Indication(s):

Treatment of persistent (nontransient) facial erythema of rosacea.

Pharmacology:

Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of brimonidine gel may reduce erythema through direct vasoconstriction.

Clinical Trials:

Mirvaso gel was eva luated for the topical treatment of moderate-to-severe, persistent (nontransient) facial erythema of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trial involved 533 patients aged ≥18 years who were treated once daily for 4 weeks with either Mirvaso or vehicle gel.

Baseline disease severity was graded using a 5-point Clinical Erythema Assessment (CEA) scale, and a 5-point Patient Self Assessment (PSA) scale, on which patients scored either “moderate” or “severe” on both scales.

The primary efficacy endpoint in both pivotal trials was 2-grade Composite Success, defined as the proportion of subjects with a 2-grade improvement on both CEA and PSA measured at Hours 3, 6, 9, and 12 on Day 29.

Results from both studies demonstrated a significantly greater improvement in the facial redness of rosacea in patients who were treated with Mirvaso compared to those treated with the vehicle gel (Study 1: at Hour 3 [31% vs. 11%], Hour 6 [30% vs. 10%], Hour 9 [26% vs. 10%], Hour 12 [23% vs. 9%]; and Study 2: at Hour 3 [25% vs. 9%], Hour 6 [25% vs. 9%], Hour 9 [18% vs. 11%], Hour 12 [22% vs. 10%]).

Legal Classification:

Rx

Adults:

≥18years: apply a pea-size amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek); spread gel smoothly and evenly in a thin layer. Wash hands after use.

Children:

<18years: not established.

Warnings/Precautions:

Not for oral, ophthalmic, or intravaginal use. Avoid eyes and lips. Depression. Cerebral or coronary insufficiency. Raynaud’s phenomenon. Orthostatic hypotension. Thrombangiitis obliterans. Scleroderma. Sjögren’s syndrome. Severe or unstable cardiovascular disease. Pregnancy (Category B). Nursing mothers: not recommended.

Interaction(s)

Caution with beta-blockers, other antihypertensives, cardiac glycosides. Consider possibility of additive effects with CNS depressants (eg, alcohol, barbiturates, opiates, sedatives, anesthetics). Concomitant MAOIs may affect the metabolism and uptake of circulating amines; caution.

Adverse Reaction(s)

Erythema, flushing, burning sensation, contact dermatitis.

How Supplied:

Gel—30g, 45g

LAST UPDATED:

10/4/2013

Galderma公司的药物Mirvaso已成功获得美国食品及药物管理局认定，用于酒糟鼻的治疗。其主要成分为0.33%酒石酸溴莫尼定，一种α-2肾上腺素受体激动剂（alpha-2 adrenergic agonist）。mirvaso是外用凝胶，可以通过压缩面部扩张血管减少酒渣鼻发红。mirvaso使用豌豆大小的量，每日一次，每次脸上的五个区域可以使用：额头，下巴，鼻子和两颊。

据称，每日使用一次，mirvaso可迅速减少酒渣鼻的发红，并持续12小时。

该药物的验证采取了常规的对比验证，基于超过550例患者的样本，在一个月的时间内对两个3期小组（一为实验组，一为对照组）临床研究中所收集的数据。

研究的结果表明，使用mirvaso凝胶的患者表现出比使用vehicle gel（嘛玩意？不知道什么药物）的患者面部发红有更大的改善。此外，还进行了长期的药物使用研究，有276名受试者使用mirvaso长达12个月。

副作用：在临床试验中，最常见的不良反应包括红斑（≥1%），皮肤烧灼感和接触性皮炎。抑郁症患者注意，该药物可造成脑或冠状动脉供血不足，雷诺氏现象，体位性低血压，血栓闭塞性脉管炎，硬皮病，或öSJ干燥综合征。α-2肾上腺素能药物可降低血压。严重或不稳定或不受控制的心血管疾病患者慎用。