RESUMO
OBJECTIVE: To estimate both the number of patients with hepatocellular carcinoma (HCC) eligible annually for second-line therapy following sorafenib in Germany and the healthcare costs accrued by patients meeting eligibility criteria. METHODS: Patients with an HCC diagnosis and one or more sorafenib prescription were identified from samples of > 3 million insured persons in each of 2012, 2013 and 2014 using the anonymised Betriebskrankenkasse health insurance scheme database. Incidence rates from 2013 were extrapolated to the German population using data from the statutory health insurance system database and Robert Koch Institute. Resource use and cost data were collected for a subset of patients with follow-up data post-sorafenib. RESULTS: Between 1032 and 1484 patients with HCC in Germany (893-1390 publicly insured patients) were estimated as likely to be eligible for second-line therapy after sorafenib annually. For post-sorafenib analyses, 117 patients were identified with HCC, one or more sorafenib prescription and considered potentially eligible for second-line treatment, 15 of whom were alive after 12 months' follow-up. Total mean costs per patient accrued in the 12 months after sorafenib treatment ended were 11,152 (hospital care, 6483 [58.1%]; outpatient prescriptions, 3137 [28.1%]). CONCLUSION: The estimated number of publicly insured HCC patients annually eligible for second-line therapy in Germany was < 1400 and mean total costs accrued in the year after completion of sorafenib therapy were approximately 11,000 per patient for the German statutory healthcare system. These estimates can be used when evaluating the budgetary impact of new second-line therapies for advanced HCC in Germany.
RESUMO
We conducted a meta-analysis of cohort and case-control studies to evaluate all-cause and cardiovascular (CV) mortality of patients with type 2 diabetes mellitus (T2DM) who received sulphonylurea (SU) treatment, when compared to any other diabetes treatment. Only studies reporting raw data on mortality during SU treatment were included. Data were combined using random-effects (RE) models. Unadjusted odds ratios (ORs) are presented. Of 4991 publication titles and abstracts reviewed, 20 studies (n = 551,912 patients) were included. For cohort studies (n = 276,050), patients receiving SU monotherapy or combination treatment had significantly higher all-cause and CV mortality risks compared to any non-SU treatment [all-cause, 13 studies: OR = 1.92, 95% confidence interval (CI) = 1.48-2.49; CV, 5 studies: OR = 2.72, 95% CI = 1.95-3.79]. Validity was limited by the high treatment group heterogeneity (I (2) > 90%) and study-inherent biases/design differences. In conclusion, patients receiving SU treatment had increased all-cause and CV mortality risks. However, the meta-analysis was limited by the high heterogeneity of non-randomized studies.
