Impact of mycophenolate mofetil (MMF)-related gastrointestinal complications and MMF dose alterations on transplant outcomes and healthcare costs in renal transplant recipients.

Mycophenolate mofetil (MMF), a mycophenolic acid prodrug, is a highly effective adjunct immunosuppressive agent in transplant therapy. Although MMF is generally well tolerated, optimal therapy may be limited by adverse effects, in particular gastrointestinal (GI) toxicity, which has been reported to occur in up to 45% of MMF-treated patients. MMF dose changes resulting from these adverse events may lead to sub-therapeutic dosing and impaired clinical outcomes. This retrospective study analyzed clinical records from 772 renal transplant patients from 10 US transplant centers who were initiated on MMF. The analysis revealed that 49.7% (n = 382) of patients experienced at least one GI complication within the first 6 months post-transplant, with 66.8% (n = 255) of these having multiple GI complications. Of the patients with GI complications, 39.0% experienced MMF dose adjustments or discontinuation of MMF therapy. Patients with GI complications who experienced MMF dose adjustments/discontinuation had a significantly increased incidence of acute rejections compared with patients without GI complications (30.2% vs. 19.4%; p = 0.005). Mean treatment costs were higher in patients with GI complications than in those with no GI complications, particularly in those who experienced MMF dose adjustments/discontinuation (p = 0.0001). The mean incremental cost for patients experiencing GI complications was US$3700 per patient during the 6 months post-transplant (p < 0.001), which was mainly attributable to hospitalization costs. In summary, GI complications and MMF dose adjustments/discontinuations are associated with a significant negative impact on transplant outcomes and markedly increase short-term treatment costs.

[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.

[A cost analysis of diagnostic screening for the differentiation of type-1 and type-2 diabetics aged 30 to 45. A health economics modelling calculation]. / Kostenanalyse eines Diagnostik-Screenings zur Differenzierung von Typ-1- und Typ-2-Diabetikern im Alter von 30 bis 45 Jahren. Gesundheitsökonomische Modellrechnung.

BACKGROUND AND OBJECTIVE: Because of its chronic course and increasing incidence diabetes mellitus is assuming increasing importance not only for medical reasons but also on health policy. Early recognition of carriers of autoantibodies among type 2 diabetics (noninsulin-dependent; NIDDM) and the resulting optimization of blood glucose could lead to a reduction of secondary diseases. A health-economic model for calculating costs was used to test the socioeconomic significance of a screening programme for identifying carriers of antibodies against glutamic acid decarboxylase among NIDDM diabetics. PATIENTS AND METHODS: Health-economic analysis was based on the incidence of positive autoantibody tests among diabetics aged between 30 and 45 years. Results for a cohort of diabetics who had been screened were compared with those obtained in a control group without screening. A time-span of 20 years was chosen because of the late manifestations of diseases secondary to DM. The model calculations used a cost analysis. Data were based on interventional clinical and epidemiological studies. Cost of treatment of secondary diseases was confined to a one-year period. In the first instance the direct medical costs and additionally the indirect economic costs, generated by patients' loss of production and disability to work were calculated. One-dimensional sensitivity analysis was used to check the assumptions underlying the model. RESULTS: Per patient in the model, total costs of the screening programme over a period of 20 years were calculated at DM 31,278, of which DM 7,799 were direct and DM 23,479 indirect costs. The calculated costs for the control subjects (no screening) were DM 35,290, of which DM 10,984 were direct and DM 24,306 indirect costs. CONCLUSIONS: Extrapolating to the entire population, with an investment by the statutory health insurance of ca. DM 22.8 million, employing a full screening programme would lead to a saving of DM 2.6 billion.