Cisapride and ventricular arrhythmia

Hennessy, Sean; Leonard, Charles E.; Newcomb, Craig; Kimmel, Stephen E.; Bilker, Warren B.

doi:10.1111/j.1365-2125.2008.03249.x

Cited by 48 publications

(60 citation statements)

References 22 publications

(29 reference statements)

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“…In our days, we can assume that cisapride is associated with an approximate doubling to tripling of the risk of hospitalization for ventricular arrhythmia and sudden cardiac death [18]. This risk is more marked in the initial prescription period in which it can be eightfold [18]. These data are consistent with the finding that 61% of cases of QT prolongation and ventricular arrhythmia reported to FDA in association with cisapride were produced within 30 days of initiation of therapy [11].…”

Section: Cisapride: Pre-marketing Research An D Detection Of Adverse supporting

confidence: 89%

“…Indeed, subsequent studies with larger population size have shown a high rate of arrhythmia associated with cisapride [14,15]. In our days, we can assume that cisapride is associated with an approximate doubling to tripling of the risk of hospitalization for ventricular arrhythmia and sudden cardiac death [18]. This risk is more marked in the initial prescription period in which it can be eightfold [18].…”

Section: Cisapride: Pre-marketing Research An D Detection Of Adverse mentioning

confidence: 97%

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Prokinetic Agents and QT Prolongation: A Familiar Scene with New Actors

Keller¹,

Girolamo²

2010

CDS

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Prokinetic agents are a very large family of drugs with different mechanisms of action. Only QT prolongation by cisapride has made notable impact and deserved its partial restriction and/or withdrawal from the market. Postmarketing surveillance initially showed that cisapride was generally safe and well tolerated, but in the past decade, more recent data have shown some risk in the patient populations. QT prolongation by prokinetic agents can raised from different mechanisms: some involve increased plasma concentrations of cisapride due to increased bioavailability by inhibiting P glycoprotein, and inhibition of metabolism or deficit in the elimination. On the other hand, pharmacodynamic interactions can also enhance the arrhythmogenic effect of cisapride. The present article presents the mechanisms and reviews the main interactions studied so far, and the role of pharmacovigilance in the detection of rare clinical events. We emphasize the need for physicians to look for conditions (either clinical or not) prone to increase the risk of QT interval prolongation.

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Section: Cisapride: Pre-marketing Research An D Detection Of Adverse supporting

confidence: 89%

Section: Cisapride: Pre-marketing Research An D Detection Of Adverse mentioning

confidence: 97%

Prokinetic Agents and QT Prolongation: A Familiar Scene with New Actors

Keller¹,

Girolamo²

2010

CDS

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“…Rerunning these models with a different set of ICD-9 codes for VA based on the study by Hennessey et al [35] (sensitivity analysis 3; Additional file 1: Appendix 2) or additional adjustment for anti-arrhythmic medications, mexilitine, propafenone, and dofetilide (sensitivity analysis 4; Additional file 1: Appendix 3), confirmed the main results.…”

Section: Resultssupporting

confidence: 52%

Allopurinol and the risk of ventricular arrhythmias in the elderly: a study using US Medicare data

Singh

Cleveland

2017

BMC Med

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BackgroundThere are no published human studies investigating whether the use of allopurinol, the most commonly used medication for the treatment of hyperuricemia in gout, the most common type of inflammatory arthritis in adults, has any beneficial effects on ventricular electrophysiology. The objective of our study was to assess whether allopurinol use is associated with a reduction in the risk of ventricular arrhythmias (VA).MethodsWe used the 5% random sample of Medicare beneficiaries from 2006–2012 to examine new allopurinol use and the risk of incident VA. Multivariable Cox regression analyses were adjusted for demographics (age, race, sex), comorbidity, cardiac medications, and conditions associated with VA. We calculated hazard ratios (HR) and 95% confidence intervals (CI).ResultsOf the 28,755 episodes of new allopurinol use, 2538 were associated with incident VA (8.8%). Among patients with incident VA, 54% were male, 78% were White, 75% had gout as the underlying diagnosis, and the mean Charlson–Romano comorbidity score was 4.8. The crude incidence of VA per 1,000,000 person-days declined as the duration of allopurinol use increased: 1–180 days, 151; 181 days to 2 years, 105; and > 2 years, 85. In multivariable-adjusted analyses, compared to non-use, allopurinol use was associated with lower HR of VA of 0.82 (95% CI, 0.76–0.90). Compared to allopurinol non-use, longer allopurinol use durations were significantly associated with lower multivariable-adjusted HR for VA: 1–180 days, 0.96 (95% CI, 0.85–1.08); 181 days to 2 years, 0.76 (95% CI, 0.68–0.85); and > 2 years, 0.72 (95% CI, 0.60–0.87). Multiple sensitivity analyses adjusting for cardiac conditions, anti-arrhythmic drugs and alternate definitions confirmed our findings with minimal/no attenuation of estimates.ConclusionAllopurinol use and use duration of more than 6 months were independently associated with a lower risk of VA. Future studies need to assess the pathophysiology of this potential benefit.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0816-6) contains supplementary material, which is available to authorized users.

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“…Medicare data were obtained in persons eligible for both programs to ensure complete capture of outcomes. These data have been previously described and are of high quality 16–18. Medicaid is a state run program providing hospital, medical, and outpatient pharmaceutical coverage for certain categories of low income and special-needs individuals.…”

Section: Methodsmentioning

confidence: 99%

Exogenous Estrogen Does Not Attenuate the Association Between Rofecoxib and Myocardial Infarction in Perimenopausal Women

Wade¹,

Ellenberg²,

Großer³

et al. 2011

Journal of Cardiovascular Pharmacology

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Rofecoxib has been proposed to increase the risk of myocardial infarction (MI) through suppression of cyclooxygenase (COX)-2 mediated prostacyclin. Estrogen may have protective effects through augmenting COX-2 expression and subsequently increasing prostacyclin. Estrogen may attenuate the association between rofecoxib and MI. We used 1999-2002 Medicaid claims data to measure the MI-hazard ratio (HR) attributed to rofecoxib exposure in estrogen exposed and unexposed 45-65 year old women. We identified 184,169 female rofecoxib users who contributed 309,504 person-years and experienced 1217 first MIs. Estrogen exposure appeared protective (MI-HR 0.72, 95% CI 0.62-0.84) in this cohort. Rofecoxib was associated with an elevated MI-HR in both estrogen exposed (2.01, 95% CI 1.60-2.54) and estrogen unexposed women (1.69, 95% CI 1.43-1.99). The rofecoxib-estrogen interaction ratio was not significantly different from 1 (1.19, 95% CI 0.91-1.57). Although estrogen use was associated with a lower risk of MI, it did not appear to attenuate the association between rofecoxib and MI.

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Cisapride and ventricular arrhythmia

Cited by 48 publications

References 22 publications

Prokinetic Agents and QT Prolongation: A Familiar Scene with New Actors

Prokinetic Agents and QT Prolongation: A Familiar Scene with New Actors

Allopurinol and the risk of ventricular arrhythmias in the elderly: a study using US Medicare data

Exogenous Estrogen Does Not Attenuate the Association Between Rofecoxib and Myocardial Infarction in Perimenopausal Women

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