[Atrial fibrillation in Germany: A prospective cost of illness study]. / Vorhofflimmern in Deutschland--eine prospektive Krankheitskostenstudie.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice and associated with a high risk of stroke, heart failure and hospitalization. This study examines the indication-specific costs of illness of AF patients in Germany. METHODS: The study was conducted nationwide with 54 general practitioners and internists, as well as 12 practicing cardiologists. The observational period per patient was one year. Costs were calculated from the perspective of the German statutory health insurance. The study collected the annual direct indication-specific costs and additional patient relevant outcomes. RESULTS: Indication-specific services of 361 patients (age: 75, male: 55%) documented by general practitioners and internists cause average costs of 582 € per patient. The highest cost are caused by hospitalization (289 €), followed by outpatient treatment costs (151 €) and costs of anticoagulation with 52 € per patient. Additional consulting of a cardiologist (115 patients) causes average costs of 81 €. Assuming that a patient with AF is treated once a year by a resident cardiologist, the average annual cost amounted to 664 €. CONCLUSION: The results of this prospectively cost of illness analysis for AF patients under real life conditions in Germany indicate a high socio-economic burden of AF.

[General practitioners in palliative care in Germany: a systematic review]. / Stand der hausärztlichen Palliativversorgung in Deutschland. Ein systematischer Literaturreview.

To investigate the role of general practitioners among the increasing specialization in outpatient palliative care, meaningful research topics, developments of new collaborations and structures in the outpatient sector of palliative care, 52 articles were reviewed. Results have shown that general practitioners are still involved in outpatient palliative care research and show a distinct participation in quality development. Typical research topics in outpatient palliative care research are quality of care and structures. However, cooperative structures between general practitioners and palliative specialists are rare in the field of outpatient palliative care research.

[Treatment recommendations for alcohol dependence--comparison of German and international guidelines]. / Behandlungsempfehlungen zur Alkoholabhängigkeit. Ein Vergleich deutscher und internationaler Leitlinien.

In order to identify relevant recommendations for the treatment of alcohol dependent adults a systematic guideline research was conducted on national and international guideline providers. The research showed differences between German and international guidelines in terms of the treatment goal and the resulting treatment recommendations. In Germany, abstinence is the only accepted treatment goal. An alcohol reduction in terms of harm reduction is recommended by one guideline as an intermediate goal. The recommended treatment options include intensive inpatient measures such as detoxification and alcohol withdrawal. Further outpatient treatment of alcohol dependency is not recommended by German guidelines. International guidelines also recommend abstinence as the goal for all patients. Beyond, the reduction of alcohol consumption is recommended as a possible treatment goal under certain conditions if abstinence not (yet) is possible. Thereby the treatment goal should be set individually considering the patient's feasibility and wishes. Besides abstinence also the reduction of alcohol consumption leads to an improvement of health. Therefore patients aiming for this goal should also be supported. Furthermore, the inclusion of patient's wishes in the goal setting leads to better treatment outcomes. Therefore, an extension of goal setting and treatment recommendations towards the reduction of alcohol consumption seems reasonable for Germany. Furthermore, the adaption to the state of international guidelines seems reasonable.

[Use of St. John's Wort for depression in primary care - a non-interventional study]. / Stellenwert von Johanniskraut- extrakt in der hausärztlichen Depressionstherapie. Eine nicht interventionelle Studie.

BACKGROUND: Mild to moderate depression is frequently treated by general practitioners in Germany, quite often with St. John's Wort preparations. In contrast, controlled clinical trials were usually performed in psychiatric specialist centers or hospitals. METHODS: In this one-armed, prospective non-interventional study 408 general practitioners documented 1300 patients with mild or moderate depression, which received 600 mg St. John's Wort extract WS 5570 once daily. The observation period was 8 to 10 weeks. Therapeuticeffectand tolerabilityof WS 5570 were investigated. Additionally, doctors were asked for their experienceswith and attitudes to depression therapy and complementary medicine, reasons for administration of St. Johns Wort and its contribution totreatmentsuccess. RESULTS: 807 patients, who were included in the analysis corresponding to the protocol, had rates for successful treatment (> 50% decrease of the Hamilton 17-item depression scale [HAMD]) 79,3%, respectively for remission 68,4%. Six patients (0.46%) dropped out for adverse drug reactions. For comparison with the results of an earlier controlled clinical study (WS 5570 600 mg/d vs. 1200 mg/d vs. placebo), which was conducted mainly by medical specialists, 257 patients complying with the inclusion criteria of the controlled study were analysed. HAMD-scores at entry (22.9) and improvement after 2 (-6.6) and 6 weeks (-10.8) were very similar to those reported in the controlled clinical trial. 202 evaluable questionnaires completed by 408 doctors were available. Doctors regarded self-healing and placebo effects as important therapeuticfactors; however, in 75% of the cases they assigned at least 50% of treatment success to the St. John's Wort preparation, and in 19% it was regarded as the only reason for improvement. CONCLUSIONS: General practitioners consider St. John's Wort extract WS 5570 a well tolerable therapeutic instrument contributing more than 50% to total treatment effect. Causal conclusions to the efficacy of WS 5570 cannot be drawn in this study because of the non-interventional design. Efficacy of treatment of mild to moderate depression in primary care is comparable to findings in specialist-based controlled clinical studies.

