A controlled trial conducted by researchers at the E-DA Hospital in Kaohsiung, Taiwan, suggests that a combination of band ligation and nadolol may not be the most effective prophylaxis for first variceal bleeding resulting from cirrhosis. Results of this study appear in the July issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).
Esophageal varices (EV) are abnormally enlarged veins in the esophagus that occur when portal hypertension obstructs normal blood flow to the liver and causes the blood to back up into the esophageal vessels. Variceal rupture is a life-threatening condition. Approximately one third of cirrhotic patients with esophageal varices bleed, and the mortality rate associated with first bleed may be as high as 50%.
The World Gastroenterology Organization practice guideline for esophageal varices in patients with cirrhosis and medium or large varices, but no hemorrhage, recommends nonselective beta blockers (propranolol or nadolol) or endoscopic variceal ligation (EVL) for prevention of first variceal hemorrhage for patients at highest risk, and propranolol or nadolol for those who are not high risk or in whom EVL is not tolerated.
Beta blockers are generally considered the treatment of choice for prophylaxis of first variceal bleeding. A noninvasive method, beta blockers are able to reduce portal pressure, thus reducing the risk of variceal bleeding. While some studies suggest that EVL is superior to beta blockers, it is also associated with serious complications. The Taiwan study was conducted to evaluate the effectiveness of both treatments administered in combination.
Study leader Gin-Ho Lo, M.D. explained the rational behind testing these treatment approaches together. "The strength of EVL lies in its ability to obliterate varices, but portal pressure may be elevated after repeated procedures. Moreover, varices frequently recur after variceal obliteration achieved by EVL and beta blockers were documented to be able to reduce variceal recurrence. A combination of nadolol and EVL has been well established in preventing secondary variceal bleeding, but the effectiveness of this approach is unknown in preventing the first variceal bleeding."
Cirrhotic patients with high-risk esophageal varices but without bleeding history were enrolled in the randomized study. Eligible patients were required to have portal hypertension resulting from cirrhosis; moderate varices associated with red color signs (red wale markings, cherry red spots); no history of hemorrhage from esophageal varices or other upper gastrointestinal lesion; and no current treatment with beta-blockers. Seventy patients received band ligation plus nadolol and seventy received nadolol alone.
Patients in the combined group received regular ligation treatment at an interval of 4 weeks until variceal obliteration. Nadolol was administered at a dose to reduce 25% of pulse rate in both groups. During a median follow-up of 26 months, 18 patients (26%) in the combined group and 13 patients (18%) in nadolol group experienced upper gastrointestinal bleeding. Esophageal variceal bleeding occurred in 10 patients (14%) in the combined group and 9 patients (13%) in nadolol group. Adverse events were noted in 48 patients (68%) in the combined group and 28 patients (40%) in nadolol group. Sixteen patients in each group died, mostly from hepatic failure or sepsis.
"Our findings indicated that the addition of ligation to nadolol may increase adverse events and does not enhance effectiveness in preventing first variceal bleeding, concluded Dr. Lo. "Previous meta analysis of trials found that severe adverse events were significantly less in EVL compared with beta blockers. Based on our observation, nadolol alone did not cause severe adverse events if nadolol was reduced or discontinued in patients who reported side effects. The value of EVL in combination therapy requires further investigation."
Article: "A Controlled Trial of Ligation Plus Nadolol Vs. Nadolol Alone for the Prevention of First Variceal Bleeding." Gin-Ho Lo, Wen-Chi Chen, Huay-Min Wang, Ching-Chang Lee. Hepatology; Published Online: February 23, 2010 (DOI: 10.1002/hep.23617); Print Issue Date: July 2010. www3.interscience.wiley/journal/123300097/abstract
This study is published in Hepatology.
Source:
Dawn Peters
Wiley-Blackwell
суббота, 31 марта 2012 г.
суббота, 24 марта 2012 г.
Ethicon Endo-Surgery Launches New Realize™ Adjustable Gastric Band-C
Continuing its commitment to long-term patient success, Ethicon Endo-Surgery, Inc. announced the launch of the REALIZE™ Adjustable Gastric Band-C, the newest addition to the REALIZE portfolio. REALIZE Band-C is a new gastric band with a streamlined design that eases placement and has an expanded adjustment range that can accommodate larger patients.
The REALIZE Band-C has the same clinically proven high-volume, low-pressure system as the original REALIZE Band, but in addition to its new design, it has a 14 percent greater stoma adjustment range to accommodate larger patients. 2 The REALIZE Band-C has a width of 23 mm, making it the widest gastric band available potentially reducing the risk of band slippage.
