The launch of opicapone for Parkinson's disease: negatives versus positives.
Ana Castro CaldasTiago TeodoroJoaquim José FerreiraPublished in: Expert opinion on drug safety (2018)
Opicapone is a novel, third generation COMT inhibitor approved for the treatment of Parkinson's disease. Safety and tolerability data is critical to determine the benefit-harm balance and anticipate therapeutic adherence. Areas covered: This review evaluates the tolerability and safety profile of opicapone. These data were extracted from all published clinical trials, including preclinical, phase I, phase II and phase III studies as well as postmarketing data. Opicapone was safe and well tolerated, with frequencies of treatment-emergent adverse events similar to placebo. Expert opinion: Opicapone have shown a good safety and tolerability profile. This adds to its proven efficacy and convenient once-daily administration, supporting a role of opicapone as a first-line therapy for motor complications in Parkinson's disease patients.
Keyphrases
- open label
- phase iii
- phase ii
- clinical trial
- double blind
- placebo controlled
- electronic health record
- end stage renal disease
- big data
- chronic kidney disease
- study protocol
- newly diagnosed
- randomized controlled trial
- ejection fraction
- physical activity
- peritoneal dialysis
- adipose tissue
- mesenchymal stem cells
- patient reported outcomes
- cell therapy
- metabolic syndrome
- machine learning
- deep learning
- clinical practice