title: Awareness of potential valvulopathy risk with pergolide and changes in clinical practice after label change: a survey among European neurologists.
abstract: In response to concern about the reported frequency of ergot-associated valvulopathy in patients with Parkinson's disease (PD), Eli Lilly and Company updated the Risk Minimization Program for pergolide, changing the Summary of Product Characteristics (SmPC) and distributing a Dear Doctor Letter (DDL) highlighting the new label changes. A survey was conducted subsequently to assess neurologists' awareness of the revised SmPC and their resulting changes in practice. A random sample of 20.3% of neurologists (n = 4056) from 12 eligible EU countries were invited to participate. Of the target population of 247 neurologists who treated patients with PD, used pergolide in 2005, and were willing to participate, 244 (99%) responded. Overall awareness of the DDL and the SmPC changes was 94.2%. Over half (58.3%) of neurologists indicated that they prescribe pergolide exclusively as second-line treatment, although some (21.9%) used pergolide exclusively as first-line treatment. In response to the DDL, most neurologists perform echocardiograms before treatment (67.5%) and during treatment (76.7%), and over half (55%) avoid prescribing doses >5 mg/day. Overall, use of a DDL to communicate an SmPC change was effective in increasing the awareness of pergolide-associated valvulopathy and in modifying neurologists' clinical practice to minimize this risk.
authors.affiliation: Lilly Research Centre, Eli Lilly and Company, Windlesham, Surrey, UK. lledo.a@lilly.com
authors.forename: A
authors.initials: A
authors.lastname: Lledó
authors.forename: M A
authors.initials: MA
authors.lastname: Dellva
authors.forename: I M
authors.initials: IM
authors.lastname: Strombom
authors.forename: J L
authors.initials: JL
authors.lastname: Wilkie
authors.forename: Mark E
authors.initials: ME
authors.lastname: Jungemann
authors.forename: M G
authors.initials: MG
authors.lastname: Royer
authors.forename: V E
authors.initials: VE
authors.lastname: Simmons
authors.forename: P A
authors.initials: PA
authors.lastname: Cavazzoni
mesh_terms: D000978:Antiparkinson Agents / Q000009:adverse effects*; D001364:Awareness; D003625:Data Collection; D005060:Europe; D005260:Female; D006349:Heart Valve Diseases / Q000139:chemically induced*; D006801:Humans; D007391:International Cooperation; D008297:Male; D009462:Neurology; D010479:Pergolide / Q000009:adverse effects*; D010818:Practice Patterns, Physicians'
chemical_list: D000978:Antiparkinson Agents; D010479:Pergolide