"The REALIZE Band-C is an excellent innovation that streamlines the procedure for the surgeon and improves the overall experience for the patient," said Erik Wilson, MD, FACS, Director, Minimally Invasive and Bariatric Surgery, University of Texas, Houston, who has already begun using the REALIZE Band-C. "This new design builds on the original and retains all its clinical and procedural benefits for long-term patient success."
Additional features of the REALIZE Band-C include:
- Unlockable/Relockable Closing Mechanism that allows intra-operative repositioning.
- Removable Band Extender with a Pre-lock Position to ease gastric band placement and accommodate multiple locking techniques and provide greater surface area to grasp.
- Radiopaque Band and Tubing to enhance visualization under fluoroscopy.
- Removable One-way Valve to maintain balloon evacuation during gastric band preparation.
REALIZE Band-C patients have access to the REALIZE mySUCCESS™ program, an innovative Web-based tool to help facilitate positive long-term outcomes for patients. Patients who regularly use REALIZE mySUCCESS lose significantly more weight than those who do not. 3 REALIZE mySUCCESS is an integral element of the REALIZE offering through which the patient and bariatric practice stay connected pre- and post-surgery to help develop actionable strategies specific to each patient's individual challenges. The comprehensive solution helps to identify the root cause of obstacles to success, as well as provide tools to overcome them. The bariatric practice has access to the patient's information to help monitor progress and can step in when necessary to keep patients on track.
About The REALIZE Bands
The REALIZE Band, which is marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S., has been commercially available outside the U.S. since 1996 and has been used by hundreds of thousands of patients worldwide to help manage their weight. According to the American Society for Metabolic and Bariatric Surgery (ASMBS), about 220,000 people had some form of weight loss surgery last year.
The REALIZE Bands are intended for use in weight reduction for adults with morbid obesity and are indicated for adults with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. They are for use in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.
In a gastric band procedure with the REALIZE Bands, a soft, flexible silicone band is wrapped around the stomach to create two chambers - a small upper stomach with a narrow opening to the lower stomach. After the procedure, the upper stomach can only hold about four ounces of food, which limits food intake, makes patients feel full faster and longer, and slows digestion.
Once the band is in place, surgeons attach the REALIZE Injection Port to the abdominal wall underneath the skin. Using the REALIZE Injection Port Applier, this can be completed in less than a minute, which can decrease time under anesthesia.5 The REALIZE Injection Port allows doctors to inject or remove saline to tighten or loosen the band. The tighter the band, the more quickly the upper stomach fills up and the less food a person can eat. Adjustments are made periodically based on the patient's individual needs.
The REALIZE Band is not for patients with certain medical conditions that may put them at increased risk during or after surgery, or for patients who are unwilling to make significant changes in eating and behavior patterns. It may not be right for individuals with certain digestive tract conditions. All surgery presents risks. A patient's weight, age and medical history determine specific risks. Individual patient results may vary and are not indicative of all outcomes.
Source
Ethicon Endo-Surgery, Inc.
The REALIZE Band-C has the same clinically proven high-volume, low-pressure system as the original REALIZE Band, but in addition to its new design, it has a 14 percent greater stoma adjustment range to accommodate larger patients. 2 The REALIZE Band-C has a width of 23 mm, making it the widest gastric band available potentially reducing the risk of band slippage.
"The REALIZE Band-C is an excellent innovation that streamlines the procedure for the surgeon and improves the overall experience for the patient," said Erik Wilson, MD, FACS, Director, Minimally Invasive and Bariatric Surgery, University of Texas, Houston, who has already begun using the REALIZE Band-C. "This new design builds on the original and retains all its clinical and procedural benefits for long-term patient success."
Additional features of the REALIZE Band-C include:
- Unlockable/Relockable Closing Mechanism that allows intra-operative repositioning.
- Removable Band Extender with a Pre-lock Position to ease gastric band placement and accommodate multiple locking techniques and provide greater surface area to grasp.
- Radiopaque Band and Tubing to enhance visualization under fluoroscopy.
- Removable One-way Valve to maintain balloon evacuation during gastric band preparation.
REALIZE Band-C patients have access to the REALIZE mySUCCESS™ program, an innovative Web-based tool to help facilitate positive long-term outcomes for patients. Patients who regularly use REALIZE mySUCCESS lose significantly more weight than those who do not. 3 REALIZE mySUCCESS is an integral element of the REALIZE offering through which the patient and bariatric practice stay connected pre- and post-surgery to help develop actionable strategies specific to each patient's individual challenges. The comprehensive solution helps to identify the root cause of obstacles to success, as well as provide tools to overcome them. The bariatric practice has access to the patient's information to help monitor progress and can step in when necessary to keep patients on track.
