MRC Human Nutrition Research
Cambridge, Cambridgeshire, CB1 9NL, United Kingdom
NCT Number: NCT02300428
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.
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Observational
Cambridge, Cambridgeshire, CB1 9NL, United Kingdom
Our research objective is to gather evidence for the unmet clinical need for safe, low-side-effect oral iron in the UK.
To achieve this objective we aim to determine:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)
Other names: 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)
Time frame: 12 months
number of prescriptions of iron supplements issued at the patient level in the year
Time frame: 10 years
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.
Time frame: 12 months
increase in Hb of at least 2 g/dL or to >12 g/dL
Time frame: 12 months
At least one event of i. change in product; ii. reduction in dose; iii cessation of treatment with no improvement in Hb during the 12 months
dora pereira
Other Gov
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