[Is it possible to compare different studies on efficacy of biologicals in patients with rheumatoid arthritis? : mixed treatment comparison as a new tool for indirect comparison of clinical studies]. / Ist der Vergleich verschiedener Studien zur Wirksamkeit von Biologika bei Patienten mit rheumatoider Arthritis möglich? : "Mixed treatment comparison" als neuer Ansatz zum indirekten Vergleich klinischer Studien.

Head-to-head studies as randomized, double blind clinical studies are the best method for directly comparing the efficacy of different therapeutic strategies. However, at the moment no such studies are available for biological agents in the treatment of patients with rheumatoid arthritis. Therefore it is only possible to compare different treatment strategies by indirect comparisons, for example by adjusted indirect comparison or mixed treatment comparison (MTC). The MTC is accepted by European authorities as supportive clinical evidence. As with the case of meta-analyses the quality of an indirect comparison is determined by the homogeneity of the studies included in the analysis.A short review of eight published indirect comparisons of the efficacy of biological agents in the treatment of patients with rheumatoid arthritis showed that the results with respect to tumor necrosis factor (TNF) blockers are similar and that there are differences in the efficacy of non-TNF biological agents.

The Los Angeles and Savary-Miller systems for grading esophagitis: utilization and correlation with histology.

The aim of the study is to determine the proportion of patients who have esophageal biopsy specimens taken for an endoscopic diagnosis of reflux esophagitis in which an endoscopic grade of esophagitis (Los Angeles [LA] or Savary-Miller [SM]) is communicated to the pathologist, and to evaluate the correlation between those endoscopic grades and histopathologic findings. We searched the database of Caris Diagnostics (a large, gastrointestinal pathology practice that receives specimens from community-based endoscopy centers), and extracted data from all patients who had an endoscopy with esophageal biopsies submitted in a 12-month period. There were esophageal biopsy specimens from 49,480 patients obtained during 58,986 endoscopies. The LA grade was provided in 5513 cases (27.9% of 19,778 with endoscopic esophagitis); the SM grade was stated in only 2416 cases (12.2%). A histopathologic diagnosis of erosive or ulcerative esophagitis was made significantly less often in LA grade A patients (3.2%) than in those with LA grades C (20.0%) and D (23.3%); erosive or ulcerative esophagitis was found in only 1.4% of patients with SM grade I and in 35.5% of cases with grade IV. Endoscopists who biopsy the esophagus of patients with reflux esophagitis usually do not communicate the grade of esophagitis to the pathologist. Although both the LA and SM grading systems are based on the presence of esophageal mucosal breaks (erosions or ulcers), in practice such breaks are documented in only a minority of esophageal biopsy specimens taken from patients with reflux esophagitis of any grade.

Cost-minimisation analysis comparing gemcitabine/cisplatin, paclitaxel/carboplatin and vinorelbine/cisplatin in the treatment of advanced non-small cell lung cancer in Italy.

A retrospective cost-minimisation analysis was conducted comparing novel chemotherapies for the treatment of chemo-naive patients with locally advanced, recurrent, and/or metastatic non-small cell lung cancer (NSCLC). Resource use information was obtained from a Phase III randomised trial investigating the efficacy and toxicity of gemcitabine/cisplatin (Gem/Cis), paclitaxel/carboplatin (Pac/Carbo) and vinorelbine/cisplatin (Vin/Cis) combination regimens in 612 patients with advanced NSCLC. Since there were no statistically significant differences between the three treatments in terms of progression-free or overall survival in this trial, a cost-minimisation analysis was considered to be the appropriate type of economic evaluation. The perspective was that of the national healthcare provider in Italy. Medical resource use was obtained from the clinical trial database, from which mean cost streams were calculated for each treatment group. The mean total treatment costs per patient were 8094 euros, 11,203 euros and 9320 euros for the Gem/Cis, Pac/Carbo and Vin/Cis regimens, respectively. Based on resource consumption in a clinical trial, Gem/Cis had the lowest overall mean costs of the three chemotherapy regimens. Gem/Cis therefore has the potential to save costs in the treatment of advanced NSCLC in Italy.

Determining patient preferences for improved chemotoxicity during treatment for advanced bladder cancer.

Determining patient preferences for improved chemotoxicity during treatment for advanced bladder cancer Conventional treatment for advanced bladder cancer is methotrexate, vinblastine, doxorubicin plus cisplatin (MVAC), with a median survival of 1 year but significant toxicity. The newer combination of gemcitabine plus cisplatin (GC) has demonstrated comparable survival and an improved toxicity profile (Von der Maase et al. 2000). At present, the importance to patients of the toxicity of chemotherapy has not been widely studied. An earlier study in bladder cancer indicated that toxicity was an important determinant of treatment preference (Davey et al. 2000). A study of preferences for advanced bladder cancer therapy in the UK was proposed.

Cost effectiveness of fluticasone propionate and flunisolide in the treatment of corticosteroid-naive patients with moderate asthma.

