Ranitidine and other histamine H2-receptor antagonists – a drug utilisation study

Study type

• Study topic:
  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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BA) H2-receptor antagonists

Population studied

• Short description of the study population:
  The study population consisted of all persons with observation time during the study period.; Subjects were included in the study if they contributed active follow-up time during the study period. No other inclusion or exclusion criteria were applied.
• Age groups:
  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)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1300000

Study design details

• Main study objective:
  1/ To study the prevalence and incidence of exposure to H2-receptor antagonists (H2RA) as a class and by individual ingredient2/ To explore the characteristics of H2RA use 3/ To explore the indication of use of H2RA by class level, individual ingredient and by formulationRA4/ To explore the proportion of patients treated with H2RA suffering from renal impairment
• Data analysis plan:
  All results will be presented by database. Results pooled over the different databases will be provided for the indication of use and history of renal impairment. Drug use both for prevalent and incident users will be expressed as the number of users per 1,000 persons presented by calendar year, age category (10 years), formulation and sex. Per patient, the cumulative duration will be calculated which is the sum of the duration of the Drug Eras per H2RA ingredient. Results on cumulative duration will be presented as median (and corresponding Q1, Q3, P5, P95, min, max) by class and type of H2RA ingredient, stratified by age category at start, gender and also by formulation (oral or parenteral).Results on PDD/DDD ratio and cumulative exposure (=cumulative number of DDDs) will be presented as median (and corresponding Q1, Q3, P5, P95, min, max) by type of H2RA and stratified by age category, gender, and formulation

Documents

Study results

Rantidine_finalreport_7thapril2020