% (change between the groups P less than .001).
In addition, women seen by internal providers were more likely to undergo induction of labor after the guideline change (25% to 29%), while labor induction decreased for women seen by external providers (31% to 29%) for a relative risk of 1.2.
Neonatal hypoglycemia increased from 1% to 2% among women seen by internal providers, but decreased slightly from 2.4% to 2.1% for women seen by external providers, for a relative risk of 1.77.
There were no significant differences between the women seen by internal and external providers in risk of primary cesarean section, large for gestational age, small for gestational age, or neonatal ICU admission.
The main limitation of the study was the potential confounding variables including maternal diet and exercise, and possible underreporting of risk factors such as smoking, the researchers noted. However, the results were strengthened by the large study population, and the results “do not suggest a benefit of adopting the one-step over the two-step approach.
“Kaiser Permanente Washington has revised [its] guidelines to return to a two-step process. We recommend that any health care system considering switching to the one-step approach incorporate a rigorous evaluation of changes in maternal and neonatal outcomes,” Dr. Pocobelli and her associates added.
Dr. Pocobelli disclosed funding from Jazz Pharmaceuticals for work unrelated to this study. The study was supported in part by a grant from the Group Health Foundation Momentum Fund.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Increased diagnoses of gestational diabetes did not significantly improve maternal or fetal outcomes.
Major finding: Adoption of a one-step screening process for gestational diabetes increased diagnoses by 41%.
Study details: The data come from a before-and-after cohort study with a population of 23,257 women.
Disclosures: Dr. Pocobelli disclosed funding from Jazz Pharmaceuticals for work unrelated to this study. The study was supported in part by a grant from the Group Health Foundation Momentum Fund.
Source: Pocobelli G et al. Obstet Gynecol. 2018;132:859-67.
Half as many people are trying heroin, but marijuana use grows
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Children with BCP-ALL show inflammatory marker differences at birth
Patients who develop B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in childhood may have dysregulated immune function at birth, according to a study published in Cancer Research.
Investigators evaluated neonatal concentrations of inflammatory markers and found significant differences between children who were later diagnosed with BCP-ALL and leukemia-free control subjects.
“Our findings suggest that children who develop ALL are immunologically disparate already at birth,” said study author Signe Holst Søegaard, PhD, of Statens Serum Institut in Copenhagen. “This may link to other observations suggesting that children who develop ALL respond differently to infections in early childhood, potentially promoting subsequent genetic events required for transformation to ALL, or speculations that they are unable to eliminate preleukemic cells.”
She noted that the study could not determine if the associations shown are causal or consequential so further studies will be needed both to confirm the findings and identify the underlying mechanisms.
For this study, Dr. Søegaard and her colleagues measured concentrations of 10 inflammatory markers on neonatal dried blood spots from 178 patients with BCP-ALL and 178 matched controls. The patients were diagnosed with BCP-ALL at ages 1-9 years.
Compared with controls, children who later developed BCP-ALL had significantly different neonatal concentrations of eight inflammatory markers.
Concentrations of interleukin (IL)–8, soluble receptor sIL-6R alpha, transforming growth factor (TGF)–beta 1, monocyte chemotactic protein (MCP)–1, and C-reactive protein (CRP) were significantly lower among the BCP-ALL patients.
On the other hand, concentrations of IL-6, IL-17, and IL-18 were significantly higher among BCP-ALL patients than controls.
The investigators noted that IL-10 concentrations were too low for accurate measurement in all patients and controls. Additionally, a “large proportion” of patients and controls had IL-6 and IL-17 concentrations that were below the limit of detection.
“We also demonstrated that several previously shown ALL risk factors – namely, birth order, gestational age, and sex – were associated with the neonatal concentrations of inflammatory markers,” Dr. Søegaard said. “These findings raise the interesting possibility that the effects of some known ALL risk factors partly act through prenatal programming of immune function.”
The investigators found that increasing birth order was associated with significantly higher IL-18 and lower CRP concentrations.
Increasing gestational age was associated with significantly lower sIL-6R alpha and TGF-beta 1 concentrations and higher CRP concentrations. And boys had significantly lower sIL-6R alpha and IL-8 concentrations and higher CRP concentrations than girls.
However, none of the following factors were significantly associated with concentrations of inflammatory biomarkers: maternal age at delivery, maternal hospital contact attributable to infection during pregnancy, maternal prescription for antimicrobials during pregnancy, birth weight, and mode of delivery.
“Our findings underline the role the child’s baseline immune characteristics may play in the development of ALL,” Dr. Søegaard said. “However, we cannot yet use our research results to predict who will develop childhood ALL.”
The study was sponsored by the Dagmar Marshall Foundation, the A.P. Møller Foundation, the Danish Childhood Cancer Foundation, the Arvid Nilsson Foundation, and the Danish Cancer Research Foundation. The investigators reported having no conflicts of interest.
SOURCE: Søegaard SH et al. Cancer Res. 2018;78(18);5458-63.
Patients who develop B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in childhood may have dysregulated immune function at birth, according to a study published in Cancer Research.
Investigators evaluated neonatal concentrations of inflammatory markers and found significant differences between children who were later diagnosed with BCP-ALL and leukemia-free control subjects.
