Résumé
Aims: To evaluate the efficacy, safety and tolerability of atosiban in delaying preterm labour. Study Design: A prospective, open label, non comparative study. Place of Study: Lokmanya Tilak Municipal Medical College Mumbai, India. Methodology: Pregnant women (N=110) between the gestational age of 24 to 34 weeks, presenting with signs of preterm labour were enrolled in the study. Efficacy, safety and tolerability of Atosiban were assessed for a period of 72 hrs. Results: Ninety Eight patients (89.09%) remained undelivered up to 72 hrs after completion of treatment phase and ninety seven patients (88.18%) till the end of their hospital stay (upto 7 days). There were six patients with twin and one with quadruplet pregnancy; atosiban therapy was successful in delaying labour upto discharge from hospital in all the seven patients. The study medication was well tolerated as no adverse events were observed throughout the study duration. Conclusion: Atosiban, an oxytocin receptor antagonist, has proven to be an effective and well tolerated tocolytic drug and because of its favourable safety profile, it may be the best choice as a tocolytic therapy to delay the preterm labour.
Résumé
Aims: To assess the comparative efficacy, safety and tolerability of seratrodast versus montelukast in controlling mild to moderate asthma in adult patients. Study Design: Randomized, comparative, double blind, double dummy, multi-center, parallel group, non inferiority study. Methods: Patients (n=205) with mild to moderate asthma continuing on the lowest dose of inhaled corticosteroid were recruited from 3 different centers across India. Patients were randomly assigned to receive either seratrodast 80 mg (n=103) or montelukast 10 mg (n=102) once daily for 28 days. The treatments were compared for improvement from the baseline values, as per the changes in asthma symptom score (wheezing, shortness of breath, expectoration, cough and chest tightness), lung function parameters (PEF, FVC and FEV1), sputum and mucociliary parameters [fucose, eosinophil cationic protein (ECP) and albumin]. Results: Seratrodast and montelukast showed improvement in the clinical parameters of asthma as well as in the lung function tests and sputum parameters from baseline. Both the treatments significantly increased mean values of PEF, FVC and FEV1 from the baseline after a 4 week treatment but seratrodast produced significantly greater improvement in PEF (0.416 L/s, P=.01). Moreover, there was significantly more reduction in expectoration score (P=.01), sputum concentrations of ECP (P<.001) and albumin (P<.001) in seratrodast group, signifying improvement in asthma condition. The two treatment groups had similar tolerability profiles. Mild increase in hepatic enzymes was seen in both the groups with no clinical significance. No serious adverse events were observed during the study. Conclusions: Seratrodast, a Thromboxane A2 receptor antagonist, was found to be better in the improvement of PEF, reduction in expectoration, ECP and albumin levels as compared to montelukast. Seratrodast can be recommended as a controller medication in mild to moderate asthma.
Résumé
Aims: To assess the efficacy of lafutidine therapy versus rabeprazole in Indian patients with endoscopically and histologically proven gastritis and peptic ulcer. Study Design: A double blind, double dummy, randomized, comparative study. Place and Duration of Study: Global Liver and Gastroenterology Centre, Bhopal, India, between March 2010 and October 2010. Methodology: A total of 100 patients were enrolled, including 50 with endoscopically and histologically proven gastritis and other 50 with peptic ulcer (over 5 mm in diameter). Each group was randomized to receive either lafutidine or rabeprazole tablet and their corresponding competitor placebo dummy tablet, for a period of 4 weeks. Cure rate was confirmed endoscopically at the end of week 4 as compared to the baseline evaluation. Symptom response and Helicobacter pylori (H. Pylori) eradication were also compared among the two drugs at the end of the treatment period. Results: Complete cure of gastritis was observed in all the patients (100%) treated with lafutidine and 95.24% [20/21; 95% CI: 76.18 to 99.88%] patients treated with rabeprazole. Complete cure of ulcer was observed in 72.0 (18/25, 95% CI = 50.61 to 87.93%) and 79.16% (19/24, 95% CI = 57.85 to 92.87%) patients treated with lafutidine and rabeprazole respectively. There was no significant difference in gastritis/ulcer cure rate and symptom response rate between the two treatment groups at the end of the study. H pylori eradication rates was 82.61% (19/23) in lafutidine group vs 47.37% (9 /19) in rabeprazole group (Δ=35.2%, 95% CI = 3.2 to 67.3%; P= .023). Both, lafutidine and rabeprazole were well tolerated during the entire study. Conclusion: Endoscopically proven cure rate in patients suffering from gastritis and peptic ulcers is found to be comparable after 4 weeks treatment with Lafutidine and rabeprazole, but lafutidine showed better H. pylori eradication rate as compared to rabeprazole.
Résumé
Aims: To evaluate the symptomatic efficacy and safety of Lafaxid™ (lafutidine 10 mg) in Indian patients with Acid Peptic disorder (APD). Study Design: An observational, prospective, uncontrolled, open-label multi-centric study. Place and Duration of Study: Patients were recruited from 12 cities across India by 61 investigators, between October 2010 and December 2011. Methodology: We included 1500 patients (973 men, 527 women; age range 15-85 years) with Acid Peptic disorder. Lafutidine (10 mg tablets) was prescribed by the physicians as once daily dose (OD) for 28 days. The efficacy was analysed based on the change in the symptom baseline score on the 100 point Visual Analogue Scale (VAS) for individual symptoms, and the safety was determined based on adverse events reported during the study with the prescribed usage of lafutidine on day 14 and day 28 after start of the treatment. Results: Lafutidine monotherapy was given to 1378 patients. A very high reduction in the mean VAS score was observed from baseline for individual symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 120.34 ± 67.58 to 14.18 ± 26.97 at the end of the study (P < .001). There were 124 APD patients, previously treated but uncontrolled, with acid inhibitors like PPIs, H2RAs etc., also showed a significant reduction (157.42 ± 83.88 to 26.47 ± 46.34) in the VAS score on day 28 (P<.001). During the entire study, adverse events of mild and moderate nature were observed in 0.4% (6 patients) of the total patient population. Conclusion: The present study demonstrates that therapy with Lafaxid™ is symptomatically effective and well tolerated in patients with APDs.