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8 May 2006
I.
WHAT'S NEW?
Software
Development Update
II. QUIZ
(Fill In The Blanks)
Scientists
Solve Heart Development Mystery
III.
HISTORY OF MEDICINE
Chiron - The Inventor of Medicine
IV. CARDIOLOGY
Maximal Exercise Testing in the Elderly - Walking Predicts Outcomes
V. RHEUMATOLOGY
Methotrexate and Intraarticular Betamethasone in Early RA
VI. WOMEN'S HEALTH
B Vitamins, Genetics and IVF Outcomes
VII. PEDIATRICS
Long-Term Effects of Liver Transplantation
VIII. FDA
FDA Approves First Treatment for Myelodysplastic Syndrome
IX. Target Health Inc.
Software
Development Update
Target Health, a full
service e*CRO, is pleased to announce that it has begun programming and
validating Target Encoder™ which will be integrated by the end of May with
all Target e*CRF® applications. Target Encoder™ will be used with MedDRA and
WHO DRUG and is being developed to work with any database, anywhere. For more information, please contact Dr.
Jules T. Mitchel.
Scientists Solve Heart
Development Mystery
New results in
the May 5th issue of Science show that the embryonic vertebrate heart tube is a
dynamic suction pump, where blood flows by a dynamic suction action (similar to
the action of the mature left ventricle) that arises from wave motions in the
tube. It was previously thought that the embryonic heart pumped through 1) ___
movements. The new findings could lead to new treatments of certain heart 2)
___ that arise from congenital defects. The study, performed at the
Answers: 1) peristaltic;
2) diseases; 3) imaging; 4) tube; 5) microscopes; 6) resolutions; 7)
circulation; 8) adult; 9) hair; 10) heart
Chiron - The Inventor of
Medicine
In Greek mythology, the
centaur, Chiron, was wounded by Hercules. Though he was immortal, it is said
that he invented medicine in order to heal himself. He taught Asclepius the art
of healing, which became the source of all divine medical knowledge among the
Greeks. Chiron was also the teacher of the hero, Achilles, who was thought to
have had some special medical knowledge.
Maximal Exercise Testing in
the Elderly - Walking Predicts Outcomes
Decreasing
mobility, along with lack of muscle strength and a decline in aerobic ability, are common aspects of aging that can diminish
quality of life. Understanding the mechanisms of how people lose mobility may
keep people functioning independently longer. While it is well known that
aerobic fitness is an important predictor of cardiovascular disease and
mortality, aerobic fitness is difficult to assess by maximal exercise testing
in older adults. Extended walking tests have been examined as outcome
predictors in medically ill populations but not in community-dwelling older
adults. As a result, a study published in the Journal of the American Medical
Association (2006;295:2018-2026) was performed to
determine whether an extended walking test predicts poor outcomes in older
adults. The investigation was an observational cohort study enrolling 3,075
community-dwelling adults aged 70 to 79 years living in
Methotrexate and
Intraarticular Betamethasone in Early RA
According to an
article published in Arthritis & Rheumatism (2006;54:1401-1409), a study
was performed to investigate whether disease control can be achieved in early
active rheumatoid arthritis (RA) by treatment with methotrexate and
intraarticular betamethasone, and whether the addition of cyclosporine to the
regimen has any additional effect. In terms of study design, patients (n = 160)
were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg
of body weight/day (combination therapy) or methotrexate plus
placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4
weeks thereafter, betamethasone was injected into swollen joints (maximum 4
joints or 4 ml per visit). Beginning at week 8, if synovitis was present, the
methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent
stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4
mg/kg. Study results showed that after 52 weeks of treatment, 20% improvement
according to the American College of Rheumatology criteria (ACR20) was achieved
in 85% of the combination therapy group versus 68% of the monotherapy group (P
= 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was
80.0% and 54.5%, respectively (P = 0.025). At 48 and 52 weeks, ACR remission
criteria were met in 35% of the combination therapy group and 28% of the
monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 ± 6.5 and
0.4 ± 6.9 (mean ± SD) in the combination therapy and monotherapy groups,
respectively. Serum creatinine levels increased by 7%, and
hypertrichosis (hairiness) was more prevalent, in the combination
therapy group. According to the authors, combined treatment with methotrexate
and intraarticular glucocorticoid showed excellent disease control and stopped
the progression of erosions in patients with early active RA, who had a poor
prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas
the ACR50 and ACR70 responses, remission rates, and radiographic changes did
not differ between the 2 study groups.
