Why Vono
Vonoprazan, a novel class of Potassium Competitive Acid Blocker has been introduced in the space of Anti-peptic ulcerants post 3 long decades of PPI existence as the best alternative. This superior molecule promises to be the future with its key attributes of 24-hour pH > 4 holding time ratio, peak action with its first dose, and immediate symptomatic relief & no restriction of mealtime dosing for best patient outcomes. Dr. Reddys who has been at the forefront in Gastroenterology therapy are among the first few top Indian Pharma Companies to launch the patented molecule Vono ( Vonoprazan) along with a non-exclusive patent licensing agreement with manufacturers to commercialize Vono (Vonoprazan) in India.
A recent study demonstrated that 3 L split-dose polyethylene glycol (PEG) is superior to 2 L polyethylene glycol for colonoscopic bowel preparation in individuals with relatively high BMI. This study was published in the journal, BMC Gastroenterology.
This was a multicenter randomized controlled trial that included 710 individuals with high BMIs (≥ 24 kg/m2), who were scheduled to undergo colonoscopy. The participants were randomly assigned into the 3 L split-dose polyethylene glycol (PEG) group (n=353) and the 2 L PEG group (n=357). The primary outcome of the study was the rate of adequate bowel preparation, and the secondary outcomes included the Boston Bowel Preparation Scale (BBPS) score, polyp detection rate, cecal intubation rate, and adverse reactions during bowel preparation. Additionally, the study had exploratory subgroup analyses for adequate bowel preparation.
After enrollment, 15 participants did not undergo colonoscopy, only 345 participants received 3 L split-dose PEG regimen, and 350 participants received 2 L PEG regimen for colonoscopic bowel preparation. It was shown that the rate of adequate bowel preparation was superior in the 3 L split-dose PEG regimen (81.2%) compared to the 2 L PEG regimen (74.9%). Additionally, it was found that the BBPS score (6.71±1.15 vs. 6.37±1.31) and the rate of polyp detection (62.0% vs. 52.9%) were better with the 3 L split-dose PEG regimen compared to the 2 L PEG regimen. In the subgroup analysis, the 3 L split-dose PEG regimen performed better than the 2 L PEG regimen in the overweight individuals (BMI 25-29.9 kg/m2).
These findings suggest that a 3 L split-dose PEG regimen is superior to a 2 L PEG regimen for colonoscopic bowel preparation in individuals with high BMI (25-29.9 kg/m2).
A recent study demonstrated that 3 L split-dose polyethylene glycol (PEG) is superior to 2 L polyethylene glycol for colonoscopic bowel preparation in individuals with relatively high BMI. This study was published in the journal, BMC Gastroenterology.
This was a multicenter randomized controlled trial that included 710 individuals with high BMIs (≥ 24 kg/m2), who were scheduled to undergo colonoscopy. The participants were randomly assigned into the 3 L split-dose polyethylene glycol (PEG) group (n=353) and the 2 L PEG group (n=357). The primary outcome of the study was the rate of adequate bowel preparation, and the secondary outcomes included the Boston Bowel Preparation Scale (BBPS) score, polyp detection rate, cecal intubation rate, and adverse reactions during bowel preparation. Additionally, the study had exploratory subgroup analyses for adequate bowel preparation.
After enrollment, 15 participants did not undergo colonoscopy, only 345 participants received 3 L split-dose PEG regimen, and 350 participants received 2 L PEG regimen for colonoscopic bowel preparation. It was shown that the rate of adequate bowel preparation was superior in the 3 L split-dose PEG regimen (81.2%) compared to the 2 L PEG regimen (74.9%). Additionally, it was found that the BBPS score (6.71±1.15 vs. 6.37±1.31) and the rate of polyp detection (62.0% vs. 52.9%) were better with the 3 L split-dose PEG regimen compared to the 2 L PEG regimen. In the subgroup analysis, the 3 L split-dose PEG regimen performed better than the 2 L PEG regimen in the overweight individuals (BMI 25-29.9 kg/m2).
These findings suggest that a 3 L split-dose PEG regimen is superior to a 2 L PEG regimen for colonoscopic bowel preparation in individuals with high BMI (25-29.9 kg/m2).
A recent study suggests that incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections was significantly lower with antibiotic prophylaxis in patients with biliary obstruction. The study's findings were published in The American Journal of Gastroenterology.