[Costs of patient controlled analgesia in postoperative pain management in Germany]. / Kosten der patientenkontrollierten Analgesie (PCA) im Rahmen des postoperativen Schmerzmanagements in Deutschland.

PURPOSE: This systematic literature review was conducted to analyze the costs of postoperative patient controlled analgesia (PCA) in Germany. METHODS: The literature search comprised the search criteria "therapeutic procedure", "postoperative pain management", the routes of administration "intravenous PCA" (PCIA) and "epidural PCA" (PCEA), as well as their corresponding costs and economic analyses. RESULTS: Due to differences in indications, calculated costs and medical expenses it was not possible to compare the results from the respective studies. CONCLUSION: A critical examination of benefits and costs of therapeutic options in hospitals has become necessary with the implementation of the German DRG compensation system. This has created a substantial need for the optimization of resources and processes. There is an enormous demand for research on the costs for PCA in Germany. The identification of cost-driving factors is necessary to determine saving potentials and thereby develop new technologies for postoperative analgesia.

Added therapeutic value of memantine in the treatment of moderate to severe Alzheimer's disease.

When evaluating the added therapeutic value of a drug, evidence of greater overall benefit or at least an add-on benefit is increasingly being required. Therefore, cost-effectiveness in addition to clinical efficacy is an important consideration. The efficacy of a drug must be examined on the basis of clinical trials by measuring specific parameters that are affected by the drug (for example blood pressure with antihypertensive treatment). Today not only efficacy but also patient-relevant changes (patient benefits) must be demonstrated for a drug, often by measuring quality of life. In order to evaluate the benefit of monotherapy with the N-methyl-D-aspartate antagonist memantine in the management of moderate to severe Alzheimer's disease, a systematic literature review was conducted. The results showed a benefit for memantine in comparison with placebo in terms of a decrease in nursing care, a delay in care dependency and a delay in admission to nursing homes. In addition, an increase in quality of life has been observed.

[The situation of patients with dementia may be rectified by Ginkgo biloba. Results of a health services research study concerning the ability of patients with dementia, quality of life of the nursing family members and total treatment costs]. / Versorgungssituation von Demenzkranken kann durch Ginkgo biloba verbessert werden. Ergebnisse einer Studie zur Versorgungsforschung hinsichtlich der Leistungsfähigkeit der Demenzkranken, der Lebensqualität der Pflegenden und der Gesamtkosten der Behandlung.

UNLABELLED: BACKGROUND AND ISSSUES: Ginkgo biloba-extracts are often used in therapy of patients with dementia. In this study, benefit and structure of Ginkgo biloba-extract EGb 761 in treatment of patients with dementia was examined. PATIENTS AND METHODS: For the assessment of quality of life of care-taking relatives and patients as well as treatment costs were documented. The study was conducted as a non-randomised, two-armed cohort study with an open design for 683 slightly or moderately demented patients, aged between 65 and 80 years. Society's perspective was taken. Barthel-Index and MMST were also documented. Because of significant differences at inclusion of both cohorts, a matched-pairs-analysis and multiple regression analysis conducted. RESULTS: According to PLC a significant improvement in quality-of-life of care-taking relatives (p < 0.001) and patients (positive mood p = 0.018, negative mood p < 0.001) was only observed in the Ginkgo-cohort. Also Barthel-Index indicated an improvement in the Ginkgo-cohort (p < or = 0,001). MMST-scores increased significantly only in the Ginkgo-cohort (p < 0.001). Average total cost per patient amounted to 3.614,75 euro in the standard-cohort, whereas these costs per patient in the Ginkgo-cohort amounted to 3.031,78 euro (p = 0.067). Results were confirmed by matched-pairs-analysis. RESULTS: Ginkgo treatment has a valid place in caretaking structure of health services. Gingko attributes to a higher quality of life for both care-takers and patients, the progression of disease is slowed down and treatment costs are lower.

[Effectiveness of echinacin in therapy of chronic recurrent respiratory disease]. / Nutzenbewertung der Therapie chronisch rezidivierender Atemwegsinfekte mit Echinacin.