B Vitamins, Genetics and
IVF Outcomes
In the area of in-vitro
fertilization (IVF), there is a need to understand what affects treatment
success, including the rate of twin births, so that pregnancy rates can be
improved and multiple gestations avoided. As a result, a study published in The
Lancet (2006; 367:1513-1519), was performed to assess the role of B vitamins
and genetics on IVF outcomes. The study included 602 women undergoing fertility
treatment. For each study participant, folate and vitamin B12 intake was
assessed with a questionnaire and plasma and red-blood-cell concentrations
measured by radioimmunoassay. In addition, five B-vitamin-related gene variants
were measured in women who received treatment and in 932 women who conceived
naturally. Study results showed that the likelihood of a twin birth after IVF
rose with increased concentrations of plasma folate (p=0·032) and red-cell
folate (p=0·039). There was no association between folate and vitamin B12
levels and likelihood of a successful pregnancy. Women homozygous for the 1298
CC variant of methylenetetrahydro-folate reductase (MTHFR), rather than the AA
variant, were less likely to produce a livebirth after IVF (p=0·003) or to have
had a previous pregnancy (p=0·008). According to the authors, the study
findings suggest that MTHFR genotype is linked to a woman's potential to
produce healthy embryos (possibly through interaction with genes related to DNA
methylation). In women likely to have a successful IVF pregnancy, high folate
status increases the likelihood of twin birth after multiple embryo transfer.
The authors suggested that proposals to fortify the
Long-Term Effects of Liver
Transplantation
According to an article
published in The Journal of Pediatrics (2006;148:
475-480), a study was performed to determine the prevalence and identify
variables associated with renal dysfunction in long-term survivors of pediatric
liver transplantation. For the study, data were analyzed from 117 patients who
survived ≥3 years after liver transplantation. Demographic and clinical
information was obtained from chart review and from a clinical care database.
The dependent variable was renal function as determined by measured glomerular
filtration rate (mGFR). Univariate and multivariate analyses were performed to
identify independent variables associated with renal dysfunction (mGFR <70
mL/min per 1.73 m2). The average time since liver transplant was 7.6 ± 3.4
years (range, 3 to 14.6 years). When the last available mGFR was analyzed,
renal dysfunction was present in 32% of the patients. In the univariate
analysis, mGFR at 1 year after transplant, cyclosporine immunosuppression, and
time since transplant were significant; the second two were strongly collinear.
Using multiple logistic regression modeling excluding
time since transplant, cyclosporine and mGFR at 1 year after transplant were
strongly associated with renal dysfunction. According to the authors, renal
dysfunction is a common complication in children who survive liver
transplantation, and that the study results are of critical importance because
children may live long enough to move from a stage of renal insufficiency
characterized by asymptomatic decreased GFR, to symptomatic end-stage renal
disease.
TARGET HEALTH excels in
Regulatory Affairs and works closely with many of its clients performing all
FDA submissions. TARGET HEALTH receives daily updates of new developments at
FDA. Each week, highlights of what is going on at FDA are shared to assure that
new information is expeditiously made available.
FDA Approves First Treatment for
Myelodysplastic Syndrome
Orphan products are developed to
treat rare diseases or conditions that affect fewer than 200,000 people in the
For more information
about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr.
Glen Park.
TARGET HEALTH INC. (www.targethealth.com)
is a full service e*CRO with fulltime staff dedicated to all aspects of drug
and device development. Areas of expertise include Regulatory Affairs,
comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions,
execution of Clinical Trials, Project Management, Biostatistics and Data
Management, Web Trials, utilizing Target e*CRF™, our proprietary Internet-based
Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical
Advisory Dream Team (PADT) assists companies in strategic planning from
Discovery to Market Launch. Let us help you on your next project.
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