TherapeuticsMD vitaMedMD presentation 3.20 ppt

Introducing vitaMedMD™
Prenatal Vitamins
Developing a new standard in prenatal care
“A specialty pharmaceutical company developing a full line
of unique products for women’s health issues from
menarche through the menopause”
Clinical Focus
 1.
 2.
Clinical focus IS on achieving levels of nutrient intake
that optimizes pregnancy outcome before, during, and
after pregnancy
Why is that “Clinical Focus” important:
 Nearly 50% of pregnancies are unplanned
 Nutritional needs ARE considerably higher prior to conception, during implantation,
during pregnancy, and highest during lactation
 Recommendations from the CDC and U.S. Public Health Service is that ALL
women of childbearing age should take 400 mcg of supplemental folic acid daily
 Problem: only 30% of non-pregnant women of childbearing age in the U.S. “report”
taking 400 mcg or more routinely
Proactively Reducing Pregnancy Induced
Risk Factors
 1.
 2.
 3.
 4.
 5.
Importance of folic acid use pre-conception
vitaMedMD PNVs advantages over 3rd generation FA
Importance of folic acid use throughout a woman’s life
Introduction of Quatrefolic – 4th generation folic acid
Importance of DHA in pregnancy and breast feeding
MTHFR mutations/polymorphism
Importance of elevated homocysteine (HHC)
Understanding Thrombophilia and its consequences
Why is It So Important in a Prenatal Vitamin?
• Folic acid role well established in prenatal care
Reduction of NTDs, birth defects, anemia, preterm birth,
• MTHFR Polymorphism
> 50% of women cannot metabolize folic acid
Few women tested
• Quatrefolic® bypasses MTHFR folate polymorphisms and is
immediately available for its biological action
• More bioavailable than other forms of folate
Importance of Adequate Folate
 Known that humans need to maintain an adequate dietary
intake of folate during various stages of their lives
 Folate plays an essential role in cell division and DNA
 Folate is involved in human growth and development
 Folate deficiency has far-reaching NEGATIVE health
consequences at all stages of life
 Folate deficiency has been implicated in the etiology of a
variety of disorders including but not limited to:
Benefits of Folic Acid
 “It has been estimated that as many as half of all birth defects
can be prevented if women of childbearing age consume an
adequate amount of folic acid . . .” †
 Prevention of neural tube defects (NTDs)
 Reduction of other birth defects
 (congenital heart disease, urinary tract anomalies, oral facial
clefts, limb defects, pyloric stenosis)
 Reduction in anemia
 Reduction of implantation failure
 Reduction in incidence of early (1st trimester) miscarriages
 Reduction in preterm birth
 Reduction in postpartum blood clots
Benefits of Folic Acid
 Reduction in language delay in offspring
 Reduction in various forms of cardiovascular diseases
 Reduction in age-related dementia
 Reduction in onset and severity of Alzheimer’s disease
 Reduction in prevalence of Osteoporosis
 Reduction in male infertility (Abnormal DNA)
 Reduction in all consequences of thrombophilia (increased
tendency of excessive clotting)
 Reduction in pregnancy-induced headaches
Folic Acid and Autism:
The Link
A recent study, “The Association Between Maternal Use of Folic Acid
Supplements and the Risk of Autism Spectrum Disorders in Children”,
by Pal Suren, MD, MPH, was published in The Journal of the American
Medical Association (JAMA).
This study examined the association between maternal use of prenatal folic
acid supplements and subsequent risk of Autism Spectrum Disorders
Folic Acid and Autism:
The Link
Key Quotes from the Study
“A recent study of 38,954 children in the Norwegian Mother and Child Cohort Study found
that maternal intake of folic acid supplements from 4 weeks to 8 weeks after
the start of pregnancy was associated with a lower risk of severe language delay at age 3
“A case-control study from California of autism spectrum disorder (ASD) showed that
maternal intake of folic acid and prenatal vitamins during the 3 months prior to
pregnancy and the first month of pregnancy was associated with a lower risk of ASD in
offspring, and complementary genetic analysis indicated that the association was
modified by gene variants that determine the ability to utilize available folate.”
(Referencing MTHFR polymorphism)
“There is also evidence that maternal folic acid supplementation during pregnancy may be
associated with reduced risk of other neurodevelopmental disorders in children.”
Telomere dynamics: the influence of
folate and DNA methylation
Telomere shortening/dysfunction is now recognized as increasing
generative disease risk.
