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News from the Literature |
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American Gastroenterological Association News From The Literature Combination Treatment for Hepatitis B Peginterferon alfa-2a offers superior efficacy over lamivudine monotherapy on the basis of Hepatitis B e antigen seroconversion, Hepatitis B DNA suppression, and Hepatitis B s antigen seroconversion, reports this week's New England Journal of Medicine. Current treatments for chronic Hepatitis B are suboptimal. Researchers compared the efficacy and safety of treatments for Hepatitis B e antigen-positive chronic Hepatitis B treatments. The investigators searched for improved therapies by comparing pegylated interferon alfa plus lamivudine, and pegylated interferon alfa without lamivudine. The investigative team also compared these with lamivudine alone for the treatment of hepatitis B e antigen-positive chronic Hepatitis B. A total of 814 patients with Hepatitis B e antigen-positive chronic Hepatitis B received 1 of 3 different treatments. Patients were treated for 48 weeks and followed for an additional 24 weeks. The investigators gave patients in Group 1 peginterferon alfa-2a 180 µg once weekly plus oral placebo. The patients in Group 2 received peginterferon alfa-2a plus lamivudine 100 mg daily, and patients in Group 3 received lamivudine alone. The investigative team reported that the majority of patients in the study were Asian and noted that most patients were infected with Hepatitis B virus genotype B or C. The researchers found that after 24 weeks of follow-up, more patients in Group 1 and Group 2 had Hepatitis B e antigen seroconversion than limivudine monotherapy. The team also found that after 24 weeks of follow-up, more patients in Group 1 and Group 2 had Hepatitis B DNA levels below 100,000 copies per milliliter. The investigators observed that 16 patients receiving peginterferon alfa-2a, alone or in combination, had Hepatitis B surface antigen seroconversion. The team compared the rate of seroconversion in the group receiving lamivudine alone and found this to be 0. The most common adverse events were those known to occur with therapies based on interferon alfa. The investigators noted that serious adverse events occurred in 4 percent, 6 percent, and 2 percent of patients in Groups 1, 2 and 3, respectively. The team reported that two patients receiving lamivudine monotherapy in Group 3 had irreversible liver failure after the cessation of treatment. Of these two patients in the lamivudine monotherapy group, one patient underwent liver transplantation, and the other died. New England Journal of Medicine; 2005: 352(26): 2682-95
Laparoscopic Roux-en-Y vs. Mini-gastric Bypass for Obesity In the most recent issue of Annals of Surgery researchers show that laparoscopic mini-gastric bypass is a simpler and safer procedure that has no disadvantage compared with laparoscopic Roux-en-Y gastric bypass. Researchers conducted a prospective, randomized trial to compare
treatments of morbid obesity. The team compared the safety and effectiveness
of laparoscopic Roux-en-Y gastric bypass and laparoscopic mini-gastric
bypass in the treatment of morbid obesity. The researchers found one conversion in the laparoscopic Roux-en-Y gastric bypass group. Operation time was shorter in laparoscopic mini-gastric bypass group and there was no mortality in either group. The team observed that the operative morbidity rate was higher in the laparoscopic Roux-en-Y gastric bypass group, at 20 percent versus 8 percent. The late complications rate was the same in the two groups at 8 percent with no re-operation. The team noted that weight loss was 59 percent and 60 percent at one and two years, respectively, in the laparoscopic Roux-en-Y gastric bypass group. The team noted that percentage weight loss in the group was 65 percent and 64 percent in the laparoscopic mini-gastric bypass group. Residual excess weight of less than 50 percent at two years postoperatively was achieved in 75 percent of patients in the laparoscopic Roux-en-Y gastric bypass group. In comparison, the researchers found that residual excess weight loss at two years in the laparoscopic mini-gastric bypass group was 95 percent. A significant improvement of obesity-related clinical parameters and complete resolution of metabolic syndrome in both groups were noted. In addition, the researchers observed that gastrointestinal quality of life increased significantly without any significant difference between the groups. Annals of Surgery; 2005: 242(1): 20-8
