RESUMO
Background: Osteoarthritis (OA) is the most common form of and a leading cause of chronic disability between fourth and fifth decade of life, with a prevalence ranging between 17-60.6% in India. Objective: To compare the efficacy and safety profile of glucosamine HCl- sustained release (GLU-SR) with that of Glucosamine HCl- immediate release (GLU-IR) in patients with knee osteoarthritis (OA). Methods: This was an open labelled, randomised, controlled trial conducted in a tertiary care hospital at Kanpur. The study involved 60 patients with knee OA, randomised to receive single oral dose of 1,500 mg GLU-SR and GLU-IR for 60 days with 30 patients in each group. The primary efficacy being reduction in pain and improvement in function was assessed using visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Intention-to-treat principle, repeated measure of ANOVA and mixed model analysis were used for statistical analysis. The history of adverse reactions experienced was collected throughout the study period. Results: There was a significant reduction in algo functional indices as primary outcome measure in both the groups (P < 0.001). A significant difference (P < 0.05) in the number of patients reporting ADR in the GLU-SR arm (38% lesser) was noted as compared to GLU-IR arm, with no difference in the use of rescue medications in both arms. Conclusions: From the observations made in this study it is concluded that GLU-SR is as effective as GLU-IR in the management of knee OA; with an advantage of having a better safety profile.
RESUMO
Background: Ischemic heart disease is one of the leading causes of global disease burden. Despite treatment with standard therapy, many patients with chronic stable angina pectoris remain symptomatic making it an urgent necessity to introduce new strategies. Hence this study was planned to compare the efficacy and tolerability of Ivabradine and Ranolazine; the two novel antianginal drugs. Methods: This was a single blind, randomised, controlled trial. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were randomised into two groups. Patients filled a pretested questionnaire on frequency of angina attacks and adverse reactions experienced at baseline and 2, 4 and 8 weeks. The haemodynamic parameters, routine laboratory investigations were evaluated at the baseline and after intervention. Results: There was no significant difference in the frequency of angina attacks per week between the IVA and RAN study groups. There was a statistically significant difference (P < 0.01) in the number of patients reporting ADR from the IVA group as compared to RAN group. In the IVA group, the most common ADR was dizziness (36.6%); whereas nausea (30%) and dizziness (23.3%) was most common in RAN group. The routine haematological and biochemical evaluations did not show any significant difference between the baseline and post intervention. However, IVA significantly decreased the resting heart rate after eight weeks of intervention.. Conclusion: Both IVA and RAN are comparable and efficacious antianginal agents. However, RAN had a better safety and tolerability profile than IVA.