References

1. Definition of guideline compliance If no or mild nasal symptoms are present (nss_b<5) and the nasal congestion is mild, no co-medication should be given according to the guidelines. In the event of a low sum score (nss_b<5) and considerable nasal congestion, according to the guidelines either a decongestant nasal spray or a nasal corticoid should be administered in addition to the antihistamine. Should the sum score be higher (nss_b>4) but nasal congestion be only minor, a nasal corticoid should be given. If both values are high, the nasal corticoid and the decongestant nasal spray should also be administered. In the broader sense, guideline compliance is also fulfilled when a topical corticoid is administered in the event that the nasal sum score is high, without consideration of nasal congestion. Guideline-compliant treatment of allergic rhinitis in practice – an evaluation on the basis of 48000 cases R. Mösges1, Kai Goetze1, Astrid Plenker2, Andrea Hilgenfeld1 1Institute for Medical Statistics, Informatics and Epidemiology, Medical Faculty, University of Cologne, Cologne, Germany 2Essex Pharma GmbH, Munich, Germany P-21-13 Introduction Table 1 The study population n= 47953 “Clinical guidelines are systematically developed statements designed to help practitioners and patients make decisions about appropriate and effective health care. Guidelines have existed in various countries for decades and hundreds of them have been published for many diseases including asthma and allergic rhinitis. There is considerable interest in guidelines as a tool for implementing health care based on proof of effectiveness. Guidelines should be informative, simple, easy to use and in a form that can be widely disseminated within the medical community in order to improve patient care. Unfortunately, many guidelines are not tested and may be difficult to use by nonspecialists. Evidence-based medicine is an important method of preparing guidelines. Moreover, the implementation of guidelines is equally important”.[1] Objective • The following was to be investigated: • Is treatment according to guidelines more successful than non-compliant therapy? • Does monotherapy with desloratadine 5mg/die make more sense or is co-medication, in whatever • combination, more advantageous for the patient suffering from allergic rhinitis? • Can a (topically administered) corticoid given in addition to desloratadine distinctly improve • symptoms? Figure 1: guideline compliant non-compliant Methodology For this purpose, a recommended procedure which was the “least common denominator” was educed from published guidelines for the treatment of allergic rhinitis. The strategy was formulated as an algorithm and an appropriate database program was developed. Using this algorithm therapy data were examined which were contained in the database of a post-marketing survey in seasonal allergic rhinitis [2]. The post-marketing study comprised 47953 patients and was not assigned to any certain group of medical specialists. As a basis all patients were prescribed the antihistamine desloratadine at a dose of 5mg/die. In addition, the physicians who participated in the study were instructed to act “normally,” that is, after assessing the severity of patient symptoms to take further treatment measures. Mean improvement of nasal symptom score Figure 2: Figure 3: guideline compliant non-compliant Desloratadine monotherapy Desloratadine plus nasal steroid and/or nasal decongestant Results Surprisingly, the sole administration of the antihistamine desloratadine lead to the greatest possible symptom relief and to improvement of the disease-related restrictions in daily life (“quality of life”). The supplementary use of further treatment modalities as provided for in the guidelines did not result in additional improvements. On the contrary, patients treated solely with desloratadine at a dosage of 5 mg indicated on the whole a more favorable course than those treated according to the guidelines but with additional application of nasal steroids or decongestant nasal sprays. Mean improvement of nasal symptom score Discussion Mean improvement of nasal symptom score These results contrast clearly to the published investigations on treatment compliant with guidelines [3]. The latter investigations, however, normally emanated from experimental study designs and described patient collectives that were more than two orders of magnitude smaller than the collective presented here. • Allergic rhinitis and its impact on asthma.Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. J Allergy Clin Immunol., 2001 Nov;108(5 Suppl):S147-334 • Mösges R, Virchow JC, Plenker A.; Desloratadin. Eine Praxisstudie mit 47953 Patienten. ComMed Healthcare 2002, Basel • Van Cauwenberge P. J Allergy Clin Immunol. 2000; 10, 1 (part 2): S.1136 References Baseline symptom score Baseline symptom score Research funded by: Essex Pharma GmbH Munich, Germany Study performed by The German Rhinitis Study Group