Recent studies have suggested that both dietary patterns and individual
cronutrients--including folate--can influence telomere length and function.
Folate is an important dietary vitamin required for DNA synthesis, repair, and
e-carbon metabolism within the cell.
4. Recent published knowledge identifies the residual knowledge gaps.
Specifically, this review addresses whether it is plausible that folate deficiency
(1) cause accelerated telomere shortening
(2) intrinsically affect telomere function
(3) cause increased telomere-end fusions and subsequent breakage-fusion-bridge cycles in the
Ann N Y Acad Sci. 2011 Jul;1229:76-88. doi: 10.1111/j.1749-6632.2011.06101.x.
Telomere dynamics: the influence of
folate and DNA methylation
A telomere is a region of repetitive nucleotide sequences at each end of a
chromatid, which protects the end of the chromosome from deterioration or from
fusion with neighboring chromosomes
Telomere regions deter the degradation of genes near the ends of chromosomes
by allowing chromosome ends to shorten, which necessarily occurs during
chromosome replication
Without telomeres, the genomes would progressively lose information and
be truncated after cell division
Over time, due to each cell division, the telomere ends become shorter
Neural Tube Defects (NTDs)
Folic Acid in Preventing NTDs
Folate intake and NTDs: dose-response
 Epidemiology 2003, March;14(2):200-5
 Used data from 23,228 women
 Predominantly from the NE area of the U.S.
 Enrolled 1984-1987
 Prospective study of early prenatal exposure and
pregnancy outcomes
 NTDs ascertained through PN testing and by report of
the delivering physician
 Diet and vitamin intake data gathered in early 2nd
Folate intake and NTDs: dose-response
 Dietary folate equivalents (DFEs)
 Compared with women having the lowest total intakes
of 0-149 folate equivalents (in mcg):
 Prevelance of NTDs declined by
 34% with intake between 150-399 mcg
 30% with intake between 400-799 mcg
 56% with intake between 800-1199 mcg
 77% with intake of > or = to 1200 mcg
Dose-Response Relation of FA & NTDs
Folate/Folic Acid:
Is There a Difference?
• Folate is the naturally occurring form of this B-vitamin that is
found in foods
Only ~50% of natural folate is utilized by the body
• Folic Acid
Synthetic form
Variable absorption in both food and multivitamin preparations
Requires absorption and transformation into the biologically active
MTHFR Polymorphisms
Folic Acid
• 1st Generation
Folate (food)
• 2nd Generation
Folic acid (synthetic folic acid)
• 3rd Generation (Metafolin®)
5-methyltetrahydrofolate calcium salt (reduced folate)
• 4th Generation (Quatrefolic®)
Glucosamine salt of (6S)-5-methyltetrahydrofolate (L-Methylfolate)
Folic Acid:
Absorption and Transformation
• Folate must be transformed into the 5-methyltetrahydrofolate (5-MTHF) form which
then passes by diffusion from blood into all body cells and then can convert
homocysteine to methionine for DNA and protein synthesis.
Folate Methylation
• Methylenetetrahydrofolate
reductase (MTHFR):
metabolizes folic acid to the
active form of folic acid
• Over 50% of pregnant women
have MTHFR polymorphism
and cannot fully metabolize folic
acid to its active form
• 4th generation Quatrefolic® is
structurally analogous to
5-methylfolate available for its
immediate biological action
4th Generation Folic Acid
• Glucosamine salt of
• Structurally equivalent to the
reduced and active form of folic
acid (5-methyltetrahydrofolate)
• Immediately available and
active form
• Greater bioavailability and
stability when compared to the
3rd generation calcium salt
S. Ismaili. Crossover Comparative Bioavailability Study of 5-Methyltetrahydrofolate Glucosmaine Salt (GN10G) Compared to the
Reference Metafolin in Healthy Volunteers. Institute for Pharmacokinetic and Analytical Studies. Ligornetto, Switzerland.