This double-blind, placebo-controlled, randomized trial included 378 patients who were randomly assigned in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin (n=189) or normal saline (n=189; placebo), 30 minutes before undergoing ERCP. The incidence of infectious complications after ERCP comprised the primary outcome of this trial.
At the end of the study, it was found that the risk of infectious complications after ERCP was 2.8% and 9.8% in the antibiotic prophylaxis group and placebo group, respectively. The incidence rates of bacteremia in the antibiotic prophylaxis and placebo groups were 2.3% and 6.4%, respectively. Finally, the incidence rate of cholangitis was 1.7% in the antibiotic prophylaxis group and 6.4% in the placebo group.
Based on the above results, it can be concluded that before ERCP, antibiotic prophylaxis resulted in a significantly lower risk of infectious complications, especially cholangitis, in patients with biliary obstruction.
A recent study suggests that incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections was significantly lower with antibiotic prophylaxis in patients with biliary obstruction. The study's findings were published in The American Journal of Gastroenterology.
This double-blind, placebo-controlled, randomized trial included 378 patients who were randomly assigned in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin (n=189) or normal saline (n=189; placebo), 30 minutes before undergoing ERCP. The incidence of infectious complications after ERCP comprised the primary outcome of this trial.
At the end of the study, it was found that the risk of infectious complications after ERCP was 2.8% and 9.8% in the antibiotic prophylaxis group and placebo group, respectively. The incidence rates of bacteremia in the antibiotic prophylaxis and placebo groups were 2.3% and 6.4%, respectively. Finally, the incidence rate of cholangitis was 1.7% in the antibiotic prophylaxis group and 6.4% in the placebo group.
Based on the above results, it can be concluded that before ERCP, antibiotic prophylaxis resulted in a significantly lower risk of infectious complications, especially cholangitis, in patients with biliary obstruction.
A recent study found that risankizumab, an anti-interleukin-23 antibody is safe and effective in patients with moderate-to-severe Crohn’s disease. This study’s findings were published in the Journal of Gastroenterology and Hepatology.
This was a post hoc sub analysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. ADVANCE and MOTIVATE were double-blind, placebo-controlled, phase 3 induction studies that included a total of 198 patients who had previously experienced intolerance or inadequate response to biologic (MOTIVATE) or a conventional therapy (ADVANCE). The participants were randomized to receive intravenous risankizumab (600 or 1200 mg) or placebo at weeks 0, 4, and 8. The clinical responders to risankizumab entered the placebo-controlled maintenance withdrawal study (FORTIFY). Patients were re-randomized to receive subcutaneous risankizumab (180 or 360 mg) or placebo (withdrawal) every 8 weeks for 52 weeks.
Among 198 patients in the induction studies, the rates of clinical remission and endoscopic response at week 12 were achieved by 61.4% and 40.0% of patients in the risankizumab 600 mg group, 59.5% and 35.8% of patients in the risankizumab 1200 mg group, and 27.3% and 9.1% of patients in the placebo group, respectively. At week 52, among 67 patients who entered the maintenance study, clinical remission and endoscopic response rates were achieved by 57.1% and 52.4% of patients in the risankizumab 180 mg group, 75.0% and 40.0% of patients in the risankizumab 360 mg group, and 53.8% and 34.6% of patients in the placebo (withdrawal) group. Additionally, it was observed that fistula closure was observed in 28.6% (induction) and 57.1% (maintenance) of patients with risankizumab treatment.
Based on the above findings, it may be concluded that risankizumab was effective and well tolerated in patients with Crohn's disease.
A recent study found that risankizumab, an anti-interleukin-23 antibody is safe and effective in patients with moderate-to-severe Crohn’s disease. This study’s findings were published in the Journal of Gastroenterology and Hepatology.
This was a post hoc sub analysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. ADVANCE and MOTIVATE were double-blind, placebo-controlled, phase 3 induction studies that included a total of 198 patients who had previously experienced intolerance or inadequate response to biologic (MOTIVATE) or a conventional therapy (ADVANCE). The participants were randomized to receive intravenous risankizumab (600 or 1200 mg) or placebo at weeks 0, 4, and 8. The clinical responders to risankizumab entered the placebo-controlled maintenance withdrawal study (FORTIFY). Patients were re-randomized to receive subcutaneous risankizumab (180 or 360 mg) or placebo (withdrawal) every 8 weeks for 52 weeks.
