Flexilev microtablets containing both levodopa/carbidopa, used with an automatic dose dispenser, seemed to improve self-reported symptom control in some patients with Parkinson’s disease, according to a first report of the treatment’s real-life use.
The study, “First clinical experience with levodopa/carbidopa microtablets in Parkinson’s disease,” also noted that most patients considered the system user-friendly. Researchers said that larger studies are needed to better assess the benefits of this treatment approach. The work was published in the journal Acta Neurologica Scandinavica.
Flexilev has been prescribed in Sweden since 2013, and was recently approved in 13 other EU countries. The automatic dispenser, used with Flexilev, sounds an alarm to remind its user to take a tablet — a way to improve adherence to treatment. It also has a diary function, making it possible for patients to easily report symptoms they are experiencing.
To assess its effectiveness and ease, researchers at Uppsala University in Sweden collected data from the first 11 users of Flexilev along with the dispenser. They analyzed the patients’ medical records, along with four reports from dose dispensers. In addition, nine of the patients completed a questionnaire.
Among those who started the treatment, nine did so because of motor fluctuations and difficulties in finding an appropriate dose with their standard regimen, while a tenth patient started because of difficulties with swallowing tablets. One did not offer a reason for trying the system.
Six patients discontinued its use, with a median treatment duration of 78 days. Among those who remained on the treatment, the median duration was 610 days. In both groups, however, the duration varied widely.
Among those who discontinued, four did so because of general disease progression, one had impaired cognition, and another’s eyesight was too poor to continue handling the dispenser.
Researchers only had access to four adherence reports, since earlier versions of the dispenser software did not allow reporting. Analyses showed that adherence to dose intervals ranged from 74% to 100%. The total adherence ranged between 89% and 101%.
Two patients who discontinued the treatment had cognitive impairment too severe to complete the questionnaire.
Six of the patients who completed the survey felt that Flexilev used with the dispenser improved the effect of treatment. Two did not notice a difference, while one experienced worse symptom control.
The ability to perform daily tasks improved in four patients, but four others noted no difference. One could not remember.
The majority, however, had a positive opinion on the system’s user-friendliness, with eight patients stating that treatment became easier with the dose dispenser, and seven stating that it improved their treatment adherence.
The effects on movement symptoms varied, with three patients reporting shorter durations of slowed movements. Three patients responded that the duration of troublesome dyskinesias had become worse, and four stated that the magnitude of such symptoms had increased while using Flexilev.
For all movement symptoms assessed, half or more of the group stated that the symptoms were either unchanged or better.
The researchers now aim to perform larger evaluations of the treatment approach.
Flexilev is not approved in the U.S.