Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

NCT02300428 | Completed

• 1 other identifier: 6531
• Study Type: observational
• Target: 406,902
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS. Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects. In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

Conditions

Anemia

Keywords

iron deficiency

Outcome Measures

Primary Outcomes (2)

• Prescription rate

  number of prescriptions of iron supplements issued at the patient level in the year

  12 months

• Health Economics Modelling

  In this analysis we will determine the following to parameterise the model that will be based on the cohort study over a 10 years period: i) Frequency of repeat oral iron prescriptions, ii) Number of hospital admissions, i) Incidence of gastrointestinal side-effects, ii) Treatment cessation rate iii) Haemoglobin changes The basis for the model will be the above data extracted from the CPRD, further informed by publicly available clinical trial data.

  10 years

Secondary Outcomes (2)

• Efficacy

  12 months

• Gastrointestinal intolerance

  12 months

Study Arms (2)

1-year cohort

Patients with at least 1 prescription of any oral iron preparation in the last 2 years and who have at least 1 year of follow up data post-prescription. It is anticipated that ca. 123,000 patients in CPRD fulfil this criteria.

Dietary Supplement: oral iron

10-year cohort

All pre-menopausal women (18-45 years old) with at least 1 prescription of one ferrous iron salt (i.e. sulphate, fumarate and gluconate) since January 2000. It is anticipated that ca. 299,000 patients in CPRD fulfil this criteria.

Dietary Supplement: oral iron

Interventions

oral iron DIETARY_SUPPLEMENT

BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

Also known as: Dried ferrous sulphate tablets 200mg, Ferrous fumarate tablets 210mg, Ferrous gluconate tablets 300mg, Ferrous fumarate tablets 322mg (incl. Fersaday), Ferrous fumarate capsules 305mg (incl. Galfer), Dried ferrous sulphate MR tab 325mg (incl. Ferrograd)

1-year cohort; 10-year cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For the 1-year cohort study we are not defining a sub-population group and will investigate all individuals (adults and children) prescribed any type of oral iron at least once in the time period assessed, although a breakdown by key sociodemographic (age, gender, ethnicity) will be conducted. For the 10-year plus cohort study, pre-menopausal women in receipt of ferrous iron supplements are our study population of interest. Pre-menopausal women are the population group with the largest number of individuals affected (nearly 2M) by IDA in the UK, mainly because dietary iron intake does not sufficiently offset menorrhagic iron losses.

You may qualify if:

• patients prescribed oral iron in primary care practices included in the UK CPRD database

You may not qualify if:

• N/A

Sponsors & Collaborators

• dora pereira: lead
• University of Cambridge: collaborator
• Bangor University: collaborator
• University of Oxford: collaborator

Study Sites (1)

MRC Human Nutrition Research

Cambridge, Cambridgeshire, CB1 9NL, United Kingdom

Location

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

Iron; ferrous fumarate; ferrous gluconate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Dora Pereira, PhD

  MRC Human Nutrition Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Investigator Scientist

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

GB (1)