Management of Peptic Ulcer Disease in Older People Gregory J Lockrey

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1 GERIATRIC THERAPEUTICS Editors: Dr Michael Woodward, Director of Aged Care Services, Dr Margaret Bird, Consultant Geriatrician, Ms Sarah McKernin, Clinical Pharmacist, Austin & Repatriation Medical Centre, Vic.; Ms Helen Lourens, Director of Pharmacy, Coffs Harbour Hospital, NSW; Mrs Robyn Saunders, Clinical Services Consultant, Slade Pharmacy, Vic. Management of Peptic Ulcer Disease in Older People Gregory J Lockrey ABSTRACT Peptic ulcer disease is common in older people, and they bear much of the impact of its complications. Improved understanding of the principal causes of ulcers Helicobacter pylori and non-steroidal anti-inflammatory drugs has recently led to significant advances in drug treatment for ulcer disease. These new treatments offer the prospect of better symptom relief and improved mortality in the elderly. Aust J Hosp Pharm 1999; 29: INTRODUCTION Peptic ulcer disease has its greatest impact on older people. The principal aetiological factors use of aspirin or non-steroidal anti-inflammatory drugs, and Helicobacter pylori infection are more common in those aged over 60. Add to that a greater prevalence of cardiovascular and respiratory disease, and it is not surprising that the morbidity and mortality of ulcer disease are highest in the elderly. The actual management of ulcer disease changes little with the age of an individual patient. But improved management of peptic ulcers, and their complications, should be a priority in the older age groups, whose members have much to gain. AETIOLOGY Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID use by the elderly population is increasing steadily. Close to half of all such drugs are used by those aged over 60; approximately 15% of persons over 60 take NSAIDs. 1 Aspirin or NSAID use is more common in patients diagnosed with gastric ulcer, and in those presenting with bleeding ulcers (gastric or duodenal). 1 Various authors have reported that the incidence of both gastropathy (ulcers or erosions) and death is 3 to 10 times higher in NSAID users than in non-users. In two large studies of NSAID users, the prevalence of ulcer disease was around 20 to 30%. ulcers were twice as common as duodenal. 2,3 Helicobacter pylori In Australia, the organism H. pylori infects approximately 38% of Anglo-Celtic adults. Prevalence increases with age, from 18% of year-olds to 53% of those aged over 70. The organism is probably acquired in childhood, yet its associated diseases mostly present in adult life. Infection rates are falling as living standards improve; high prevalence rates in older persons reflect the infection rate when they were children. This infection is more common in men, smokers, and those with lower incomes. 4 Rates of infection are higher in some population groups. Over 95% of duodenal ulcers and 65-70% of gastric ulcers are H. pylori positive. 5 Eradication of infection has been shown to alter the otherwise chronic, relapsing nature of peptic ulcer disease; reinfection is an uncommon event. 6 H. pylori infection can be diagnosed by a variety of methods (Table 1). The particular method selected in any individual will depend on whether ulcer disease has already been diagnosed, or ulcer healing needs to be checked. It is important to remember Gregory J Lockrey, MB BS (Melb), MPH, FRACP Gastroenterology Unit Austin & Repatriation Medical Centre Heidelberg, Victoria Address for correspondence: Dr Gregory Lockrey Austin Private Consulting Suite 226 Burgundy Street, Heidelberg Vic lockgj@internex.net.au The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

2 Table 1. Methods of diagnosing Helicobacter pylori infection Endoscopic (invasive) Breath test (non-invasive) Blood test (non-invasive) Test Advantages Disadvantages Urease testing Histology Culture 14 C-urea 13 C-urea Fast, accurate, cheap Detects other diagnoses Detects drug resistance Accessible, accurate Accurate, simple, no radiation, 'gold standard' Expensive Slow, difficult, expensive Radiation use Limited availability Serology Simple Variability, cannot assess eradication that both endoscopic and breath tests for H. pylori may produce false negatives when performed within four weeks of eradication therapy, other antibiotic therapy, or treatment with bismuth or proton pump inhibitors (PPIs). Serological tests, while simple, are prone to be very variable, and require validation in the particular population being studied. Reports of false positive antibody rates of around 30% in elderly people should prompt caution in their use. 7 Because it can take months for antibody levels to fall, this method is unsuitable for assessing eradication. NSAIDs and H. pylori The information available about whether these two factors interact in causing ulcers is limited. The presence of H. pylori in patients with NSAID-associated ulcers is (paradoxically) associated with a higher healing rate with drugs which do not eradicate the organism. 