MTHFR and Quatrefolic
MTHFR = Methylenetetrahydrofolate Reductase
 The enzyme limiting step responsible for metabolizing folic
acid to 5-methyltetrahydrofolate
 Due to a genetic variation, up to 50% of patients may have
an enzyme that functions less efficiency
 4th-generation Quatrefolic, the glucosamine salt of (6S)5-methyltetrahydrofolate is structurally analogous to the
reduced and active form of folic acid 5methyltetrahydrofolate
 Quatrefolic does not require transformation and exists in
the active form of folate for its immediate biological action
 Quatrefolic has been shown to be more bioavailable than
other forms of folate
 Quatrefolic increases hemoglobin levels better than folic
 Quatrefolic reduces homocysteine levels better than folic
MTHFR Mutation/Polymorphism
 Polymorphism (biology)(meaning "many" "forms") is a
discontinuous genetic variation where two or more forms
exist in the same species within the same population. It can
apply to biochemical, morphological, and behavioral
characteristics, but must be discontinuous
 Types of MTHFR polymorphisms
 Homozygous (C667T) both alleles
 Heterozygous (C667T) single allele
 Compound Heterozygous (C667T and A1298C) alleles
Prevalence of MTHFR Polymorphism
Among Ethnic Groups
MTHFR Variant Frequency
African American
Asian Indian
Asian – Chinese, Japanese, Korean
 1.
Thrombophilia is a medical term used to describe
the condition where the blood has an increased
tendency to clot secondary to:
 Excess of certain proteins, called blood clotting factors, or
 Inadequate anti-clotting proteins that limit clot formation
 2.
 3.
Can be inherited (15% of people in U.S.) or acquired later
Estimated that > 600,000 Americans die/year of blood
 4.
Acquired type usually related to a specific cause
like trauma, prolonged periods of bed rest after surgery,
cancer, ingestion of oral hormones (BCPs,
 5.
 6.
Most people with a thrombophilia have no
Others develop thrombosis like:
 DVTs (legs)
 VTEs (Pulmonary emboli)
 Strokes
 Heart attacks
 Dementia
 Alzheimer’s
 Migraine Headaches
 Pregnancy-induced Headaches
Most common inherited (autosomal dominant) types
Factor V Leiden mutation (2-8%) = mutation causes protein to
be inherited as an abnormal shape preventing it from being
broken down properly by proteins C and S which leads to
blood clot formation
Prothrombin mutations (2%)
Antithrombin deficiency (<1%)
Protein C deficiency (<1%)
Protein S deficiency (<1%)
 8.
Most common acquired type is (APS)
antiphospholipid syndrome
 Occurs in 5-10% of pregnant women
 Body makes antibodies (autoimmune disorder) that
attack certain fats (phospholipids) that line the blood
vessels leading to blood clot formation
APS and Pregnancy
 1.
 2.
 3.
 4.
 5.
 6.
 7.
 8.
Spontaneous miscarriage
Repeated miscarriages
Repetitive pregnancy losses (at any gestational age)
Pre-term labor
Placental abruption
Postpartum hemorrhage
APS and Rx in Pregnancy
 1.
 2.
 3.
Depends on specific type of thrombophilia
Past history of repetitive pregnancy loss
Past history of a blood clot
 Anticoagulant therapy (ASA, Lovenox, Progesterone
supplementation, vitaMedMD products)
 Treat throughout pregnancy and postpartum
Importance of DHA
 1.
 2.
 3.
 4.
DHA (Docosahexaenoic acid) is the most abundant
omega-3 fatty acid in the human body
It is found in every tissue of the body and makes up
97% of the omega-3 fatty acid in the brain and 93% in
the retina
Few individuals get the recommended daily amount of
DHA from our diets
Numerous studies support supplementing your diet
with DHA with positive benefits for your health
Importance of DHA
 Brain (increased cognitive activity, decreased risk of dementia or memory
loss, may slow progression of Alzheimer’s disease, supports cognitive
function throughout life)
 Eyes (decreased progression of ARMD, decreased progression of
Glaucoma, decreased symptoms of DES)
 Heart (stabilizes heart rhythm and improved vascular reactivity)
 Increased gestational length of pregnancy
 Improved blood lipid profiles for individuals with high lipids (lowers
triglycerides, lowers LDL, increases HDL)
 Improvement in attention and intellectual performance
 Anti-inflammatory effects (arthritis, SLE, SS, bowel inflammatory disease)
Life’s DHA Advantage
 1.
Unlike other sources of DHA omega-3, DHA Advantage comes
from a vegetarian source (algae)
 2.
As not from fish, there is no worry of ocean-borne
contaminants or risk of fish-related allergies
 3.
Grown in an FDA-inspected facility
 4. Scientific evidence showing DHA much more important
than EPA (eicosapentaenoic acid), major omega-3 in
fish oils
 5.
Presence of EPA, present in fatty fish, is less important in
advancing health issues and often demonstrates the opposite effects
on bodily function than the benefits of DHA alone
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