New Findings on Morning Sickness Treatment Presented at Society for Maternal-Fetal Medicine Annual Pregnancy Meeting
Early use of Diclectin(®) reduces the severity of nausea and vomiting of pregnancy (NVP) symptoms
in pregnant women who had severe NVP in a previous pregnancy
BLAINVILLE, QC (CANADA), Feb. 14, 2013 /PRNewswire/ – Duchesnay Inc. announced results from a new study concluding that pre-emptive use of
Diclectin(®) (a delayed-release combination of 10 mg doxylamine and 10 mg
pyridoxine) is effective in reducing symptoms of severe NVP in patients
at high risk for recurrence of severe NVP. The study was conducted by
Gideon Koren, M.D., and Caroline Maltepe, B.A., of The Motherisk
Program, Division of Clinical Pharmacology and Toxicology, Hospital for
Sick Children in Toronto, Ontario. Data were presented in an oral
abstract in San Francisco, California on February 14, 2013 during the
Society for Maternal-Fetal Medicine’s Annual meeting ‘The Pregnancy
Meeting’, and will be published in the American Journal of Obstetrics
and Gynecology(1).
The randomized, controlled study recruited pregnant women who had
experienced severe NVP or hyperemesis gravidarum (HG) – an extreme form
of morning sickness – in a previous pregnancy. These women were
instructed either to start using Diclectin(®) before NVP symptoms appeared (the pre-emptive group), or to start
Diclectin(® )at the first sign of NVP symptoms (the control group). The severity of
NVP symptoms was compared between the two groups.
Results demonstrate that women who started using Diclectin(®) before NVP symptoms began had significantly reduced symptoms of severe
NVP compared to women who only started Diclectin(®) when NVP symptoms appeared. In the pre-emptive group, there were 70%
fewer cases of moderate-to-severe NVP compared to the control group
during the 3 first weeks of NVP (p=0.05). Pre-emptive use of Diclectin(®) was also found to decrease the recurrence of HG in women with a
previous history of HG (p=0.047).
“Women with NVP commonly report feeling unsupported by the medical
community, and many physicians and pharmacists are hesitant to
prescribe anti-emetics to pregnant women,” said lead researcher Dr.
Gideon Koren. “These new, important data continue to prove that NVP is a serious
medical condition, and drive awareness of safe and effective treatment
options to alleviate NVP symptoms and possibly prevent extreme cases of
hyperemesis gravidarum.”
The delayed release combination of 10 mg doxylamine and 10 mg pyridoxine
(Diclectin(®), Duchesnay, Inc.) is labeled in Canada specifically for NVP, and has
been shown to be safe and effective in more than 200,000 pregnant
women.(2,3 )
About the Motherisk Program
The Motherisk Program is a clinical, research and teaching program dedicated to drug,
chemical, and disease risk counselling in pregnancy. Motherisk provides
evidence-based information and guidance about the safety or risk to the
developing fetus or infant, of maternal exposure to drugs, chemicals,
diseases, radiation and environmental agents. The program maintains
several Helplines, one of which is the toll-free NVP Helpline which was
created to improve the management of NVP.
About NVP and HG
Nausea and vomiting of pregnancy, or morning sickness, affects up to 85%
of pregnant women, with symptoms that range from nausea to severe
vomiting and retching.(4) More than half of pregnant women report daily episodes of vomiting.(3) For most pregnant women, symptoms generally decrease between 12-16
weeks gestation.(5) However, some women can experience symptoms throughout their pregnancy,(3,4) and 40% of women experience symptoms severe enough to interfere with
their lifestyle.(3) Although NVP is not usually a life-threatening medical condition, if
left untreated, it may progress to HG.(1) HG occurs in up to 3% of pregnant women and may require hospitalization
to care for nutritional deficiency, weight loss, and fluid, electrolyte
and acid-based imbalances.(1,6) The American Congress of Obstetricians and Gynecologists (ACOG)
advocates that early treatment of NVP may prevent the escalation of
symptoms that lead to HG.(7)
About Duchesnay Inc.
Duchesnay Inc. is a unique healthcare company exclusively devoted to
safeguarding the health and well-being of expectant mothers and their
unborn babies. Founded in 1970 in Canada, the family-owned company
realigned its business in 1992 to focus specifically on pregnant women
after a family member experienced a very difficult pregnancy.
Duchesnay’s mission became to improve the health and quality of life of
pregnant women by working at advancing maternal-fetal medicine to
reduce the risk of birth defects and by developing safe and effective
pharmacological solutions for use during pregnancy and breastfeeding.
For more information, visit www.duchesnay.com.
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(1) Koren G, Maltepe C. Preemptive Diclectin therapy for the management of
nausea and vomiting of pregnancy and hyperemesis gravidarum. AJOG.
2013 208:1 (Suppl): 20.
(2) Clark SM, Costantine MM, Hankins GD. Review of NVP and HG and early
pharmacotherapeutic intervention. Obstet Gynecol Int. 2012 25: 2676.
Epub 2011 Nov 24.
(3) Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and
vomiting of pregnancy. Int J Women’s Health. 2010 2: 241-8.
(4) “Nausea and Vomiting of Pregnancy,” Association of Professors of
Gynecology and Obstetrics. 2011.
(5) Lacroix R, Eason E, Melzack R. Nausea and vomiting during pregnancy: a
prospective study of its frequency, intensity, and patterns of change.
Am J Obstet Gynecol. 2000 182:931-937.
(6) Verberg, MFG, DJ Gillott, N Al-Fardan and JG Grudzinskas. Hyperemesis
gravidarum, a literature review. Human Reproduction Update. 2005 11(5):
527-549.
(7) “Nausea and Vomiting of Pregnancy,” ACOG Practice Bulletin # 52,
2004.
SOURCE Duchesnay inc.