PURPOSE: Echinacea purpurea (echinacin) is frequently used in the therapy of chronic recurrent respiratory disease. The aim of this study was to show whether treatment of chronic recurrent respiratory disease with echinacin has a greater benefit in terms of effectiveness than therapy without an immunomodulator. MATERIALS AND METHODS: Frequency, duration of recurrence, resources used and patients' satisfaction was documented in order to assess benefit. In this prospective, non-randomised, multi-centre, nationwide, two-armed health services research study, data of 995 patients (782 echinacin-, 213 standard-cohort) with chronic recurrent respiratory disease were collected. The perspectives of statutory health insurance (SHI), patients and health policy were taken into consideration. RESULTS: The risk of falling ill was 2.3 fold higher and the duration of relapse 1.4 days more compared to the standard-cohort. There was a clinical and economical benefit from the therapy with echinacin for SHI and health policies. In contrast, patients experienced a greater financial burden. Average total costs per patient during the observation period of 3 months amounted to 238.35 in the standard-cohort and to 228.95 in the echinacin-cohort. Results of the intent-to-treat-analysis were reconfirmed in a per-protocol-analysis. CONCLUSION: This health services-research-study taking the therapy of chronic recurrent respiratory disease with echinacin as an example has shown that even non-prescription drugs can have clinical and economic benefits.

[Treatment of interdigital tinea pedis]. / Behandlung der Tinea pedis vom interdigitalen Typ. Systematischer Review.

BACKGROUND AND OBJECTIVE: Local antimycotic therapy of interdigital tinea pedis is widely accepted and efficacious. In Germany at present, the azoles and allylamines--part from the hydroxypyridone derivative ciclopiroxolamine--are the pharmacological agents applied most often. This study focuses on the efficacy of topical therapeutic options in Germany, by regarding the mycological and clinical cure rates of interdigital tinea pedis. METHODS: Only randomised, double-blind and controlled clinical trials of tinea pedis therapy were selected for the evaluation. Microbiological culture and microscopic information were indispensable criteria for the clinical diagnoses. RESULTS: The data from 40 randomised clinical trials of azoles and allylamines were included in the analysis. The comparison of azoles with the placebo revealed mycological cure rates between 60 - 91 % (placebo 10 - 67 %) and clinical cure rates between 64 - 95 % (placebo 10 - 63 %). Placebo-controlled trials of allylamines (naftifine and terbinafine) indicated mycological cure rates between 62 - 100 % (placebo 10 - 45 %) and clinical cure rates between 66 - 86 % (placebo 4 - 44 %). Both the azoles and the allylamines were significantly superior to the placebo. Comparative studies between azoles and allylamines occasionally indicated the significantly superior cure rates of allylamines (especially terbinafine). The high cure rates of terbinafine could be detected after therapy duration of merely one week, whereas the azoles have to be applied for four weeks before good efficacy was reached. CONCLUSION: In several trials the allylamines--especially terbinafine--proved superior to the azoles. This may be explained by the fungicidal mode of action of the allylamines and the favourable pharmacokinetic characteristics of terbinafine, in contrast to the fungistatic mechanism of the azoles.

Cost-effectiveness of adjuvant treatment with acamprosate in maintaining abstinence in alcohol dependent patients.

An open prospective cohort study was performed in Germany in order to evaluate the costs of treating alcohol dependence under real-world conditions. Eight hundred and fourteen recently detoxified alcohol-dependent patients were provided with psychosocial rehabilitation support. In addition, 540 alcohol-dependent patients treated with adjuvant acamprosate therapy were compared with 274 patients without pharmacotherapy. Real costs were assessed over a period of one year. Of the patients who were treated with acamprosate, 33.6% remained abstinent compared to only 21.1% in the standard cohort. The mean total costs per patient treated with acamprosate were EUR 1,631.49 per year. In the standard cohort, total costs were EUR 2,068.83. This difference is highly significant (p = 0.012). Direct costs amounted to 76.9% of the total costs, with a 27% difference between the cohorts (p < 0.001). There was no difference in indirect costs between the two groups (p = 0.324). This real-cost study confirms the favourable cost-effectiveness of acamprosate previously suggested by pharmaco-economic modelling studies.

Quality of life in acute exacerbation of chronic bronchitis: results from a German population study.

This study reports on data from a study conducted in the Federal Republic of Germany examining the quality of life (QoL) of patients with chronic bronchitis (CB) and its acute exacerbations (AECB). Data from 320 patients were collected at AECB and subsequently during a stable phase (non-AECB) utilizing the St George's Respiratory Questionnaire (SGRQ) and the Nottingham Health Profile (NHP). As expected, the QoL of CB patients was poor, even at non-AECB, with patients reporting lower scores than patients with other chronic conditions. Patients reported significantly poorer QoL at AECB than at non-AECB. After adjusting for the severity of the underlying condition, poorer QoL at AECB was significantly and independently associated with older age, unemployment, increasing BMI, increasing number of prior AECBs, and Anthonisen AECB grade. While younger subjects reported significantly greater deterioration in QoL at AECB, the factors most consistently and independently associated with relative QoL deterioration at AECB were the number of prior AECBs and exposure to air pollution at home. In conclusion, this study highlights the detrimental effect of CB, and in particular AECB, on QoL. The association between QoL and patient reports of previous AECB number and air pollution are consistent with reports from other studies.

