Although the relationship between alcohol and esophageal squamous cell carcinoma is well established, studies investigating the association between alcohol intake and reflux esophagitis (RE), Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC) have reported inconsistent findings. Furthermore, little is known regarding the effect of alcohol on BE, especially related to alcohol types.

Two recent studies published in Gastroenterology further our understanding of these illnesses. Gastroenterology is the official journal of the American Gastroenterological Association (AGA) Institute.

Education Status Is Significantly Inversely Associated with BE Risk

A new diagnosis of BE is associated with alcohol types, and the effects are modified by the presence of vitamin supplement use, according to a new study in Gastroenterology. The observed associations are independent of demographic and life-style factors that are related to choice of alcoholic beverages, including vitamin supplement use. In addition, higher education level is inversely related to the risk.

People with BE have a 30 to 125 fold increased risk of developing EAC compared to the general population. The incidence of EAC has increased by more than 500 percent in the last three decades, more rapidly than any other malignancy in the U.S. The rate of increase is most predominant among Caucasian males, suggesting that environmental or lifestyle factors may play important roles in the change in incidence.

“The identification of risk factors for BE may provide information on early events in the carcinogenic pathway for EAC that could lead to effective intervention strategies,” said Ai Kubo, PhD, of Kaiser Permanente and lead author of the study.

This study is the first community or population-based study in the U.S. to evaluate alcohol and socio-demographic factors as risk factors for BE. Using a case-control study within the Kaiser Permanente Northern California membership, patients with a new diagnosis of BE (n=320) between 2002 and 2005 were matched to persons with gastroesophageal reflux disease (GERD; n=316) and to population controls (n=317). Information was collected using validated questionnaires during direct in-person interviews; analyses used multivariate unconditional logistic regression.

Total alcohol use was not significantly associated with the risk of BE, although stratification by beverage type showed an inverse association for wine drinkers compared to nondrinkers (seven+ drinks wine/week versus none: OR=0.44, 95 percent CI (0.20-0.99); multivariate analysis). Among population controls, those who preferred wine were more likely to have college degrees and regularly take vitamin supplements than those who preferred beer or liquor. Adjustment for these factors or GERD symptoms did not eliminate the inverse association between wine consumption and BE. Education status was significantly inversely associated with the risk of BE.

“Future studies examining the interaction between vitamin supplement and alcohol types and how socioeconomic status may affect GERD and BE are needed,” added Dr. Kubo.

Total Alcohol Consumption at 21 Is Significantly Associated with RE

Alcohol consumption in early adulthood may lead to the development of reflux esophagitis (RE), according to a new study in Gastroenterology. However, more recent alcohol consumption does not appear to confer any increased risk of RE, BE or EAC. In fact, wine consumption may reduce the risk of these esophageal disorders.

Gastroesophageal reflux (GER) symptoms are common in Western societies with 10 to 20 percent of adults experiencing at least weekly symptoms. GER is the main predisposing risk factor for erosive RE, BE and EAC; alcohol may increase GER by causing relaxation of the lower esophageal sphincter.

Using data collected as part of an all-Ireland case-control study, the FINBAR (Factors INfluencing the Barrett’s Adenocarcinoma Relationship) study, information relating to alcohol consumption (at age 21 and five years before the interview date) was collected from 230 RE, 224 BE and 227 EAC patients and 260 frequency-matched population controls. Logistic regression analyses were used to compare alcohol consumption in the three case groups to controls with adjustment for potential confounders. The FINBAR study is one of the largest case-control studies to date to investigate the association between alcohol consumption and RE, BE and EAC using the same control group.

Population controls reporting GER symptoms were less likely than controls without symptoms to drink alcohol five years before the interview date (OR 0.44, 95 percent CI 0.20-0.99). No associations were observed between total alcohol consumption five years before the interview date and RE, BE or EAC (ORs, 95 percent CI: 1.26, 0.78-2.05, 0.72, 0.43-1.21 and 0.75, 0.46-1.22, respectively). Wine was inversely associated with RE (OR 0.45, 95 percent CI 0.27-0.75). Total alcohol consumption at age 21 was significantly associated with RE (OR 2.24, 95 percent CI 1.35-3.74), but not with BE or EAC (ORs, 95 percent CI: 1.06, 0.63-1.79 and 1.27, 0.77-2.10, respectively).

These preliminary findings warrant further research. Future studies should consider the influence of reflux symptoms and the temporality of the association carefully when interpreting the association between alcohol and RE, BE and EAC.

About the AGA Institute

The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is one of the oldest medical-specialty societies in the U.S. Comprised of two non-profit organizations – the AGA and the AGA Institute – our more than 17,000 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. The AGA, a 501(c6) organization, administers all membership and public policy activities, while the AGA Institute, a 501(c3) organization, runs the organization’s practice, research and educational programs. On a monthly basis, the AGA Institute publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The organization’s annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. For more information, please visit http://www.gastro.org/.

About Gastroenterology

Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, CABS, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit http://www.gastrojournal.org.

Asked if they would support a trigger law that would ban the procedure if Roe is overturned, 21 state senators said they would support it; six said they would not. Three senators said they would support a measure that would protect abortion rights if Roe is overturned. In addition, three senators said they were not sure, three gave no selection and 12 did not participate in the survey, the Associated Press reports.