“Our findings suggest that children who develop ALL are immunologically disparate already at birth,” said study author Signe Holst Søegaard, PhD, of Statens Serum Institut in Copenhagen. “This may link to other observations suggesting that children who develop ALL respond differently to infections in early childhood, potentially promoting subsequent genetic events required for transformation to ALL, or speculations that they are unable to eliminate preleukemic cells.”
She noted that the study could not determine if the associations shown are causal or consequential so further studies will be needed both to confirm the findings and identify the underlying mechanisms.
For this study, Dr. Søegaard and her colleagues measured concentrations of 10 inflammatory markers on neonatal dried blood spots from 178 patients with BCP-ALL and 178 matched controls. The patients were diagnosed with BCP-ALL at ages 1-9 years.
Compared with controls, children who later developed BCP-ALL had significantly different neonatal concentrations of eight inflammatory markers.
Concentrations of interleukin (IL)–8, soluble receptor sIL-6R alpha, transforming growth factor (TGF)–beta 1, monocyte chemotactic protein (MCP)–1, and C-reactive protein (CRP) were significantly lower among the BCP-ALL patients.
On the other hand, concentrations of IL-6, IL-17, and IL-18 were significantly higher among BCP-ALL patients than controls.
The investigators noted that IL-10 concentrations were too low for accurate measurement in all patients and controls. Additionally, a “large proportion” of patients and controls had IL-6 and IL-17 concentrations that were below the limit of detection.
“We also demonstrated that several previously shown ALL risk factors – namely, birth order, gestational age, and sex – were associated with the neonatal concentrations of inflammatory markers,” Dr. Søegaard said. “These findings raise the interesting possibility that the effects of some known ALL risk factors partly act through prenatal programming of immune function.”
The investigators found that increasing birth order was associated with significantly higher IL-18 and lower CRP concentrations.
Increasing gestational age was associated with significantly lower sIL-6R alpha and TGF-beta 1 concentrations and higher CRP concentrations. And boys had significantly lower sIL-6R alpha and IL-8 concentrations and higher CRP concentrations than girls.
However, none of the following factors were significantly associated with concentrations of inflammatory biomarkers: maternal age at delivery, maternal hospital contact attributable to infection during pregnancy, maternal prescription for antimicrobials during pregnancy, birth weight, and mode of delivery.
“Our findings underline the role the child’s baseline immune characteristics may play in the development of ALL,” Dr. Søegaard said. “However, we cannot yet use our research results to predict who will develop childhood ALL.”
The study was sponsored by the Dagmar Marshall Foundation, the A.P. Møller Foundation, the Danish Childhood Cancer Foundation, the Arvid Nilsson Foundation, and the Danish Cancer Research Foundation. The investigators reported having no conflicts of interest.
SOURCE: Søegaard SH et al. Cancer Res. 2018;78(18);5458-63.
Patients who develop B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in childhood may have dysregulated immune function at birth, according to a study published in Cancer Research.
Investigators evaluated neonatal concentrations of inflammatory markers and found significant differences between children who were later diagnosed with BCP-ALL and leukemia-free control subjects.
“Our findings suggest that children who develop ALL are immunologically disparate already at birth,” said study author Signe Holst Søegaard, PhD, of Statens Serum Institut in Copenhagen. “This may link to other observations suggesting that children who develop ALL respond differently to infections in early childhood, potentially promoting subsequent genetic events required for transformation to ALL, or speculations that they are unable to eliminate preleukemic cells.”
She noted that the study could not determine if the associations shown are causal or consequential so further studies will be needed both to confirm the findings and identify the underlying mechanisms.
For this study, Dr. Søegaard and her colleagues measured concentrations of 10 inflammatory markers on neonatal dried blood spots from 178 patients with BCP-ALL and 178 matched controls. The patients were diagnosed with BCP-ALL at ages 1-9 years.
Compared with controls, children who later developed BCP-ALL had significantly different neonatal concentrations of eight inflammatory markers.
Concentrations of interleukin (IL)–8, soluble receptor sIL-6R alpha, transforming growth factor (TGF)–beta 1, monocyte chemotactic protein (MCP)–1, and C-reactive protein (CRP) were significantly lower among the BCP-ALL patients.
On the other hand, concentrations of IL-6, IL-17, and IL-18 were significantly higher among BCP-ALL patients than controls.
The investigators noted that IL-10 concentrations were too low for accurate measurement in all patients and controls. Additionally, a “large proportion” of patients and controls had IL-6 and IL-17 concentrations that were below the limit of detection.
“We also demonstrated that several previously shown ALL risk factors – namely, birth order, gestational age, and sex – were associated with the neonatal concentrations of inflammatory markers,” Dr. Søegaard said. “These findings raise the interesting possibility that the effects of some known ALL risk factors partly act through prenatal programming of immune function.”
The investigators found that increasing birth order was associated with significantly higher IL-18 and lower CRP concentrations.
Increasing gestational age was associated with significantly lower sIL-6R alpha and TGF-beta 1 concentrations and higher CRP concentrations. And boys had significantly lower sIL-6R alpha and IL-8 concentrations and higher CRP concentrations than girls.
