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With Lansoprazole, a New Proton Pump Inhibitor, Compared with Ranitidine

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With Lansoprazole, a New Proton Pump Inhibitor, Compared with Ranitidine 1458 Gut 1993; 34:1458-1462 CLINICAL TRIAL Gut: first published as 10.1136/gut.34.10.1458 on 1 October 1993. Downloaded from Improved symptom reliefand duodenal ulcer healing with lansoprazole, a new proton pump inhibitor, compared with ranitidine C J Hawkey, RG Long, K D Bardhan, K G Wormsley, K M Cochran, J Christian, I K Moules Abstract ly the discovery of substituted benzimidazoles, The purpose of this study was to compare which inhibit the (H+, K+) ATPase (proton duodenal ulcer healing, symptom relief, and pump) ofthe parietal cell' has led to the develop- safety of lansoprazole (a new proton pump ment of compounds that can profoundly inhibit inhibitor) given at doses of30 mg and 60 mg, in gastric acid production. Lansoprazole is a novel the morning with ranitidine 300 mg at bedtime. member ofthis new generation ofacid inhibiting Two hundred and eighty nine patients were drugs, the proton pump inhibitors. It selectively enrolled over a 20 month period in a double inhibits the proton pump in vitro23 and in vivo.4 blind randomised paraliel group comparative Human clinical pharmacology studies have study set in outpatient endoscopy units of six shown profound and prolonged suppression of United Kingdom medical centres. Patients 24 hour intragastric acidity with single 15 or were randomised to receive lansoprazole 30 mg doses of lansoprazole, which increased 30 mg in the morning (n=95), 60 mg in the with repeated doses.56 In addition a single 60 mg morning (n=96), or ranitidine 300 mg at bed- dose produced almost total inhibition of 24 hour time (n=98) for four weeks. Efficacy was gastric acidity as well as inhibiting pentagastrin assessed by gastroscopy at study entry and stimulated acid secretion by 92%.6 Early clinical after two and four weeks of treatment. studies with lansoprazole showed a dose related http://gut.bmj.com/ Symptom relief was monitored by patient increase in duodenal ulcer healing rates at daily diaries and physician review at two and four doses of 7 5 mg, 15 mg and 30 mg.7 We, weeks. Both doses of lansoprazole resulted therefore, compared lansoprazole at single daily in significantly greater ulcer healing than doses of 30 mg and 60 mg in the morning with ranitidine after two and four weeks. Respective ranitidine 300 mg at bedtime for four weeks in healing rates on lansoprazole 30 mg, 60 mg, the treatment ofpatients with duodenal ulcer, to and ranitidine 300 mg were 78%, 80%, and 60% investigate whether these doses of lansoprazole on September 27, 2021 by guest. Protected copyright. after two weeks and 93%, 97%, and 81% after were superior to ranitidine and determine which four weeks. Patients on lansoprazole 30 mg was optimal. Efficacy was assessed by endo- (p=0O002) and lansoprazole 60 mg (p=0026) scopic evidence of healing and by symptomatic also recorded greater relief of night time pain relief. Safety was monitored in terms of clinical Department of in the diary cards during the first seven days of adverse events as well as biochemical and Therapeutics, University Hospital, Nottingham treatment than those on ranitidine. Patients on haematological screening. C J Hawkey lansoprazole 60 mgreported significantly better R G Long pain relief at their two week visit compared Rotherham District with those receiving ranitidine (p=0 007). Methods General Hospital, There were no differences between treatment Rotherham groups in the occurrence or pattern of adverse STUDY DESIGN KD Bardhan drug reactions during the trial. It is concluded The study was a double blind, randomised, Ninewelis Hospital, that for patients with duodenal ulcer, lanso- parallel group comparison of lansoprazole Dundee prazole 30 mg or 60 mg is associated with 30 mg, lansoprazole 60 mg both in the morning K G Wormsley faster ulcer healing and better symptom relief and ranitidine 300 mg at bedtime conducted Victoria Infirmary, than ranitidine 300 mg at bedtime. There at six hospitals in Nottingham, Rotherham, Glasgow were no significant differences between Glasgow, and Dundee, United Kingdom. K M Cochran lansoprazole 30 mg and 60 mg. These data Lederle Laboratories, indicate that lansoprazole should be used at a Gosport once daily dose of 30 mg for the treatment of PATIENT SELECTION J Christian duodenal ulcer. Patients between the ages of 18 and 75 I K Moules (Gut 1993; 34: 1458-1462) (inclusive), with duodenal ulcer(s) proved by Correspondence to: endoscopy greater than 3 mm but not more than Professor C J Hawkey, Department of Therapeutics, 2-5 cm in diameter were eligible if they had not University Hospital, Nottingham NG7 2UH. The efficacy ofinhibitors ofgastric acid secretion received therapeutic doses of ulcer treatment in Accepted for publication in healing duodenal ulcers has been repeatedly the previous six days or bismuth within