Resistance to Long-term Lamivudine Treatment in Hep B As reported in July's issue of the Journal of Viral Hepatitis researchers find no influence of Hepatitis B genotype on the development of resistance to lamivudine, however liver disease severity is influenced by genotype. Lamivudine is effective in suppressing viral replication, normalizing alanine aminotransferase, and improving histological appearance in Hepatitis B e-positive and negative hepatitis. It is unclear whether Hepatitis B virus genotype influences the response to lamivudine. Researchers from Canada investigated the long-term response of lamivudine. The researchers included patients with chronic Hepatitis B with and without cirrhosis at baseline treated with lamivudine according to Hepatitis B genotype. The research team retrospectively reviewed charts of all patients treated with lamivudine monotherapy between 1993 and 2002. Response to therapy was defined as alanine aminotransferase in the normal range, and undetectable Hepatitis B DNA. The team defined response to therapy in the Hepatitis B e antigen positive group as loss of Hepatitis B e antigen and/or the development of anti-Hepatitis B e. The researchers measured Hepatitis B DNA by the Digene Hybrid capture assay at a sensitivity of 1.4 with 106 copies/mL. YMDD mutation at rtL180M and rtM204V/I were measured by restriction digest of amplified products. The researchers performed genotyping by sequencing and phylogenetic tree analysis of the preS region of the virus genome. The research team reported that 71 patients were treated with lamivudine for six months or more, of which 53 were male with an average age of 47 years. They also reported that 38 of the patients were Hepatitis B e antigen-positive and 33 were Hepatitis B e antigen-negative. The team noted that mean baseline Hepatitis B DNA viral titre was 1280 copies/mL and 518 copies/mL respectively. Cirrhosis was present in 30 patients. The researchers examined sera for YMDD mutations at last patient visit in 86 percent, and were detected in 74 percent, there being no association with a particular genotype. The team observed that data from up to five years on lamivudine indicated no difference in biochemical or virological response between genotypes. The research team found that cirrhosis was more prevalent with specific genotypes. Journal of Viral Hepatitis; 2005: 12(4): 398
Combination therapy Improves Liver Transplant Outcomes Mycophenolate mofetil added to tacrolimus-based immunosuppression at discharge is associated with improved outcomes after liver transplantation with and without Hepatitis C, according to researchers in July's issue of Liver Transplantation. Researchers in Minnesota evaluated the impact of mycophenolate mofetil on long-term outcomes of tacrolimus and corticosteroids. The investigators analyzed data reported to the Scientific Registry of Transplant Recipients between 1995 and 2001. The investigative team considered data for 11,670 adult patients, of which 3463 had Hepatitis C, who underwent primary, single-organ, liver transplantation. The team included 4466 patients with mycophenolate mofetil of which 1322 had Hepatitis C. The team also included 7204 patients without mycophenolate mofetil of which 2140 had Hepatitis C. The included patients were discharged from the hospital on tacrolimus-based immunosuppression. The investigators found that recipients treated at discharge with mycophenolate mofetil, tacrolimus, and corticosteroids had and 81 percent patient survival rate. Patients’ survival was 77 percent for those treated with tacrolimus and corticosteroids alone. The team observed that graft survival was 76 percent for the combination group versus 73% for tacrolimus and corticosteroids alone. The investigators noted acute rejection rates of 29 percent for the mycophenolate mofetil recipients versus 33 percent treated with tacrolimus and corticosteroids alone. A trend toward lower rates of death from infection at 4 years was observed with 6% for mycophenolate mofetil versus 7 percent for tacrolimus and corticosteroids. The team reported however, that this result did not reach statistical significance. In multiple regression analyses, mycophenolate mofetil triple therapy at discharge was associated with a reduced risk of death. In addition, the team found that triple therapy was associated with reduced graft loss, acute rejection, and death from infectious complications. The investigators found similar outcomes for the cohort with Hepatitis C. Liver Transplantation; 2005: 11(7): 750-9
Chemotherapy for Advanced Colorectal Cancer In a study published in the latest Lancet Oncology, systemic adjuvant chemotherapy is shown useful in the treatment of advanced colorectal cancer, resulting in improved survival and reduced metastases. Systemic adjuvant chemotherapy can improve overall survival and reduce the incidence of distant metastases for patients with advanced colon cancer. Researchers investigated survival and recurrence for patients with stage
II to III colorectal cancer. The team considered whether regional chemotherapy
combined with systemic chemotherapy was more effective than systemic chemotherapy
