PMID- 21155707 OWN - NLM STAT- MEDLINE DCOM- 20110512 LR - 20141120 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 27 IP - 2 DP - 2011 Feb TI - Utilisation, efficacy and safety of voriconazole: prospective, non-interventional study on treatment of IFIs in clinical practice. PG - 335-42 LID - 10.1185/03007995.2010.542137 [doi] AB - OBJECTIVE: Invasive fungal infections (IFIs) are an important cause of morbidity and mortality, particularly in patients with cancer. The triazole voriconazole, given as oral or intravenous formulation, has a high bioavailability and proven efficacy against invasive aspergillosis, candidiasis and other fungi. We aimed to assess the utilisation, efficacy and safety of voriconazole with emphasis on the route of administration under standard clinical conditions. METHODS: Prospective, observational study performed by 17 hospitals and office-based physicians in Germany. RESULTS: A total of 264 patients received oral (53%) or intravenous (22%) voriconazole or both formulations sequentially (25%). Of 228 patients with specified fungal diagnosis, 95 (36.0%) had aspergillosis, 73 (27.7%) candidiasis. Sixty (22.7%) received voriconazole for other fungal indications (OFI). In 195 of 226 patients (86.2%), treatment was successful (39.8% cured and 46.5% partial response). In terms of primary diagnoses, favourable responses were noted in 90% for pulmonary aspergillosis, 85% for candidiasis and 87% for OFI. Microbiological success was documented in 138 patients, of whom 105 (76.1%) had complete eradication of fungi. Response rates by initial route were similar for oral and intravenous administration (86 and 87%). Twenty-six of 264 patients died during the study, 53 patients experienced a serious adverse event (five treatment related), and 10 withdrew due to all-causality adverse events (AEs). Tolerability was assessed as very good in 55%, and good in 40% of patients. CONCLUSIONS: Voriconazole as oral or intravenous formulation was well tolerated and equally effective in critically ill patients with IFIs. This study in daily care confirms the outcomes of controlled clinical trials. FAU - Heinz, Werner J AU - Heinz WJ AD - Department of Internal Medicine II, Division of Infectious Diseases, University of Wuerzburg Medical Centre, Wuerzburg, Germany. Heinz_w@klinik.uni-wuerzburg.de FAU - Silling, Gerda AU - Silling G FAU - Bohme, Angelika AU - Bohme A LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20101215 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Antifungal Agents) RN - 0 (Pyrimidines) RN - 0 (Triazoles) RN - JFU09I87TR (Voriconazole) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antifungal Agents/administration & dosage/adverse effects MH - Child MH - Child, Preschool MH - Critical Illness/epidemiology/therapy MH - Female MH - Humans MH - Infant MH - Injections, Intravenous MH - Male MH - Middle Aged MH - Mycoses/*drug therapy/epidemiology MH - Professional Practice/*statistics & numerical data MH - Prospective Studies MH - Pyrimidines/*administration & dosage/*adverse effects MH - Treatment Outcome MH - Triazoles/*administration & dosage/*adverse effects MH - Voriconazole MH - Young Adult EDAT- 2010/12/16 06:00 MHDA- 2011/05/13 06:00 CRDT- 2010/12/16 06:00 PHST- 2010/12/16 06:00 [entrez] PHST- 2010/12/16 06:00 [pubmed] PHST- 2011/05/13 06:00 [medline] AID - 10.1185/03007995.2010.542137 [doi] PST - ppublish SO - Curr Med Res Opin. 2011 Feb;27(2):335-42. doi: 10.1185/03007995.2010.542137. Epub 2010 Dec 15.