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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/14166
• EU PAS number:
  EUPAS1821
• Study ID:
  14166
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The study describes the pattern of use of the Recombinant Human Growth Hormone (somatropin) over two decades 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 therapyThe study population includes new users of somatropin between 1 January 1990 and 30 May 2010. Only permanent patients with a minimum of 6 months’ registration with the practice at the time of the first prescription are included.This is a retrospective analysis of somatropin users selected in The Health Improvement Network (THIN) database. The Network collects pseudo-anonymised electronic medical records of patients managed in the UK primary care setting. Comprehensive patient-level data include diagnostic codes, prescriptions and other health-relevant patient information. Clinical characteristics of treated patients are compared to those of a random sample of untreated patients matched on age and sex to treated patients. Study measures include:• Frequency distribution of study population by sex, age groups and indications, including: GH deficiency, Turner syndrome, chronic renal insufficiency, Prader-Willi syndrome, small at birth for gestational age, other indication • Frequency distribution of dosage at start of therapy and of average length of treatment• Prevalence of major co-morbidities, such as endocrine, cardiovascular, and respiratory diseases, and neoplasmsCategorical data are presented as number and percentage of patients, continuous data are summarized by the number of patients, mean, standard deviation, median, lower and upper quartiles, minimum and maximum values. Where appropriate, two-sided 95% confidence intervals are presented. Statistical testing is reported using a 2-sided significance level of 0.05
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/12/2010

Actual: 01/12/2010

Study start date

Planned: 01/12/2010

Actual: 01/12/2010

Date of final study report

Planned: 28/03/2011

Actual: 28/03/2011

Sources of funding

EMA

Study protocol

Initial protocol

GH_protocol_v1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable