Study of exposure and use patterns of alternatives to ranitidine-containing medicines in patients treated with ranitidine (Ranitidine)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective population-based study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BA01) cimetidine

  (A02BA02) ranitidine

  (A02BA04) nizatidine

  (A02BA06) roxatidine

  (A02BA08) lafutidine

  (A02BA51) cimetidine, combinations
• Medical condition to be studied:
  Peptic ulcer
• Additional medical condition(s):
  Incidence of use of ranitidine and alternatives medicines to ranitidine (other H2RA, PPIs, antacids and other drugs used for peptic ulcer and GERD) Treatment discontinuation in patients treated with ranitidine Switching from ranitidine to alternative medicines

Population studied

• Short description of the study population:
  The study population included all individuals exposed to ranitidine-containing medicines identified from six databases from six European countries namely IPCI (the Netherlands), SIDIAP (Catalonia Spain) and IQVIA (UK IMRD, LPD Belgium, DA Germany and LPD France) for the period of 1st January 2017 until 1st January 2023.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1250000

Study design details

• Main study objective:
  To determine drug utilisation and prescription patterns of medicinal products containing ranitidine (A02BA02) and alternative medicinal products (other H2 receptor antagonists, proton pump inhibitors and other medicinal products for acid-related disorders).
• Outcomes:
  Incidence of use of ranitidine and alternatives medicines to ranitidine (other H2RA, PPIs, antacids and other drugs used for peptic ulcer and GERD) Treatment discontinuation in patients treated with ranitidine Switching from ranitidine to alternative medicines
• Data analysis plan:
  An initial exploratory analysis will be conducted for each country-specific cohort to summarise baseline demographic characteristics, medical conditions at time of treatment initiation, indication and exposure. Incident drug use will be expressed as the number of users per 1,000 persons per quarter, calendar year and by referral period. For each database (and thus by country), stratum specific estimates will be presented separately according to: referral period (pre-, during- and post-referral), indication, age category, sex and formulation.

Documents

Study results

Ranitidine report_30 March 2023_clean