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Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine.
Am J Med. 1993 Jul; 95(1):38-48.AJ

Abstract

PURPOSE

To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure.

PATIENTS

Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years).

METHODS

After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level).

RESULTS

Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p < 0.001 versus placebo). Midodrine improved (p < 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%).

CONCLUSION

We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.

Authors+Show Affiliations

Department of Neurology, Baylor College of Medicine, Houston, Texas 77030.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7687093

Citation

Jankovic, J, et al. "Neurogenic Orthostatic Hypotension: a Double-blind, Placebo-controlled Study With Midodrine." The American Journal of Medicine, vol. 95, no. 1, 1993, pp. 38-48.
Jankovic J, Gilden JL, Hiner BC, et al. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. Am J Med. 1993;95(1):38-48.
Jankovic, J., Gilden, J. L., Hiner, B. C., Kaufmann, H., Brown, D. C., Coghlan, C. H., Rubin, M., & Fouad-Tarazi, F. M. (1993). Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. The American Journal of Medicine, 95(1), 38-48.
Jankovic J, et al. Neurogenic Orthostatic Hypotension: a Double-blind, Placebo-controlled Study With Midodrine. Am J Med. 1993;95(1):38-48. PubMed PMID: 7687093.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. AU - Jankovic,J, AU - Gilden,J L, AU - Hiner,B C, AU - Kaufmann,H, AU - Brown,D C, AU - Coghlan,C H, AU - Rubin,M, AU - Fouad-Tarazi,F M, PY - 1993/7/1/pubmed PY - 1993/7/1/medline PY - 1993/7/1/entrez KW - NASA Discipline Cardiopulmonary KW - NASA Discipline Number 14-10 KW - NASA Program Space Physiology and Countermeasures KW - Non-NASA Center SP - 38 EP - 48 JF - The American journal of medicine JO - Am J Med VL - 95 IS - 1 N2 - PURPOSE: To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure. PATIENTS: Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years). METHODS: After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level). RESULTS: Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p < 0.001 versus placebo). Midodrine improved (p < 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%). CONCLUSION: We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/7687093/Neurogenic_orthostatic_hypotension:_a_double_blind_placebo_controlled_study_with_midodrine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0002-9343(93)90230-M DB - PRIME DP - Unbound Medicine ER -