Upper GI bleed: Starting NSAIDs increased the risk of GI bleed.

Clinical bottom line (level 1b)

  1. Patients who started NSAIDs were at increased risk of developing GI bleeding or perforation requiring hospitalisation.
McMahon et al: Journal of ClinicalEpidemiology 1997; 50 (3): 351-356
Expires October 2002

The study

Prospective cohort study with objective outcomes, adjusted for confounding factors, not validated in an independent set of patients.

Setting: urban community,UK

156398 patients (aged , % male)

Excluded if
  • moved out of study area
  • died during screening period
  • not registered with a general practitioner, or changed GPtwice during study



    • Factors studied:
  • age, sex, prior hospitalisation for GI bleed, prior endoscopy, use of anti-ulcer medication
  • newly startedNSAIDs




    • Poisson regression performed on risk factors.

    ?100% followed for length of prescription plus 15 days (6 to 7 weeks)
    Outcomes studied:
  • GI haemorrhage or perforation confirmed on endoscopy

    • 200 comparator groups were randomly selected from the patients not on NSAIDs.

    The evidence

    outcome time to outcome number of patients/total number %
    (95% CI)    		 NNF
    (95% CI)
    GI haemorrhage or perforation length of prescription plus 15 days (6 to 7 weeks) 172/156398 0.11%
    (0.094% to 0.13%)    		 909
    (791 to 1069)

    prognostic factor for
    GI haemorrhage or perforation     		time to outcome control rate (%) adjusted OR
    (95% CI)    		 NNF+
    (95% CI)
    newly startedNSAIDs 6 weeks 51/78207
    (0.07%)     		2.48
    (1.87 to 3.29)     		1533
    (1203 to 2113)

    Comments

    1. These admissions are emergencies; perhaps lack of awareness among people without prior bleed increases this rate.

    Citation

    1. McMahon AD, Evans JM, White G, et al: A cohort study (with re-sampled comparator groups) to measure the association between new NSAID prescribing and upper gastrointestinal hemorrhage and perforation. Journal of ClinicalEpidemiology 1997; 50 (3): 351-356
    Contributor: Chris Ball and Musab Hayatli, October 1999
    Reviewer: Daniel Sontheimer

    Clinical Question.
    Patient healthy
    Intervention or Exposure NSAID
    Outcome upper GI haemorrhage or perforation