Pattern of use of Human Growth Hormone (Somatropin) in the United Kingdom general practice setting: A Drug Utilization Study in The Health Improvement Network (THIN) database (Somatropin use in routine clinical practice in UK)

Study type

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SOMATROPIN

Population studied

• Short description of the study population:
  Patients prescribed with somatropin between January 1, 1990 and May 30, 2010, permanent patients with a minimum of 6 months’ registration with the practice at the time of the first prescription
• Age groups:
  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:
  1200

Study design details

• Main study objective:
  To describe the pattern of use of somatropin in patients selected within the UK primary care setting. Namely: • Indications for somatropin • Demographic and clinical characteristics of the treated population • How the clinical profile of somatropin users compare to that of the general population• Pattern of dosage and duration of therapy
• Data analysis plan:
  All analyses will be conducted using SAS Enterprise Guide version 4.1. All analyses will be presented for all patients and separately by indication subgroup, in particular for the group of children with idiopathic GH deficiency.Categorical data will be summarised by the number and percentage of patients in each category. Continuous data will be summarised by the number of patients, mean, standard deviation, median, minimum and maximum values. Where appropriate, two-sided 95% confidence intervals will be presented. Any statistical testing will be reported using a 2-sided significance level of 0.05 for each analysis or, when equivalence is asserted, using confidence intervals.Any difference in clinical characteristics of somatropin versus control patients will be examined with chi square tests. Summaries will also be provided for age sub-groups of patients, as appropriate.