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[Interferon-alpha. Results of a pharmaco-epidemiologic study]
A M Grion1, R M Gaion, L Cordella
1Dipartimento di Farmacologie dell'Università, Centro Regionale per la Documentazione e l'Informazione sul Farmaco, Padova.
La Clinica Terapeutica
|March 1, 1994
Summary
This study assessed alpha-interferon (IFN) use in Veneto, Italy. Results show frequent side effects and a negative impact on quality of life for many patients undergoing this therapy.
Area of Science:
- Hepatology
- Pharmacology
- Public Health
Background:
- Alpha-interferon (IFN) is a therapeutic agent used for various conditions.
- Its application in the Veneto Region of Italy was evaluated in a specific patient cohort.
- Understanding real-world usage patterns and outcomes is crucial for optimizing treatment protocols.
Purpose of the Study:
- To evaluate the clinical use of alpha-IFN in outpatients within the ULSS 21 of the Veneto Region.
- To collect data on prescribed therapies, observed side effects, and the impact on patients' quality of life.
- To compare the use of alpha-IFN against FDA and Italian Ministry of Health approvals.
Main Methods:
- A cohort of 114 outpatients treated with alpha-IFN between June-July 1992 was interviewed.
- A standard questionnaire was employed to gather information on therapy details, adverse events, and quality of life.
- Data were analyzed to identify common indications, dosages, and reported side effects.
Main Results:
- Alpha-IFN was primarily prescribed for chronic non-A non-B hepatitis, with 35% of patients receiving it for conditions approved by the Italian Ministry of Health but not the FDA.
- A standard dose of 9 MU/week was commonly administered, often below recommended literature doses.
- Frequent adverse effects included fever, chills, headache, fatigue, and myalgia. Less frequent effects were mild mental disturbances and thyroid dysfunction.
- Approximately half of the patients reported a negative influence of alpha-IFN therapy on their quality of life.
Conclusions:
- The study highlights frequent adverse effects associated with alpha-IFN therapy.
- A significant proportion of patients experienced a diminished quality of life during treatment.
- Findings suggest a need for careful consideration of alpha-IFN dosage and patient-reported outcomes in clinical practice.