alone. The investigators also compared systemic chemotherapy with fluorouracil
and folinic acid to that of fluorouracil and levamisole. The investigative
team randomly assigned 753 patients during surgery, with stage II to III
colorectal cancer. Patients were randomized either to systemic chemotherapy
alone, of which 379 received fluorouracil and folinic acid in Group 1 and
374 received fluorouracil and levamisole in Group 2. The team also randomized
748 patients to postoperative regional chemotherapy with fluorouracil followed
by systemic chemotherapy and with further randomization into Groups 3 and
4. The five-year overall survival was 72 percent for patients assigned regional and systemic chemotherapy, compared with 72 percent for systemic chemotherapy alone.The team also found that five-year overall survival for all patients assigned fluorouracil and levamisole was 72 percent. In addition, the five-year overall survival for all those assigned fluorouracil and folinic acid was 72.3 percent. The team noted that the hazard ratios for five-year disease-free survival were 0.94 for regional versus non-regional treatment. The investigators also noted that the hazard ratios for all fluorouracil and levamisole versus fluorouracil and folinic acid were 0.92. The team found that Grade 3 to 4 toxic effects were low in all groups. Lancet Oncology; 2005: Early Online Publication
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Policy Update Sens. Grassley and Baucus Introduce Legislation Linking Medicare Payments to Quality On June 30, Senators Charles Grassley, R-IA, and Max Baucus, D-MT (chairman of the Senate Finance Committee and ranking Democrat on Finance) introduced the Medicare Value Purchasing Act that would link Medicare payment to the quality of care delivered by hospitals, physicians, health plans, home health agencies and skilled nursing facilities. The legislation calls on the Secretary of Health and Human Services to contract with a private, non-profit entity that would be charged with approving quality measures in consultation with medical specialty societies. The quality measures would be evidence-based and would include measures of process, structure, outcomes, efficiency, patient experience, and equity. The legislation would require physicians to begin reporting on efficiency measures in 2007 and those physicians that report would receive the full Medicare update. Those physicians that do not report would receive an update reduced by 2 percent. Starting in 2008, physicians’ payments would be linked to quality performance or quality improvements, also known as pay-for-performance. Physicians would receive an additional 1-2 percent increase in payments for meeting certain thresholds in quality. Unfortunately, the legislation does not make changes to the current Medicare physician payment formula, known as the sustainable growth rate other than language recommending that it be fixed. Physicians are scheduled to receive a 4.3 percent reduction in payments beginning on Jan. 1, 2006 if Congress does not act. The AGA firmly believes that there are opportunities to improve the quality of gastroenterology care in our country. Consequently, the AGA is in the process of defining GI Quality indicators and developing related metrics for common GI conditions and procedures. Sen. Grassley would like to take action on this legislation in the fall and the AGA will continue to monitor any new developments as this important issue unfolds.
President Bush Signs Patient Navigator Legislation President Bush signed the Patient Navigator, Outreach and Chronic Disease Prevention Act into law last week, legislation authored by Rep. Robert Menendez, D-NJ, that would help low-income people who are at high-risk for cancer and other chronic illnesses obtain access to care. The legislation authorizes $25 million to train and deploy counselors to help patients gain access to screenings, early diagnoses, and clinical trials.
Enzi-Kennedy Introduce Health Information Technology Legislation Senate Health, Education, Labor and Pensions (HELP) Committee Chair Mike Enzi, R-WY, and Ranking Member Edward M. Kennedy, D-MA, introduced legislation that would make health information technology (IT) for providers interoperable nationwide. The Enzi-Kennedy bill would create a public-private collaborative for developing necessary technical standards to implement health care IT nationwide and provide grants to help smaller hospitals and doctors afford the necessary technology. Senate Majority Leader Bill Frist, R-TN, who has introduced his own health IT legislation with Sen. Hillary Clinton, praised the Enzi-Kennedy legislation and vowed to work together to pass legislation this year. Proponents of health IT say the technology can save our health care system billions of dollars and reduce medical errors. Chairman Enzi is scheduled to hold hearings on health IT this month in the HELP Committee.