3 Attempts to reduce ulcer incidence amongst NSAID users by eradicating H. pylori prior to anti-inflammatory use have not had consistent results. 3,8,9 A recent consensus conference viewed NSAIDs and H. pylori as independent, though possibly additive, risk factors for the development of ulcer disease. 10 CLINICAL PRESENTATION AND COMPLICATIONS The overall incidence of peptic ulceration, and the proportion of ulcers which are gastric, both increase with increasing age. 1,11 While older persons may describe epigastric pain related to meals, relieved by eating or antacids, they often have an atypical history for ulcer disease: absent or trivial pain, weight loss, anaemia. 11 Bleeding is the most common complication; perforation is less common, with diagnosis often delayed by a paucity of abdominal signs; obstruction is rare. It is interesting to note that: 70% of persons hospitalised for ulcer complications are aged over 60; 80% of ulcer deaths occur in persons over 65 years, with 74% of these deaths from gastric ulcers; mortality is high in the elderly approximately 30% for complicated ulcers. 1 MANAGEMENT PRINCIPLES Uncomplicated Ulcers Endoscopy is the preferred means of diagnosis, and it permits the taking of biopsies, both to exclude malignancy and for urease testing. Endoscopy is well tolerated in older persons, and its use is preferable to empirical therapy. Drug therapy is aimed at ulcer healing, both for symptom control, and to reduce complications. Other issues to be addressed are whether to cease NSAIDs, possibly substituting other analgesics, and when to use co-therapy (to prevent NSAID-associated damage) or maintenance ulcer healing therapy (these issues are discussed in more detail below.) Repeat endoscopy (possibly with biopsies) is indicated to demonstrate ulcer healing of gastric ulcers, and to check for H. pylori eradication (when appropriate). Verification of healing is not usually advised for uncomplicated duodenal ulcers. Complicated Ulcers Admission to hospital is essential, for resuscitation and investigation. Endoscopy provides an accurate diagnosis, identifies those still bleeding or with a higher probability of re-bleeding, and permits endoscopic therapy. Most bleeding ulcers stop spontaneously. 12 Endoscopic therapy is effective in four out of five actively bleeding ulcers, reducing the need for urgent surgery. 11,12 Surgery remains important for dealing with continuing or recurrent bleeding resistant to endoscopic therapy, and is the preferred treatment for perforation. There is some evidence that high dose acid suppression may be effective in reducing re-bleeding, and the need for surgery, in patients who have presented with bleeding ulcers. 13,14 The precise role for such therapy, in relation to endoscopic therapy, remains to be determined by appropriate trials. 12 Until then, this area remains controversial. The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

3 Table 2. Drugs used for ulcer healing Duration Efficacy Comments H 2 (full dose at night, or half twice daily) cimetidine 800 mg famotidine 40 mg nizatidine 300 mg ranitidine 300 mg Proton pump inhibitors (daily dose) lansoprazole 30 mg omeprazole pantoprazole 40 mg Prostaglandin agonist misoprostol 800 µg (in 2-4 doses) Cytoprotectants colloidal bismuth subcitrate 108 mg four times daily (or 216 mg twice a day) sucralfate 1 g four times a day 6-12 weeks Good healing; high relapse rate if drug ceased, or if H. pylori not eradicated 4-8 weeks More effective and more rapid healing than H weeks Similar efficacy to H weeks Similar efficacy to H 2 Few interactions or adverse events (although more common in those aged over 70); gastric ulcers often slower to heal; maintenance therapy is an option Particularly useful for NSAID ulcers and for treatment failures with other drugs Useful for NSAID ulcers (superior to standard dose H 2 for NSAID gastric ulcers) Mostly used in triple therapy regimens; maintenance therapy not recommended Not widely used DRUG THERAPY NSAID Ulcers Prevention of ulcers in NSAID users would be the most logical approach to the problem in older persons. Misoprostol has been shown to be effective therapy for prophylaxis of NSAID ulcers. Its major limitation is associated abdominal cramping and/or diarrhoea. A combination of misoprostol and diclofenac (Arthrotec available in Australia through the Repatriation, but not the general, Pharmaceutical Benefits Scheme) has been shown in several studies to produce fewer gastroduodenal ulcers than diclofenac, piroxicam or naproxen alone. 