However, none of the following factors were significantly associated with concentrations of inflammatory biomarkers: maternal age at delivery, maternal hospital contact attributable to infection during pregnancy, maternal prescription for antimicrobials during pregnancy, birth weight, and mode of delivery.
“Our findings underline the role the child’s baseline immune characteristics may play in the development of ALL,” Dr. Søegaard said. “However, we cannot yet use our research results to predict who will develop childhood ALL.”
The study was sponsored by the Dagmar Marshall Foundation, the A.P. Møller Foundation, the Danish Childhood Cancer Foundation, the Arvid Nilsson Foundation, and the Danish Cancer Research Foundation. The investigators reported having no conflicts of interest.
SOURCE: Søegaard SH et al. Cancer Res. 2018;78(18);5458-63.
FROM CANCER RESEARCH
Key clinical point:
Major finding: Neonatal concentrations of some inflammatory markers were significantly different between BCP-ALL patients and controls.
Study details: Ten markers were measured in 178 patients with BCP-ALL and 178 matched controls.
Disclosures: The study was sponsored by the Dagmar Marshall Foundation, the A.P. Møller Foundation, the Danish Childhood Cancer Foundation, the Arvid Nilsson Foundation, and the Danish Cancer Research Foundation. The investigators reported having no conflicts of interest.
Source: Søegaard SH et al. Cancer Res. 2018;78(18);5458-63.
Severe maternal morbidity climbs; racial disparities persist
The rate of severe maternal morbidity in the United States has climbed steadily since 2006, increasing 45% overall in the decade ending in 2015, according to a new report from the Agency for Healthcare Research and Quality that also found large ethnic and racial, geographic, and socioeconomic variation in rates of severe maternal morbidity.
The longstanding increased risk for severe maternal morbidity for black women, compared with white women, continued essentially unchanged, with black women 112%-115% more likely to experience any of 21 conditions and procedures that defined severe maternal morbidity in the report. Disparities also existed between white women and those of Hispanic or Asian/Pacific Islander origin, but those gaps are narrowing, according to the report.
“Black women, Hispanic women, and women of other races/ethnicities were overrepresented among deliveries involving severe maternal morbidity, as compared with white women,” wrote Kathryn Fingar, PhD, and her coauthors. “White women constituted a lower percentage of deliveries with any severe maternal morbidity than they did other deliveries” – 23% lower.
The 21 indicators, developed by the Centers for Disease Control and Prevention, range from conditions such as renal failure and sepsis to in-hospital procedures such as blood transfusion and hysterectomy. Women were considered to have severe maternal morbidity if any of the indicators were present, regardless of whether in-hospital death occurred.
Dr. Fingar of IBM Watson Health, Cambridge, Mass., and her collaborators summarized data from AHRQ’s Healthcare Cost and Utilization Project (H-CUP) in the statistical brief. The two most common procedures that indicate severe maternal morbidity are blood transfusion and hysterectomy, and these indicators were tracked in deliveries where women had a condition that served as one of the severe maternal morbidity indicators.
Dr. Fingar and her colleagues noted that they excluded data for the final quarter of 2015, because that is when the transition from the 9th to the 10th edition of the International Classifications of Diseases was made.
In addition to the overall increase from 101.3 to 146.6 women per 10,000 experiencing any severe maternal morbidity, the incidence of blood transfusion during a delivery hospitalization, either alone or in conjunction with other indicators, rose from 78.9 to 121.1 women per 10,000, an increase of 54%.
Showing that increased blood transfusions were a major driver of the jump in severe maternal morbidity, the composite increase in the rates of all other indicators went from 34 to 42 per delivery hospitalization, an increase of just 24%, or less than half the increase in blood transfusions.
There was significant variation in trends over time for the rates of the other indicators: acute renal failure, shock, the need for mechanical ventilation, and sepsis all increased by at least 100% (range, 104%-134%), and the rates of aneurysm increased by 99%. Rates of other indicators fell; pulmonary edema, embolism, eclampsia, myocardial infarction, cerebrovascular disorders, serious anesthesia complications, and intraoperative heart failure and arrest all declined by 25%-53% during the data-gathering period.
Looking at the data another way, 78% of cases of severe maternal morbidity in 2006 and 83% in 2015 involved a blood transfusion, making it the most common indicator. Far fewer delivery hospitalizations involved disseminated intravascular coagulation (DIC) and hysterectomy, the next most common indicators, which were seen in just 8% of cases.
Blood transfusions were most likely in women with shock (72%), amniotic fluid embolism (63%), sickle cell disease with crisis (54%), and DIC (51%).
One in three women who experienced shock during delivery had a hysterectomy, as did more than 20% of women who experienced adult respiratory distress syndrome or cardiac arrest (or ventricular fibrillation).
Women delivering at the youngest and oldest ends of the age spectrum were more likely to experience severe maternal morbidity. For women younger than 20 years of age, the rate was 206 per 10,000. In the group of women aged 40 years and over, the rate of any severe maternal morbidity was 248 per 10,000 delivery hospitalizations. Women in their 20s and 30s had rates of 136 and 143 per 10,000, respectively.
