Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To report results of an investigator-initiated trial to show the non-inferiority of pyridostigmine bromide (PB) vs. fludrocortisone (FC) in the treatment of symptomatic orthostatic hypotension (OH) in Parkinson’s disease (PD).
Background: Current treatment regimes for OH in PD aim at elevating overall blood pressure (bp) by increasing endovascular volume, while PB aims at strengthening the baro-reflex, avoiding the risk of causing iatrogenic hypertension.
Methods: Small, multicentre, randomized, active-controlled, double blind, crossover phase II non-inferiority trial. 13 PD patients (mean age 71.3 ± 5.6 yrs; BMI 24.4 ± 2.9; 2 female) with confirmed OH were randomized after informed consent. Study procedures at baseline and endpoints included Schellong test, 7day home blood pressure (7d-bp) recording in sitting position, clinical (UPDRS III, MoCA) and questionnaire-based (HADS, autonomic questionnaire, OH symptom assessment (OHSA) scale) and quality of life (PDQ-39) assessments. Study medication was given orally for 14 days with 21 days washout before crossover and was started at 3x30mg/d (PB) and 1×0.1mg/d (FC) (3 days) before elevation to 3x60mg/d and 1×0.2mg/d. Participants continued on their dopaminergic medication throughout the study.
Results: Repeated-measures ANOVA of complete data sets (n=7) revealed no significant difference in the primary endpoint of diastolic bp drop (baseline 20.7 ± 19.1 vs. PB 24.5 ± 16.3 vs. FC 14.0 ± 14.1 mmHg; p=0.17) on Schellong testing. 7d-bp recordings revealed a significant rise in systolic (FC 140.1 ± 13.0 vs. baseline 130.2 ± 10.6 vs. PB 127.5 ± 14.2; F=14.8, p<0.001) and diastolic (FC 80.3 ± 9.7 vs. baseline 75.7 ± 9.1 vs. PB 73.8 ± 10.8; F=9.0, p=0.006) bp with FC treatment, while PB softened subjective stool consistency (p=0.029) without affecting defaecation frequency or other autonomic functions incl. salivation and urinary urgency. UPDRS III, MoCA, tremor scores, PDQ-39 and HADS scores were unchanged. Incomplete data sets (3 withdrew consent due to strenuous study procedures, 2 received DBS implantation, 1 dropped out due to a non-study related accident) were not included.
Conclusions: Under dopaminergic medication neither PB nor FC had a significant benefit on objective or subjective OH measures in PD patients, while FC caused a significant rise in upright bp.
To cite this abstract in AMA style:
S.R. Schreglmann, F. Büchele, M. Sommerauer, L. Epprecht, G. Kägi, S. Hägele-Link, O. Götze, L. Zimmerli, D. Waldvogel, C.R. Baumann. Effects of pyridostigmine bromide vs. fludrocortison in the treatment of orthostatic hypotension in Parkinson’s disease [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/effects-of-pyridostigmine-bromide-vs-fludrocortison-in-the-treatment-of-orthostatic-hypotension-in-parkinsons-disease/. Accessed May 14, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/effects-of-pyridostigmine-bromide-vs-fludrocortison-in-the-treatment-of-orthostatic-hypotension-in-parkinsons-disease/