15 High dose famotidine (40 mg twice daily) reduces the occurrence of NSAID-associated gastric ulcer, when compared with standard dose ( twice daily) or placebo; either dose is effective prophylaxis for duodenal ulcer in NSAID recipients. 16 When ulcers occur, the simplest approach is to: stop the NSAID, substituting simple analgesics and other non-drug means of management; heal the ulcer with an appropriate drug (Table 2). If the NSAID cannot be stopped, healing is slower. Both H 2 and proton pump inhibitors have a very low incidence of side effects. Interactions with warfarin, benzodiazepines, and b-blockers can be an issue when using cimetidine. Whether reported adverse effects, such as confusion in older patients taking cimetidine, are due to the drugs, or due to coexistent illness is not resolved. 17 Two recent, double-blind, randomised trials compared omeprazole with misoprostol and ranitidine for healing NSAID ulcers and erosions when the NSAID was continued (Table 3). 2,3 In the first study, for gastric ulcers, standard (but not high) dose omeprazole was significantly better than misoprostol 200 mg four times daily. For duodenal ulcers, both doses of omeprazole were significantly better. 2 In the second study, both omeprazole doses were significantly better than ranitidine 150 mg twice daily for healing gastric ulcers; omeprazole was significantly better than ranitidine for duodenal ulcers. 3 Table 3. Healing rates at 8 weeks of NSAID ulcers (while NSAID is continued) 2,3 Ulcer type 87% 93% 84% 92% 40 mg 80% 89% 40 mg 87% 88% Misoprostol 800 µg 73% 77% Ranitidine 300 mg 64% 81% was the superior drug in both trials. However, the healing rates for misoprostol in duodenal and gastric ulcer, and ranitidine in duodenal ulcer were not that different; it is possible that such differences at eight weeks simply represented more rapid healing with the more potent acid inhibitor, omeprazole. Once NSAID-associated ulcers have been healed, co-therapy with omeprazole daily has been The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

4 shown to be an effective way of preventing ulcer recurrence in those who need to continue to use NSAIDs. 2,3 Misoprostol, 200 mg twice daily, was about as effective as omeprazole in preventing gastric ulcers, but less so for duodenal (Table 4). Side effects leading to cessation of therapy were more common with misoprostol. 2 Ranitidine, 150 mg twice daily, was less effective than omeprazole as co-therapy; this difference was more marked for gastric than for duodenal ulcers. 3 Other proton pump inhibitors may prove in the future to have a similar effect to omeprazole. Table 4. Ulcer relapses at 6 months during co-therapy (while NSAID is continued) 2,3 Ulcer type 13% 3% 5.2% 0.5% Misoprostol 400 µg Placebo 10% 10% Ranitidine 300 mg 16.3% 4.2% 32% 12% Co-therapy with misoprostol in NSAID users has been shown to prevent ulcer complications; the same cannot yet be said for co-therapy with omeprazole. However, its greater efficacy is likely to translate into reduced complication rates, for ulcer complications cannot occur if ulcers are not present. 2,3 H. pylori related ulcers Successful eradication of the organism should lead to ulcer healing, and a low incidence of gastric or duodenal ulcer recurrence. Eradication is indicated for H. pylori positive individuals with duodenal or gastric ulcer, current or previously documented. H. pylori eradication reduces complications from peptic ulcer disease. Combinations of three drugs ( triple therapy ) have been shown to be necessary to eradicate this organism. Most combinations consist of either bismuth subcitrate, ranitidine bismuth subcitrate (RBC, not available in Australia), or a PPI, plus two antibiotics out of amoxycillin,, clarithromycin, or tetracycline. Clarithromycin is only available through the Pharmaceutical Benefits Scheme as part of a single-script combination (Losec Hp7 or Klacid Hp7). Many commonly used regimens are reported to achieve eradication rates around 80 to 90%. However, the rates actually achieved may be as low as 50 to 70% when resist- ant strains of H. pylori are present. 