Besides race/ethnicity and age, a variety of other patient characteristics were associated with increased rates of severe maternal morbidity and mortality, with higher rates seen in women from the poorest quartile than the wealthiest (177 versus 122 per 10,000, respectively). Women with Medicaid were more likely than those with private insurance to experience severe maternal morbidity during a delivery hospitalization (175 versus 121 per 10,000, respectively).
Similarly, severe maternal morbidity was more common in safety net hospitals and in minority-serving hospitals (182 versus 128 and 176 versus 123 per 10,000, respectively) than other hospitals.
Regionally, severe maternal morbidity was most common in the Northeast and the South, at 165 and 164 per 10,000, respectively, compared with rates of 132 and 116 in the West and Midwest, respectively.
Hospital deaths per 100,000 delivery hospitalizations were 248% higher for black than white women in 2006. By the end of 2015, that figure declined modestly to 193%, with absolute rates of 19 versus 5.5 deaths per 100,000 delivery hospitalizations for black versus white women in 2006. In 2015, the absolute rates were 11 versus 4 per 100,000.
The study was conducted by the Agency for Healthcare Research and Quality. There were no reported conflicts of interest.
SOURCE: Fingar K et al. Agency for Healthcare Research and Quality Statistical Brief #243.
The data here confirm, again, that we have a crisis in maternal health care in the United States. Not only is severe maternal morbidity increasing, but disparities in outcomes between white and black women persist, such that severe maternal morbidity is twice as common among black women as it is among white women.
It’s tempting to attribute the gap to social determinants of health that are outside the control of the obstetrician-gynecologist. But education doesn’t protect black women: the New York City Department of Health and Mental Hygiene found that non-Hispanic black women with a college degree have higher rates of severe maternal morbidity than women of other race/ethnicities who never graduated high school. It’s a stark finding that’s illustrated by the heartbreaking story of Shalon Irving, a PhD epidemiologist at the Centers for Disease Control and Prevention, whose postpartum death was reported by ProPublica last winter.
One contributing factor is likely to be implicit biases that affect how well we see and hear patients who are different from us. I was mortified to see my own implicit biases when I took the Project Implicit Social Attitudes test (https://implicit.harvard.edu/implicit/). These aren’t the beliefs that we choose – they are the patterns that we absorb from our day-to-day lives. If you search Google images for “pregnancy,” “motherhood,” or “breastfeeding,” the overwhelming majority of images feature white women, whereas the phrase “welfare queen” is used to denigrate the reproduction of women of color. That’s the world we live in, and these patterns reinforce mental short cuts that are more likely to drive our behavior when we’re pressed for time, as we are every day in clinical practice. In one study in a pediatric emergency department, the busier the shift, the higher the providers’ implicit bias at the end of the shift.
We might start by looking at the images on our web sites and hanging in our offices and hospital corridors – do they look like the women we care for? Do they celebrate pregnancy and parenthood for diverse families? And how can we make sure that we pause, before we walk into a patient’s room, so that we can be fully present to her individual strengths and vulnerabilities, and tailor our care to her as an individual?
Alison Stuebe, MD, of the University of North Carolina, Chapel Hill, is medical director of lactation services and on the steering committee for Moms Rising North Carolina, the Breastfeeding Expert Work Group for the American College of Obstetricians and Gynecologists, and a board member of the Society for Maternal-Fetal Medicine. She was asked to comment on the AHRQ report by this newspaper.
The data here confirm, again, that we have a crisis in maternal health care in the United States. Not only is severe maternal morbidity increasing, but disparities in outcomes between white and black women persist, such that severe maternal morbidity is twice as common among black women as it is among white women.
It’s tempting to attribute the gap to social determinants of health that are outside the control of the obstetrician-gynecologist. But education doesn’t protect black women: the New York City Department of Health and Mental Hygiene found that non-Hispanic black women with a college degree have higher rates of severe maternal morbidity than women of other race/ethnicities who never graduated high school. It’s a stark finding that’s illustrated by the heartbreaking story of Shalon Irving, a PhD epidemiologist at the Centers for Disease Control and Prevention, whose postpartum death was reported by ProPublica last winter.
One contributing factor is likely to be implicit biases that affect how well we see and hear patients who are different from us. I was mortified to see my own implicit biases when I took the Project Implicit Social Attitudes test (https://implicit.harvard.edu/implicit/). These aren’t the beliefs that we choose – they are the patterns that we absorb from our day-to-day lives. If you search Google images for “pregnancy,” “motherhood,” or “breastfeeding,” the overwhelming majority of images feature white women, whereas the phrase “welfare queen” is used to denigrate the reproduction of women of color. That’s the world we live in, and these patterns reinforce mental short cuts that are more likely to drive our behavior when we’re pressed for time, as we are every day in clinical practice. In one study in a pediatric emergency department, the busier the shift, the higher the providers’ implicit bias at the end of the shift.
We might start by looking at the images on our web sites and hanging in our offices and hospital corridors – do they look like the women we care for? Do they celebrate pregnancy and parenthood for diverse families? And how can we make sure that we pause, before we walk into a patient’s room, so that we can be fully present to her individual strengths and vulnerabilities, and tailor our care to her as an individual?
