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Review
. 2014 Feb 24;10(1):10-8.
doi: 10.5114/aoms.2014.40729. Epub 2014 Feb 23.

Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients

Shilan Mozaffari  1 , Shekoufeh Nikfar  2 , Mohammad Abdollahi  3
Affiliations
Review

Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients

Shilan Mozaffari et al. Arch Med Sci. .

Abstract

Introduction: By targeting different subtypes of 5-hydroxytryptamine (5HT) receptors in the gastrointestinal (GI) tract, several drugs have been introduced for the management of irritable bowel syndrome (IBS). Renzapride is a full agonist for 5HT4 receptor and an antagonist to 5HT2b and 5HT3 receptors which is thought a promising therapeutic agent for constipation predominant IBS (C-IBS) patients due to its accelerating effect on the GI tract. In this meta-analysis, our aim was to evaluate the efficacy and tolerability of renzapride in the management of IBS.

Material and methods: A search was done from 1992 to February 2013 for placebo-controlled trials that investigated the efficacy of renzapride in IBS.

Results: Relative risk (RR) for clinical efficacy in IBS patients treated for 5 weeks or less comparing renzapride to placebo was 1.07 (95% CI = 0.89-1.29, p = 0.38). This value for IBS patients treated for more than 5 weeks was 1.04 (95% CI = 0.78-1.239, p = 0.77). The RR for clinical efficacy in IBS patients treated with renzapride (4 mg) for 5 weeks or less and more than 5 weeks in comparison to placebo was 1.2 (95% CI = 0.97-1.48, p = 0.1) and 1.16 (95% CI = 0.98-1.37, p = 0.08), respectively, which were statistically non-significant but clinically important. The analysis of tolerability demonstrated that amongst different reported adverse effects, renzapride caused diarrhea more than placebo (RR = 1.61 with a 95% CI = 1.16-2.24, p = 0.004). The RR for withdrawals from renzapride compared to placebo was 1.58 (95% CI = 1.26-2.07, p = 0.0007).

Conclusions: Renzapride is not superior to placebo in relieving IBS symptoms and causes significant incidences of diarrhea and drop-outs due to adverse effects in treated patients vs. placebo. Thus, this medicine might be a cost burden to patients without providing good effectiveness.

Keywords: 5-hydroxytryptamine; clinical trial; irritable bowel syndrome; meta-analysis; renzapride; systematic review.

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Figures

Figure 1
Figure 1
Molecular formula and structure of renzapride
Figure 2
Figure 2
Flow diagram of the study selection process
Figure 3
Figure 3
A – Individual and pooled relative risk for the outcome of “clinical efficacy treated for 5 weeks or less” in the studies considering renzapride compared to placebo therapy in IBS patients. B – Heterogeneity indicators for the outcome of “clinical efficacy treated for 5 weeks or less” in the studies considering renzapride compared to placebo therapy in IBS patients
Figure 4
Figure 4
A – Individual and pooled relative risk for the outcome of “clinical efficacy treated for more than 5 weeks” in the studies considering renzapride compared to placebo therapy in IBS patients. B – Heterogeneity indicators for the outcome of “clinical efficacy treated for more than 5 weeks” in the studies considering renzapride compared to placebo therapy in IBS patients
Figure 5
Figure 5
A – Individual and pooled relative risk for the outcome of “clinical efficacy treated for 5 weeks or less” in the studies considering renzapride 4 mg daily compared to placebo therapy in IBS patients. B – Heterogeneity indicators for the outcome of “clinical efficacy treated for 5 weeks or less” in the studies considering renzapride 4 mg daily compared to placebo therapy in IBS patients
Figure 6
Figure 6
A – Individual and pooled relative risk for the outcome of “clinical efficacy treated for more than 5 weeks” in the studies considering renzapride 4 mg daily compared to placebo therapy in IBS patients. B – Heterogeneity indicators for the outcome of “clinical efficacy treated for more than 5 weeks” in the studies considering renzapride 4 mg daily compared to placebo therapy in IBS patients
Figure 7
Figure 7
A – Individual and pooled relative risk for the outcome of “withdrawal” in the studies considering renzapride compared to placebo therapy in IBS patients. B – Heterogeneity indicators for the outcome of “withdrawal” in the studies considering renzapride compared to placebo therapy in IBS patients
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