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"LATEST NEWS"
Prucalopride
Relieves Constipation with No Signs of Heart Risk |
By Charles Bankhead, Staff Writer, MedPage Today
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston. |
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ROCHESTER, Minn., May 28 -- Patients with
severe, chronic constipation had a two- to three-fold improvement in bowel movements with the selective 5-HT4 receptor
agonist prucalopride (Resolor) versus placebo, investigators here reported.
In a 12-week trial, bowel function improved
significantly with prucalopride, whether defined by total number of bowel movements or the percentage of patients with three
or more movements weekly, Michael Camilleri, M.D., of the Mayo Clinic, and colleagues reported in the May 29 issue of the
New England Journal of Medicine.
The agent's stimulation of three or more bowel movements in significantly
more patients "reflects the normalization of bowel function," the authors said. Moreover, the improved bowel function was
associated with a 50% decrease in the need for rescue medication.
Action Points
- Explain to patients that an investigational drug for chronic constipation significantly
improved bowel function in a randomized clinical trial.
- Note that the drug is not yet available and that the findings require confirmation in additional
studies.
Patients' satisfaction with bowel function and
treatment and their perception of constipation severity also improved with both doses of prucalopride evaluated in the study.
Additionally, the treatment caused no significant cardiovascular effects.
Concern about cardiovascular effects led to
the demise of two earlier 5-HT4 receptor agonists. Tegaserod was withdrawn from the U.S. market after evidence
of ischemic events, and cisapride was pulled because of conduction abnormalities leading to a prolonged QT interval.
The disappearance of those two agents left lubiprostone
(Amitiza) as the only prescription drug approved in the U.S. for treatment of chronic constipation and constipation-predominant
irritable bowel syndrome.
Tegaserod, cisapride, and several other 5-HT4
receptor agonists are nonselective and exert effects on other types of 5-HT receptors and on the ether-a-go-go related (hERG)
protein channel. The lack of specificity for 5-HT4 receptors may lead to an unfavorable cardiovascular profile,
said Dr. Camilleri and colleagues. In contrast, prucalopride is highly selective for the 5-HT subtype 4 receptor.
Prucalopride improves colonic motility and transit.
In phase II trials, the drug significantly increased the frequency of bowel movement and patient satisfaction with bowel function.
Clinical investigation of prucalopride continued
in a phase III trial involving 620 patients with a history of chronic constipation, defined as two or fewer spontaneous, complete
bowel movements weekly for at least six months. Additionally, patients had to pass hard or very hard stools, have a sensation
of incomplete evacuation, or straining during defecation during at least 25% of bowel movements.
Patients were randomized to placebo or to 2
or 4 mg of prucalopride daily for 12 weeks. The primary efficacy endpoint was the proportion of patients having three or more
spontaneous, complete bowel movements weekly, averaged over the 12 weeks of the trial.
At the end of the study, 30.9% of patients treated
with 2 mg of prucalopride had three or more bowel movements weekly, as did 28.4% of the 4-mg prucalopride group, versus 12%
in the placebo group (P<0.001). Additionally, 47.3% of the 2-mg group and 46.6% of the 4-mg group had an increase
of at least one bowel movement weekly, averaged over the 12 weeks of the study (P<0.001).
The overall patient-assessed symptom score decreased
significantly with prucalopride versus placebo, as did the stool and abdominal symptom subscore (P=0.008 to P<0.001).
Patients on active treatment reported significant improvement in quality of life (P<0.001 versus placebo) and
significant reductions in the need for rescue medication for constipation (P<0.001 versus placebo).
The most common treatment-related adverse events
were headache and abdominal pain.
Though encouraging, the results do not establish
the cardiovascular safety of prucalopride, particularly given the relatively small number of patients who continued treatment
for the entire 12 weeks of the study (85% of total), University of Rochester (N.Y.) cardiologist Arthur J. Moss, M.D., wrote
in an accompanying editorial.