Alison Stuebe, MD, of the University of North Carolina, Chapel Hill, is medical director of lactation services and on the steering committee for Moms Rising North Carolina, the Breastfeeding Expert Work Group for the American College of Obstetricians and Gynecologists, and a board member of the Society for Maternal-Fetal Medicine. She was asked to comment on the AHRQ report by this newspaper.
The data here confirm, again, that we have a crisis in maternal health care in the United States. Not only is severe maternal morbidity increasing, but disparities in outcomes between white and black women persist, such that severe maternal morbidity is twice as common among black women as it is among white women.
It’s tempting to attribute the gap to social determinants of health that are outside the control of the obstetrician-gynecologist. But education doesn’t protect black women: the New York City Department of Health and Mental Hygiene found that non-Hispanic black women with a college degree have higher rates of severe maternal morbidity than women of other race/ethnicities who never graduated high school. It’s a stark finding that’s illustrated by the heartbreaking story of Shalon Irving, a PhD epidemiologist at the Centers for Disease Control and Prevention, whose postpartum death was reported by ProPublica last winter.
One contributing factor is likely to be implicit biases that affect how well we see and hear patients who are different from us. I was mortified to see my own implicit biases when I took the Project Implicit Social Attitudes test (https://implicit.harvard.edu/implicit/). These aren’t the beliefs that we choose – they are the patterns that we absorb from our day-to-day lives. If you search Google images for “pregnancy,” “motherhood,” or “breastfeeding,” the overwhelming majority of images feature white women, whereas the phrase “welfare queen” is used to denigrate the reproduction of women of color. That’s the world we live in, and these patterns reinforce mental short cuts that are more likely to drive our behavior when we’re pressed for time, as we are every day in clinical practice. In one study in a pediatric emergency department, the busier the shift, the higher the providers’ implicit bias at the end of the shift.
We might start by looking at the images on our web sites and hanging in our offices and hospital corridors – do they look like the women we care for? Do they celebrate pregnancy and parenthood for diverse families? And how can we make sure that we pause, before we walk into a patient’s room, so that we can be fully present to her individual strengths and vulnerabilities, and tailor our care to her as an individual?
Alison Stuebe, MD, of the University of North Carolina, Chapel Hill, is medical director of lactation services and on the steering committee for Moms Rising North Carolina, the Breastfeeding Expert Work Group for the American College of Obstetricians and Gynecologists, and a board member of the Society for Maternal-Fetal Medicine. She was asked to comment on the AHRQ report by this newspaper.
The rate of severe maternal morbidity in the United States has climbed steadily since 2006, increasing 45% overall in the decade ending in 2015, according to a new report from the Agency for Healthcare Research and Quality that also found large ethnic and racial, geographic, and socioeconomic variation in rates of severe maternal morbidity.
The longstanding increased risk for severe maternal morbidity for black women, compared with white women, continued essentially unchanged, with black women 112%-115% more likely to experience any of 21 conditions and procedures that defined severe maternal morbidity in the report. Disparities also existed between white women and those of Hispanic or Asian/Pacific Islander origin, but those gaps are narrowing, according to the report.
“Black women, Hispanic women, and women of other races/ethnicities were overrepresented among deliveries involving severe maternal morbidity, as compared with white women,” wrote Kathryn Fingar, PhD, and her coauthors. “White women constituted a lower percentage of deliveries with any severe maternal morbidity than they did other deliveries” – 23% lower.
The 21 indicators, developed by the Centers for Disease Control and Prevention, range from conditions such as renal failure and sepsis to in-hospital procedures such as blood transfusion and hysterectomy. Women were considered to have severe maternal morbidity if any of the indicators were present, regardless of whether in-hospital death occurred.
Dr. Fingar of IBM Watson Health, Cambridge, Mass., and her collaborators summarized data from AHRQ’s Healthcare Cost and Utilization Project (H-CUP) in the statistical brief. The two most common procedures that indicate severe maternal morbidity are blood transfusion and hysterectomy, and these indicators were tracked in deliveries where women had a condition that served as one of the severe maternal morbidity indicators.
Dr. Fingar and her colleagues noted that they excluded data for the final quarter of 2015, because that is when the transition from the 9th to the 10th edition of the International Classifications of Diseases was made.
In addition to the overall increase from 101.3 to 146.6 women per 10,000 experiencing any severe maternal morbidity, the incidence of blood transfusion during a delivery hospitalization, either alone or in conjunction with other indicators, rose from 78.9 to 121.1 women per 10,000, an increase of 54%.
Showing that increased blood transfusions were a major driver of the jump in severe maternal morbidity, the composite increase in the rates of all other indicators went from 34 to 42 per delivery hospitalization, an increase of just 24%, or less than half the increase in blood transfusions.
There was significant variation in trends over time for the rates of the other indicators: acute renal failure, shock, the need for mechanical ventilation, and sepsis all increased by at least 100% (range, 104%-134%), and the rates of aneurysm increased by 99%. Rates of other indicators fell; pulmonary edema, embolism, eclampsia, myocardial infarction, cerebrovascular disorders, serious anesthesia complications, and intraoperative heart failure and arrest all declined by 25%-53% during the data-gathering period.
