药品中文名称 : 尼伐地平 

药品英文名称 : Nilvaldipine 

药品所属类别 : 抗高血压药 

药物说明书 

【外文名】Nivaldipine, NIVADIL,Escor 

【性状】黄色结晶性粉末；无臭。易溶于丙酮、氯仿、甲醇，不溶于水。 
【药理及应用】为二氢吡啶类钙拮抗药，其与Ca2+通道特异部位的结合力比硝苯地平强10倍，作用持续时间亦较之长2～3倍。血管扩张作用选择性强，对心脏的作用较小，故降低血压作用明显。此外，尚有抗心绞痛及抗动脉粥样硬化作用。口服可吸收，血药浓度峰时间为2小时，t1/2约10小时。可用于防治心绞痛、高血压、脑血管痉挛及缺血性心脏病。 

【用法】口服，1次2～4mg，1日2次。 

【注意】常见的不良反应有面部潮红及发热感，心悸。偶见氨基转移酶升高、头痛、眩晕、腹部不适及过敏反应。 

【规格】片剂：每片2mg；4mg。 

Fujisawa to Apply for Partial Change of Indication on Nivadil 

 
Osaka, June 29, 2001 - (JCN Newswire) - Fujisawa Pharmaceutical Co., Ltd., today announced the results of post-marketing double blind placebo-controlled clinical trial on "Nivadil 2mg Tablet" (generic name: nilvadipine), which has been performed in the sequelae of cerebral infarction. The primary evaluation item of the trial is "improvement of decreased spontaneity" and its efficacy rate was found to be 43.6% (51/117) for the Nivadil group compared to 38.4% (43/112) for the placebo group. With no statistically significant difference in efficacy between the two groups, the efficacy of Nivadil 2mg Tablet in the area of sequelae of cerebral infarction could not be demonstrated in this trial. Based on the results, the company has decided to make an application with the Health Authorities for a partial change to withdraw the indication of "sequelae of cerebral infarction" for Nivadil 2mg Tablet.

Nivadil is a calcium antagonist originally developed by Fujisawa and was approved for essential hypertension in January, 1989. Subsequently, the cerebrocirculatory improving activity of Nivadil was confirmed in clinical pharmacology study and the clinical trials were performed to demonstrate efficacy. Nivadil showed a significant superiority to placebo in Phase 2 trials and to Nicardipine in the Phase 3 trials. Both clinical trials used the double blind comparative method. As a result, an additional indication of sequelae of cerebral infarction was approved for Nivadil in July 1992.

Regarding sequelae of cerebral infarction, Nivadil was designated in January 1999 and September 1999 as a drug for re-evaluation, and Fujisawa has conducted post-marketing double blind placebo-controlled clinical trials, using the new "SKETCH" evaluation scale since November 1999. According to the results of this clinical trial, however, we could not demonstrate the efficacy of the Nivadil 2mg Tablet as summarized above. In general, the placebo effect is usually high in clinical trials of this type, leading to difficulty in evaluation. Assuming the placebo effect is similarly high in this clinical trial, the company intends to analyse the data in detail and explore the reason clearly. The company has accepted the results and will proceed to make an application for deletion of the indication. This information will be transmitted to medical institutions, advising them not to prescribe for this indication.

The main indication of "Nivadil 2mg Tablet" and "Nivadil 4mg Tablet", "essential hypertension" remains unchanged and can still be prescirbed as before.

About Fujisawa Pharmaceutical Company Limited

Fujisawa Pharmaceutical (TSE: 4511) produces and markets pharmaceuticals, medical equipment and supplies, home care business, chemicals and animal health products. The company is one of Japan's largest drug makers, with its main strength in antibiotics. About 35 percent of sales come from overseas, much of which is from sales of its immunosuppressive agent Prograf.