Research Article

Off-Label Drug Use in Patients with Age-Related Macular Degeneration in Turkey

10.37696/nkmj.672247

  • Hanife RAHMANLAR
  • Cemile ÜÇGÜL ATILGAN
  • Mehmet ÇITIRIK
  • Ali ALKAN
  • Hakkı GÜRSÖZ

Received Date: 08.01.2019 Accepted Date: 24.06.2020 Nam Kem Med J 2020;8(2):249-257

Aim:

To evaluate the demographic characteristics of patients who use off-label drugs for Age-related Macular Degeneration (AMD) in Turkey.

Materials and Methods:

The applications for off-label drug use in patients with AMD (bevacizumab, ranibizumab, aflibercept, verteporfin) from hospitals in Turkey to the Turkish Medicines and Medical Devices Agency from January to December 2013 were evaluated retrospectively. The files of the cases were evaluated in terms of demographic data, previous treatment regimens, reasons for application, dosage and usage of the drug.

Results:

This study included 64 patients who applied for off-label drug use under the diagnosis of AMD. The mean age of all patients was 70.12 ± 11.01 years and 46.9 % were male, 53.1 % were female. Of these, 39.1 % was ranibizumab, 29.7 % was verteporfin, 18.8 % was aflibercept, and 12.5 % was bevacizumab. Applications belonged to Ege (48.4%), Central Anatolia (23.4%), Marmara (25.0%) and East Anatolia (3.1%) regions. In the distribution of the referring hospitals, the first three hospitals were the state universities (48.4 %), the education and research hospitals (40.6%) and the foundation universities (7.8%) Of patients, twelve (18.8%) were naïve patients with no previous treatment regimen. Resistance to other anti-vascular endothelial growth factors as the cause of admission was in the 1st rank with 64.1%.

Conclusion:

In the treatment of AMD, determining the off-label drug application information and the actual records related to this subject will give us instructive information about our treatment options as well as its contribution to the literature.

Keywords: Age-related macular degeneration; off-label drug, vascular endothelial growth factor, VEGF