Efficacy and Tolerability of Moxifloxacin in Patients With Sinusitis Treated in General Practice

W. Elies; H. Landen; K. Stauch

Disclosures

Clin Drug Invest. 2004;24(8) 

In This Article

Patients and Methods

This PMS study had an open, uncontrolled, prospective, non-randomised study design and was carried out between October 2001 and June 2002 in Germany. The main objective of the study was to gain further information on the efficacy, safety and tolerability of moxifloxacin therapy under real-life treatment conditions in patients with RTIs including acute sinusitis. Most patients were treated by general practitioners, and the remaining patients were treated by specialists in internal medicine, respiratory medicine and otorhinolaryngology. All therapeutic decisions were made solely by the attending physician. Treatment with moxifloxacin should comply with the summary of product characteristics in terms of recommended dose (400mg once daily) and given contraindications.

An initial visit and two follow-up visits could be documented, one during the treatment period and one at the end of therapy. Observations included the patient's demographic parameters, diagnosis of the infection, documentation of moxifloxacin therapy, pretreatment with antibiotics and any other drugs, concomitant medication and diseases, course of symptoms, and the clinical outcome. The severity of symptoms characteristic of sinusitis, such as fever, cough, nasal obstruction, nasal secretion and headache, were assessed by the attending physician at baseline and at each follow-up visit. Physicians classified symptoms as 'absent', 'mild' or 'severe'. The course of symptoms during moxifloxacin therapy was analysed in terms of the categories 'cured', 'improved', 'unchanged' or 'worse'. The number of days until patients experienced an improvement in their condition was recorded. Physicians also rated patient satisfaction with moxifloxacin therapy on a 4-point scale from 'insufficient' to 'very good'. Patient data was documented using standardised and barcoded case report forms. Prior to data entry and analysis, case report forms were screened for completeness and plausibility and the relevant investigators were questioned in case of missing or implausible data.

All adverse events (AEs) during the study had to be recorded, irrespective of possible causal relationship to treatment. In addition, the severity of any AE, possible relationship to treatment, action taken and outcome were also recorded. A serious adverse event (SAE) was defined as one resulting in death, a life-threatening event, hospitalisation or prolongation of existing hospitalisation, or any condition causing persistent or significant disability/incapacity. In the case of an SAE, the complete documentation was forwarded to the Drug Safety Department of Bayer Vital GmbH within 24 hours. The procedure for handling such reports is outlined in figure 1. In addition to the formal reporting process, there was extensive screening of case report forms in order to identify any hidden adverse events. Comprehensive checks for completeness and plausibility were made, and any missing item on the adverse event form was followed up with the relevant physician repeatedly by mail and/or telephone.

Procedure for monitoring adverse events. AE = adverse event; CRO = Clinical Research Organisation; SAE = serious adverse event.

The statistical analyses performed in this PMS study were entirely descriptive and exploratory using the statistical software SAS® for Windows version 8.00. Analysis was restricted to data for all patients with sinusitis whose cases were recorded prospectively and for whom information was available regarding moxifloxacin treatment. Absolute and relative frequencies were calculated for qualitative variables. Data were reported as mean ± standard deviation (SD). Concomitant diseases were codified using the International Classification of Diseases, 9th edition, Clinical Modification (ICD-9-CM) and concomitant medications according to the German Drug List (Rote Liste® 2002). Adverse events were categorised according to the Medical Dictionary for Regulatory Activities (MedDRA).

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