Efficacy and safety of nicardipine prolonged-release implants for preventing vasospasm in humans

Stroke. 2002 Apr;33(4):1011-5. doi: 10.1161/01.str.0000014563.75483.22.

Abstract

Background and purpose: Despite extensive investigative efforts, there are few treatments that can prevent vasospasm after subarachnoid hemorrhage. This study was conducted to examine the efficacy and safety of nicardipine prolonged-release implants (NPRI) for humans, which have already been proven in dogs.

Methods: Twenty consecutive subarachnoid hemorrhage patients with thick subarachnoid clot were treated with NPRI (a pellet of diameter 2 mm, length 10 mm, containing 4 mg of nicardipine) during surgery after clipping of their aneurysm. The number and location of pellets depended on the amount and site of subarachnoid clot on preoperative CT and on craniotomy.

Results: Two to 10 pellets were implanted in the cistern of the internal carotid, middle cerebral, and/or anterior cerebral artery, where thick clots existed and therefore vasospasm related to delayed ischemic neurological deficits was highly likely. Delayed ischemic neurological deficits and cerebral infarctions were seen in 1 patient. Angiography performed on days 7 to 12 revealed no vasospasm in any arteries near which NPRI were placed. No complications were experienced.

Conclusions: Vasospasm was completely prevented for the arteries in thick clot cisterns, when NPRI were placed adjacent to the arteries during surgery. This drug-delivery system offers a promising approach for preventing vasospasm.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anterior Cerebral Artery / diagnostic imaging
  • Anterior Cerebral Artery / drug effects
  • Anterior Cerebral Artery / surgery
  • Carotid Artery, Internal / diagnostic imaging
  • Carotid Artery, Internal / drug effects
  • Carotid Artery, Internal / surgery
  • Cerebral Angiography
  • Craniotomy
  • Delayed-Action Preparations / administration & dosage
  • Drug Evaluation
  • Drug Implants / administration & dosage
  • Female
  • Humans
  • Male
  • Middle Aged
  • Middle Cerebral Artery / diagnostic imaging
  • Middle Cerebral Artery / drug effects
  • Middle Cerebral Artery / surgery
  • Nicardipine / administration & dosage*
  • Postoperative Complications / prevention & control
  • Subarachnoid Hemorrhage / complications
  • Subarachnoid Hemorrhage / drug therapy*
  • Subarachnoid Hemorrhage / surgery
  • Treatment Outcome
  • Vascular Surgical Procedures
  • Vasospasm, Intracranial / etiology
  • Vasospasm, Intracranial / prevention & control*

Substances

  • Delayed-Action Preparations
  • Drug Implants
  • Nicardipine