Looking at the data another way, 78% of cases of severe maternal morbidity in 2006 and 83% in 2015 involved a blood transfusion, making it the most common indicator. Far fewer delivery hospitalizations involved disseminated intravascular coagulation (DIC) and hysterectomy, the next most common indicators, which were seen in just 8% of cases.
Blood transfusions were most likely in women with shock (72%), amniotic fluid embolism (63%), sickle cell disease with crisis (54%), and DIC (51%).
One in three women who experienced shock during delivery had a hysterectomy, as did more than 20% of women who experienced adult respiratory distress syndrome or cardiac arrest (or ventricular fibrillation).
Women delivering at the youngest and oldest ends of the age spectrum were more likely to experience severe maternal morbidity. For women younger than 20 years of age, the rate was 206 per 10,000. In the group of women aged 40 years and over, the rate of any severe maternal morbidity was 248 per 10,000 delivery hospitalizations. Women in their 20s and 30s had rates of 136 and 143 per 10,000, respectively.
Besides race/ethnicity and age, a variety of other patient characteristics were associated with increased rates of severe maternal morbidity and mortality, with higher rates seen in women from the poorest quartile than the wealthiest (177 versus 122 per 10,000, respectively). Women with Medicaid were more likely than those with private insurance to experience severe maternal morbidity during a delivery hospitalization (175 versus 121 per 10,000, respectively).
Similarly, severe maternal morbidity was more common in safety net hospitals and in minority-serving hospitals (182 versus 128 and 176 versus 123 per 10,000, respectively) than other hospitals.
Regionally, severe maternal morbidity was most common in the Northeast and the South, at 165 and 164 per 10,000, respectively, compared with rates of 132 and 116 in the West and Midwest, respectively.
Hospital deaths per 100,000 delivery hospitalizations were 248% higher for black than white women in 2006. By the end of 2015, that figure declined modestly to 193%, with absolute rates of 19 versus 5.5 deaths per 100,000 delivery hospitalizations for black versus white women in 2006. In 2015, the absolute rates were 11 versus 4 per 100,000.
The study was conducted by the Agency for Healthcare Research and Quality. There were no reported conflicts of interest.
SOURCE: Fingar K et al. Agency for Healthcare Research and Quality Statistical Brief #243.
The rate of severe maternal morbidity in the United States has climbed steadily since 2006, increasing 45% overall in the decade ending in 2015, according to a new report from the Agency for Healthcare Research and Quality that also found large ethnic and racial, geographic, and socioeconomic variation in rates of severe maternal morbidity.
The longstanding increased risk for severe maternal morbidity for black women, compared with white women, continued essentially unchanged, with black women 112%-115% more likely to experience any of 21 conditions and procedures that defined severe maternal morbidity in the report. Disparities also existed between white women and those of Hispanic or Asian/Pacific Islander origin, but those gaps are narrowing, according to the report.
“Black women, Hispanic women, and women of other races/ethnicities were overrepresented among deliveries involving severe maternal morbidity, as compared with white women,” wrote Kathryn Fingar, PhD, and her coauthors. “White women constituted a lower percentage of deliveries with any severe maternal morbidity than they did other deliveries” – 23% lower.
The 21 indicators, developed by the Centers for Disease Control and Prevention, range from conditions such as renal failure and sepsis to in-hospital procedures such as blood transfusion and hysterectomy. Women were considered to have severe maternal morbidity if any of the indicators were present, regardless of whether in-hospital death occurred.
Dr. Fingar of IBM Watson Health, Cambridge, Mass., and her collaborators summarized data from AHRQ’s Healthcare Cost and Utilization Project (H-CUP) in the statistical brief. The two most common procedures that indicate severe maternal morbidity are blood transfusion and hysterectomy, and these indicators were tracked in deliveries where women had a condition that served as one of the severe maternal morbidity indicators.
Dr. Fingar and her colleagues noted that they excluded data for the final quarter of 2015, because that is when the transition from the 9th to the 10th edition of the International Classifications of Diseases was made.
In addition to the overall increase from 101.3 to 146.6 women per 10,000 experiencing any severe maternal morbidity, the incidence of blood transfusion during a delivery hospitalization, either alone or in conjunction with other indicators, rose from 78.9 to 121.1 women per 10,000, an increase of 54%.
Showing that increased blood transfusions were a major driver of the jump in severe maternal morbidity, the composite increase in the rates of all other indicators went from 34 to 42 per delivery hospitalization, an increase of just 24%, or less than half the increase in blood transfusions.
There was significant variation in trends over time for the rates of the other indicators: acute renal failure, shock, the need for mechanical ventilation, and sepsis all increased by at least 100% (range, 104%-134%), and the rates of aneurysm increased by 99%. Rates of other indicators fell; pulmonary edema, embolism, eclampsia, myocardial infarction, cerebrovascular disorders, serious anesthesia complications, and intraoperative heart failure and arrest all declined by 25%-53% during the data-gathering period.
Looking at the data another way, 78% of cases of severe maternal morbidity in 2006 and 83% in 2015 involved a blood transfusion, making it the most common indicator. Far fewer delivery hospitalizations involved disseminated intravascular coagulation (DIC) and hysterectomy, the next most common indicators, which were seen in just 8% of cases.