About The REALIZE Bands
The REALIZE Band, which is marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S., has been commercially available outside the U.S. since 1996 and has been used by hundreds of thousands of patients worldwide to help manage their weight. According to the American Society for Metabolic and Bariatric Surgery (ASMBS), about 220,000 people had some form of weight loss surgery last year.
The REALIZE Bands are intended for use in weight reduction for adults with morbid obesity and are indicated for adults with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. They are for use in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.
In a gastric band procedure with the REALIZE Bands, a soft, flexible silicone band is wrapped around the stomach to create two chambers - a small upper stomach with a narrow opening to the lower stomach. After the procedure, the upper stomach can only hold about four ounces of food, which limits food intake, makes patients feel full faster and longer, and slows digestion.
Once the band is in place, surgeons attach the REALIZE Injection Port to the abdominal wall underneath the skin. Using the REALIZE Injection Port Applier, this can be completed in less than a minute, which can decrease time under anesthesia.5 The REALIZE Injection Port allows doctors to inject or remove saline to tighten or loosen the band. The tighter the band, the more quickly the upper stomach fills up and the less food a person can eat. Adjustments are made periodically based on the patient's individual needs.
The REALIZE Band is not for patients with certain medical conditions that may put them at increased risk during or after surgery, or for patients who are unwilling to make significant changes in eating and behavior patterns. It may not be right for individuals with certain digestive tract conditions. All surgery presents risks. A patient's weight, age and medical history determine specific risks. Individual patient results may vary and are not indicative of all outcomes.
Source
Ethicon Endo-Surgery, Inc.
суббота, 17 марта 2012 г.
HPV Vaccine Safe, Effective For Anal Cancer Prevention In Studies, FDA Document Says
Merck's human papillomavirus vaccine Gardasil is safe and effective at preventing anal cancer in both sexes, according to FDA background materials released on Monday, MedPage Today reports. The research materials were provided ahead of an FDA Vaccines and Related Biological Products Advisory Committee meeting on Wednesday.
View drug information on Gardasil.
The panel will discuss whether to expand Gardasil's approval to include prevention of anal cancer and associated precancerous lesions in people ages nine to 26. HPV is believed to cause 90% of anal cancers. Women have a higher incidence of anal cancer than men, though anal cancer rates are even higher among certain male populations, including men who have had receptive anal sex and those with HIV.
Gardasil was approved in 2006 to prevent genital warts and cervical cancer in girls and women ages nine to 26. The approval was expanded in 2009 to include prevention of male genital warts in the same age group. If the advisory committee agrees with information provided in the background document, it likely will endorse Merck's request for approval to prevent anal lesions and cancer. FDA is not required to follow the committee's recommendation, but it usually does.
Details of Background Materials
The FDA Center for Biologics Evaluation and Research analyzed new trial data on 4,065 men, including 602 men who have sex with men. Three percent of participants who received Gardasil developed anal cancer, compared with 12% in the placebo group. The vaccine was 78% effective at preventing anal intraepithelial neoplasia -- an abnormal cell growth associated with certain strains of HPV-- and 75% effective at preventing advanced dysplasia.
The reviewers concluded that the data show Gardasil is effective at preventing anal cancer caused by HPV in boys and men ages 16 through 25. The data can be extrapolated to women and younger people, they added. Merck did not submit new data on Gardasil's safety, but the reviewers said the vaccine "continues to have an acceptable safety profile" based on previous data provided to FDA (Walker, MedPage Today, 11/15).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
View drug information on Gardasil.
суббота, 10 марта 2012 г.
AmitizaTM (lubiprostone) May Help Improve Symptoms Of Irritable Bowel Syndrome With Constipation
A new study found that AMITIZA™ (lubiprostone) may help relieve the symptoms associated with constipation-predominant irritable bowel syndrome (IBS-C). IBS is a condition that affects nearly 30 million people in North America and accounts for 25-50 percent of referrals to gastroenterologists. The study was presented today at Digestive Disease Week, the largest annual meeting of digestive disease specialists.
"The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. "There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings."
AMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time AMITIZA has been tested exclusively in the IBS-C population.
About the Study
In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.
Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all AMITIZA groups.
Overall, the improvements were typically highest in the highest AMITIZA dose group (48 micrograms/day). Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of AMITIZA.
