OBJECTIVE<\/p>\n
Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration\u2019s Subpart H approval, under which midodrine was initially approved, requires post-marketing studies to confirm midodrine\u2019s clinical benefit in this indication. The purpose of this study was to evaluate the clinical benefit of midodrine with regard to symptom response.<\/p>\n
METHODS<\/p>\n
This was a double-blind, placebo-controlled, randomized, crossover, multicenter study (NCT01518946). Following screening, patients aged \u226518 years with severe symptomatic orthostatic hypotension and on a stable dose of midodrine for at least 3 months were randomized to treatment with either their previous midodrine dose or placebo on day 1 and the respective alternate treatment on day 2. The primary endpoint measured time to syncopal symptoms or near-syncope using a 45-min tilt-table test at 1 h post-dose.<\/p>\n
RESULTS<\/p>\n
Thirty-three patients were screened for inclusion: 19 received at least one dose of midodrine and had at least one post-dose measurement of the primary endpoint. The least-squares mean time to syncopal symptoms or near-syncope after tilt-table initiation (mean \u00b1 standard error) was 1626.6 \u00b1 186.8 s for midodrine and 1105.6 \u00b1 186.8 s for placebo (difference, 521.0 s; 95 % confidence interval 124.2\u2013971.7 s; p = 0.0131). There were 15 adverse events in 10 patients; all of these were mild or moderate in severity, with none considered by the investigators to be related to midodrine.<\/p>\n
INTERPRETATION<\/p>\n
Midodrine is a well-tolerated and clinically effective treatment for symptomatic orthostatic hypotension.<\/p>\n
Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study<\/a>, by William Smith, Hong Wan, David Much, Antoine G. Robinson, and Patrick Martin in<\/span>\u00a0Clinical Autonomic Research<\/em>, 2 July 2016<\/p>\n","protected":false},"excerpt":{"rendered":" Research abstract: OBJECTIVE Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration\u2019s Subpart H approval, under which midodrine was initially approved, requires post-marketing … Continue reading