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Published on: March 21, 2013
Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension
Jung-Ick Byun1, Jangsup Moon1, Do-Yong Kim1
1From the Department of Neurology (J.-I.B., J.M., D.-Y.K., H.S., J.-S.S., J.-A.L., T.-J.K., W.-J.L., H.S.L., J.-S.J. S.-T.L., K.-H.J., K.-Y.J., S.K.L., K.C.), Laboratory for Neurotherapeutics, Comprehensive Epilepsy Center, Center for Medical Innovations, Biomedical Research Institute, Seoul National University Hospital; Department of Neurology (J.-I.B.), Kyung Hee University Hospital at Gangdong; Program in Neuroscience (J.-I.B., J.M., H.S., J.-A.L., T.-J.K., W.-J.L., H.S.L., J.-S.J., S.-T.L., K.-H.J., K.-Y.J., S.K.L., K.C.), Seoul National University College of Medicine; Department of Neurology (J.-S.S.), Soonchunhyang University Seoul Hospital; Department of Neurology (J.-A.L.), National Center for Mental Health, an affiliate of the Ministry for Health & Welfare; and Department of Neurology (K.-I.P.), Seoul National University Hospital Healthcare System Gangnam Center, Republic of Korea.
Objective:
To evaluate the long-term (for up to 3 months) efficacy and safety of single or combined therapy with midodrine and pyridostigmine for neurogenic orthostatic hypotension (OH).
Methods:
This was a randomized, open-label clinical trial. In total, 87 patients with symptomatic neurogenic OH were enrolled and randomized to receive 1 of 3 treatments: midodrine only, pyridostigmine only, or midodrine + pyridostigmine. The patients were followed up at 1 and 3 months after treatment. The primary outcome measures were improvement in orthostatic blood pressure (BP) drop at 3 months. Secondary endpoints were improvement of the orthostatic BP drop at 1 month and amelioration of the questionnaire score evaluating OH-associated symptoms.
Results:
Orthostatic systolic and diastolic BP drops improved significantly at 3 months after treatment in all treatment groups. Orthostatic symptoms were significantly ameliorated during the 3-month treatment, and the symptom severity was as follows: midodrine only < midodrine + pyridostigmine < pyridostigmine only group. Mild to moderate adverse events were reported by 11.5% of the patients.
Conclusions:
Single or combination treatment with midodrine and pyridostigmine was effective and safe in patients with OH for up to 3 months. Midodrine was better than pyridostigmine at improving OH-related symptoms.
Clinicaltrialsgov Identifier:
NCT02308124.
Classification Of Evidence:
This study provides Class IV evidence that for patients with neurogenic OH, long-term treatment with midodrine alone, pyridostigmine alone, or both midodrine and pyridostigmine is safe and has similar effects in improving orthostatic BP drop up to 3 months.
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