Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension. (5th September 2017)

• Record Type: Journal Article
• Authors: Byun, Jung-Ick; Moon, Jangsup; Kim, Do-Yong; Shin, Hyerim; Sunwoo, Jun-Sang; Lim, Jung-Ah; Kim, Tae-Joon; Lee, Woo-Jin; Lee, Han Sang; Jun, Jin-Sun; Park, Kyung-Il; Lee, Soon-Tae; Jung, Keun-Hwa; Jung, Ki-Young; Lee, Sang Kun; Chu, Kon
• Is Part Of: Neurology. Volume 89:Number 10(2017)
• Publication Date: 2017-09-05
• Subjects: Neurology -- Periodicals; Neurology -- Periodicals; Neurologie -- Périodiques; 616.8
• DOI: 10.1212/WNL.0000000000004340
• Languages: English
• ISSNs: 0028-3878

Abstract

Abstract : 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. Clinicaltrials.gov 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.