OBJECTIVE: The aim of this study was to determine the cost effectiveness of 2 inhaled corticosteroids, fluticasone propionate and flunisolide, in the management of asthma from a third-party payer perspective in Germany (German Sickness Fund). DESIGN AND SETTING: Direct treatment costs were retrospectively applied to 2 prospective randomised parallel group clinical trials conducted in Germany comparing fluticasone propionate and flunisolide: one 6-week open-label study (n = 332) and one 8-week double-blind study (n = 308) in corticosteroid-naive patients with asthma of moderate severity aged between 18 and 70 years. All costs were adjusted to 1997 Deutschmarks. Efficacy parameters included changes in morning and evening peak expiratory flow rate (PEFR) measurements, the number of successfully treated patients (defined as those with a PEFR improvement of > or = 10%) and proportion of symptom-free days. MAIN OUTCOME MEASURES AND RESULTS: The fluticasone propionate groups had higher respective proportions of successfully treated patients and symptom-free days than the flunisolide groups in both the open-label (56.8 vs 39.6% and 36.4 vs 28.5%) and double-blind (55.3 vs 44.5% and 35.1 vs 31.1%) studies. Improvements in both morning and evening PEFR measurements were also significantly (p < 0.01) greater with fluticasone propionate than with flunisolide. Although average daily treatment costs were slightly higher in the fluticasone propionate groups than in the flunisolide groups, all cost-effectiveness ratios (daily cost per successfully treated patient and daily cost per symptom-free day) favoured fluticasone propionate. Sensitivity analysis showed that these results were robust over a wide range of assumptions. CONCLUSION: In these patients, management with fluticasone propionate was more cost effective than with flunisolide in the German healthcare setting.

Cost effectiveness of fluticasone and budesonide in patients with moderate asthma.

OBJECTIVE: The objective of this study was to assess the relative cost effectiveness of fluticasone via metered dose inhaler and budesonide via Turbuhaler((R)) in corticosteroid-naive patients with moderate asthma from a third-party payer perspective (German Sickness Funds). PATIENTS AND METHODS: A retrospective economic assessment of direct medication costs of treatment was performed on data from a prospective, randomised, parallel group, 6-week clinical trial. 457 corticosteroid-naive patients between the ages of 18 and 70 years with moderate asthma were included in the intention-to-treat analysis. RESULTS: The fluticasone group had a higher proportion of successfully treated patients (those with a peak expiratory flow rate improvement of >/=10%) [47 vs 42%], a higher average proportion of symptom-free days (40 vs 34%) and lower direct healthcare costs [1997 Deutschmarks (DM)] per day (DM4.23 vs DM5.19) than the budesonide group. Therefore, the daily costs per successfully treated patient (DM9.00 vs DM12.36) and the cost per symptom-free day (DM10.58 vs DM15.26) were both lower with fluticasone than with budesonide. Sensitivity analysis demonstrated that these results were relatively robust over a wide range of plausible assumptions. CONCLUSION: These results showed that from the perspective of a third-party payer, fluticasone was more cost effective than budesonide over the 6-week study period.

[Cost of asthma therapy in relation to severity. An empirical study]. / Kosten der Asthmatherapie nach Schweregrad. Eine empirische Untersuchung.

BACKGROUND: The aim of asthma therapy, i.e. the permanent elimination of the patient's symptoms, is as a rule, achievable over the long-term only with the aid of anti-inflammatory drugs. As well as medical, this approach also has considerable economic implications. The comparatively low compliance among asthmatics makes treatment in this context all the more difficult. An alternative that presents itself is the use of combination preparations, a mixture of a long-term prophylactic and a therapeutic agent. PATIENTS AND METHODS: With the aid of standardised questionnaires, data were acquired from 216 patients and assigned to subgroups in accordance with the degree of severity of the asthma. The patients were treated in the offices of a total of 23 GPs and internists selected at random from a complete list of all relevant practices in Germany. The use of resources, i.e. all diagnostic and therapeutic measures, was recorded retrospectively for a period of 1 year. In this way, all those resources of relevance to the health insurance carriers used during the observation period were identified. In addition to direct costs, so-called indirect costs were also estimated, i.e. in the present study the productivity loss to the economy due to illness-related absence from work. RESULTS: The annual cost of treating adult asthmatics was calculated to be DM 3,339 for level 1 severity, DM 5,260 for level 2 severity and DM 12,016 for level 3 severity. As the illness progresses in particular the direct cost of inpatient care and the indirect costs rise disproportionately. The yearly expenditure for women sufferers is about DM 800 more than for male sufferers. The direct cost of asthma treatment in children amounts to DM 2,950 for level 1, DM 3,225 for level 2, and DM 4,811 for level 3, severity. Here, drug-related costs in particular, rise significantly as the disease progresses. CONCLUSION: One of the results of the present study is the fact that for asthma sufferers in general, there is a positive correlation between average total costs and degree of severity. It may thus be postulated that preventive medical treatment of asthma that slows the progression of the illness, together with appropriate patient instruction, would have a positive effect on the total expenditure per patient. If, for example, the appropriate use of drugs in combination with patient instruction improved the compliance of asthmatics, lower treatment costs and a better quality of life for the patient could be expected.