Gains in Life Quality Evident With Duodopa Use by Advanced Patients
Duodopa (levodopa-carbidopa intestinal gel) reduces motor and non-motor symptoms and improves well-being and quality of life in adults with advanced Parkinson’s disease, according to six-month data from an observational study in Spain.
These real-world findings add to previous clinical trial data showing an easing of symptoms and a better quality of life — as well as associations between the two — supporting the therapy’s benefits in this patient population.
To the researchers’ surprise, the observed benefits did not associate with significant improvements in caregivers’ well-being, burden, or life quality, except in anxiety. Future studies are needed to clarify the link between patients’ symptoms and life quality and caregivers’ burden and quality of life, the researchers noted.
The study, “Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease,” was published in the journal npj Parkinson’s Disease.
AbbVie’s Duodopa — called Duopa in the U.S. — 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.
Levodopa increases brain levels of dopamine, the signaling molecule progressively lost in Parkinson’s, by delivering its precursor to cells, while carbidopa helps prevent levodopa breakdown, so more of it is available for the brain to make dopamine.
This combination allows smaller doses of levodopa to be administered, reducing side effects such as nausea and vomiting.
While Duodopa/Duopa has been shown to safely and effectively ease both motor and non-motor symptoms in people with advanced Parkinson’s, data is limited on its effects on aspects of patients’ quality of life, as well as on caregiver’s quality of life, well-being, and burden.
The AbbVie-funded multicenter and observational ADEQUA trial (NCT02289729) was designed to evaluate Duodopa’s effects over six months on advanced Parkinson’s patient- and caregiver-reported symptoms and outcomes, including quality of life, in a real-world setting.
Eligible patients were only using levodopa and showed severe motor fluctuations and dyskinesia, or involuntary movements, highlighting the need for better treatment.
The study enrolled 62 patients and respective caregivers at 23 Spanish centers; of them, 59 patients were evaluable and included in the final analysis.
Patients’ mean age was 67.9, most were men (61%) and married or in a couple’s relationship (76.3%), and they had been living with a Parkinson’s diagnosis for a mean of 12.7 years. The mean age of caregivers was 58.8 and 64.4% were women.
Study assessments, using validated measures and conducted at study entry and after six months of treatment, included patients’ quality of life (the study’s main goal), motor and non-motor symptoms, emotional well-being, fatigue, and treatment satisfaction (secondary goals). Caregivers’ quality of life, burden, strain, anxiety and depression, and work productivity were also assessed.
Results showed that six months of treatment with Duodopa significantly improved patients’ quality of life, reflected as a 28% reduction in scores on the 39-item Parkinson’s Disease Questionnaire (PDQ-39). Changes greater than 10% in quality of life measures are considered clinically meaningful.
Notably, expect for social support, significant gains were observed in all PDQ-39’s domains, including mobility, activities of daily living, emotional well-being, stigma, cognition, communication, and bodily discomfort.
Motor symptoms, motor complications, and non-motor symptoms were also significantly reduced after six months of treatment. Among non-motor symptoms, sleep/fatigue and gastrointestinal problems eased the most.
A significant positive change in mood was also observed, particularly in alertness and calmness/relaxation.
Duodopa’s benefits were accompanied by a general reduction in the use of treatments for anxiety, depression, psychosis, insomnia, and constipation among the 27.1% patients on such medications at the study’s start.
Quality of life improvements were also found to be significantly associated with a lessening in motor complications, non-motor symptoms, anxiety, depression, apathy, and fatigue.
Duodopa’s safety profile in these patients was consistent with that reported in previous trials and real-world studies, the team noted. Six (10.2%) patients prematurely discontinued the study, most due to poor therapeutic response.
In contrast to some previous studies, however, no significant changes were observed in caregivers’ outcomes, except for anxiety — whose clinical relevance “might be minimal as the final total score … was still above the cut-off point for anxiety,” the researchers wrote.
They noted that these findings may be explained by the small number of included caregivers that may have limited appropriate statistical power, and a study period that may have been not long enough to provide benefits to caregivers, since previous real-world studies reporting such improvements were longer term.
Duodopa/Duopa is also an invasive therapy, and as such “requires care and learning, which could negatively impact the caregiver, mainly during the first months,” the team added.
Overall, these findings highlighted that six months of Duodopa/Duopa “administered in routine clinical practice improved the QoL [quality of life] of patients with [advanced Parkinson’s], as well as motor symptoms and [non-motors symptoms], emotional well-being, and caregiver anxiety,” the researchers wrote.
“Further studies focused on the correlation between patients’ motor symptoms, non-motor symptoms, and QoL with burden and QoL of caregivers may be warranted,” the team concluded.