Sen. Phil Erdman (R), a supporter of a law banning abortions, said, “It would be logical to have a law in place to be triggered in the event the current precedent and legal understanding is changed to provide clarity for an uncertain time.” Sen. Deb Fischer (R) said, “I am pro-life and oppose abortion. However, passing a law [to prohibit the procedure] now would be premature and could have unintended consequences.” She added, “I believe it would be more appropriate to wait and see what the court’s decision would be and then pass legislation that specifically addresses that decision” (Beck, Associated Press, 12/29/07).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2007 The Advisory Board Company. All rights reserved.

Nexium® will become the first of the proton pump inhibitors (PPI) currently available for the treatment of pediatric GERD to have a specific formulation developed for children.1

Children with GERD can experience disruptive symptoms on an everyday basis, with a recent AstaZeneca survey indicating that school performance, sleeping habits and social activities were all affected by the condition. 2 Furthermore, the impact of symptoms can be distressing for not only the child but also their parents and / or caregivers. 2

Nexium, which is licensed for treatment of GERD, will be available in a 10 mg sachet formulation of acid resistant pellets, which are dispersed in liquid. The sachet has a mild citrus-taste and does not contain any artificial flavours. Nexium® also provides the added flexibility of administration via nasogastric or gastric tube. 1

In making its recommendations, the MPA reviewed data from a range of safety and pharmacokinetic studies that investigated symptom improvement and healing as secondary endpoints. 3-6 These included a multicentre parallel group study conducted in 109 children aged 1-11 years with endoscopically proven GERD, of whom almost half had erosive esophagitis. Patients were stratified on the basis of weight and were randomized within each group to receive treatment for 8 weeks (5 or 10 mg esomeprazole [< 20kg] and 10 or 20 mg [> 20kg]) 6

Patient diary assessments by the parent/guardian showed that among the 58 patients who had moderate to severe symptoms (heartburn, acid regurgitation and epigastric pain) at baseline, over 90% experienced symptomatic improvement after treatment with Nexium.5 Reflux esophagitis was healed in the majority of patients 6 and Nexium was also shown to be generally well tolerated in the patient population.5

In children, Nexium® is approved for the treatment of GERD patients aged 1-17 years1. It is also currently under clinical evaluation for the treatment of GERD in even younger children, aged 0 – 1 year.

In adults, Nexium® is approved in Europe for the treatment of heartburn and other symptoms associated with acid reflux (GERD), for the treatment of reflux esophagitis and for the long-term management of patients with healed esophagitis to prevent relapse. Nexium® is also indicated in the EU for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. 1

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For further information, please visit http://www.astrazeneca.com.

GERD

Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications7. Symptoms can disrupt the physical, social and emotional wellbeing of many patients in spite of efforts to manage their condition8 .

In a practiced-based study, heartburn and acid regurgitation were reported as occurring on a weekly basis in approximately 2% of 3-9 year old children and about 5-8% of 10-17 year olds9

References

1. Nexium Prescribing Information, AstraZeneca

2. Parents’ Perspectives on GERD, AstraZeneca Survey. September, 2006

3. Zhao J, Li J, Hamer-Maansson JE, Andersson T, Fulmer R, Illueca M, Lundborg P. Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastroesophageal reflux disease: a randomized, open-label study. Clinical Therapeutics 2006;28(11):1868-76.

4. Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis (EE) and improvement in symptoms of gastroesophageal reflux disease (GERD) in 1- and 2-year-old children after esomeprazole treatment. Gastrointestinal Endoscopy 2007; 65(5 Suppl 1): AB118 , Abs 670.

5. Gilger M, Tolia V, Vandenplas Y, Youssef N, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006;43(4) :E20-1, Abs 23.

6. Tolia V, Youssef N, Belknap W, Gilger M, Traxler B, Illueca M. Treatment of erosive esophagitis with esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006; 43(4): E20, Abs 22.

7. Vakil N, Van Zanten SV, Kahrilas P, Dent J, Jones R and the Global Consensus Group. The Montreal Definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006;101:1900-20.

8. Liker H, Hungin P, Wiklund I. Managing gastroesophageal reflux disease in primary care: the patient perspective. J Am Board Fam Pract 2005;18:393-400.

9. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000;154:150-4.

“The availability of Protonix For Delayed-Release Oral Suspension provides adult patients who cannot swallow tablets with an effective and convenient way to treat their erosive gastroesophageal reflux disease (GERD),” says gastroenterologist Richard Lynn, MD, Senior Director, Global Medical Affairs for Wyeth Pharmaceuticals.

Protonix is one of the leading treatments for patients with erosive GERD. The addition of Protonix For Delayed-Release Oral Suspension builds upon the successful Protonix family of products, which also includes Protonix Delayed-Release Tablets and Protonix I.V. For Injection. The new Protonix For Delayed-Release Oral Suspension provides comparable acid suppression to Protonix Tablets.

Protonix For Delayed-Release Oral Suspension can be administered orally in applesauce or apple juice, or through a nasogastric (NG) tube. Protonix For Delayed-Release Oral Suspension is indicated for the treatment and maintenance of healing of erosive esophagitis with associated gastroesophageal reflux disease (GERD) symptoms. Controlled studies did not extend beyond 12 months.

The adverse reaction profile of Protonix For Delayed-Release Oral Suspension is similar to the established safety profile of Protonix Delayed-Release Tablets. In clinical trials, the most frequently reported adverse events with Protonix Delayed-Release Tablets were headache, diarrhea, and flatulence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation. Patients treated with proton pump inhibitors (PPIs) and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Wyeth Pharmaceuticals:

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, risk factors.” The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.