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Study Demonstrated AMITIZA(TM) (lubiprostone) Showed Efficacy Within 24 And 48 Hours Of Treatment
Results of a secondary
analysis of two pivotal studies were presented today at the 71st Annual
Meeting of the American College of Gastroenterology (ACG), and showed that
60 percent of patients treated with AMITIZA(TM) (lubiprostone) experienced
a spontaneous bowel movement (SBM) within 24 hours of treatment, and 80
percent experienced a SBM within 48 hours of treatment. Additionally,
AMITIZA, the first selective chloride channel activator approved by the FDA
for the treatment of chronic idiopathic constipation in adults, showed
improvement in long-term symptom relief of this disorder with significant
improvements in constipation severity, abdominal bloating and discomfort
for up to 12 months.
"These results are encouraging for physicians who treat patients with
constipation because there are few treatments approved for chronic
constipation that can be used long term," said Satish Rao, M.D., professor
of medicine and director, Neurogastroenterology and GI Motility at
University of Iowa. "These data indicate that lubiprostone may provide
rapid and long-term relief of symptoms."
Constipation, one of the most common digestive complaints, accounts for
more than 2.5 million doctor visits in the U.S. each year according to the
ACG. It is a condition that often requires rapid and predictable relief of
symptoms with limited long-term treatment options. In clinical studies,
relief was defined as three or more SBMs per week.
AMITIZA has a novel mechanism of action that works by activating
chloride channels to increase fluid secretion in the intestine, thereby
increasing the passage of stool and improving signs and symptoms associated
with chronic idiopathic constipation. AMITIZA is the only prescription
medication for chronic idiopathic constipation that has been approved by
the FDA for use in adults, including those 65 years and over and that has
demonstrated effectiveness for use beyond 12 weeks.
Study Design: Spontaneous Bowel Movements within 24 Hours and 48 Hours
To determine the onset of action of AMITIZA within 24 and 48 hours,
individual and pooled results from two well-controlled Phase III trials
were examined: 239 participants received AMITIZA 24 mcg twice daily and 240
participants received placebo. Data on time to first SBM and percentage of
patients experiencing a SBM within 24 and 48 hours following initial study-
drug administration were compared by study and pooled between treatment
groups (placebo vs. AMITIZA). For each study, the time to first SBM was
significantly shorter for patients taking AMITIZA compared with those
taking placebo (P is less than or equal to 0.006).
-- In the individual studies, 57 to 63 percent of patients treated with
AMITIZA and 32 to 37 percent of placebo patients had a SBM within 24
hours (P is less than or equal to 0.0024).
-- At the 48-hour timepoint in the individual studies, a SBM occurred in 79
to 80 percent of patients treated with AMITIZA vs. 61 to 66 percent of
placebo patients (P is less than or equal to 0.0258).
-- In the pooled analysis, 60 percent of patients treated with AMITIZA had
a SBM within 24 hours and 80 percent had a SBM within 48 hours, compared
with 35 and 63 percent of placebo patients, respectively
(P is less than 0.0001).
Study Design: Long-Term Use of AMITIZA
To evaluate the long-term safety of AMITIZA, a 48-week, open-label
trial of patients who had not received AMITIZA before was conducted. In
total, 324 participants with chronic idiopathic constipation received
AMITIZA 24 mcg taken twice daily.
The findings revealed that AMITIZA was generally well tolerated
throughout the study's duration. Sixty-seven percent of patients
experienced at least one treatment-related adverse event (AE). The most
common treatment-related AEs included nausea (30.2%) and diarrhea (19.4%).
Improvements in assessments of constipation severity, abdominal bloating
and abdominal discomfort were statistically significant at all visits
compared to baseline (P is less than or equal to 0.001).
Further, patients were asked to assess constipation severity and
abdominal symptoms of bloating and discomfort using a 5-point scale where
0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe, at each study
visit (approximately every 6 weeks). Specifically:
-- Constipation severity was improved by an average of 1.11 points at
Week 1 (N=320), 1.17 points at Week 24 (N=183), 1.28 points at Week 48
(N=152) and 0.99 points for the last on-drug measurement (N=320) from a
mean baseline value of 2.69 (N=320).
-- Abdominal bloating was improved by an average of 0.70 points at Week 1
(N=320), 0.80 points at Week 24 (N=183), 0.88 points at Week 48 (N=152)
and 0.68 points for the last on-drug measurement (N=320) from a mean
baseline value of 1.88 (N=320).
