0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Therapeutics |

Benzodiazepines were as safe as and more effective than placebo for out-of-hospital status epilepticus

Samuel Wiebe, MD, MSc
[+] Article and Author Information

*See Glossary.

†Information provided by author.

Source of funding: National Institutes of Health.

For correspondence: Dr. D.H. Lowenstein, Harvard Medical School, Boston, MA, USA. E-mail daniel_lowenstein@hms.harvard.edu.


Ann Intern Med. 2002;136(3):86. doi:10.7326/ACPJC-2002-136-3-086
Text Size: A A A

Question: In patients with out-of-hospital status epilepticus, are benzodiazepines safer and more effective than placebo when given by paramedics for terminating the condition?

Design: Randomized {allocation concealed*}†, blinded {patients, clinicians, data collectors, and outcome assessors}†,* placebo-controlled trial with follow-up to time of arrival at the emergency department.

Setting: San Francisco, California, USA.

Patients: 205 patients (258 enrollments) who were ≥ 18 years of age (mean age 51 y, 63% men, 50% white) and had an out-of-hospital diagnosis of status epilepticus. Exclusion criteria included pulse < 60 beats/min, systolic blood pressure < 100 mm Hg, and a history of long-term use of or sensitivity to benzodiazepines. Only data from the first enrollment of each patient was reported. {Follow-up was 100%.}†

Intervention: Patients were allocated to intravenous injection of lorazepam, 2 mg (n = 66); diazepam, 5 mg (n = 68); or placebo (n = 71), given over a 1- to 2-minute period and only during generalized tonic-clonic seizure activity. If seizures recurred or continued ≥ 4 minutes after the first injection, an identical second injection was given. Open-label diazepam was immediately available for a difficult or unsafe extrication of a patient or if a patient was at high risk for a life-threatening complication.

Main outcome measures: Termination of status epilepticus and out-of-hospital complications.

Main results: {Analysis was by intention to treat.}† Lorazepam and diazepam groups did not differ, but each were more effective than placebo for terminating status epilepticus (diazepam vs placebo comparison was of borderline statistical significance) (Table). An out-of-hospital complication occurred in 11%, 10%, and 23% of patients who received lorazepam, diazepam, and placebo (P = 0.08), respectively.

Conclusion: In patients with status epilepticus, both lorazepam and diazepam were as safe as and more effective than placebo when given by paramedics for terminating the condition.

Lorazepam (Lor) vs diazepam (Dia) vs placebo (Plac) for out-of-hospital status epilepticus until arrival at the emergency department‡

OutcomeComparisonsEvent ratesRBI (95% CI)NNT (CI)
Termination of<br/>status epilepticusLor vs Dia59% vs 43%37% (−13 to 80)Not<br/>significant
Lor vs Plac59% vs 21%166% (60 to 268)3 (2 to 8)
Dia vs Plac43% vs 21%80% (0 to 190)Borderline significance

‡Abbreviations defined in Glossary; RBI, NNT, and CI calculated from adjusted data in article.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)