About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a chronic disorder characterized by multiple symptoms of abdominal pain and discomfort, bloating, and changes of bowel habits such as constipation and/or diarrhea. The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity.
Three main types of IBS exist: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D) and alternating constipation and diarrhea (IBS-A). In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of pain and discomfort is what differentiates IBS-C from chronic constipation. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation, whereas men are more likely to report diarrhea.
About AMITIZA
AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation.
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 (>=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 amitiza.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. (Sucampo) was founded in 1996 and is an emerging pharmaceutical company, based in Bethesda, Maryland. Under the direction of Sachiko Kuno, the company's president and CEO, it is transitioning itself from a research & development company to a fully integrated pharmaceutical company which now employs a small yet specialized sales force. Sucampo R&D focuses on the development and commercialization of drugs based on prostones. The therapeutic potential of prostones was first identified by co-founder, CSO and COO, Dr. Ryuji Ueno. Sucampo is focused on developing prostones with novel mechanisms of action for the treatment of gastrointestinal, respiratory, vascular and central nervous system diseases and disorders for which there are unmet or underserved medical needs and significant commercial potential.
In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market Sucampo's first approved product, 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. AMITIZA™ is a trademark of Sucampo Pharmaceuticals, Inc.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, 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 tpna.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
For more information, visit ddw.
View drug information on Amitiza.
"The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. "There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings."
AMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time AMITIZA has been tested exclusively in the IBS-C population.
About the Study
In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.
Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all AMITIZA groups.
Overall, the improvements were typically highest in the highest AMITIZA dose group (48 micrograms/day). Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of AMITIZA.
About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a chronic disorder characterized by multiple symptoms of abdominal pain and discomfort, bloating, and changes of bowel habits such as constipation and/or diarrhea. The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity.
Three main types of IBS exist: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D) and alternating constipation and diarrhea (IBS-A). In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of pain and discomfort is what differentiates IBS-C from chronic constipation. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation, whereas men are more likely to report diarrhea.
About AMITIZA
AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation.
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 (>=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 amitiza.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. (Sucampo) was founded in 1996 and is an emerging pharmaceutical company, based in Bethesda, Maryland. Under the direction of Sachiko Kuno, the company's president and CEO, it is transitioning itself from a research & development company to a fully integrated pharmaceutical company which now employs a small yet specialized sales force. Sucampo R&D focuses on the development and commercialization of drugs based on prostones. The therapeutic potential of prostones was first identified by co-founder, CSO and COO, Dr. Ryuji Ueno. Sucampo is focused on developing prostones with novel mechanisms of action for the treatment of gastrointestinal, respiratory, vascular and central nervous system diseases and disorders for which there are unmet or underserved medical needs and significant commercial potential.
In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market Sucampo's first approved product, 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. AMITIZA™ is a trademark of Sucampo Pharmaceuticals, Inc.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, 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 tpna.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
For more information, visit ddw.
View drug information on Amitiza.
суббота, 3 марта 2012 г.
Researchers Describe How Chronic Inflammation Can Lead To Stomach Cancer
A multi-center research team, led by Columbia University Medical Center, has uncovered a major contributor to the cause of stomach cancer the second leading cause of cancer-related mortality in the world. The team described for the first time, that elevated levels of a single proinflammatory cytokine, an immune system protein called interleukin-1 beta (IL-1??), can start the progression towards stomach cancer. These results are published in the Nov. 4, 2008 issue of Cancer Cell. The researchers hope to use this finding to develop ways to block this process, thereby preventing cancer from developing.
"This study shows that accumulation of IL-1??, which is induced by infection with the bacterium Helicobacter pylori (H. pylori) in the gastrointestinal tract, is a significant contributor to the onset of stomach cancer," said lead author Timothy C. Wang, M.D., chief of the Division of Digestive and Liver Diseases and the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University College of Physicians and Surgeons. "We show in this study that IL-1?? works by activating a type of white blood cell known as myeloid derived suppressor cells (MDSCs), which in our study appeared to be strongly pro-inflammatory. Blocking IL-1?? or the myeloid (MDSCs) cells may represent a potential strategy to prevent stomach cancer."
Previous research has shown that stomach cancer is strongly linked to chronic inflammation, and that infection with H. pylori may trigger the chronic inflammation that can lead to malignancy, but it was not known exactly how. While H. pylori infection is extremely prevalent, only a small minority (less than one percent) of infected individuals will, after many years, go onto develop stomach cancer. Previous research had linked H. pylori infection to the overexpression of IL-1??, and the susceptibility to gastric cancer to high-expressing IL-1?? genotypes [Nature 2000;404:398-404], so Dr. Wang and his research team developed a transgenic mouse model in order to investigate the specific role of IL-1?? in gastric carcinogenesis.
