A study looking at the real-world use of Abbott’s Uprima drug for erectile dysfunction found little evidence for efficacy, and could be a valuable strategy to gauge the clinical usefulness of other medications, according to UK researchers.
Abbott allowed the European marketing authorisation for Uprima (apomorphine hydrochloride) to lapse at the end of May after sales failed to live up to initial expectations.
The latest study, published in the urology journal BJU International, was based on prescription-event monitoring and suggests this was because efficacy shown in trials failed to be reproduced in clinical practice. This type of approach could be used to quickly pick up products which lack efficacy, and also those which have safety issues, according to the researchers.
The team at the UK’s Drug Safety Research Unit and University of Portsmouth analysed prescribing data for 11,185 patients seen by National Health Service family doctors.
The data was gathered from official Green Form Questionnaires that ask doctors to record any significant events recorded in a patient’s notes after prescribing newly marketed medicines.
The survey found that two thirds of doctors said their patient stopped taking Uprima because they felt it wasn’t effective while 14% said the patient didn’t request a further prescription. Further analysis showed that 59% of patients who didn’t find it effective stopped taking Uprima after a month and another 23% had joined them by month two.
“Prescription-Event Monitoring provides surveillance on a national scale after new drugs are launched,” explained lead researcher Professor Saad Shakir.
At least six months after the first prescription for Uprima was issued for each patient, their family doctor was sent a Green Form Questionnaire that requested details about the patient’s age and sex and their use of Uprima.
They were also asked to record any significant events that had occurred since the patient was prescribed Uprima, such as suspected drug reactions, unexpected deterioration or improvement in the patient’s condition, referral to a specialist or any clinically important changes in laboratory tests.
“The result is real world clinical data that provides information of illness and death in patients treated with newly marketed drugs – a valuable tool in drug safety assessment,” said Shakir.
Prior to the lapse of its marketing authorisation, Uprima was marketed in Ireland, the UK, Spain, France, Sweden and Norway. Abbott’s commercial partner Takeda, which sold the product as Ixense, withdrew its marketing authorisation for the product in Europe in 2004. Takeda had sold it in Austria, Germany, France and Italy.