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Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group.
JAMA. 1997 Apr 02; 277(13):1046-51.JAMA

Abstract

OBJECTIVE

To evaluate the efficacy of a 10-mg dose of midodrine 3 times per day in improving blood pressure (BP) and ameliorating symptoms of orthostatic hypotension in patients with neurogenic orthostatic hypotension. Midodrine hydrochloride, an alpha-agonist, could improve orthostatic BP by increasing vasomotor and venomotor tone.

DESIGN/METHODS

A total of 171 patients with orthostatic hypotension participated in a multicenter, randomized, placebo-controlled study. They were randomized to a 10-mg dose of midodrine or placebo 3 times per day in a 6-week study, comprising single-blind run-in (at week 1) and washout at weeks 5 and 6, with an intervening double-blind period (weeks 2 to 4).

SETTING

Twenty-five centers, with most patients evaluated in referral centers.

MAIN OUTCOME MEASURES

The primary end points were improvement in standing systolic BP, symptoms of lightheadedness, and a global symptom relief score (by the investigator and patient separately).

RESULTS

Nine patients were not evaluable because of noncompliance or taking concomitant vasoactive medications (3 in the midodrine group, 6 in the placebo group). In the evaluable patients, midodrine resulted in improvements in standing systolic BP at all time points (P<.001 at visits 2, 3, 4, and 5), in reported symptoms by the end of the second week of treatment (P=.001), and in the global symptom relief score rated by both the patient (P=.03) and the investigator (P<.001). There was no effect by center, severity of orthostatic hypotension, use of fludrocortisone or compression garments, or diagnosis. The main adverse effects were those of pilomotor reactions, urinary retention, and supine hypertension.

CONCLUSIONS

Midodrine is efficacious and safe in the treatment of neurogenic orthostatic hypotension.

Authors+Show Affiliations

Department of Neurology, Mayo Clinic, Rochester, Minn 55905, USA. low.phillip@mayo.eduNo 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

9091692

Citation

Low, P A., et al. "Efficacy of Midodrine Vs Placebo in Neurogenic Orthostatic Hypotension. a Randomized, Double-blind Multicenter Study. Midodrine Study Group." JAMA, vol. 277, no. 13, 1997, pp. 1046-51.
Low PA, Gilden JL, Freeman R, et al. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA. 1997;277(13):1046-51.
Low, P. A., Gilden, J. L., Freeman, R., Sheng, K. N., & McElligott, M. A. (1997). Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA, 277(13), 1046-51.
Low PA, et al. Efficacy of Midodrine Vs Placebo in Neurogenic Orthostatic Hypotension. a Randomized, Double-blind Multicenter Study. Midodrine Study Group. JAMA. 1997 Apr 2;277(13):1046-51. PubMed PMID: 9091692.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. AU - Low,P A, AU - Gilden,J L, AU - Freeman,R, AU - Sheng,K N, AU - McElligott,M A, PY - 1997/4/2/pubmed PY - 1997/4/2/medline PY - 1997/4/2/entrez KW - Non-programmatic SP - 1046 EP - 51 JF - JAMA JO - JAMA VL - 277 IS - 13 N2 - OBJECTIVE: To evaluate the efficacy of a 10-mg dose of midodrine 3 times per day in improving blood pressure (BP) and ameliorating symptoms of orthostatic hypotension in patients with neurogenic orthostatic hypotension. Midodrine hydrochloride, an alpha-agonist, could improve orthostatic BP by increasing vasomotor and venomotor tone. DESIGN/METHODS: A total of 171 patients with orthostatic hypotension participated in a multicenter, randomized, placebo-controlled study. They were randomized to a 10-mg dose of midodrine or placebo 3 times per day in a 6-week study, comprising single-blind run-in (at week 1) and washout at weeks 5 and 6, with an intervening double-blind period (weeks 2 to 4). SETTING: Twenty-five centers, with most patients evaluated in referral centers. MAIN OUTCOME MEASURES: The primary end points were improvement in standing systolic BP, symptoms of lightheadedness, and a global symptom relief score (by the investigator and patient separately). RESULTS: Nine patients were not evaluable because of noncompliance or taking concomitant vasoactive medications (3 in the midodrine group, 6 in the placebo group). In the evaluable patients, midodrine resulted in improvements in standing systolic BP at all time points (P<.001 at visits 2, 3, 4, and 5), in reported symptoms by the end of the second week of treatment (P=.001), and in the global symptom relief score rated by both the patient (P=.03) and the investigator (P<.001). There was no effect by center, severity of orthostatic hypotension, use of fludrocortisone or compression garments, or diagnosis. The main adverse effects were those of pilomotor reactions, urinary retention, and supine hypertension. CONCLUSIONS: Midodrine is efficacious and safe in the treatment of neurogenic orthostatic hypotension. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/9091692/Efficacy_of_midodrine_vs_placebo_in_neurogenic_orthostatic_hypotension__A_randomized_double_blind_multicenter_study__Midodrine_Study_Group_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/277/pg/1046 DB - PRIME DP - Unbound Medicine ER -