1. Safety and efficacy of transdermal fentanyl in patients with cancer pain: phase IV, Turkish oncology group trial
- Author
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Mustafa Altinbaş, K. Altundağ, M. Aliustaoğlu, Süreyya Sarihan, Yücel Pak, Serdar Özkök, F. Özdemir, M. Yaylaci, L. Atahan, Binnaz Demirkan, O. Manavoğlu, Ali Aydin Yavuz, H.S. Turna, R. Cooper, Serdar Turhal, Şeref Kömürcü, Uludağ Üniversitesi/Tıp Fakültesi/Tıbbi Onkoloji Anabilim Dalı., Uludağ Üniversitesi/Tıp Fakültesi/Radyasyon Onkolojisi Anabilim Dalı., Manavoǧlu, Osman, and Sarıhan, Süreyya
- Subjects
Narcotic analgesic agent ,Male ,Turkey ,Turkish ,Transdermal fentanyl ,Turkey (republic) ,Fentanyl ,Neoplasms ,Prospective Studies ,Cancer pain ,Transdermal ,Pain Measurement ,Morphine ,Rehabilitation ,Middle Aged ,Multicenter study ,Clinical trial ,Analgesics, Opioid ,Treatment Outcome ,Oncology ,Anesthesia ,language ,Female ,Human ,medicine.drug ,Adult ,Phase 4 clinical trial ,medicine.medical_specialty ,Breakthrough Pain ,Cancer Pain ,Narcotic Analgesic Agent ,Adolescent ,Pain assessment ,Pain ,Nursing ,Malignancy ,Administration, Cutaneous ,Article ,Internal medicine ,medicine ,Humans ,Prospective study ,Adverse effect ,business.industry ,Intradermal drug administration ,Cancer ,medicine.disease ,language.human_language ,Opioids ,Opioid ,Release ,Neoplasm ,business ,Health care sciences & services - Abstract
We have performed a prospective evaluation of the efficacy, safety and convenience of the transdermal therapeutic system - fentanyl (TTS-F) in Turkish cancer patients when it was newly available in Turkey. Ninety-nine patients with historically confirmed malignancy and pain entered the study; the mean age was 55.1 (16-58) years. The study duration was 28 days. Transdermal therapeutic system - fentanyl was used in opioid-naive or pre-treated patients. Most patients reported a decrease in pain severity. Use of rescue medication decreased from day 4 to day 28. The majority of patients rated patch convenience of use as excellent. A total of 22.2% of patients experienced adverse events that were either probably related or very likely to be related to the study drug. The majority of the adverse events mentioned were related to the digestive system. Eighteen serious adverse events were reported by 13 patients. Six events were doubtfully related, and 12 events were not related to the study drug. Four patients died during the trial. None of these deaths was attributed to the study drug. In conclusion, the trial showed that TTS-F is easily managed, effective and will help to enable the appropriate opioid administration to patients who are suffering from cancer pain in Turkey.
- Published
- 2007