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Background: This study was a pre-planned country-specific secondary analysis of results in Germany from a multinational multicenter observational study to retrospectively evaluate clinical outcomes with caspofungin in patients with probable and proven invasive fungal infection following solid organ transplantation (SOT).Methods: Data were retrospectively collected on a single episode of invasive fungal infection (IFI) in patients who had a SOT between January 2004 and June 2007. Effectiveness was reported as the proportion of patients who received at least five doses of caspofungin with a favorable (complete or partial) response. Safety was assessed for patients who received at least one dose of caspofungin. Descriptive statistics were employed for all evaluations.Results: A total of 41 SOT patients (27 male, 14 female; median age 56 years, median APACHE II score at start of caspofungin therapy 23) were enrolled from 5 sites in Germany. Organs transplanted were mainly heart (51%) and liver (46%). Prevalent risk factors for IFI at baseline were use of central venous catheter (37 out of 41 patients, 90%), steroid use (37 out of 41 patients, 90%), recent stay in intensive care (36 out of 41 patients, 88%),and duration of SOT procedure >5 hours (21 out of 41 patients, 51%). Candidiasis was diagnosed in 34 patients (83%) and aspergillosis in 10 patients (24%). The lungs were the most common site of IFI (21 out of 41, 51%). Caspofungin as monotherapy was received by 28 patients (68%); 6 patients (15%) received caspofungin as salvage therapy for IFI, in most cases because they were refractory to prior antifungal drugs. Immunosuppressants were administered with caspofungin in 39 out of 41 patients (95%). In subjects with at least 5 doses of caspofungin (modified intention to treat population) the favorable response rate at the end of caspofungin therapy was 88% overall, 29 out of 33 patients; 95% confidence interval (95%-CI) 72-97%), 86% (19 out of 22 patients) with monotherapy and 91% (10 out of 11 patients) with combination therapy. No (serious) adverse events or drug interactions related to treatment with caspofungin were reported. The overall survival rate was 79% (26 out of 33 patients; 95%-CI 61-91%) at 7 days after completion of caspofungin treatment.Conclusion: Caspofungin was found to be an effective treatment of probable and proven invasive fungal infections in patients following SOT in Germany. [ABSTRACT FROM AUTHOR]

Aims Systematic data are sparse on clinical outcome after acute coronary disease followed by cardiac rehabilitation therapy. Therefore, our objective was to determine the long-term development of cardiac risk factors, recurrent clinical events, and cardiac medication in patients undergoing routine inhospital cardiac rehabilitation therapy.Methods and Results In the prospective PIN Study (Post Infarct Care), 2441 consecutive patients (78% men, 60±10 years, 22% women, 65±10 years) were enrolled in 18 inpatient rehabilitation centres in Germany following myocardial infarction (56%), coronary artery bypass graft (38%) or percutaneous transluminal coronary angioplasty (6%). Cardiac risk factors, pre-specified clinical end-points, and the prescription of cardiac medication were prospectively documented on admission to and at discharge from rehabilitation therapy, and 3, 6 and 12 months later by obtaining information with standardized questionnaires from the patients and their physicians. The cardiac risk factors improved initially during cardiac rehabilitation therapy, but deteriorated within the following 12 months: 39% patients smoked at the beginning vs 5% at the end of inhospital rehabilitation vs 10% at 12 months follow-up (P<0·001). The respective numbers for patients with blood pressure >140 and/or 90mmHg were 24 vs 8 vs 25% (P<0·01) and with plasma cholesterol >200mg.dl−157 vs 29 vs 51% (P<0·01). A total of 886 patients experienced one or more recurrent clinical events during the first year, 69% of those within the initial 6 months. At 12 months follow-up, 77% of patients received aspirin, 70% beta-blockers, 62% lipid lowering medication, and 53% angiotensin converting enzyme inhibitors.Conclusion The present results indicate that the benefit of cardiac rehabilitation therapy following acute coronary events is only partially maintained during the following year. Continuous strategies of medical care need to be developed to improve the long-term outcome in coronary patients. [ABSTRACT FROM PUBLISHER]