Blood transfusions were most likely in women with shock (72%), amniotic fluid embolism (63%), sickle cell disease with crisis (54%), and DIC (51%).
One in three women who experienced shock during delivery had a hysterectomy, as did more than 20% of women who experienced adult respiratory distress syndrome or cardiac arrest (or ventricular fibrillation).
Women delivering at the youngest and oldest ends of the age spectrum were more likely to experience severe maternal morbidity. For women younger than 20 years of age, the rate was 206 per 10,000. In the group of women aged 40 years and over, the rate of any severe maternal morbidity was 248 per 10,000 delivery hospitalizations. Women in their 20s and 30s had rates of 136 and 143 per 10,000, respectively.
Besides race/ethnicity and age, a variety of other patient characteristics were associated with increased rates of severe maternal morbidity and mortality, with higher rates seen in women from the poorest quartile than the wealthiest (177 versus 122 per 10,000, respectively). Women with Medicaid were more likely than those with private insurance to experience severe maternal morbidity during a delivery hospitalization (175 versus 121 per 10,000, respectively).
Similarly, severe maternal morbidity was more common in safety net hospitals and in minority-serving hospitals (182 versus 128 and 176 versus 123 per 10,000, respectively) than other hospitals.
Regionally, severe maternal morbidity was most common in the Northeast and the South, at 165 and 164 per 10,000, respectively, compared with rates of 132 and 116 in the West and Midwest, respectively.
Hospital deaths per 100,000 delivery hospitalizations were 248% higher for black than white women in 2006. By the end of 2015, that figure declined modestly to 193%, with absolute rates of 19 versus 5.5 deaths per 100,000 delivery hospitalizations for black versus white women in 2006. In 2015, the absolute rates were 11 versus 4 per 100,000.
The study was conducted by the Agency for Healthcare Research and Quality. There were no reported conflicts of interest.
SOURCE: Fingar K et al. Agency for Healthcare Research and Quality Statistical Brief #243.
FROM AN AHRQ STATISTICAL BRIEF
Key clinical point:
Major finding: Black women were over 100% more likely to experience severe maternal morbidity, compared with white women.
Study details: Statistical analysis of Healthcare Cost and Utilization Project (H-CUP) data.
Disclosures: The study was funded by the Agency for Healthcare Research and Quality. The authors reported no conflicts of interest.
Source: Fingar K et al. Agency for Healthcare Research and Quality Statistical Brief #243.
Zika virus infection: Novel assay extends diagnostic window
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
REPORTING FROM ICEID 2018
Key clinical point: A novel assay extends the time frame for diagnosing Zika virus infection.
Major finding: The PSQ assay detected and sequence confirmed Zika virus in all 60 samples; 40 negative control samples all tested negative.
Study details: An analysis of 60 tissue samples using a novel assay.
Disclosures: Dr. Bhatnagar reported having no disclosures.
Source: Bhatnagar J et al. ICEID 2018, Abstract O1.
Psoriatic arthritis activity spikes briefly postpartum
Disease activity for women with psoriatic arthritis seeking pregnancy was relatively stable through 1 year after delivery, but there was a significant jump at 6 months postpartum follow-up, based on data from a prospective study of more than 100 patients.
Previous research has described rheumatoid arthritis remission during pregnancy, but the symptoms of psoriatic arthritis (PsA) before, during, and after pregnancy have not been well studied, wrote Kristin Ursin, MD, of Trondheim (Norway) University Hospital, and her colleagues.
In a study published in Arthritis Care & Research, the investigators reviewed data from 108 pregnancies in 103 women with PsA who were diagnosed between January 2006 and October 2017.
The participants were enrolled in a Norwegian nationwide registry that followed women with inflammatory diseases from preconception through 1 year after delivery. Disease activity was measured using the DAS28-CRP (28-Joint Disease Activity Score with C-reactive Protein). Participants were assessed at seven time points: before pregnancy, during each trimester, and at 6 weeks, 6 months, and 12 months after delivery.
Although approximately 75% of the women had stable disease activity throughout the study period, activity spiked at 6 months after delivery; DAS28-CRP scores at 6 months post partum were significantly higher than scores at 6 weeks post partum (2.71 vs. 2.45, respectively; P = .016).
The researchers conducted an additional analysis of the potential role of tumor necrosis factor inhibitor use and found that women taking a TNFi had significantly lower disease activity during pregnancy, compared with women not taking a TNFi; mean DAS28-CRP scores at 6 months post partum for these groups were 2.22 and 2.72, respectively (P = .043).
The study was limited by the use of DAS28-CRP as the main measure of disease activity; the index does not include potentially affected distal interphalangeal joints. In addition, not all the participants were assessed at each of the seven time points. However, the results suggest that most pregnant women with PsA experience low levels of disease activity, the researchers said. “Future research on pregnancy in women with PsA should include extended joint count (66/68 joints), and assessment of dactylitis, entheses, axial skeleton, and psoriasis,” they added.
The researchers had no financial conflicts to disclose. The study was funded by the department of rheumatology at Trondheim University Hospital and the Research Fund of the Norwegian organization for people with rheumatic disease.
SOURCE: Ursin K et al. Arthritis Care Res. 2018 Sep 7. doi: 10.1002/acr.23747.
