Evidence map›Paper›PMID 38829496›Full record

ArticleDrugs - real world outcomes2024

Real-World Evidence on Levetiracetam-Induced Hypokalemia: An Active Comparator Cohort Study.

Ohoud Almadani, Raseel Alroba, Almaha Alfakhri, Sumaya Almohareb, Turki Althunian, Adel A Alrwisan

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Article in Drugs - real world outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

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0cells of the map it votes in
3citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ohoud AlmadaniSaudi Food and Drug Authority, Riyadh, Saudi Arabia.
Raseel AlrobaSaudi Food and Drug Authority, Riyadh, Saudi Arabia.
Almaha AlfakhriSaudi Food and Drug Authority, Riyadh, Saudi Arabia.
Sumaya AlmoharebDepartment of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Turki AlthunianSaudi Food and Drug Authority, Riyadh, Saudi Arabia.
Adel A AlrwisanSaudi Food and Drug Authority, Riyadh, Saudi Arabia. aarwisan@sfda.gov.sa.ORCID http://orcid.org/0000-0002-9422-7390

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLevetiracetam is an anti-seizure medication (ASM) with an established safety profile. However, a potential safety signal of hypokalemia following levetiracetam use was published in the World Health Organization newsletter.

objectiveTo investigate the possible causal association between the use of levetiracetam and the development of hypokalemia.

methodThis was a new-user, active-comparator retrospective cohort study using Real-world Evidence Research Network data at the Saudi Food and Drug Authority from 2016 to 2022. Adults (≥ 18 years old) with an incident prescription for either levetiracetam or carbamazepine were followed for up to 6 months from the prescription date. Hypokalemia was ascertained by using diagnostic code (i.e., E87.6) or by serum potassium level below 3.5 mmol/L. A Cox proportional hazards model, adjusted with stabilized inverse probability of treatment weight, was fitted to compare the hazard of hypokalemia between levetiracetam and carbamazepine exposed patients.

resultsA total of 8,982 patients entered the study cohort. The incidence rate of hypokalemia was 303 cases per 10,000 patient-years in the levetiracetam-exposed cohort compared to 57 cases per 10,000 patient-years among carbamazepine users. Compared to carbamazepine users, patients exposed to levetiracetam had an adjusted hazard ratio related to induced hypokalemia of 1.99 (95% confidence interval, 0.88-4.49). Results of sensitivity analyses were comparable to the main analysis.

conclusionThe hazard ratio for hypokalemia with the use of levetiracetam versus carbamazepine was statistically comparable. However, the potential association between levetiracetam use and hypokalemia cannot be ruled out given the elevated hazard ratios from the main and sensitivity analyses. Further studies may provide a more precise assessment of this association.

Identifiers

PMID38829496
PMCPMC11176145

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