Efficacy of ilaprazole in the treatment of duodenal ulcers:A meta-analysis

AIM:To compare the efficacy and tolerance of ilaprazole compared with other proton pump inhibitors(PPIs)in the treatment of duodenal ulcer.METHODS:An electronic database search of Medline,Embase,the Cochrane controlled trials register,Web of Science,PubMed,and the Chinese Biomedical Literature Database(updated to July 2013),and manual searches were conducted.A meta-analysis of randomized controlled trials comparing the efficacy and tolerance of ilaprazole and other PPIs in the treatment of duodenal ulcers was performed.RESULTS:Five articles involving 1481 patients were included.The meta-analysis showed no difference in the4-wk healing rate between ilaprazole and other PPIs[89.7%vs 87.0%;relative risk(RR)=1.02;95%CI:0.98-1.06;Z=1.00;P=0.32].The results did not change in the sensitivity analyses.The meta-analysis indicated that the adverse effect rate in the ilaprazole group was lower than that in the control group,but the difference was not significant(9.7%vs 13.0%;RR=0.81;95%CI:0.60-1.07;Z=1.47;P=0.14).CONCLUSION:Ilaprazole is a highly effective and safe PPI in the treatment of duodenal ulcers.Ilaprazole can be recommended as a therapy for acid-related disorders,especially in Asian populations.

Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets

A methodology(HPLC)proposed in this paper for simultaneously quantitative determination of ilaprazole and its related impurities in commercial tablets was developed and validated.The chromatographic separation was carried out by gradient elution using an Agilent C8 column(4.6 mm×250 mm,5 mm)which was maintained at 25℃.The mobile phase composed of solvent A(methanol)and solvent B(solution consisting 0.02 mmol/l monopotassium phosphate and 0.025 mmol/l sodium hydroxide)was at a flow rate of 1.0 ml/min.The samples were detected and quantified at 237 nm using an ultraviolet absorbance detector.Calibration curves of all analytes from 0.5 to 3.5 mg/ml were good linearity(r≥0.9990)and recovery was greater than 99.5% for each analyte.The lower limit of detection(LLOD)and quantification(LOQ)of this analytical method were 10 ng/ml and 25 ng/ml for all impurities,respectively.The stress studies indicated that the degradation products could not interfere with the detection of ilaprazole and its related impurities and the assay can thus be considered stability-indicating.The method precisions were in the range of 0.41-1.21 while the instrument precisions were in the range of 0.38-0.95 in terms of peak area RSD% for all impurities,respectively.This method is considered stabilityindicating and is applicable for accurate and simultaneous measuring of the ilaprazole and its related impurities in commercial enteric-coated tablets.

Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application

In Korea and China,ilaprazole is a widely used proton pump inhibitor in the treatment of gastric ulcers.In this study,a specific and sensitive LC-MS/MS method has been developed and validated for the quantification of ilaprazole enantiomers in the rat plasma,using R-lansoprazole as the internal standard.The enantioseparation was achieved on a CHIRALPAK AS-RH column(4.6 mm×150 mm,i.d.5 mm),with a mobile phase composed of 10 m M ammonium acetate aqueous solution and acetonitrile(60:40,V/V),at a flow-rate of 0.5 m L/min.The method was validated over the concentration range of 0.5 e300 ng/m L for both,R-and S-ilaprazole.The lower limit of quantification was 0.5 ng/m L for both enantiomers.The relative standard deviation(RSD)of intra-and inter-day precision of R-ilaprazole and S-ilaprazole was less than 10.9%,and the relative error accuracy(RE)ranged fromà0.5%e2.0%.Finally,the method was successfully evaluated in rats in a stereoselective pharmacokinetic study of the ilaprazole racemate.

Modified sequential therapy vs quadruple therapy as initial therapy in patients with Helicobacter infection

AIM: To evaluate the efficacy and safety of modified sequential therapy and to compare modified sequential therapy with standard quadruple therapy for Helicobacter pylori(H. pylori) eradication.METHODS: In total, 200 consecutive patients who were diagnosed with H. pylori-infected chronic gastritis by electronic endoscopy and rapid urease testing from December 2012 to October 2013 were enrolled in this study. The patients had not previously received H. pylori eradication treatment, and were randomized into two groups. The patients in Group A(n = 101) were treated with ilaprazole + bismuth potassium citrate + amoxicillin and clavulanate potassium + levofloxacin, and the patients in Group B(n = 99) were administered a modified sequential therapy composed of ilaprazole at 5 mg bid and amoxicillin and clavulanate potassium at 914 mg for the first five days followed by ilaprazole at 5 mg bid, furazolidone at 100 mg bid and levofloxacin at 500 mg qid for the next five days. Four to six weeks after the end of treatment, a 14C-urea breath test was performed for all the subjects to confirm the eradication of H. pylori. The intention-to-treat and per-protocol eradication rates were determined.RESULTS: A total of 190 of the 200 patients completed the study. All 200 patients were included in the intention-to-treat analysis, whereas 190 patients were included in the per-protocol analysis. In the intentionto-treat analysis, the rates of H. pylori eradication in Groups A and B were 85.15%(86/101) and 81.82%(81/99), respectively. In the per-protocol analysis, the H. pylori eradication rates in Groups A and B were 88.66%(86/97) and 87.09%(81/93), respectively. No significant difference was observed(χ2 = 0.109, P = 0.741) in the eradication rate between Groups A and B. The rates of adverse effects observed in the groups were similar at 6.19%(6/97) for Group A and 7.53%(7/93) for Group B(P > 0.05). No mortality or major morbidities were observed in any of the patients. Symptomatic improvements in the presentation of stomachache, acid regurgitation, and burning sensation were not significantly different between the two groups.CONCLUSION: Ilaprazole-based 10-d standard quadruple therapy does not offer an incremental benefit over modified sequential therapy for the treatment of H. pylori infection, as both treatment regimens appear to be effective, safe, and well-tolerated as initial treatment options.