Disease activity for women with psoriatic arthritis seeking pregnancy was relatively stable through 1 year after delivery, but there was a significant jump at 6 months postpartum follow-up, based on data from a prospective study of more than 100 patients.
Previous research has described rheumatoid arthritis remission during pregnancy, but the symptoms of psoriatic arthritis (PsA) before, during, and after pregnancy have not been well studied, wrote Kristin Ursin, MD, of Trondheim (Norway) University Hospital, and her colleagues.
In a study published in Arthritis Care & Research, the investigators reviewed data from 108 pregnancies in 103 women with PsA who were diagnosed between January 2006 and October 2017.
The participants were enrolled in a Norwegian nationwide registry that followed women with inflammatory diseases from preconception through 1 year after delivery. Disease activity was measured using the DAS28-CRP (28-Joint Disease Activity Score with C-reactive Protein). Participants were assessed at seven time points: before pregnancy, during each trimester, and at 6 weeks, 6 months, and 12 months after delivery.
Although approximately 75% of the women had stable disease activity throughout the study period, activity spiked at 6 months after delivery; DAS28-CRP scores at 6 months post partum were significantly higher than scores at 6 weeks post partum (2.71 vs. 2.45, respectively; P = .016).
The researchers conducted an additional analysis of the potential role of tumor necrosis factor inhibitor use and found that women taking a TNFi had significantly lower disease activity during pregnancy, compared with women not taking a TNFi; mean DAS28-CRP scores at 6 months post partum for these groups were 2.22 and 2.72, respectively (P = .043).
The study was limited by the use of DAS28-CRP as the main measure of disease activity; the index does not include potentially affected distal interphalangeal joints. In addition, not all the participants were assessed at each of the seven time points. However, the results suggest that most pregnant women with PsA experience low levels of disease activity, the researchers said. “Future research on pregnancy in women with PsA should include extended joint count (66/68 joints), and assessment of dactylitis, entheses, axial skeleton, and psoriasis,” they added.
The researchers had no financial conflicts to disclose. The study was funded by the department of rheumatology at Trondheim University Hospital and the Research Fund of the Norwegian organization for people with rheumatic disease.
SOURCE: Ursin K et al. Arthritis Care Res. 2018 Sep 7. doi: 10.1002/acr.23747.
Disease activity for women with psoriatic arthritis seeking pregnancy was relatively stable through 1 year after delivery, but there was a significant jump at 6 months postpartum follow-up, based on data from a prospective study of more than 100 patients.
Previous research has described rheumatoid arthritis remission during pregnancy, but the symptoms of psoriatic arthritis (PsA) before, during, and after pregnancy have not been well studied, wrote Kristin Ursin, MD, of Trondheim (Norway) University Hospital, and her colleagues.
In a study published in Arthritis Care & Research, the investigators reviewed data from 108 pregnancies in 103 women with PsA who were diagnosed between January 2006 and October 2017.
The participants were enrolled in a Norwegian nationwide registry that followed women with inflammatory diseases from preconception through 1 year after delivery. Disease activity was measured using the DAS28-CRP (28-Joint Disease Activity Score with C-reactive Protein). Participants were assessed at seven time points: before pregnancy, during each trimester, and at 6 weeks, 6 months, and 12 months after delivery.
Although approximately 75% of the women had stable disease activity throughout the study period, activity spiked at 6 months after delivery; DAS28-CRP scores at 6 months post partum were significantly higher than scores at 6 weeks post partum (2.71 vs. 2.45, respectively; P = .016).
The researchers conducted an additional analysis of the potential role of tumor necrosis factor inhibitor use and found that women taking a TNFi had significantly lower disease activity during pregnancy, compared with women not taking a TNFi; mean DAS28-CRP scores at 6 months post partum for these groups were 2.22 and 2.72, respectively (P = .043).
The study was limited by the use of DAS28-CRP as the main measure of disease activity; the index does not include potentially affected distal interphalangeal joints. In addition, not all the participants were assessed at each of the seven time points. However, the results suggest that most pregnant women with PsA experience low levels of disease activity, the researchers said. “Future research on pregnancy in women with PsA should include extended joint count (66/68 joints), and assessment of dactylitis, entheses, axial skeleton, and psoriasis,” they added.
The researchers had no financial conflicts to disclose. The study was funded by the department of rheumatology at Trondheim University Hospital and the Research Fund of the Norwegian organization for people with rheumatic disease.
SOURCE: Ursin K et al. Arthritis Care Res. 2018 Sep 7. doi: 10.1002/acr.23747.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point: Disease activity for pregnant women with PsA decreased during pregnancy, increased significantly by 6 months post partum, and returned to baseline by 12 months post partum.
Major finding: The average DAS28-CRP was 2.71 at 6 months vs. 2.45 at 6 weeks (P = .016).
Study details: The data come from 108 women with 103 pregnancies who were part of a national registry in Norway.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded by the department of rheumatology at Trondheim University Hospital and the Research Fund of the Norwegian organization for people with rheumatic disease.
Source: Ursin K et al. Arthritis Care Res. 2018 Sep 7. doi: 10.1002/acr.23747.