18,19 Metronidazole resistance rates in Australia vary greatly, but may be greater than 30%. The trend overseas has been for resistance rates to increase over time. With resistant strains, the eradication rates achieved by PPI-based therapies fall by 5-10%; with bismuth-based regimens the eradication rate may drop to around 50%. Combinations which include clarithromycin are generally more effective (over 90%). Currently there is little evidence of clarithromycin resistance in this country; it remains to be seen whether it will increase. Compliance is the other important factor in achieving successful eradication. 19 Side effects from medication seem to be most common with (nausea, a disulfiram-like reaction with alcohol) and bismuth (nausea, diarrhoea, blackened tongue and stools). Clarithromycin may cause disturbed taste, and all the antibiotics may lead to candidiasis or, rarely, to pseudomembranous colitis. Currently recommended therapies for use in the Asia Pacific region are listed in Tables 5. 10,19 Several single-pack combinations are available in Australia through the Pharmaceutical Benefits Scheme (Table 6). Small differences between the regimens relate to issues of drug availability, or to a two-week course of therapy being marketed in Australia, when many authors would recommend using the drugs for one week. These differences probably do not alter efficacy, but longer duration of therapy may worsen compliance or increase side effects. The management of treatment failure is more complex, and there is insufficient evidence to make firm recommendations. One approach, when has been used in the first regimen, is to repeat the triple therapy, replacing with amoxycillin. Some authors advocate giving a second course of PPI-amoxycillin-clarithromycin. Alternatively, a one-week course of bismuth--tetracycline, with added proton pump inhibitor, has been proposed. 10 With increasing use of eradication therapy, we can expect to see fewer people requiring maintenance acid suppression for ulcer disease. Nevertheless, there remain some patients, often elderly, for whom maintenance therapy, with an H 2 -antagonist or an acid pump inhibitor, is reasonable where eradication therapy has failed, or is contraindicated because of drug side effects or likely interactions. NSAIDs and H. pylori In the absence of appropriate trials, it seems prudent to eradicate H. pylori in those NSAID ulcer patients who also have the organism. Whether H. pylori eradi- The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

5 Table 5. Recommended therapies for Helicobacter pylori eradication 10,19 Drug combination Proton pump inhibitor, OR amoxycillin, clarithromycin Dose Standard dose (twice daily) 1000 mg twice daily Duration of treatment (weeks) Eradication rate (%) 1 >90 Ranitidine bismuth subcitrate,* OR amoxycillin, clarithromycin If clarithromycin is not available, consider either of: Proton pump inhibitor,, amoxycillin Colloidal bismuth subcitrate,, tetracycline 1000 mg twice daily Standard dose (twice daily) 1000 mg twice daily 1 four times daily 500 mg four times daily *not currently available in Australia; colloidal bismuth subcitrate available in 108 mg strength in Australia 1 > Table 6. Single-script Helicobacter pylori eradication therapies available through the Australian Pharmaceutical Benefits Scheme Product Losec Helicopak (Astra) omeprazole amoxycillin Helidac (Pharmacia Upjohn) bismuth tetracycline Losec Hp7 (Astra) Klacid Hp7 (Abbott) omeprazole amoxycillin clarithromycin Dose twice daily 400 mg three times daily 500 mg three times daily 108 mg four times daily 200 mg three times daily, 400 mg at night 500 mg four times daily twice daily Duration of treatment (weeks) Eradication rate (%) >90 cation should be attempted before NSAID use, to reduce the probability of ulcers arising, is controversial. The Asia Pacific Consensus group advocated eradication therapy in persons with an ulcer history who required NSAID therapy, but did not recommend routine testing for H. pylori prior to initiating treatment with NSAIDs. 10 FUTURE DIRECTIONS The problem of drug resistance may change our approach to H. pylori. A program monitoring antibiotic sensitivity patterns around Australia is now starting. 18 The discovery, in animals, that immunisation could cure existing infection promises to move the focus away from drugs in eradication and prevention of H. pylori infection. 20 Knowledge of the complete genome of H. pylori should aid the future development of genetically engineered therapeutic vaccines using multiple bacterial antigens. 