In order to establish a basis for the planning of improved medical care of migraine in Germany, we report on the proportion of migraine patients under primary care and the continuity of consultations for migraine as determined by age, gender, and history of migraine and nonmigraine practice contact (Primary Care of Migraine, PCAOM Study). A primary-care-physician-based migraineurs' sample of 16,573 women and 4,636 men (MediPlus, IMS Health) was placed in relation to cases expected according to International Headache Society criteria in the base population, and was followed for up to 3 years for repeat consultations. Overall, no more than 51% and 37%, respectively, of female and male statutory health-insured migraine headache sufferers had a migraine diagnosis mentioned at least once a year in primary care. At younger ages, substantially less advantage was taken of available primary healthcare for migraine; 79% of the women and 74% of the men were estimated to present again to the same primary-care physician within 3 years because of migraine, the corresponding figures for patients with no history of migraine in the practice concerned being 41% and 31%, respectively. Following first migraine contacts, time to recontact and quarterly recontact prevalences for migraine did not differ, whether on the basis of an established nonmigraine primary care relationship or a first encounter with a medical practice. Trust evidenced by an existing nonmigraine doctor-patient relationship apparently did not carry over to migraine. Results indicate that one of the greatest challenges in relation to the care of migraine patients in Germany is to establish and maintain solid doctor-patient relationships. [ABSTRACT FROM AUTHOR]

We estimate the extent to which recommendations on the prevention and treatment of migraine issued by professional medical bodies are implemented in medical practice in Germany. Computerized data (MediPlus, IMS Health) were analyzed in 4,636 male and 16,573 female migraineurs from 383 primary care practices 1994 through 1996 (Primary Care of Migraine, PCAOM study). A total of 90,540 drug prescriptions with a documented diagnosis of migraine were issued in 45,669 person-years (1,492 prescriptions [DM 40.99] per person-year to men, 2,109 prescriptions [DM 62.01] per person-year to women). Approximately three of every four prescriptions were incompatible with the recommendations of the German Migraine and Headache Society (DMKG), amounting to extrapolated costs of DM 49 million per year borne by the German statutory health insurance fund for combination migraine preparations. The density of non-DMKG therapies for diagnosed migraine followed a sigmoid curve with increasing patient age, while DMKG-compliant therapies described a bell-shaped curve. Referrals to neurological care specialists were not associated with subsequent primary care focus on recommended therapies. We conclude that medication prescribed for migraine is largely not according to long-standing recommendations by medical societies in Germany. [ABSTRACT FROM AUTHOR]

Background and Aim: Unstable angina, a common serious clinical entity, is associated with a high rate of complications. The aim of our study was to evaluate treatment costs of patients with uncomplicated and complicated follow-up in order to evaluate the economic consequences of new therapeutic strategies, like the introduction of GPIIb/IIIa blockers at our hospital., Methodology: All 103 patients who were admitted to the medical intensivecare unit of Johann Wolfgang Goethe-University Hospital, Frankfurt am Main between March 2, 1992 and October 31, 1997 for unstable angina of Braunwald class III B were enrolled in the study. Clinical events were the occurrence of refractory ischemia, nontransmural or transmural myocardial infarction or cardiac death. The following were documented: duration of treatment in the ICU and in the general ward, cardiac catheterizations, balloon angioplasties (PTCA), and bypass operations. Treatment costs were calculated on the basis of daily rates, flat rates, and special fees., Results: Following successful primary treatment, a clinical event occurred in 48 of the 103 patients, recurrent refractory ischemia in 34 patients, nontransmural infarction in eight patients, transmural infarction in three patients, and death in four patients. Patients with events were significantly less likely to have had a history of PTCA (38% vs 60%, p < 0.05) and were significantly less likely to be undergoing long-term treatment with aspirin (63% vs 80%, p < 0.05). Other sociodemographic data as well as the initial treatment strategies were comparable. The occurrence of a complication significantly prolonged the duration of treatment in the ICU from 2.6 days (95%-CI [2.1; 3.0]) to 3.6 days (95%-CI [3.1; 4.1]) and the total duration of treatment from 7.0 days (95%-CI [5.7; 8.4]) to 12.8 days (95%-CI [9.6; 16.1]). The total treatment costs rose accordingly from DM 14,360 (95%-CI [12,360; 16,360]) to DM 26,690 (95%-CI [23,150; 30,240])., Conclusion: The data show that ischemic complications following successful primary treatment of unstable angina constitute a common problem. Such complications are associated with significantly more intensive treatment and significantly longer hospitalization times, resulting in a near doubling of treatment costs.

