Itopride for gastric volume,gastric emptying and drinking capacity in functional dyspepsia

AIM To study the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in functional dyspepsia(FD). METHODS Randomized controlled trial was conducted to check the effect of itopride on gastric accommodation, gastric emptying, capacity of tolerating nutrient liquid and symptoms of FD. We recruited a total of 31 patients having FD on the basis of ROME III criteria. After randomization, itopride was received by 15 patients while 16 patients received placebo. Gastric accommodation was determined using Gastric Scintigraphy. ^(13) C labeled octanoic breadth test was performed to assess gastric emptying. Capacity of tolerating nutrient liquid drink was checked using satiety drinking capacity test. Theintervention group comprised of 150 mg itopride. Patients in both arms were followed for 4 wk. RESULTS Mean age of the recruited participant 33 years(SD = 7.6) and most of the recruited individuals, i.e., 21(67.7%) were males. We found that there was no effect of itopride on gastric accommodation as measured at different in volumes in the itopride and control group with the empty stomach(P = 0.14), at 20 min(P = 0.38), 30 min(P = 0.30), 40 min(P = 0.43), 50 min(P = 0.50), 60 min(P = 0.81), 90 min(P = 0.25) and 120 min(P = 0.67). Gastric emptying done on a sub sample(n = 11) showed no significant difference(P = 0.58) between itopride and placebo group. There was no significant improvement in the capacity to tolerate liquid in the itopride group as compared to placebo(P = 0.51). Similarly there was no significant improvement of symptoms as assessed through a composite symptom score(P = 0.74). The change in QT interval in itopride group was not significantly different from placebo(0.10). CONCLUSION Our study found no effect of itopride on gastric accommodation, gastric emptying and maximum tolerated volume in patients with FD.

Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form

A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol：water：ammonium acetate; 4.0：1.0：0.5 （v/v/v）. This system was found to give compact and dense spots for both itopride hydrochloride （Rf value of 0.55__＋0.02） and pantoprazole sodium （Rf value of 0.85＋0.04）. Densitometric analysis of both drugs was carried out in the reflectance- absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988___0.0012 in the concentration range of 100--400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990_＋0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

Efficacy of Itopride in the Prevention of Lubiprostone-Induced Nausea

Background: The efficacy of lubiprostone for chronic constipation has been established through phase III clinical trials. Nevertheless, the continuation of lubiprostone therapy is reportedly difficult due to the development of nausea. The objective of this study is to determine whether the administration of itopride hydrochloride can reduce lubiprostone-related nausea. Methods: Two hundred and thirty-five patients who were receiving lubiprostone (24 μg capsule twice daily) were enrolled. Seventy-one patients took a prophylactic dose of itopride (50 mg tablet twice daily) together with lubiprostone to prevent nausea. Thus, the patients were divided into 2 groups: lubiprostone alone (164;control group) and combination therapy with lubiprostone and itopride (71;itopride group). Efficacy measures included changes in constipation scoring system scores, the incidence of treatment-related adverse events including nausea, and the percentage of patients who discontinued treatment within two weeks after administration. Results: Of the 235 patients who were enrolled, 196 were available for analysis. Both treatment groups experienced statistically significant improvements in constipation scoring system scores. The percentage of patients who reported ≥1 adverse event was significantly higher in the control group (40.9%) than in the itopride group (21.9%). The percentage of patients experiencing nausea was statistically and significantly lower in the itopride group than in the control group (9.4% versus 22.7%). The itopride regimen was also statistically superior compared to the control regimen in terms of treatment discontinuation. Conclusion: The prophylactic administration of itopride can decrease the risk of nausea in patients receiving lubiprostone and consequently reduce the risk of treatment discontinuation.

达立通联合伊托必利治疗功能性消化不良

目的探讨达立通联合伊托必利治疗功能性消化不良的治疗效果。方法：将500例功能性消化不良患者随机分成治疗组160例和对照组140例。治疗组每次口服伊托必利50mg＋达立通6000mg，对照组口服伊托必利50mg，两组均每日5次，餐前30min服用；两组均治疗15天，5个月后随访，观察有效率和不良反应发生率。结果：治疗15天后，治疗组的有效率高于对照组（P〈0．05），不良反应发生率显著低于对照组（P〈0．05），两组的复发率无显著性差异。结论：达立通联合伊托必利治疗功静陛消化不良的效果优于单用伊托必利。