EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Observational [Patient Registry]

Summary: 
      By describing the characteristics of iron deficiency (ID) patients treated with various oral
      or intravenous iron formulations and their outcomes, this registry will provide the medical
      community with important information to support treatment decisions for their patients
      regarding data on effectiveness, safety, tolerability, treatment persistence, quality of
      life, and therapeutic costs. This will ultimately support improvements to patient care,
      including the long-term outcomes of patients with ID.
    

Detailed description: 
      Iron deficiency (ID) anaemia is a prevalent condition in Germany and other Western countries.
      It is a common complication in inflammatory bowel disease (IBD), cardiovascular disease
      including chronic heart failure, cancer, chronic kidney disease (CKD), gynaecological
      conditions, and others.

      Anaemia has a strong impact on patient's quality of life and ability to work, and removing
      the condition by increasing the haemoglobin may improve QoL and other patient-related
      outcomes. While in certain patient groups, such as CKD, anaemia is addressed on a routine
      basis, in others it remains widely undertreated. For example, in IBD patients across various
      European countries, iron supplementation was administered in only up to 28% of individuals.

      For iron supplementation aimed to replenish to body' iron stores, there are numerous oral,
      and intravenous preparations available.

      The most convenient approach is oral administration, where Fe2+ salts are mostly used.
      Usually low doses between 50 - 100 mg daily are recommended, as the duodenum can only absorb
      10 - 20 mg daily, and higher doses are associated with gastrointestinal side effects
      including diarrhoea, nausea, flatulence and gastric erosions. To reduce these common side
      effects, Fe3+ formulations like ferric maltol (Feraccru) have been newly introduced.

      Intravenous preparations are all Fe3+ oxyhydroxides with a carbohydrate coat (iron dextran,
      gluconate, sucrose, carboxymaltose, or ferumexytol). These preparations are typically used
      second-line in patients with ID who had unsatisfactory treatment results under oral
      treatment. IV iron infusions have been associated with hypophosphataemia and hypersensitivity
      reactions. However these events depend on the preparation and are infrequent.

      EXPLAIN-IRON has been set up as the first interdisciplinary registry to add further
      information on the situation and management of patients who receive iron substitution in
      various indications: IBD, chronic kidney disease, cancer- or therapy-induced ID,
      gynaecological conditions (hypermenorrhoea, post-partum, fatigue), cardiological indications
      (congenital heart disease; chronic heart failure) and other causes of ID.

      The registry will allow for documentation of all approved oral and IV preparations. As the
      registry also serves the specific purpose to collect data on the newly introduced preparation
      Feraccru (oral ferric maltol), about half of the patient population will be treated with that
      agent.

      The registry will be of interest to assess to which extent the various guidelines on iron
      substitution have been adopted in clinical practice. Overall, EXPLAIN-IRON is expected to
      provide a comprehensive picture on the use and the outcomes of iron substitution in Germany.
      By describing the characteristics of ID patients treated with various iron formulations and
      their outcomes, this registry will provide the medical community with important information
      to support treatment decisions for their patients regarding data on effectiveness, safety,
      tolerability, treatment persistence, quality of life, and therapeutic costs. This will
      ultimately support improvements to patient care, including the long-term outcomes of patients
      with ID.
    

Intervention name(s): Iron Supplement
Intervention type(s): Drug
Intervention description(s): any oral or intravenous prescription iron supplement
Other intervention name(s): Iron bivalent or trivalent oral; Iron trivalent oral; Feraccru (Ferric Maltol)
Intervention MeSH terms: Iron; Ferric maltol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with iron deficiency in one of the following indications:

        (i) Inflammatory bower disease, (ii) chronic kidney disease, (iii) cancer- or
        therapy-induced iron deficiency, (iv) gynaecological conditions (hypermenorrhea,
        post-partum, fatigue), (v) cardiology (including iron deficiency in patients with
        congenital heart disease or chronic heart failure), and (vi) diverse other causes of iron
        deficiency.