-- Abdominal discomfort was improved by an average of 0.65 points at Week 1
(N=320), 0.66 points at week 25 (N=183), 0.78 points at Week 48 (N=152)
and 0.60 points for the last on-drug measurement (N=320) from a mean
baseline value of 1.60 (N=320).
AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in
January 2006 for the treatment of chronic idiopathic constipation in
adults, was developed by Sucampo Pharmaceuticals, Inc., and is jointly
marketed in the United States by Sucampo and Takeda Pharmaceuticals North
America, Inc.
About Chronic Idiopathic Constipation
Constipation is one of the most common digestive complaints, affecting
more than 42 million adults in the United States. It is the cause of 2.5
million visits to physicians and 92,000 hospitalizations annually. Chronic
idiopathic constipation is defined by the infrequent or difficult passage
of the stool for a period of at least three months. "Idiopathic" means the
cause of the constipation is unknown and not due to an underlying illness
or medication. The signs and symptoms associated with chronic idiopathic
constipation include abdominal discomfort, bloating, straining, and hard or
lumpy stools.
About AMITIZA
AMITIZA is indicated for the treatment of chronic idiopathic
constipation in the adult population. AMITIZA should not be used in
patients with a known hypersensitivity to any components of the formulation
and in patients with a history of mechanical gastrointestinal obstruction.
Patients with symptoms suggestive of mechanical gastrointestinal
obstruction should be evaluated prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. In
guinea pigs, lubiprostone has been shown to have the potential to cause
fetal loss. AMITIZA should be used during pregnancy only if the benefit
justifies the potential risk to the fetus. Women who could become pregnant
should have a negative pregnancy test prior to beginning therapy with
AMITIZA and should be capable of complying with effective contraceptive
measures.
AMITIZA should not be administered to patients that have severe
diarrhea. Patients should be aware of the possible occurrence of diarrhea
during treatment. If the diarrhea becomes severe, patients should consult
their health professional.
In clinical trials, the most common adverse event was nausea (31%).
Other adverse events (greater than or equal to 5% of patients) included
diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain
(7%), flatulence (6%), sinusitis (5%) and vomiting (5%).
For full prescribing information, visit http://www.amitiza.com.
AMITIZA(TM) is a trademark of Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is an emerging pharmaceutical company
based in Bethesda, Md. Sucampo was founded in 1996 by Sachiko Kuno, Ph.D.,
the company's President and Chair of the Board of Directors, and Ryuji
Ueno, M.D., Ph.D., Ph.D., the company's Chief Executive Officer and Chief
Scientific Officer. Sucampo focuses on the development and
commercialization of drugs based on prostones, a class of compounds derived
from functional fatty acids that occur naturally in the human body. The
therapeutic potential of prostones was first identified by Dr. Ueno. In
January 2006, Sucampo received marketing approval from the FDA for its
first product, AMITIZA, for the treatment of chronic idiopathic
constipation in adults.
In October 2004, Sucampo entered into an agreement with Takeda
Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market
AMITIZA in the United States and Canada. Sucampo's specialized sales force
complements the efforts of Takeda by focusing on institutional and
long-term care facilities. Currently, two pivotal Phase 3 clinical trials
of AMITIZA for the treatment of irritable bowel syndrome with constipation
(IBS-C) are ongoing, and Phase 2/3 pivotal clinical trials for the
treatment of opioid bowel dysfunction (OBD) are expected to commence in
early 2007.
To learn more about the company and its products, visit
http://www.sucampo.com.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the
largest pharmaceutical company in Japan. In the United States, Takeda
currently markets oral diabetes, insomnia, cholesterol-lowering and
gastroenterology treatments, and has a robust pipeline with compounds in
development for diabetes, cardiovascular disease and other conditions.
Takeda is committed to striving toward better health for individuals and
progress in medicine by developing superior pharmaceutical products. To
learn more about the company and its products, visit http://www.tpna.com/.
Takeda Pharmaceuticals North America, Inc
http://www.tpna.com/
View drug information on Amitiza.
Studiul a demonstrat AMITIZA (TM) (lubiprostone) au demonstrat eficacitatea În termen de 24 ºi 48 de ore de tratament - Study Demonstrated AMITIZA(TM) (lubiprostone) Showed Efficacy Within 24 And 48 Hours Of Treatment - articole medicale engleza - startsanatate