A comparative study of efficacy and safety of combination of indacaterol and tiotropium versus formoterol and budesonide in moderate to severe COPD

Background: COPD patients suffer persistent airflow obstruction and exacerbation despite treatment with LABA and ICS. Presently LABA+LAMA is least tested combination hence we want to compare efficacy and safety of combination of indacaterol and tiotropium versus formoterol and budesonide in moderate to severe COPD.Methods: This was an open labelled, parallel group trial involving 60 patients. of moderate to severe COPD having baseline postbronchodilator FEV1 ≥30% predicted and less than 80% predicted already on some kind of COPD treatment were included and, efficacy on lung function (FEV1)  and  safety in two  groups, indacaterol+tiotropium once daily dpi versus formoterol+budesonide twice daily bd dpi were testedi24 hours postdose (trough) DPI in symptomatic patients of COPD of moderate to severe grade. Statistical analysis was done using repeated measures of ANOVA followed by Turkeys test. P value less than 0.05 were considered statistically significant.Results: Patient with baseline/post bronchodilator FEV1 ≥30% predicted and less than 80% predicted were included. The mean age was 55±5 years. At 4 weeks mean±SEM in peak FEV1 in indacaterol+tiotropium was 85.77±4.002 and in formoterol+budesonide was 77.33±5.598. At 12 weeks, mean ±SEM in peak FEV1 in indacaterol+tiotropium was 112.30±4.69 and formoterol+budesonide was 103±6.35. At 24 weeks, mean ±SEM in peak FEV1 in indacaterol+tiotropium= 125.3±5.18 and formoterol+budesonide=112.7±5.89. Adverse events were less in indacaterol+tiotropium group. No serious adverse event occurred. Indacaterol+tiotropium once daily is efficacious and safe as compared to formoterol+budesonide twice daily with less exacerbation.Conclusions: In patients having poorly controlled COPD despite background therapy (LABA, etophylline+theophylline, etc.) the introduction of indacaterol+tiotropium once daily compared to formoterol+budesonide twice daily DPI significantly improved the FEV1 by sustained bronchodilation, decreased exacerbation and is safe. Further studies are needed to assess quality of life and cost analysis

The Antidepressant like action of ethanolic extract of areca catechu on behavioral models of depression in rats

Background: The objective was to investigate the anti-depressant like activity of areca catechu nut ethanolic extract (ACEE) using behavioural tests in rats.Methods: Forced swim test (FST) and tail suspension test (TST) were used to assess the anti-depressant like effect of ACEE rats. Motor coordination was also assessing using rota-rod test in rats to see generalised CNS depression. Fluoxetine was the reference standard drug. Rats were divided into four groups with six rats in each group namely control group, fluoxetine 10 mg/kg group, ACEE 50 mg/kg group and fluoxetine 5 mg/kg plus ACEE 25 mg/kg. All treatments were administered orally.Results: The areca nut ethanolic extract (ACEE) (50mg/kg oral) exhibited anti-depressant like activity i.e. decrease the duration of immobility time (sec) in acute forced swim test (FST) and in acute tail suspension test (TST) in rats (104±1.7, 95%CI 99.65 to 108.4, p <0.01) Vs control and (136.3±1.94, 95%CI 131.3 to 141.3, p<0.01) Vs control respectively. ACEE in low dose of 25 mg potentiated the anti-depressant activity of low dose fluoxetine 5 mg/kg in both the test 102.3±2.60, CI 95.64 to 109.0 p<0.01) Vs control. The ACEE did not produce motor incoordination in rats.Conclusions: The results of present study suggest that the areca catechu nut ethanolic extract 50mg/kg possess potential anti-depression like effect without generalized CNS depression. Further studies are needed to confirm this

A comparative study of efficacy and safety of combination of indacaterol and tiotropium versus formoterol and budesonide in moderate to severe chronic obstructive pulmonary disease

Background: COPD patients suffer persistent airflow obstruction and exacerbation despite treatment with LABA and ICS. Presently LABA+LAMA is least tested combination hence we want to compare efficacy and safety of combination of indacaterol and tiotropium versus formoterol and budesonide in moderate to severe COPD.Methods: This was an open labelled, parallel group trial involving 60 patients. of moderate to severe COPD having baseline postbronchodilator FEV1 ≥30% predicted and less than 80% predicted already on some kind of COPD treatment were included and, efficacy on lung function (FEV1)  and  safety in two  groups, indacaterol+tiotropium once daily dpi versus formoterol+budesonide twice daily bd dpi were testedi24 hours postdose (trough) DPI in symptomatic patients of COPD of moderate to severe grade. Statistical analysis was done using repeated measures of ANOVA followed by Turkeys test. P value less than 0.05 were considered statistically significant.Results: Patient with baseline/post bronchodilator FEV1 ≥30% predicted and less than 80% predicted were included. The mean age was 55±5 years. At 4 weeks mean±SEM in peak FEV1 in indacaterol+tiotropium was 85.77±4.002 and in formoterol+budesonide was 77.33±5.598. At 12 weeks, mean ±SEM in peak FEV1 in indacaterol+tiotropium was 112.30±4.69 and formoterol+budesonide was 103±6.35. At 24 weeks, mean ±SEM in peak FEV1 in indacaterol+tiotropium= 125.3±5.18 and formoterol+budesonide=112.7±5.89. Adverse events were less in indacaterol+tiotropium group. No serious adverse event occurred. Indacaterol+tiotropium once daily is efficacious and safe as compared to formoterol+budesonide twice daily with less exacerbation.Conclusions: In patients having poorly controlled COPD despite background therapy (LABA, etophylline+theophylline, etc.) the introduction of indacaterol+tiotropium once daily compared to formoterol+budesonide twice daily DPI significantly improved the FEV1 by sustained bronchodilation, decreased exacerbation and is safe. Further studies are needed to assess quality of life and cost analysis

The antidepressant like action of ethanolic extract of areca catechu on behavioral models of depression in rats

Background: The objective was to investigate the anti-depressant like activity of areca catechu nut ethanolic extract (ACEE) using behavioural tests in rats.Methods: Forced swim test (FST) and tail suspension test (TST) were used to assess the anti-depressant like effect of ACEE rats. Motor coordination was also assessing using rota-rod test in rats to see generalised CNS depression. Fluoxetine was the reference standard drug. Rats were divided into four groups with six rats in each group namely control group, fluoxetine 10 mg/kg group, ACEE 50 mg/kg group and fluoxetine 5 mg/kg plus ACEE 25 mg/kg. All treatments were administered orally.Results: The areca nut ethanolic extract (ACEE) (50mg/kg oral) exhibited anti-depressant like activity i.e. decrease the duration of immobility time (sec) in acute forced swim test (FST) and in acute tail suspension test (TST) in rats (104±1.7, 95%CI 99.65 to 108.4, p &lt;0.01) Vs control and (136.3±1.94, 95%CI 131.3 to 141.3, p&lt;0.01) Vs control respectively. ACEE in low dose of 25 mg potentiated the anti-depressant activity of low dose fluoxetine 5 mg/kg in both the test 102.3±2.60, CI 95.64 to 109.0 p&lt;0.01) Vs control. The ACEE did not produce motor incoordination in rats.Conclusions: The results of present study suggest that the areca catechu nut ethanolic extract 50mg/kg possess potential anti-depression like effect without generalized CNS depression. Further studies are needed to confirm this