the 12 May 1993 confirmed during the past 18 years. More recent- previous three months. Standard exclusion Duodenal ulcer healingand lansoprazole 1459 criteria were used, the principal ones being TABLE I Demography ofpatients studied concomitant reflux oesophagitis, oesophageal stricture, Barrett's oesophagus, gastric ulcer- Lansoprazole Lansoprazole Ranitidine 30 mg 60 mg 300 mg Gut: first published as 10.1136/gut.34.10.1458 on 1 October 1993. Downloaded from upper gastro- ation, gastrointestinal bleeding, No of patients 95 96 98 intestinal malignancy, previous gastric surgery, M/F 71/24 65/31 68/30 inflammatory bowel disease, or any serious Mean age (SD) 43 (14) 46 (16) 48 (13) or of Smokers (%) 57 67 63 cardiac, renal hepatic disorders. Women Drinkers (%) 73 69 60 child bearing potential could be enroled pro- Receiving NSAIDs (%) 2 5 7 vided they were practising effective contracep- New patient (%) 42 59 53 Relapsed (%) 57 40 47 tion. Patients taking steroids or anti-coagulants Refactory (%) 1 1 0 were excluded. History (%) <1 year 15 25 22 1-5 years 44 32 38 >5 years 41 41 40 TREATMENT Patients were stratified for smoking habits before NSAIDs=non-steroidal anti-inflammatory drugs. randomisation (in blocks of three at each centre) to receive lansoprazole 30 mg or 60 mg in the morning or ranitidine 300 mg at bedtime. Drugs regression analysis'0 was used to assess the in- and placebo were provided as white, hard gelatin fluence of prognostic factors and to justify the capsules in blister packs to maintain blinding. pooling of response data across trial centres Patients took two capsules in the morning half an (centre/treatment interaction). The Kruskal- hour before food and two capsules at night before Wallis test was used to compare the frequency retiring. Patients received treatment for 28 (+ or of pain and antacid use, and adverse events. minus three days) regardless of healing state Analysis of variance was used to assess changes (see below). Maalox tablets were provided for in laboratory values. All calculations were per- additional symptom relief as required. formed using the SAS package."I 12 Sample size was calculated assuming a healing rate of 65% with ranitidine at week 2. With 95 EVALUATIONS patients in each treatment group, a 20% im- Patients were entered into the study within seven provement with either lansoprazole group could days of an endoscopy showing active duodenal be detected with a power of 80% at a two sided ulceration. Duodenal ulcer was defined as a significance value of 5%. break in the mucosa distal to the opening of the pylorus with excavation and slough at the base. Healing was monitored by repeat endoscopy Results performed after 14 (+ or minus three days) of Two hundred and eighty nine patients were http://gut.bmj.com/ treatment, and (in those unhealed at 14 days) enroled into the study over a period of 20 after 28 (+ or minus three days). months. One hundred and eighty were smokers The occurrence of pain, nausea, and vomiting and 109 were non or former smokers. Table I (occasional, daily, continual) over the previous shows the distribution of patient characteristics week were assessed by the investigator at each across the three treatment groups. Age, sex, visit. In addition, patients recorded day and smoking, and alcohol use seem to be relatively night time pain (none, mild, moderate, severe) well balanced across the treatment groups. Any on September 27, 2021 by guest. Protected copyright. and antacid consumption on a daily diary card. effect these factors may have had on healing rates Compliance was monitored by capsule count at were examined using logistic regression analysis. each visit. Safety evaluation was based upon adverse event monitoring as well as physical examination, urinalysis, blood count, urea and ULCER HEALING electrolytes, liver function tests, uric acid, The primary analysis showed a statistically calcium and phosphate estimations. significant difference across treatment groups both at week 2 (p=0 005) and week 4 (p=0 001). Pairwise comparisons showed that the STATISTICAL METHODS superiority of healing rates with both doses The primary end point was cumulative ulcer healing in evaluable patients (all those having an endoscopy at a particular visit). This can be TABLE II Healing rates in evaluable patients regarded as a pragmatic approach.8 In addition a secondary 'per protocol' analysis was per- Lansoprazole Lansoprazole Ranitidine 30 mg 60 mg 300 mg formed, in those patients who met the eligibility criteria (patient selection) and evaluability No of patients 95 96 98 within Week 2: No of patients 65/83 67/84 52/87 criteria (repeat endoscopy three days of healed (%) (78 3) (79 8) (59-8) specified time having taken 75% of treatment) as % Difference (95% CI) 18-5 20 0 specified'in the protocol. Healing rates at weeks compared with 2 and 4 were compared across treatment groups ranitidine* (4 9, 32-1) (6-6, 33 4) Week 4: No of patients 81/87 87/90 75/92 using a 3x2 x2.
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