药理类别：
对氨基水杨酸。

活性成分（S）：
巴柳氮二钠（前体药物美沙拉嗪）1.1克;弹片;含有钠126mg/tab。

公司
Salix制药公司
指示（S）：
治疗轻度至中度活动期溃疡性结肠炎的男性患者。

用途：女性患者在治疗的有效性的限制并没有表现出来。超过8周的治疗的安全性和有效性尚未确立。

药理作用：
巴柳氮，美沙拉嗪（5 - 氨基水杨酸，5-ASA）的前体药物。 5-ASA的作用机制是未知的，但似乎是本地的结肠粘膜而非全身。增加粘膜生产花生四烯酸的代谢物，通过环氧合酶途径，即，前列腺素类，并通过脂氧合酶途径，即，白三烯和羟酸，溃疡性结肠炎患者，它是可能的5-ASA减少通过阻断炎症在结肠中的花生四烯酸代谢物的生产。

临床试验：
一项双盲，安慰剂对照，多中心临床试验的250名成年患者（49％为男性）进行了轻度到中度活动期溃疡性结肠炎。疾病活动性评估采用改良的梅奥疾病活动指数（MMDAI），这是一笔四个单项分（排便频率，直肠出血，内窥镜的外观，和医生的全球评估），每个从0-3不等，分数越高表明恶化疾病。中位数基线MMDAI得分分别为8和基线直肠出血子分数中位数为2。患者被随机2:1接受要么Giazo3.3克每日两次或安慰剂治疗8周。

主要疗效终点是患者的比例，达到临床治疗8周结束在直肠出血量表MMDAI完善和改进。被定义为≥3点从基线改善在MMDAI评分≥1点在直肠出血子分数从基线改善临床症状的改善。两个关键的次要疗效终点是患者的临床缓解和粘膜愈合治疗8周结束时的比例。

经过8周的治疗，谁见了定义临床改善的患者比例更大为Giazo治疗组与安慰剂组相比。这些差异有统计学显着在整体人口（55％与Giazo与安慰剂组为40％，P = 0.0237），然而，这些影响完全驱动的结果（57％与Giazo与20％的男性亚群安慰剂）。多重调整后，有统计学显着性差异也见于男性患者临床缓解（35％与Giazo与安慰剂组为13％）和黏膜愈合（与Giazo与52％，安慰剂组为20％）。不有效性Giazo被在女性亚临床试验证明。

法律分类：
接收

成人：
≥0-18岁：3个标签，每日两次;最大8周。

儿童：
<0-18岁：不成立的。

警告/注意事项：
监测溃疡性结肠炎的症状恶化。停止，如果怀疑有急性不耐受综合征。已知或肾功能不全的历史。之前的initating治疗期间定期监测肾功能。肝功能受损;考虑监测肝功能试验，在治疗过程中。老年人。妊娠（部件B）。哺乳期的母亲。

不良反应（S）
在男性患者：贫血，腹泻，咽喉疼痛，尿路感染。

如何提供：
标签-180

最后更新：
2013年7月25日

GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in male patients 18 years of age and older. Effectiveness in female patients was not demonstrated in clinical trials. Safety and effectiveness of GIAZO beyond 8 weeks have not been established.
GIAZO is the only b.i.d. 5-ASA UC agent for men that works independently of pH levels to help induce remission.
GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets.
Pharmacological Class:
Aminosalicylate.

Active Ingredient(s):
Balsalazide disodium (prodrug of mesalamine) 1.1g; tabs; contains sodium 126mg/tab.

Company
Salix Pharmaceuticals, Inc.
Indication(s):
Treatment of mildly-to-moderately active ulcerative colitis in male patients.

Limitations of use: effectiveness in treatment of female patients was not demonstrated. Safety and effectiveness of therapy beyond 8 weeks have not been established.

Pharmacology:
Balsalazide is a prodrug of mesalamine (5-aminosalicylic acid, 5-ASA). The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, ie, prostanoids, and through the lipoxygenase pathways, ie, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

Clinical Trials:
A double-blind, placebo-controlled, multicenter trial was conducted in 250 adult patients (49% male) with mildly-to-moderately active ulcerative colitis. Disease activity was assessed using a modified Mayo Disease Activity Index (MMDAI), which was a sum of four subscores (bowel frequency, rectal bleeding, endoscopic appearance, and physician’s global assessment), each ranging from 0–3, with higher scores indicating worse disease. The median baseline MMDAI score was 8 and the median baseline rectal bleeding subscore was 2. Patients were randomized 2:1 to receive 8 weeks of treatment with either Giazo 3.3g twice daily or placebo.

The primary efficacy endpoint was the proportion of patients that achieved clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of 8 weeks of treatment. Clinical improvement was defined as having both a ≥3 point improvement from baseline in the MMDAI score and a ≥1 point improvement from baseline in the rectal bleeding subscore. Two key secondary efficacy endpoints were the proportion of patients with clinical remission and mucosal healing at the end of 8 weeks of treatment.

After 8 weeks of treatment, the proportion of patients who met the definition of clinical improvement was greater for the Giazo-treated group compared to the placebo group. These differences were statistically significant in the overall population (55% with Giazo vs. 40% for placebo, P=0.0237); however, these effects were entirely driven by the results in the male subpopulation (57% with Giazo vs. 20% for placebo). After adjusting for multiplicity, statistically significant differences were also seen in the male patients for clinical remission (35% with Giazo vs. 13% for placebo) and for mucosal healing (52% with Giazo vs. 20% for placebo). Effectiveness of Giazo was not demonstrated in the female subpopulation in the clinical trial.

Legal Classification:
Rx

Adults:
≥18yrs: 3 tabs twice daily; max 8 weeks.

Children:
<18yrs: not established.

Warnings/Precautions:
Monitor for worsening symptoms of ulcerative colitis. Discontinue if acute intolerance syndrome is suspected. Known or history of renal impairment. Monitor renal function prior to initating and periodically during therapy. Hepatic impairment; consider monitoring LFTs during therapy. Elderly. Pregnancy (Cat. B). Nursing mothers.

Adverse Reaction(s)
In male patients: anemia, diarrhea, pharyngolaryngeal pain, UTI.

How Supplied:
Tabs—180

LAST UPDATED:
7/25/2013