Peptic ulcer: duodenal: omeprazole 20 mg prevented recurrent ulcers better than ranitidine

Clinical bottom line (level 1b)

  1. Patients with a recently healed duodenal ulcer who took omeprazole 10 mg compared with rantidine were less likely to have a relapse (NNT = 11 at 12 months) .
  2. Patients who took 20 mg compared with 10 mg omeprazole were less likely to have a relapse (NNT = 7 at 12 months) .
Lauritsen et al: Can J Gastroenterol 1999; 13 ( 10 ): 806-813
Expires January 2004

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 70 centres, 16 countries in Europe and Australia

928 patients (aged 18 to 79; mean 49, 69% male) with a recent duodenal ulcer healed using omeprazole

Excluded if
  • planned or current pregnancy or lactation
  • ulcer bleeding or pyloric stenosis requiring surgical intervention
  • concomitant gastric or prepyloric ulcer, or erosive or ulcerative oesophagitis
  • previous gastric surgery except for simple closure
  • concomitant treatment or disease (renal or liver failure) likely to complicate therapy
  • incomplete healing or symptom relief
  • aged < 18, > 80
  • duodenal ulcer < 5 mm in diameter

Control Group: (n = 312, 312 analysed): ranitidine 150 mg at night
Experimental Group: (n = 308, 308 analysed): omeprazole 10 mg in the morning
Experimental Group: (n = 308, 308 analysed): omeprazole 20 mg in the morning

96% followed for 12 months

The evidence

omeprazole v. ranitidine
Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
ulcer recurrence on endoscopy: 10 mg 12 months 109
(34.9%)		 82
(26.6%)		 25%
(4% to 41%)		 8.77%
(1.49% to 16.0%)		 11
(6 to 67)
ulcer recurrence on endoscopy: 20 mg 12 months 109
(34.9%)		 37
(12.0%)		 66%
(52% to 75%)		 22.9%
(16.5% to 29.3%)		 4
(3 to 6)

omeprazole 20 mg v. 10 mg
Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
ulcer relapse on endoscopy 12 months 82
(26.6%)		 37
(12.0%)		 55%
(36% to 68%)		 14.6%
(8.48% to 20.7%)		 7
(5 to 12)

Comments

  1. Patients were stratified for centre and randomised in blocks of three.

Citation

  1. Lauritsen K, Rutgersson K, Bolling E, et al: omeprazole and ranitidine in the prevention of relapse in patients with duodenal ulcer disease. Can J Gastroenterol 1999; 13 ( 10 ): 806-813
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, January 2002
Reviewer:

Clinical Question.
Patient healed duodenal ulcer
Intervention or Exposure omeprazole
Comparison ranitidine
Outcome recurrent duodenal ulcer