[The register GiViTI about the use of the drug Xigris® in the Italian intensive care units].

Abstract

INTRODUCTION:

The Register was aimed at monitoring the use, possible side effects, and clinical effectiveness of Xigris® - drotrecogin alfa (activated) - for the treatment of severe sepsis in Italian intensive care units (ICUs).

METHODS:

Data collection was performed using an online web form or a specific electronic module of the software Margherita, available only for the ICUs adhering to the GiViTI. Drug purchase information available for each center was used to identify and stimulate collaboration of non-compliant centers. Several countermeasures were taken to have the largest participation.

RESULTS:

We analyzed data from 1001 patients treated in 161 ICUs between July 2003 and September 2007, corresponding to 70% of all the patients who received the drug in that period. The off-label use of the drug was frequent: 15.6% of cases before and 27.3% after the label change with the introduction of timing restrictions. Treatment was temporarily interrupted in 10%, and definitely stopped in 25% of cases, after the occurrence of adverse events, the most frequent being bleeding. Severe bleeding occurred in 3.8% of patients. Multivariable analysis, which allowed an adjusted comparison with a control group, showed that treatment increased mortality among elective-surgery patients (OR 2.79, 95%CI 1.31-5.97).

DISCUSSION:

The results of this study and other evidences led the European Medicines Agency (EMA) to require a confirmatory trial in 2007. In October 2011 Ely-Lilly, the producer of the drug, announced the worldwide withdrawal from the market of Xigris®, on the basis of the negative results of the confirmatory trial.

CONCLUSIONS:

The availability of purchase information is essential to carry out post-marketing drug surveillance studies, since it allows to identify and contact non-compliant centers. Actually, a representative sample of treated patients provides reliable information on the use, efficacy, and safety of the drug in daily clinical practice that could positively influence healthcare policies.

• Authors: Carlotta Rossi, Michele Giardino, Daniele Crespi, Abramo Anghileri, Daniele Poole, Guido Bertolini, Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (GiViTI)
• Journal: Recenti progressi in medicina (Recenti Prog Med) Vol. 104 Issue 6 Pg. 246-53 (Jun 2013) ISSN: 0034-1193 [Print] Italy
• Vernacular Title: Il registro GiViTI sull'utilizzo del farmaco Xigris® nelle Terapie Intensive italiane.
• PMID: 23801228 (Publication Type: Journal Article)

Chemical References

• Anti-Infective Agents
• Protein C
• Recombinant Proteins
• drotrecogin alfa activated

Topics

• Anti-Infective Agents (therapeutic use)
• Critical Care
• Female
• Humans
• Intensive Care Units
• Italy
• Male
• Product Surveillance, Postmarketing
• Protein C (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Registries