Dr. Moss also expressed concern about the nine-year
lag between the study's design and completion. Moreover, the reasons for temporary suspension of the trial in 2001 are unclear,
he added.
"It is not clear . . . why it took so long to
bring this study to publication," said Dr. Moss. |
Viagra-GP Possible Connection for Cure?
Viagra (sildenafil), which is marketed for male erectile
dysfunction, but has also shown some benefit. Researchers at Johns Hopkins University
found that part of the delay in stomach emptying occurs as a result of lack of nitric oxide in stomach tissues. The same basic
molecular problem causes impotence in men. Experiments have shown that in mice Viagra reversed gastroparesis. Human trials
are underway.
February 8, 2008 WASHINGTON (AP) — A public interest group petitioned the Food and
Drug
Administration on Thursday to increase the warnings on the
popular cosmetic and drug Botox.
Dr. Sidney Wolfe of Public
Citizen Health Research Group said severe
reactions including deaths have been linked to the product.
Botox and
another drug, Myobloc, use botulinum toxin, which blocks
nerve impulses to muscles, causing them to relax.
But in
a few cases, the toxin has spread to other parts of the body,
resulting in problems including paralysis of respiratory
muscles and
difficulty swallowing, potentially leading to food or liquids
entering the lungs and causing aspiration
pneumonia, Wolfe said.
Public Citizen sought so-called black box warnings on both products.
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Pedialyte
Proves to be Top Product for Dehydration-Great News for all Gastroparesis Patients!
Athletes and many alike have both discovered
the life-giving properties of drinks meant to starve off dehydration in sick babies, one of the top-'Pedialyte'.
Infant rehydration solutions such as
Pedialyte are the latest craze in locker rooms, replacing drinks such as Gatorade. Pedialyte products are flavored solutions
of water, glucose, sodium and potassium. They are designed to replace water and electrolytes lost by infants through diarrhea
or vomiting but now are becoming the top product for dehydration as well in adults.
The product solutions contain more sodium
and potassium than most sports drinks, such as Gatorade, said Susan Bowerman, a sports dietician and assistant director
of the Center for Human Nutrition at the University of California-Los Angeles.
* I have used Pedialyte
as a GP patient for many years and stand by this product in aid of dehydration-Give it a try and you will agree!
Proctor & Gamble Releases New Probiotic-"ALIGN" on
the Market!
There is a new product out on the market from Proctor &
Gamble called "ALIGN"-GI Daily Probiotic Suppliment.
Align aims towards those who suffer from IBS thus using
*Bifantis-Bifantis is the trademarked name for the probiotic strain Bifidobacterium infantis 35624. Clinical trials have demonstrated
that regular use of this probiotic strain promotes normal digestive health, even for people who suffer from Irritable Bowel
Syndrome Bifantis deliver millions of good bacteria to work within the digestive (IBS). These normal, friendly bacteria play
an important role in basic digestion, proper metabolism and overall well-being. Capsules of system to restore intestinal balance
and maintain normal digestive health.
*(Bifantis is not a drug; it's a natural supplement that
is similar to the active cultures found in some yogurts and fermented milks).
Align is a daily dietary supplement that works naturally
to help build and maintain a healthy, balanced digestive system. Align is an easy-to-swallow capsule that you take just once
a day, every day to help even out the ups and downs of common digestive upsets such as constipation, diarrhea, abdominal discomfort,
urgency, gas, and bloating. Align capsules contain Bifantis, a unique probiotic strain that has been clinically proven to build and maintain
a strong, healthy digestive system.
People who occasionally suffer from one or more of the following
common digestive upsets would benefit from taking Align:
- Constipation
- Diarrhea
- Abdominal discomfort
- Urgency
- Gas and bloating
SMARTWATER
New product to hit the market from the makers
of 'VitaWater'-Glaceau company. This is one of the best new drinks for all GP'ers as well those who are physically active
to help stay hydrated and keep those electrolytes in balance which lack of leads to dehydration and unwanted medical bills.