Objective: Recent data indicate that the combination of a low cholesterol diet and simvastatin following heart transplantation is associated with significant reduction of serum cholesterol levels, lower incidence of graft vessel disease (GVD) and significantly superior 4-year survival rates than dietary treatment alone. On the basis of this first randomised long term study evaluating survival as the clinical end-point, we investigated the cost effectiveness of the above regimens as well as the long term consequences for the patient and for heart transplantation as a high-tech procedure., Design and Setting: The perspective of the economic analysis was that of the German health insurance fund. Life-years gained were calculated on the basis of the Kaplan-Meier survival curves from the 4-year clinical trial and from the International Society for Heart and Lung Transplantation (ISHLT) overall survival statistics. Incremental costs and incremental cost-effectiveness ratios were determined using various sources of data, and both costs and consequences were discounted by 3% per year. Sensitivity analyses using alternative assumptions were conducted in addition to the base-case analysis., Patients and Participants: As in the original clinical trial, the target population of the economic evaluation comprised all heart transplant recipients on standard triple immunosuppression consisting of cyclosporin, azathioprine and prednisolone, regardless of the postoperative serum lipid profile., Interventions: The therapeutic regimens investigated in the analysis were the American Heart Association (AHA) step II diet plus simvastatin (titrated to a maximum dosage of 20 mg/day) and AHA step II diet alone., Main Outcome Measures and Results: Four years of treatment with simvastatin (mean dosage 8.11 mg/day) translated into an undiscounted survival benefit per patient of 2.27 life-years; 0.64 life-years within the trial period and 1.63 life-years thereafter. Discounted costs per year of life gained were $US1050 (sensitivity analyses $US800 to $US15,400) for simvastatin plus diet versus diet alone and $US18,010 (sensitivity analyses $US17,130 to $US21,090) for heart transplantation plus simvastatin versus no transplantation (all costs reflect 1997 values; $US1 = 1.747 Deutschmarks)., Conclusions: Prevention of GVD with simvastatin after heart transplantation was cost effective in all the scenarios examined with impressive prolongation of life expectancy for the heart recipient. Simvastatin also achieved an internationally robust 21% improvement in the cost effectiveness of heart transplantation compared with historical cost-effectiveness data.

In the second World Health Organization MONItoring Trends and Determinants in CArdiovascular Disease (MONICA) Augsburg survey in 1989-1990 (n = 4,940), the association between nephelometric plasma fibrinogen level and lifestyle-related potential determinants was assessed in 4,434 subjects aged 25-74 years (89.8% of participants). Irrespective of pregnancy and the use of oral contraceptives, crude fibrinogen values were consistently higher in women than in men of all ages (age-standardized difference, 12.2 mg/dl; 95% confidence interval, 7.0-17.4 mg/dl). Fibrinogen concentrations were positively correlated (p less than or equal to 0.0001) with age, body mass index, and waist-to-hip ratio in both sexes and with cigarette smoking in men and were negatively correlated with alcohol consumption in both sexes. In multiple linear regression analyses using categorized determinants as independent variables, a strongly J-shaped relation for body mass index in women and a linear association for waist-to-hip ratio in men were revealed. Smoking had a dose-dependent effect on fibrinogen concentration in men but a lesser effect in women. For alcohol consumption a U-shaped association was found, particularly in men. The curvilinear relations were confirmed in multiple polynomial regression models using continuous determinant variables. The potential epidemiological impact of a determinant was assessed by calculating differences in adjusted fibrinogen concentrations associated with the 10th and 90th percentile values of the determinant distributions actually observed among the study participants. This impact on the population fibrinogen level was most pronounced for age in both sexes, followed by body mass index, cigarette smoking, and alcohol consumption in women and by smoking, waist-to-hip ratio, and alcohol consumption in men.(ABSTRACT TRUNCATED AT 250 WORDS)