Medicare Prescription Drug Benefit Update CMS has provided the attached document on their timeline for implementation of the Medicare Prescription Drug benefit (Medicare Part D) which is effective on Jan. 1, 2006. Medicare Calendar (PDF). Starting in July, the publication “Your Guide to Medicare Prescription Drug Plans” is available by calling 1-800-MEDICARE or by visiting www.medicare.gov. Medicare prescription drug coverage will be offered by Medicare Advantage Plans, Medicare Cost Plans and by stand alone Medicare Prescription Drug Plans. Beneficiaries will be able to choose a health plan once per year and have the choice of at least two plans. Beneficiaries may choose to keep their Medigap policy with drug coverage and will get a detailed notice from their insurance company in order to make a comparison with other drug plans. A typical beneficiary who is paying for drugs on his or her own today will receive help worth about $1,300, because the coverage will pay for part of their prescription drug costs after a deductible. Medicare will pay about 95 percent of the cost of prescriptions after a beneficiary’s out-of-pocket expenses reach $3,600 a year. Beneficiaries will pay a monthly premium that is expected to average about $37 in 2006. Beneficiaries may enroll with a drug plan starting on November 15 and must call the company offering the plan to enroll or enroll through 1-800-MEDICARE. Medicare prescription drug coverage begins Jan. 1 for those who enrolled in a plan by Dec. 31, 2005. Enrollment after the May 15, 2006 deadline will involve an increase in premiums. In April and May, Medicare will send a reminder to those beneficiaries who have not enrolled in a Medicare prescription drug plan. Beneficiaries who are dual eligible (Medicare/Medicaid) will automatically be eligible for assistance in paying for prescription drugs. In addition, the Social Security Administration is currently mailing information to about 20 million low income beneficiaries encouraging them to apply for assistance (up to 95 percent of their drug costs). CMS believes that up to 49 percent of beneficiaries will be consulting their own health care professional to obtain information about the Medicare Prescription Drug benefit. Physicians should encourage their patients to contact 1-800-MEDICARE or www.medicare.gov for more information about local resources and assistance in evaluating the health plans. CMS has created a number of tools that can be used in the health professional's office, including a provider tool kit filled with fact sheets and reproducible artwork. This information is available at www.cms.hhs.gov/medlearn/drugcoverage.asp.
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News For Clinicians AGA Offers GI Coding & Reimbursement Seminars The AGA is a proud sponsor of gastroenterology coding and reimbursement seminars presented by McVey Associates. Read an online brochure for more information. Following are dates and locations of the one-day seminars to be held this month.
AGA members can register for these workshops at the reduced fee of $250 ($230 for each additional registrant from a physician’s office.) If you are interested in attending a seminar, click on the city name above for a registration form.
AGA Fellowship Recognizes Professional Achievement AGA is honoring superior professional achievement in clinical practice and in basic/clinical research with Fellowship in the organization. AGA will award Fellowships annually to members whose accomplishments and contributions demonstrate personal and professional commitment to the field of gastroenterology. The program recognizes the achievements of both clinical practitioners and basic/clinical researchers. Fellowship in the AGA is by application only and applicants must meet certain criteria in order to apply. Visit the AGA Web site for details on eligibility. Applications are due in September of each year with Fellowship commencing in May. The application deadline for 2006 is Sept. 15, 2005. Fellowship will begin in May 2006. Members who have received the prestigious designation of Fellow will be able the use of the letters “AGAF” in their professional activities. They will also be recognized at DDW and in the association’s publications and communication vehicles. If you have further questions about the Fellowship program, please contact Cecile Katzoff at the AGA National Office at 301-941-2639 or ckatzoff@gastro.org.
Register for AGA’s Fall Postgraduate Course Join course directors Philip Schoenfeld, MD, MSEd, MSc (Epid), and Sander Van Zanten, MD, PhD as they present AGA’s Fall Postgraduate Course, Evidence Based Gastroenterology: Translating Evidence into Practice that will be held Sept. 10-11, 2005, during the World Congress of Gastroenterology (WCOG) meeting in Montreal, Canada. They have brought together an internationally renowned faculty to discuss the most recent and best-designed clinical research data and offer clear recommendations about the management of patients with a variety of GI disorders. Topics that will be addressed include on-going controversies in gastroenterology, including management of patients with relapsing Hepatitis C infections, infliximib for maintenance of Crohn’s disease, endoscopic polypectomy for complicated polyps, and the most successful approaches to non-ulcer dyspepsia. This one-and-a half day course was designed to update academic and private practice gastroenterologists about difficult patient management issues by applying an evidence-based approach to each topic. Each presenter will offer a case study with specific management questions, followed by a critical and systematic review of the best available clinical trial evidence addressing controversial management issues. When gaps in the evidence are present, the faculty will provide recommendations based on their own clinical expertise. To get more information about program sessions and to register online, click here. Save an extra 15 percent on your registration when you register for both the AGA Postgraduate Course and the WCOG Program. To secure the preferred WCOG housing rates, please reserve your accommodations before the hotel reservation deadline of July 15, 2005. Remember to make your reservations as early as possible as rooms are limited and will fill up quickly.
