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Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010-2011 seasonal influenza viruses: an open phase IV study.
Int J Infect Dis. 2012 Apr; 16(4):e273-8.IJ

Abstract

OBJECTIVE

The aim of this multicenter prospective study was to evaluate the efficacy of a new bioequivalent formulation of oseltamivir for the treatment of influenza A, influenza B, and H1N1 during the 2010-2011 influenza season.

METHODS

We compared the symptoms and signs of 300 pediatric patients presenting to three university hospitals with an influenza-like illness between January and March 2011. Nasal swab specimens were collected from all children and tested by reverse-transcription polymerase chain reaction (RT-PCR) for influenza viruses. After randomization, half of the participants were prescribed oseltamivir, while the other half were observed conservatively. Forty patients who were followed-up for influenza prior to the study were also included in the evaluation.

RESULTS

Influenza was confirmed by RT-PCR in 129 children, 71 of whom were prescribed oseltamivir. The durations of the symptoms fever, cough, nasal congestion, and rhinorrhea were significantly shorter for patients who were treated with oseltamivir compared with untreated patients (p<0.002 for all symptoms). Early initiation of oseltamivir therapy (within 48 h of the onset of symptoms) was associated with more favorable outcomes and an earlier recovery than in patients for whom treatment was delayed (beyond 48 h). Thirty-seven patients (28.7%) had H1N1, 44 (34.1%) had influenza A, 46 (35.7%) had influenza B, one (0.8%) had H1N1 plus influenza A, and one (0.8%) had influenza A plus influenza B viruses. In the comparison of the duration of symptoms according to the different virus types, a statistically significant difference was only observed in patients with influenza B who had a longer duration of cough (p<0.001), nasal congestion (p<0.001), and rhinorrhea (p<0.001).

CONCLUSIONS

Oseltamivir is an effective treatment for the management of seasonal influenza and H1N1, and should be initiated immediately without waiting for laboratory confirmation of diagnosis.

Authors+Show Affiliations

Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22310296

Citation

Ceyhan, Mehmet, et al. "Effectiveness of a New Bioequivalent Formulation of Oseltamivir (Enfluvir®) On 2010-2011 Seasonal Influenza Viruses: an Open Phase IV Study." International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, vol. 16, no. 4, 2012, pp. e273-8.
Ceyhan M, Karadag Oncel E, Badur S, et al. Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010-2011 seasonal influenza viruses: an open phase IV study. Int J Infect Dis. 2012;16(4):e273-8.
Ceyhan, M., Karadag Oncel, E., Badur, S., Ciblak, M. A., Alhan, E., Celik, U. S., Kurugol, Z., Saz, E. U., Ozsurekci, Y., Celik, M., & Parlakay, A. O. (2012). Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010-2011 seasonal influenza viruses: an open phase IV study. International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, 16(4), e273-8. https://doi.org/10.1016/j.ijid.2011.12.008
Ceyhan M, et al. Effectiveness of a New Bioequivalent Formulation of Oseltamivir (Enfluvir®) On 2010-2011 Seasonal Influenza Viruses: an Open Phase IV Study. Int J Infect Dis. 2012;16(4):e273-8. PubMed PMID: 22310296.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010-2011 seasonal influenza viruses: an open phase IV study. AU - Ceyhan,Mehmet, AU - Karadag Oncel,Eda, AU - Badur,Selim, AU - Ciblak,Meral Akcay, AU - Alhan,Emre, AU - Celik,Umit Sızmaz, AU - Kurugol,Zafer, AU - Saz,Eylem Ulas, AU - Ozsurekci,Yasemin, AU - Celik,Melda, AU - Parlakay,Aslınur Ozkaya, Y1 - 2012/02/05/ PY - 2011/08/06/received PY - 2011/12/11/revised PY - 2011/12/13/accepted PY - 2012/2/8/entrez PY - 2012/2/9/pubmed PY - 2012/7/4/medline SP - e273 EP - 8 JF - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JO - Int. J. Infect. Dis. VL - 16 IS - 4 N2 - OBJECTIVE: The aim of this multicenter prospective study was to evaluate the efficacy of a new bioequivalent formulation of oseltamivir for the treatment of influenza A, influenza B, and H1N1 during the 2010-2011 influenza season. METHODS: We compared the symptoms and signs of 300 pediatric patients presenting to three university hospitals with an influenza-like illness between January and March 2011. Nasal swab specimens were collected from all children and tested by reverse-transcription polymerase chain reaction (RT-PCR) for influenza viruses. After randomization, half of the participants were prescribed oseltamivir, while the other half were observed conservatively. Forty patients who were followed-up for influenza prior to the study were also included in the evaluation. RESULTS: Influenza was confirmed by RT-PCR in 129 children, 71 of whom were prescribed oseltamivir. The durations of the symptoms fever, cough, nasal congestion, and rhinorrhea were significantly shorter for patients who were treated with oseltamivir compared with untreated patients (p<0.002 for all symptoms). Early initiation of oseltamivir therapy (within 48 h of the onset of symptoms) was associated with more favorable outcomes and an earlier recovery than in patients for whom treatment was delayed (beyond 48 h). Thirty-seven patients (28.7%) had H1N1, 44 (34.1%) had influenza A, 46 (35.7%) had influenza B, one (0.8%) had H1N1 plus influenza A, and one (0.8%) had influenza A plus influenza B viruses. In the comparison of the duration of symptoms according to the different virus types, a statistically significant difference was only observed in patients with influenza B who had a longer duration of cough (p<0.001), nasal congestion (p<0.001), and rhinorrhea (p<0.001). CONCLUSIONS: Oseltamivir is an effective treatment for the management of seasonal influenza and H1N1, and should be initiated immediately without waiting for laboratory confirmation of diagnosis. SN - 1878-3511 UR - https://www.unboundmedicine.com/medline/citation/22310296/Effectiveness_of_a_new_bioequivalent_formulation_of_oseltamivir__Enfluvir®__on_2010_2011_seasonal_influenza_viruses:_an_open_phase_IV_study_ L2 - http://linkinghub.elsevier.com/retrieve/pii/S1201-9712(12)00020-3 DB - PRIME DP - Unbound Medicine ER -