Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study

Background The efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, have been established in two large randomized, placebo-controlled, multinational pivotal trials. Still, clinical evidence from routine practice is needed to complement the data from the pivotal trials. Methods OPTIPARK (NCT02847442) was a prospective, open-label, single-arm trial conducted in Germany and the UK under clinical practice conditions. Patients with Parkinson’s disease and motor fluctuations were treated with opicapone 50 mg for 3 (Germany) or 6 (UK) months in addition to their current levodopa and other antiparkinsonian treatments. The primary endpoint was the Clinician’s Global Impression of Change (CGI-C) after 3 months. Secondary assessments included Patient Global Impressions of Change (PGI-C), the Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire (PDQ-8), and the Non-Motor Symptoms Scale (NMSS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Results Of the 506 patients enrolled, 495 (97.8%) took at least one dose of opicapone. Of these, 393 (79.4%) patients completed 3 months of treatment. Overall, 71.3 and 76.9% of patients experienced any improvement on CGI-C and PGI-C after 3 months, respectively (full analysis set). At 6 months, for UK subgroup only (n = 95), 85.3% of patients were judged by investigators as improved since commencing treatment. UPDRS scores at 3 months showed statistically significant improvements in activities of daily living during OFF (mean ± SD change from baseline: − 3.0 ± 4.6, p < 0.0001) and motor scores during ON (− 4.6 ± 8.1, p < 0.0001). The mean ± SD improvements of − 3.4 ± 12.8 points for PDQ-8 and -6.8 ± 19.7 points for NMSS were statistically significant versus baseline (both p < 0.0001). Most of TEAEs (94.8% of events) were of mild or moderate intensity. TEAEs considered to be at least possibly related to opicapone were reported for 45.1% of patients, with dyskinesia (11.5%) and dry mouth (6.5%) being the most frequently reported. Serious TEAEs considered at least possibly related to opicapone were reported for 1.4% of patients. Conclusions Opicapone 50 mg was effective and generally well-tolerated in PD patients with motor fluctuations treated in clinical practice. Trial registration Registered in July 2016 at clinicaltrials.gov (NCT02847442)

Baseline clinical characteristics and patient profile of the TURKMI registry: Results of a nation-wide acute myocardial infarction registry in Turkey

Objective: The TURKMI registry is designed to provide insight into the characteristics, management from symptom onset to hospital discharge, and outcome of patients with acute myocardial infarction (MI) in Turkey. We report the baseline and clinical characteristics of the TURKMI population. Methods: The TURKMI study is a nation-wide registry that was conducted in 50 centers capable of percutaneous coronary intervention selected from each EuroStat NUTS region in Turkey according to population sampling weight, prioritized by the number of hospitals in each region. All consecutive patients with acute MI admitted to coronary care units within 48 hours of symptom onset were prospectively enrolled during a predefined 2-week period between November 1, 2018 and November 16, 2018. Results: A total of 1930 consecutive patients (mean age, 62.0±13.2 years; 26.1% female) with a diagnosis of acute MI were prospectively enrolled. More than half of the patients were diagnosed with non-ST elevation MI (61.9%), and 38.1% were diagnosed with ST elevation MI. Coronary angiography was performed in 93.7% and, percutaneous coronary intervention was performed in 73.2% of the study population. Fibrinolytic therapy was administered to 13 patients (0.018%). Aspirin was prescribed in 99.3% of the patients, and 94% were on dual antiplatelet therapy at the time of discharge. Beta blockers were prescribed in 85.0%, anti-lipid drugs in 96.3%, angiotensin converting enzyme inhibitors in 58.4%, and angiotensin receptor blockers in 7.9%. Comparison with European countries revealed that TURKMI patients experienced MI at younger ages compared with patients in France, Switzerland, and the United Kingdom. The most prevalent risk factors in the TURKMI population were hypercholesterolemia (60.2%), hypertension (49.5%), smoking (48.8%), and diabetes (37.9%). Conclusion: The nation-wide TURKMI registry revealed that hypercholesterolemia, hypertension, and smoking were the most prevalent risk factors. TURKMI patients were younger compared with patients in European Countries. The TURKMI registry also confirmed that current treatment guidelines are largely adopted into clinical cardiology practice in Turkey in terms of antiplatelet, anti-ischemic, and anti-lipid therapy. ©Copyright 2020 by Turkish Society of Cardiolog