Adverse drug reactions after 24-month treatment with two-dosage regimens of betaferon in patients with multiple sclerosis.
An open, prospective randomized trial in patients with multiple sclerosis was conducted to investigate the adverse drug reactions after a 24-month Betaferon treatment.


OBJECTIVE
To assess adverse drug reactions after treatment with two-dosage regimens of Betaferon.


METHODS
Fifty-five patients were included in the study. They were divided into two groups according to the dosage regimen Betaferon was administered. In group A, Betaferon 8MIU was given subcutaneously every other day. In group B, the treatment was carried out using the following dosage regimen: week 1-3 times per week, every other day in the morning, subcutaneously Betaferon in doses of 2 MIU, 4 MIU and 8 MIU, respectively; weeks 2 to 4 inclusive--3 times per week, every other day in the morning, subcutaneously Betaferon in a dose of 8 MIU; week 5 to month 24 inclusive--subcutaneously every other day in the morning Betaferon in a dose of 8 MIU. Paracetamol, ibuprofen, pentoxifylline and prednisolone were used to cope the ADR according to their type and duration.


RESULTS
There were significant changes in group B compared with group A: reduction of the flu-like symptoms and local reactions at the end of the first month of treatment, together with lower relative percentage of patients treated for ADR.


CONCLUSIONS
The reduced dosage regimen and corrective treatment reduce the adverse drug reactions and improve drug tolerability.
Manova
Maria G
MG
Neurology Department, Medical University, Plovdiv, Bulgaria.
Kostadinova
Ivanka I
II
D000082:Acetaminophen / Q000008:administration & dosage; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011446:Prospective Studies; D013997:Time Factors
D018712:Analgesics, Non-Narcotic; D000893:Anti-Inflammatory Agents; D007155:Immunologic Factors; D000068576:Interferon beta-1b; D000082:Acetaminophen; D016899:Interferon-beta