pharmacovigilance-congress-2016_posters-accepted-abstracts

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Volume 4, Issue 5 (Suppl)

J Pharmacovigil 2016

ISSN:2329-6887 JP, an open access journal

Pharmacovigilance Congress 2016

September 28-30, 2016

September 28-30, 2016 Toronto, Canada

Pharmacovigilance Congress

J Pharmacovigil 2016, 4:5 (Suppl)

Update on cardiotoxicity and safety of Domperidone for treating nausea and vomiting

Richard W. McCallum

Texas Tech University Health Sciences Center, El Paso, Texas

Background

: Domperidone, a dopamine receptor antagonist, acts peripherally as a gastrointestinal prokinetic and centrally as an

anti-emetic. A safety concern in regards to domperidone is whether it can cause ventricular arrhythmia and sudden cardiac death.

Objectives

: This systematic review has been designed to address whether there is any possible association between domperidone and

serious cardiac events such as ventricular arrhythmia or sudden cardiac death.

Data sources, study eligibility criteria & participants

: PubMed was searched for case-control studies on the cardiotoxicity associated

with domperidone. Moreover, clinical studies on the effects of domperidone in patients with gastroparesis were reviewed for any

cardiac adverse events.

Study appraisal and synthesis methods

: Seven case-control studies and 7 interventional studies were retrieved. The quality of case-

control studies were tested by the Newcastle-Ottawa Scale (NOS) based on its 3 major criteria, i.e. selection, comparability and

exposure, where good quality research is defined as ≥ 3 points for the selection domain, ≥ 2 points for the comparability domain and

≥ 2 points for the exposure domain. The odds of domperidone on outcome were assessed. Random and fixed effect models were used

based on I2 value. The rate of cardiac events in interventional studies was also determined.

Findings

: Most of the included case-control studies were graded fair or poor based on NOS, although mathematically domperidone

was a significant risk for cardiac events (unadjusted Odds ratio: 1.88 and adjusted Odds ratio 1.60; P<0.05). Serious cardiac adverse

effects were not reported in the patients with gastroparesis using domperidone at the dosage range of 30-120mg (majority ≥80 mg)

daily for up to 48 months. In the most recent study, 64 patients were receiving domperidone (40 to 120 mg daily) for various time

intervals from 3 months to 4 years; 52 for gastroparesis and 8 for chronic nausea and vomiting. Approximately 73% of the patients had

a clinically meaningful response to domperidone and there were no serious side effect. Only 3 of the 64 patients chronically receiving

high doses of domperidone reported palpitations but without any complaints of chest pain or accompanying QTc prolongation or

cardiac dysrhythmias.

Limitations

: As mentioned, the quality of most of the included case-control studies was of fair or poor grading. Some of the included

studies in meta-analysis had low prevalence of patients exposed to domperidone. This may provide biased effect size. Conclusions

and implications of key findings: Due to the low quality of case-control studies on the cardiotoxicity of domperidone, the possible

association between this medication and cardiac events is still under debate. Although, this association is not adequately clear, we

should be cautious when prescribing this medication. Well-planned prospective studies should explore the long-term adverse effects

of domperidone.