Results demonstrated that the overexpression of IL-1?? in the stomach mobilizes the recruitment of MDSCs initiating the progression of gastric inflammation into cancer. Furthermore, these findings help to explain why only a small percentage of those with H. pylori infection go onto develop stomach cancer a genetic predisposition for high expression levels of proinflammatory cytokines.
Stomach Cancer is One of the Most Deadly & Common Cancers Worldwide
Stomach (gastric) cancer is the second (after lung cancer) most common cause of cancer-related mortality worldwide with 900,000 deaths this year. Stomach cancer is much more common in South America, Japan, Korea and Iceland than in the United States, which represents just two percent (25,500) cases of all new stomach cancer diagnosed yearly. It is associated with a diet that is high in salt and low in fruits and vegetables, as well as with smoking, and is more common in men. Infection with the bacterium Helicobacter pylori (H. pylori) is the main risk factor in about 80 percent or more of stomach cancers.
H. pylori is typically acquired in childhood through person to person transmission, and the bacterium lives within the stomach just above the stomach cells, where it induces a mild inflammatory response known as gastritis. H. pylori infection is generally associated with low socioeconomic status and poor hygiene. New H. pylori infection is gradually disappearing from most industrialized countries such as the United States and is now seen predominantly in underdeveloped countries, particularly in Asia and South America. H. pylori infection can lead to both stomach cancer and stomach ulcers but in the vast majority (more than 80 percent) of infected people, it causes no health problems.
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit cumclumbia.edu.
Columbia University Medical Center
701 W 168th St., HHSC 206
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cumclumbia.edu
"This study shows that accumulation of IL-1??, which is induced by infection with the bacterium Helicobacter pylori (H. pylori) in the gastrointestinal tract, is a significant contributor to the onset of stomach cancer," said lead author Timothy C. Wang, M.D., chief of the Division of Digestive and Liver Diseases and the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University College of Physicians and Surgeons. "We show in this study that IL-1?? works by activating a type of white blood cell known as myeloid derived suppressor cells (MDSCs), which in our study appeared to be strongly pro-inflammatory. Blocking IL-1?? or the myeloid (MDSCs) cells may represent a potential strategy to prevent stomach cancer."
Previous research has shown that stomach cancer is strongly linked to chronic inflammation, and that infection with H. pylori may trigger the chronic inflammation that can lead to malignancy, but it was not known exactly how. While H. pylori infection is extremely prevalent, only a small minority (less than one percent) of infected individuals will, after many years, go onto develop stomach cancer. Previous research had linked H. pylori infection to the overexpression of IL-1??, and the susceptibility to gastric cancer to high-expressing IL-1?? genotypes [Nature 2000;404:398-404], so Dr. Wang and his research team developed a transgenic mouse model in order to investigate the specific role of IL-1?? in gastric carcinogenesis.
Results demonstrated that the overexpression of IL-1?? in the stomach mobilizes the recruitment of MDSCs initiating the progression of gastric inflammation into cancer. Furthermore, these findings help to explain why only a small percentage of those with H. pylori infection go onto develop stomach cancer a genetic predisposition for high expression levels of proinflammatory cytokines.
Stomach Cancer is One of the Most Deadly & Common Cancers Worldwide
Stomach (gastric) cancer is the second (after lung cancer) most common cause of cancer-related mortality worldwide with 900,000 deaths this year. Stomach cancer is much more common in South America, Japan, Korea and Iceland than in the United States, which represents just two percent (25,500) cases of all new stomach cancer diagnosed yearly. It is associated with a diet that is high in salt and low in fruits and vegetables, as well as with smoking, and is more common in men. Infection with the bacterium Helicobacter pylori (H. pylori) is the main risk factor in about 80 percent or more of stomach cancers.
H. pylori is typically acquired in childhood through person to person transmission, and the bacterium lives within the stomach just above the stomach cells, where it induces a mild inflammatory response known as gastritis. H. pylori infection is generally associated with low socioeconomic status and poor hygiene. New H. pylori infection is gradually disappearing from most industrialized countries such as the United States and is now seen predominantly in underdeveloped countries, particularly in Asia and South America. H. pylori infection can lead to both stomach cancer and stomach ulcers but in the vast majority (more than 80 percent) of infected people, it causes no health problems.
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