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News For Academic Clinicians & Researchers Register for AGA’s Fall Postgraduate Course Join course directors Philip Schoenfeld, MD, MSEd, MSc (Epid), and Sander Van Zanten, MD, PhD as they present AGA’s Fall Postgraduate Course, Evidence Based Gastroenterology: Translating Evidence into Practice that will be held Sept. 10-11, 2005, during the World Congress of Gastroenterology (WCOG) meeting in Montreal, Canada. They have brought together an internationally renowned faculty to discuss the most recent and best-designed clinical research data and offer clear recommendations about the management of patients with a variety of GI disorders. Topics that will be addressed include on-going controversies in gastroenterology, including management of patients with relapsing Hepatitis C infections, infliximib for maintenance of Crohn’s disease, endoscopic polypectomy for complicated polyps, and the most successful approaches to non-ulcer dyspepsia. This one-and-a half day course was designed to update academic and private practice gastroenterologists about difficult patient management issues by applying an evidence-based approach to each topic. Each presenter will offer a case study with specific management questions, followed by a critical and systematic review of the best available clinical trial evidence addressing controversial management issues. When gaps in the evidence are present, the faculty will provide recommendations based on their own clinical expertise. To get more information about program sessions and to register online, click here. Save an extra 15 percent on your registration when you register for both the AGA Postgraduate Course and the WCOG Program. To secure the preferred WCOG housing rates, please reserve your accommodations before the hotel reservation deadline of July 15, 2005. Remember to make your reservations as early as possible as rooms are limited and will fill up quickly.
September Research Award Application Deadlines The AGA Foundation for Digestive Health and Nutrition awards over $2 million annually for basic and clinical research in gastrointestinal disorders. The following research award applications are due September 5, 2005:
Award guidelines, eligibility requirements, future deadline dates and electronic applications can be obtained by visiting the Foundation website at www.fdhn.org.
AGA Fellowship Recognizes Professional Achievement AGA is honoring superior professional achievement in clinical practice and in basic/clinical research with Fellowship in the organization. AGA will award Fellowships annually to members whose accomplishments and contributions demonstrate personal and professional commitment to the field of gastroenterology. The program recognizes the achievements of both clinical practitioners and basic/clinical researchers. Fellowship in the AGA is by application only and applicants must meet certain criteria in order to apply. Visit the AGA Web site for details on eligibility. Applications are due in September of each year with Fellowship commencing in May. The application deadline for 2006 is Sept. 15, 2005. Fellowship will begin in May 2006. Members who have received the prestigious designation of Fellow will be able the use of the letters “AGAF” in their professional activities. They will also be recognized at DDW and in the association’s publications and communication vehicles. If you have further questions about the Fellowship program, please contact Cecile Katzoff at the AGA National Office at 301-941-2639 or ckatzoff@gastro.org.
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News for Trainees Register for AGA’s Fall Postgraduate Course Join course directors Philip Schoenfeld, MD, MSEd, MSc (Epid), and Sander Van Zanten, MD, PhD as they present AGA’s Fall Postgraduate Course, Evidence Based Gastroenterology: Translating Evidence into Practice that will be held Sept. 10-11, 2005, during the World Congress of Gastroenterology (WCOG) meeting in Montreal, Canada. They have brought together an internationally renowned faculty to discuss the most recent and best-designed clinical research data and offer clear recommendations about the management of patients with a variety of GI disorders. Topics that will be addressed include on-going controversies in gastroenterology, including management of patients with relapsing Hepatitis C infections, infliximib for maintenance of Crohn’s disease, endoscopic polypectomy for complicated polyps, and the most successful approaches to non-ulcer dyspepsia. This one-and-a half day course was designed to update academic and private practice gastroenterologists about difficult patient management issues by applying an evidence-based approach to each topic. Each presenter will offer a case study with specific management questions, followed by a critical and systematic review of the best available clinical trial evidence addressing controversial management issues. When gaps in the evidence are present, the faculty will provide recommendations based on their own clinical expertise. To get more information about program sessions and to register online, click here. Save an extra 15 percent on your registration when you register for both the AGA Postgraduate Course and the WCOG Program. To secure the preferred WCOG housing rates, please reserve your accommodations before the hotel reservation deadline of July 15, 2005. Remember to make your reservations as early as possible as rooms are limited and will fill up quickly.
Fellowship/Faculty Transition Awards Application Deadline The AGA Foundation for Digestive Health and Nutrition awards over $2 million annually for basic and clinical research in gastrointestinal disorders. Fellowship/Faculty Transition Award applications are due September 5, 2005. Four awards of $40,000 per year for two years are made to advanced fellows/trainees and provide salary support for additional full-time research training in basic science. Award guidelines, eligibility requirements, future deadline dates and electronic applications can be obtained by visiting the Foundation website at www.fdhn.org.
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