Treatment of iron deficiency anemia in children: a comparative study of ferrous ascorbate and colloidal iron.

OBJECTIVE: To compare the efficacy of ferrous ascorbate and colloidal iron in the treatment of iron deficiency anemia in children. METHODS: Eighty one children, aged 6 mo to 12 y, were screened for iron deficiency anemia (IDA) and those diagnosed with IDA were randomized to receive ferrous ascorbate or colloidal iron for a period of 12 wk, such that each child received elemental iron 3 mg/kg body weight/d. Increase in hemoglobin (Hb) level was the primary outcome measure. Assessment was performed at baseline, wk 4, wk 8 and wk 12. RESULTS: Of 81 children screened, 73 were included in the study. The mean rise in Hb at the end of the 12 wk was significantly higher in ferrous ascorbate group than the colloidal iron group [3.59 ± 1.67 g/dl vs. 2.43 ± 1.73 g/dl; P < 0.01]. Significantly higher proportion of children receiving ferrous ascorbate (64.86 % vs. 31.03 %; P < 0.01) became non-anemic in comparison to colloidal iron. CONCLUSIONS: Ferrous ascorbate provides a significantly higher rise in hemoglobin levels in comparison to colloidal iron. The study supports the use of ferrous ascorbate in the pediatric age group, providing evidence for its role as an efficient oral iron supplement in the treatment of iron deficiency anemia.

Assessment of intravenous iron sucrose in the management of anemia in gynecological and obstetrical practice.

OBJECTIVE: The present study was undertaken to assess the impact of intravenous iron sucrose (Feronia IV) in the treatment of iron deficiency anemia observed in gynecological and obstetrical practice. METHODS: Seventy-seven practicing gynecologists and obstetricians throughout India collaborated in the recruitment of 145 women over a period of 1 year, of which 143 were analyzable cases. RESULTS: The overall mean rise in hemoglobin level was observed to be 2.43 gm % at the end of 4 weeks. The dose of iron sucrose administered ranged from 100 to 1,050 mg. In women who received 200 mg of the drug, and the mean Hb rise was found to be 2.21 ± 1.06 gm %. The highest observable rise in hemoglobin level was 5.5 gm % with 800 mg of iron sucrose. No serious adverse reactions were reported during the observation period. CONCLUSION: Intravenous Iron sucrose is a safe and effective treatment for the rapid reversal of iron deficiency anemia, in obstetric and gynecological settings.

Lafutidine 10 mg versus Rabeprazole 20 mg in the Treatment of Patients with Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial.

Background. Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia. Aim. The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H(2)-RA, and rabeprazole and to compare their efficacy. Methods. This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS) scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks. Results. A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P < .01) and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P < .01). Both the drugs were well tolerated. Conclusion. Both lafutidine and rabeprazole provide symptom relief in patients with heartburn-dominant uninvestigated dyspepsia. The present study confirms the appropriateness of lafutidine as an empiric treatment and superior efficacy for primary care practice patients with dyspepsia.

Troxipide in the management of gastritis: a randomized comparative trial in general practice.

Background. A trial of empirical acid-suppressive therapy is the usual practice for most patients with symptoms of gastritis in primary care. Aim. To assess the relative efficacy of Troxipide and Ranitidine in patients with endoscopic gastritis over a four-week period. Methods. In all, 142 patients were randomized to Troxipide (100 mg tid) or Ranitidine (150 mg bid) for a period of four weeks. The severity of the signs of endoscopic gastritis at baseline and week 4 using a four-point scale and the subjective symptom severity at baseline and week 2 & week 4 using a Visual analog scale (VAS) were documented. Results. Troxipide was found to be superior to Ranitidine for both, the complete resolution and improvement of endoscopic gastritis. Higher proportion of patients showed complete healing of erosions (88.14%), oozing (96.77%), and edema (93.88%) with Troxipide as compared to Ranitidine (P < .01). Patients receiving Troxipide also showed a greater improvement in the VAS scores for abdominal pain, bloating, and heartburn (P < .01). Both the drugs were found to be well tolerated. Conclusion. In patients with endoscopic gastritis, Troxipide, with its superior rate of improvement, resolution of signs, and subjective clinical symptoms, can be considered as an alternative to the commonly used antisecretory agents.

An open-label, randomized, cross-over bioequivalence study of lafutidine 10 mg under fasting condition.

AIM: To assess the relative bioavailability and pharmacokinetic properties of two formulations (test and reference) of Lafutidine 10 mg. METHODS: The study was performed as an open label, randomized, two-way, two-period, two-treatment, single dose cross-over bioequivalence study, under non-fed condition to compare the pharmacokinetic profiles of the lafutidine formulation manufactured by Emcure Pharmaceuticals Ltd., India using an indigenously developed active pharmaceutical ingredient (API) and the commercially available Stogra(®) formulation, of UCB Japan Co., Ltd., Japan. The two treatments were separated by a wash-out period of 5 d. After an overnight fasting period of 10 h, the subjects were administered either the test or the reference medication as per the randomization schedule. Blood samples were collected at intervals up to 24 h, as per the approved protocol. Concentrations of lafutidine in plasma were analyzed by a validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method, and a non-compartmental model was used for pharmacokinetic analysis. The pharmacokinetic parameters were subjected to a 4-way ANOVA accounting for sequence, subjects, period and treatment. Statistical significance was evaluated at 95% confidence level (P ≥ 0.05). RESULTS: The mean (± SD) values of the pharmacokinetic parameters (test vs reference) were C(max) (265.15 ± 49.84 ng/mL vs 246.79 ± 29.30 ng/mL, P < 0.05), Area under the curve (AUC)((0-t)) (1033.13 ± 298.74 ng.h/mL vs 952.93 ± 244.07 ng.h/mL, P < 0.05), AUC((0-∞)) (1047.61 ± 301.22 ng.h/mL vs 964.21 ± 246.45 ng.h/mL, P < 0.05), and t(½)(1.92 ± 0.94 h vs 2.05 ± 1.01 h, P < 0.05). The 90% confidence intervals (CI) for the test/reference ratio of mean C(max), AUC((0-t)), and AUC((0-∞)) were within the acceptable range of 80.00 to 125.00. The mean times (± SD) to attain maximal plasma concentration (t(max)) of lafutidine were 0.95 ± 0.24 h vs 1.01 ± 0.29 h (P < 0.05) for the test and the reference formulations respectively. Both the formulations were well tolerated. CONCLUSION: In summary, this study has demonstrated the bioequivalence of the two formulations of lafutidine 10 mg. Hence it can be concluded that the two formulations can be used interchangeably in clinical settings.