Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304).

OBJECTIVE: Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care. BACKGROUND: Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics. METHODS: The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay. RESULTS: Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs (€2919 vs €4262; P < 0.001) were significantly lower in group ILC. CONCLUSIONS: In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304).

Direct costs of Alzheimer's disease in Germany.

OBJECTIVES: The aim of this analysis was to determine the direct costs for patients with Alzheimer's disease (AD) based on data supplied by a large German statutory health insurance (BARMER). Focus of the present evaluation is the exposure of total direct costs, survival rates and the types of care distribution of patients with AD. METHODS: The analysis was based on anonymised data of patients with Alzheimer's disease who were insured by a large German statutory health insurance (Barmer Ersatzkasse-BEK) in 2005 over 12 months (n = 35.684). The study population was classified into three treatment groups: patients who received memantine and no other antidementia drugs, psychotropic drugs or sedatives/hypnotics (memantine group); patients who neither received memantine nor other antidementia drugs but psychotropic drugs and/or sedatives/hypnotics (PHS group); and patients who received no antidementia drugs and no psychotropic drugs or sedatives/hypnotics (no AT group). A Markov model was designed to assess the costs of each treatment group depending on the type of care over a 5-year period. RESULTS: The results obtained for the PHS group were the following: after 5 years, 25.1% were in inpatient health care, 1.1% in partial inpatient care, 5.4% in outpatient care, and 64.5% of patients died. Only 3.9% did not require care. On average, direct costs to the amount of 7.948 € incurred per patient and year and 13.099 € per surviving patient. In the group without pharmacotherapy, 20.6% were in inpatient care, 0.3% in partial inpatient care, 12.8% in outpatient care, and 52.5% of the patients died. For 13.8% of the patients, care was not necessary. The annual costs amounted to 6.760 € per patient and 9.926 € per surviving patient. The results obtained for the memantine group were more beneficial: annual costs per patient amounted to 6.100 € and to 8.376 € per surviving patient. CONCLUSIONS: The results demonstrate that non-antidementive therapy for Alzheimer's disease causes higher costs especially for care. The memantine group proved to be superior compared to PHS group and no AT group, despite higher costs in the specific drug category.

[Cost of illness in Alzheimer's disease]. / Krankheitskosten bei Alzheimer-Demenz.

PURPOSE: The aim of this analysis was to generate cost data of provider services, drug acquisition, hospitalization, nursing care services, and adjuvants for patients with Alzheimer's disease, as well as to describe the distribution and development of care levels. MATERIAL AND METHODS: The analysis is based on anonymized data of patients with Alzheimer's disease who were insured by a large German statutory health insurance (Barmer Krankenkasse [BARMER]) in 2005 (n = 48,322). The study population was classified into three treatment groups: patients, who received memantine and no other antidementives, psychotropic drugs or hypnotics/sedatives (memantine group); patients who neither received memantine nor other antidementives, but psychotropic drugs and hypnotics/ sedatives (PHS group); and patients who received no antidementives or symptomatic therapy at all ("no dementia-specific AM"). Costs were fully assessed for patients in each treatment group and correlated with the care level. RESULTS: In the memantine group, fewer patients needed care than in the other two groups. Total costs per patient averaged 7,028 Euros in the memantine group, 13,549 Euros in the PHS group, and 8,817 Euros in the group with no specific medication. Higher costs in the PHS group and in the group without drug treatment were mainly caused by a considerably higher rate of patients in need of care, of which nursing care made up the highest proportion. Fewer costs for medical treatment could not compensate the additional expenditures for nursing care. Patients in the PHS group had the highest average costs in all cost categories except for specific drug cost. CONCLUSION: The results demonstrate that non-antidementive therapy for Alzheimer's disease causes higher costs especially in nursing care. The memantine group proved superior even though it had the highest costs in the specific drug category.

Cost-effectiveness of psoriasis therapy with etanercept in Germany.

BACKGROUND: We estimated the cost-effectiveness of intermittent therapy with etanercept in patients with moderate-to-severe plaque-type psoriasis in comparison to non-systemic therapy in Germany. PATIENTS AND METHODS: We performed a cost-utility analysis using the endpoint costs per quality-adjusted life year gained (costs/QALY). For this purpose, we adapted a UK-based Markov model by means of resource use data that we derived from a German cost study. Efficacy data, information on frequency of adverse events and changes in quality of life were derived from three pooled clinical trials. We extrapolated the further course of the disease and its treatment over a 10 year course. RESULTS: For patients with an initial Psoriasis Area and Severity Index (PASI) > 10 and a Dermatology Life Quality Index (DLQI) > 10 the incremental cost-effectiveness ratio (ICER) for etanercept compared to non-systemic therapy was 45,491 euro/QALY. For patients with PASI and DLQI > 15 costs/QALY were 32,058 euro and among patients with severe plaque psoriasis (DLQI and PASI > 20) 18,154 euro. CONCLUSIONS: According to internationally accepted levels of cost-effectiveness thresholds, the intermittent treatment of (moderate to) severe plaque-type psoriasis with etanercept is a cost-effective measure within the German healthcare system.