Teriparatide in men: persistence and geographical variation in the UK

Abstract

Dear Editors, Although teriparatide (Forsteo®, Eli Lilly) was licensed by the US Food and Drugs Agency for use in men and postmenopausal women in 2003 [1], it was not approved by the European Medicines Agency (EMEA) for use in men until July 2007 [2]. In the UK, between teriparatide’s launch and EMEA’s approval for use in men teriparatide was used on a named-patient basis. While persistence with teriparatide in postmenopausal women has been studied [3], little is known about persistence with teriparatide in men. Our aim was to determine the persistence with teriparatide in men and establish any difference in its use across the UK. Data on treating hospital, date treatment started, discontinuation date and reason for discontinuing treatment were provided by Healthcare at Home, the doorstep supplier of teriparatide [3]. The regions of the UK were divided using the Nomenclature of Units for Territorial Statistics (NUTS) classification of administrative areas [4]. Each hospital was assigned to a NUTS area and patients attending hospital in a given NUTS area were assumed to live in that area. Survival analysis was used to estimate the proportion persisting with treatment at 12 and 18 months. Log rank test was used to analyse factors affecting persistence. Cases were considered to have ‘failed’ if treatment was discontinued prematurely due to: clinical decision (nine), side effects (eight), death (nine), change of drug or service provider (two), emigration (one), patient or hospital decision (four). Cases receiving planned short treatment (four) or on treatment at time of data capture (79) were considered ‘censored’. One hundred and eighty-five men commenced teriparatide. Four stopped due to lack of government funding (mean 7 months, range 0.5–12.5 months). Data for 181 men were analysed. Mean age and mean treatment duration were 64.9 years (SD 15.3 years) and 330 days (SD 188 days). One hundred and seventy-one men were treated at NHS hospitals (81 at a district general and 90 at a university hospital); 10 were treated privately. On Kaplan–Meier analysis 81.4% and 74.3% of men were on teriparatide at 12 and 18 months respectively (Fig. 1). Persistence did not vary with age (p=0.475). Patients treated at a university hospital showed better persistence than those treated at a district general hospital at 12 and 18 months (90.8% vs 71.2% and 82% vs 71.2% respectively, p=0.03). Nine patients died while on teriparatide (mean age 67.5 years; SD 10.2 years). The causes of death are unknown but were unrelated to the drug. The mean prescription rate of teriparatide was less than the national average (9.57/million over 24 years male population [5]) in the North–East (1.21), East of England (2.77), West Midlands (3.70) and South–East (5.65) of England. This may reflect reluctance among clinicians to prescribe an “unlicensed” treatment and/or among NHS trusts to fund an expensive drug excluded from the Payments by Results tariff. In conclusion, we found that persistence with teriparatide in men is comparable to that described in the literature for postmenopausal women [3]. Wide geographic variation was noted in teriparatide’s use across the UK. It remains to be Osteoporos Int (2009) 20:1453–1454 DOI 10.1007/s00198-008-0788-7