Indeed worth looking into at your local stores!
July 11, 2006: 4:00 p.m. EST
CINCINNATI and FREMONT, Calif.,
July 11 (PRNewswire) -
CINCINNATI and FREMONT, Calif., July 11, 2006 /PRNewswire/ --
Procter &
Gamble Pharmaceuticals, Inc., a division of The Procter &
Gamble Company and ARYx Therapeutics, a private drug discovery
and
development company, today announced a strategic alliance under
which P&G will develop and commercialize ARYx's
novel drug, ATI-
7505, for the treatment of gastrointestinal disorders such as
gastroesophageal reflux disease (GERD)
and gastroparesis (delayed
emptying of the stomach).
NEUROGASTROENTEROLOGY
Severe idiopathic gastroparesis due to neuronal and interstitial cells of Cajal
degeneration: pathological findings and management.
1 Digestive System Research Unit, Hospital General Vall d’Hebron, Barcelona,
Spain
2 Intestinal Disease Research Program, McMaster University, Hamilton, Canada
ABSTRACT
Delayed gastric emptying can be due to
muscular, neural, or humoral abnormalities. In the absence of an identified cause, gastroparesis is
labelled as idiopathic. We present the case of a patient with severe idiopathic gastroparesis. Pharmacological
approaches failed, as well as reduction in gastric emptying resistance with pyloric injection of botulinum
toxin and pyloroplasty. Therefore, subtotal gastrectomy was performed. Histological and immunohistochemical
study of the resected specimen showed hypoganglionosis, neuronal dysplasia, and a marked reduction in
both myenteric and intramuscular interstitial cells of Cajal. To our knowledge, this is the first time these rare
histological findings have been described in a patient with idiopathic gastroparesis. http://gut.bmj.com/cgi/content/abstract/52/7/966
Scientists build world's first
artificial stomach
High-tech box simulates human digestion — it even vomits
Lefteris Pitarakis / AP
British scientists
have built what they say is the world's first artificial gut: a shiny, high-tech box that physically simulates human digestion.
Updated: 2:45 p.m. ET Nov 10, 2006
LONDON
- British scientists have built what they say is the world's first artificial stomach: a shiny, high-tech box that physically
simulates human digestion.
Constructed from sophisticated plastics
and metals able to withstand the corrosive acids and enzymes found in the human gut, the device may ultimately help in the
development of super-nutrients, such as obesity-fighting foods that could fool the stomach into thinking it is full.
"There have been lots of jam-jar models
of digestion before," said Dr. Martin Wickham of Norwich's Institute of Food Research, the artificial gut's chief designer,
referring to the beakers of enzymes typically used to approximate the chemical reactions in the stomach.
By understanding
how food gets processed in the gut, and in which part of the stomach nutrients get absorbed, researchers may be able to develop
foods designed to manipulate the digestive process, a strategy that would have broad implications for public health.
For instance, knowing how quickly glucose
gets absorbed into the bloodstream could potentially help treat diabetes.
"Our knowledge of what actually happens
in the gut is still very rudimentary," said Wickham, "but we hope that this model can help fill in some of the blanks."
Some experts say any artificial gut has
inherent limitations.
"The stomach is an extraordinarily complex
organ, so you cannot create a model that will undertake all of these functions," said Dr. Stephen Bloom, head of metabolic
medicine at Imperial College in London, who was not involved in the project.
Still, Bloom said that looking at issues
such as the breakdown of food and the role of enzymes in a model stomach is valuable.
So real it can even vomit
With a capacity
about half the size of an actual stomach, the artificial gut can "eat" roughly 24 ounces of food. To date, the most substantial
meal it's enjoyed is vegetable soup.
"It's so realistic that it can even vomit,"
adds Wickham.
The model gut, which was funded by the
British government, was built at a cost of approximately $1.8 million. Wickham and his colleagues are currently negotiating
with about a dozen companies regarding future projects for the gut.
*Spreading GP Awareness One Person At A Time*
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