[Adjuvant drug treatment of alcoholism with acamprosate: between sectoral budgets and disease management]. / Die adjuvante Arzneimitteltherapie der Alkoholkrankheit mit Acamprosa--Zwischen sektoraler Budgetierung und Disease Management.

OBJECTIVE: On the basis of several controlled clinical investigations the cost-effectiveness of acamprosate as adjuvant therapy of alcohol-dependent patients has yet been evaluated. These optimal conditions cannot be found in the daily ambulant practice and results in asking which of the alternatives, "standard plus acamprosate" or "standard without acamprosate", is more cost-effective in maintaining abstinence in alcohol dependent patients under realistic conditions. PATIENTS AND METHODS: In an open multi-centre study, medical care, costs and therapeutic outcome was prospectively documented. Prior to enrolling, all patients were obliged to undergo a detoxification procedure. At a mean age of 45 years the patients suffered an average of ten years from alcohol dependence. 521 patients were documented in the acamprosate cohort and 265 patients in the cohort "other therapy" over one year. Two thirds of the participating patients were male. RESULTS: At 33.6 % the rate of abstinence was remarkably higher in the acamprosate cohort in comparison to the cohort "other" at 21.1 % abstinent patients. The mean total costs per patient and year amounted to DM 3191 in the acamprosate-cohort and were significantly lower than in the cohort "other" with DM 4046. Effectiveness-adjusted costs of DM 9500 per successfully treated patient in the acamprosate-cohort were superior to the cohort "other", amounting to DM 19 148 per successfully treated patient. CONCLUSION: The described economic benefits may be utilised under conditions of an adequate disease management.

Treatment outcomes in acute exacerbations of chronic bronchitis: comparison of macrolides and moxifloxacin from the patient perspective.

Moxifloxacin, a new respiratory quinolone, was compared with the macrolides azithromycin, clarithromycin and roxithromycin in a cohort study to assess clinical, safety and health-related outcomes of these antimicrobials in general practice settings. In total 332 patients with acute exacerbations of chronic bronchitis (AECB) each received one of the antimicrobial agents for a standard short course of therapy. Random allocation of therapeutic agents occurred by centre, not individuals, and the drugs were prescribed in an open manner. In addition to clinical evaluation by their physicians, all patients kept daily diaries to assess AECB symptoms over the study period, therapy received and quality of life. The overall clinical response rate was 96% and all four regimens were well tolerated. After 14 days there were no significant differences between the study groups, but analyses of patients' daily evaluations of certain AECB specific symptoms showed a faster response rate in the moxifloxacin group.

[Socioeconomic relevance of acute exacerbations of chronic bronchitis in the Federal Republic of Germany. A prospective cost of illness study]. / Zur sozioökonomischen Relevanz akuter Exazerbationen der chronischen Bronchitis in der Bundesrepublik Deutschland. Eine prospektive Krankheitskostenstudie.

BACKGROUND AND OBJECTIVE: Prospectively determined data on costs of chronic bronchitis were not yet available for the Federal Republic of Germany. The purpose of the burden-of-illness-study conducted in the Federal Republic of Germany from October 1996 to March 1998 was to calculate direct and indirect costs of chronic bronchitis as well as its acute exacerbations per patient and year. Furthermore, the health-related quality of life of the patients was determined. PATIENTS AND METHODS: The burden-of-illness-study was conducted as an open, not randomised surveillance study. The evaluation based on 785 patients (55.4% male, 44.2% female, 0.4% unknown; mean age 60 years) who were treated by 147 general practitioners. 755 patients could be included into the cost analysis. RESULTS: Per patient and year direct costs of chronic bronchitis amounted to DM 1112.27, the calculation of indirect costs resulted in DM 959.09. 41.4% of direct costs were due to drug acquisition, hospitalisation costs shared 31.6% and costs for physicians' fee amounted to 20.6%. The severity of chronic bronchitis revealed significantly different results in cost analysis: per patient, mild disease lead to direct costs of DM 387.86, moderate disease to DM 802.62 and severe disease to DM 2224.40. This result was caused by higher costs for drug acquisition and hospitalisation costs due to chronic bronchitis in higher stages of severity. Indirect costs were calculated by applying the human-capital-approach: 45.8% of indirect costs were due to time-off-work, nursing costs amounted to 23.7%. CONCLUSION: The costs of chronic bronchitis have a considerable impact on the total costs of the health care system of Germany.