Dosage strength is associated with medication persistence with Ginkgo biloba drug products: a cohort study of ambulatory drug claims data in Germany.

BACKGROUND: Ginkgo biloba drugs (Gb) are reimbursed within the German statutory health insurance (SHI) scheme for treatment of dementia. In 2008, a novel Gb product containing 240 mg Ginkgo extract EGb761® per tablet was introduced aiming to facilitate medication use by incorporating the recommended daily dose in one single tablet. The aim of this study was to evaluate the relationship between dosage strength and persistence in a representative population of patients treated with Gb. METHODS: Retrospective cohort study in ambulatory drug claims database within the German SHI system. Persistence was defined as continuous treatment with an allowable gap of 20% between refills. Multivariate regression models were conducted to identify variables associated with persistence. RESULTS: Among 13,810 patients initiating treatment with Gb in 2008, 430 (3.1%) received a dosage strength of 240 mg, 7,070 (51.2%) a dosage strength of 120 mg and 6,310 (45.7%) dosage strengths containing less than 120 mg Gb per tablet. After 6 months, persistence was highest for patients treated with the 240 mg dosage form (22.8% of patients), although persistence was low in general (5.7% and 0% of patients treated with 120 mg and less than 120 mg, respectively). Risk for non-persistence was reduced in patients receiving 240 mg products compared to 120 mg (HR = 0.63; 95%CI 0.57 - 0.70). CONCLUSIONS: Patients initially treated with Gb 240 mg were more persistent compared to those receiving lower dosage strengths. Nevertheless, persistence with Gb therapy is generally low and should be improved in order to better realize therapeutic effects.

Incidence of thyroid hormone therapy in patients treated with sunitinib or sorafenib: a cohort study.

BACKGROUND: Sunitinib and sorafenib can induce serious adverse drug reactions (ADR) such as hypothyroidism. However, the incidence has not been reliably determined in clinical trials. AIMS: To determine incidence rates (IR) and hazard ratios (HR) of thyroid hormone (TH) therapy as a surrogate for sunitinib- and sorafenib-induced clinical hypothyroidism. METHODS: A cohort study was performed using claims data for prescriptions covering >80% of German pharmacies. Patients with a first prescription of sunitinib or sorafenib in the period between June 2006 and December 2007 were followed until incident prescription of any TH (event of interest) or censoring (due to loss to follow-up, discontinuation or switch of therapy, prescription of antithyroid drugs or the end of the study). RESULTS: One-hundred and seventy eight of 1295 sunitinib patients (13.7%) versus 77 of 1214 sorafenib patients (6.3%) received a TH. IR were 24.2 and 12.1 per 100 person-years, respectively. Unadjusted HR for TH therapy was 2.0 (95%confidence interval (CI) 1.5-2.6) for sunitinib compared to sorafenib and remained significant after adjustment for covariates, i.e. type of prescriber, region, insurance status, type of insurance fund, and relevant co-medication. CONCLUSIONS: Sunitinib- and sorafenib-induced hypothyroidism is a more frequent ADR than currently labelled. Furthermore, patients treated with sunitinib have a two-fold increased risk of requiring TH therapy compared to sorafenib. Patients being treated with sunitinib or sorafenib are, therefore, at risk of thyroid function disturbances and routine monitoring both at baseline and throughout treatment with sunitinib and sorafenib is justified.