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Long-term treatment with Duodopa (levodopa-carbidopa intestinal gel) safely and effectively lessens motor and non-motor symptoms and improves quality of life in adults with advanced Parkinson’s disease, according to two-year data from an international, observational trial.
These real-world findings further support the long-term benefits of this treatment in people with advanced Parkinson’s, its researchers said.
Data were presented by Jason Aldred, MD, an investigator with the Selkirk Neurology and Inland Northwestern Research, both in Washington, in a poster at the 2021 American Academy of Neurology virtual meeting running through April 22.
The poster was titled “Sustained Improvements in Motor and Non-Motor Symptoms in Advanced Parkinson’s Disease Patients Treated with Carbidopa Levodopa Enteral Suspension in a ‘Real-World’ Study: Interim Results of the Multinational DUOGLOBE Study With at Least 24 Months Follow-Up.”
Oral levodopa is one of the mainstays of Parkinson’s treatment. It increases the brain levels of dopamine, the signaling molecule progressively lost in Parkinson’s, by delivering its precursor to cells.
However, patients on long-term use of oral levodopa often experience “off” periods, times when treatment effects wear off and symptoms are not controlled effectively, affecting quality of life.
AbbVie’s Duodopa/Duopa is a combination of levodopa and carbidopa administered over 16 hours via a tube that is surgically inserted into the intestines of people with advanced Parkinson’s.
Carbidopa is an agent that helps prevent the breakdown of levodopa, so more of it is available to the brain to make dopamine. This reduces the amount of levodopa that needs to be administered, easing side effects such as nausea and vomiting.
While Duodopa/Duopa has been shown to effectively reduce both motor and non-motor symptoms in people with advanced Parkinson’s, long-term data on the therapy’s effects on disease symptoms, patients’ quality of life, and caregiver burden in the real-world setting are limited.
The AbbVie-funded international, observational DUOGLOBE trial (NCT02611713) evaluated Duodopa/Duopa’s long-term safety and effectiveness over three years in a real-world setting in 213 adults with advanced Parkinson’s disease.
Participants, who had not been given this treatment prior to enrolling, were recruited at 54 specialized movement disorders centers across 10 countries. This study was the first study of its kind to include sites within the U.S.
Study assessments, using validated measures and conducted every three to six months, included patient “off” periods, motor and non-motor symptoms, sleep quality and daytime sleepiness, and quality of life. Caregiver burden and treatment safety were also evaluated.
Newly presented findings covered DUOGLOBE’s two-year interim data in 196 people (121 men and 75 women), with a mean age of 70.2 and a mean disease duration of 11.2 years. Patients were experiencing a mean of six hours each day of “off” time at study entry.
Data collection ended in December 2019, so these findings were not affected by the COVID-19 pandemic, the researchers wrote.
Results showed that Duodopa, given over a median of 16 hours per day (range, 0–24 hours), significantly cut patients’ “off” time by more than half beginning three months after the start of treatment through two years.
Uncontrollable involuntary movements (dyskinesia) and non-motor symptoms were also significantly reduced throughout the study, with greater reductions observed between three and six months of treatment.
A significant lessening of daytime sleepiness, and significant improvements in sleep quality and quality of life across all time points were also seen. Caregiver burden was found to significantly ease throughout these two study years.
Duodopa’s safety profile in the real-world setting was “consistent” with that reported in previous Phase 3 clinical trials, Aldred noted. Half (52%) of the patients experienced a serious adverse event, with gastrointestinal complaints being the most common.
Adverse events were likely related to Duodopa/Duopa in 31 (15.8%) patients, and one death was deemed possibly related to treatment.
Nearly one-quarter of patients stopped the treatment due to adverse events, and 17 (8.7%) withdrew from the trial but continued using Duodopa or Duopa outside of the study.
“Our study provides further evidence of real-world effectiveness of [Duodopa/Duopa] to improve motor symptoms, non-motor symptoms, quality of life, and caregiver burden for our patients with advanced Parkinson’s disease,” Aldred said.
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