21 NSAID ulcers may be more easily prevented, if future research can predict which persons are at greatest risk, and enable targeted prophylaxis. Present NSAIDs inhibit the enzyme cyclo-oxygenase (COX). Different forms of this enzyme occur in different tissues: inhibition of the COX-1 form in gastric mucosa seems to explain how these drugs cause upper gastrointestinal toxicity; inhibition of COX-2 in inflamed joints leads to the intended effect of the drugs. NSAIDs in current use are not specific for the COX- 2 enzyme. If more selective anti-inflammatory drugs with minimal or no COX-1 inhibition can be developed, gastroduodenal toxicity might be prevented. CONCLUSION Peptic ulcer disease has a disproportionate impact on the health of older persons in our community. The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

6 Guidelines adopted recently in the US, Europe and Asia for management of H. pylori all recommend eradication of the organism whenever it is present in ulcer disease, regardless of NSAID involvement. Effective means are available for the treatment of NSAID ulcers when the drug cannot be stopped, and for prevention of ulcer recurrence thereafter. 2,3 These approaches offer the prospect of preventing ulcer complications. Neither H. pylori eradication regimens, nor therapies to treat or prevent NSAID ulcer recurrence, are perfect at present, but they have substantially advanced the management of peptic ulcers. Both should improve the wellbeing of older persons with ulcers, and contribute to improved morbidity and mortality. References 1. Peterson WL. Bleeding peptic ulcer. Epidemiology and nonsurgical management. Gastroenterol Clin North Am 1990; 19: Hawkey CJ, Karrasch JA, Szczepañski L, Walker DG, Barkun A, Swannell AJ, et al. compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: Yeomans ND, Tulassay Z, Juhasz L, Racz I, Howard JM, van Rensburg CJ, et al. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: Lin SK, Lambert JR, Nicholson L, Lukito W, Wahlqvist M. Prevalence of Helicobacter pylori in a representative Anglo- Celtic population of urban Melbourne. J Gastroenterol Hepatol 1998; 13: Tytgat GN, Rauws EA. Campylobacter pylori and its role in peptic ulcer disease. Gastroenterol Clin North Am 1990; 19: Hopkins RJ, Girardi LS, Turney EA. Relationship between Helicobacter pylori eradication and reduced duodenal and gastric ulcer recurrence: a review. Gastroenterology 1996; 110: Liston R, Pitt MA, Banerjee AK. IgG ELISA antibodies and detection of Helicobacter pylori in elderly patients. Lancet 1996; 347: Rauws EA, Tytgat GN. Helicobacter pylori, gastritis and nonsteroidal anti-inflammatory drugs. Curr Opin Gastroenterol 1997; 13 (suppl. 1): Chan FKL, Sung JJY, Chung SCS, To KF, Yung MY, Leung VK, et al. Randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers. Lancet 1997; 350: Lam SK, Talley NJ. Helicobacter pylori consensus. Report of the 1997 Asia Pacific Consensus Conference on the management of Helicobacter pylori infection. J Gastroenterol Hepatol 1998; 13: Steinheber FU. Ageing and the stomach. Clin Gastroenterol 1985; 14: Saltzman JR, Zawacki JK. Therapy for bleeding peptic ulcers [editorial]. N Engl J Med 1997; 336: Khuroo MS, Yattoo GN, Javid G, Khan BA, Shah AA, Gulzar GM, et al. A comparison of omeprazole and placebo for bleeding peptic ulcer. N Engl J Med 1997; 336: Cole AT, MacIntyre AS, Hawkey GM, Chandler J, Christian J, Long RG, et al. Lansoprazole and tranexamic acid alone and in combination for upper gastrointestinal bleeding. Gastroenterology 1995; 108 (suppl.): Silverstein FE. Improving the gastrointestinal safety of NSAIDs: the development of misoprostol from hypothesis to clinical practice. Dig Dis Sci 1998; 43: Taha AS, Hudson N, Hawkey CJ, Swannell AJ,Trye PN, Cottrell J, et al. Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med 1996; 334: Woodhouse KW. Drugs and the ageing gut, liver and pancreas. Gastroenterol Clin North Am 1985; 14: Lee A, Hazell S. Antimicrobial resistance and Helicobacter pylori: impacts on current and future therapies [editorial]. Aust N Z J Med 1998; 28: 3-4, Dev AT, Lambert JR. Diseases associated with Helicobacter pylori. Med J Aust 1998; 169: Doidge C, Crust I, Lee A, Buck F, Hazell S, Manne U. Therapeutic immunisation against helicobacter infection [letter]. Lancet 1994; 343: Graham DY. Complete genomic sequence of Helicobacter pylori: implications for the clinician. Curr Opin Gastroenterol 1998; 14 (suppl. 1): S7-8. The Australian Journal of Hospital Pharmacy Volume 29, No. 1,

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