Among 198 patients in the induction studies, the rates of clinical remission and endoscopic response at week 12 were achieved by 61.4% and 40.0% of patients in the risankizumab 600 mg group, 59.5% and 35.8% of patients in the risankizumab 1200 mg group, and 27.3% and 9.1% of patients in the placebo group, respectively. At week 52, among 67 patients who entered the maintenance study, clinical remission and endoscopic response rates were achieved by 57.1% and 52.4% of patients in the risankizumab 180 mg group, 75.0% and 40.0% of patients in the risankizumab 360 mg group, and 53.8% and 34.6% of patients in the placebo (withdrawal) group. Additionally, it was observed that fistula closure was observed in 28.6% (induction) and 57.1% (maintenance) of patients with risankizumab treatment.
Based on the above findings, it may be concluded that risankizumab was effective and well tolerated in patients with Crohn's disease.
A recent study suggests that intrarectal botulinum toxin type A (BoNTA) injections are an efficacious treatment for urge faecal incontinence. This study was published in the journal, The Lancet. Gastroenterology & Hepatology.
This phase 3 study was a double-blind, multicentre, randomized trial that included 200 adult patients who had experienced a failure of conservative or surgical treatment or had at least one urgency or faecal incontinence episode per week for a minimum of 3 months. After withdrawals, the patients were randomly assigned in a 1:1 ratio to receive either 200 units of BoNTA (n=96) or an equivalent volume of saline or placebo (n=95) injections. Three months after treatment, the number of episodes of faecal incontinence and urgency recorded in 21-day patient bowel diaries served as the primary endpoint. For the primary analysis, a modified intention-to-treat (mITT) approach was utilized, with adjustment for baseline faecal incontinence and urgency episodes.
At the end of the study, it was observed that in the BoNTA group, the mean number of faecal incontinence and urgency episodes per day, decreased from 1·9 at baseline to 0.8 at 3 months after the injections were administered while in the placebo group, it decreased from 1.4 to 1.0. The trial did not report any serious treatment-related adverse events. The non-serious adverse event (treatment-related or not) that was frequently seen was constipation, seen in 68 patients in the BoNTA group and 38 patients in the placebo group. From the above results, it can be concluded that BoNTA injections are an efficacious treatment for urge faecal incontinence in adult patients.
A recent study suggests that intrarectal botulinum toxin type A (BoNTA) injections are an efficacious treatment for urge faecal incontinence. This study was published in the journal, The Lancet. Gastroenterology & Hepatology.
This phase 3 study was a double-blind, multicentre, randomized trial that included 200 adult patients who had experienced a failure of conservative or surgical treatment or had at least one urgency or faecal incontinence episode per week for a minimum of 3 months. After withdrawals, the patients were randomly assigned in a 1:1 ratio to receive either 200 units of BoNTA (n=96) or an equivalent volume of saline or placebo (n=95) injections. Three months after treatment, the number of episodes of faecal incontinence and urgency recorded in 21-day patient bowel diaries served as the primary endpoint. For the primary analysis, a modified intention-to-treat (mITT) approach was utilized, with adjustment for baseline faecal incontinence and urgency episodes.
At the end of the study, it was observed that in the BoNTA group, the mean number of faecal incontinence and urgency episodes per day, decreased from 1·9 at baseline to 0.8 at 3 months after the injections were administered while in the placebo group, it decreased from 1.4 to 1.0. The trial did not report any serious treatment-related adverse events. The non-serious adverse event (treatment-related or not) that was frequently seen was constipation, seen in 68 patients in the BoNTA group and 38 patients in the placebo group. From the above results, it can be concluded that BoNTA injections are an efficacious treatment for urge faecal incontinence in adult patients.
A recent study suggests that seladelpar notably decreased pruritus in individuals with moderate to severe pruritus at the baseline. The study’s findings were published in The New England Journal of Medicine.
In this phase 3, double-blind, placebo-controlled trial, a total of 193 patients (who had an inadequate response to or had a previous medical history of adverse side effects with ursodeoxycholic acid) were randomly assigned in a 2:1 ratio to either receive oral seladelpar at a daily dose of 10 mg or placebo. The primary endpoint of the study was a biochemical response, characterized by an alkaline phosphatase level < 1.67 times the upper limit of normal, showing a reduction of 15% or greater from the baseline, and a normal total bilirubin level by the end of the 12th month. Key secondary endpoints included the normalization of alkaline phosphatase level at 12th month and the change in pruritus numerical rating scale score from baseline to 6th month among patients with a baseline score of at least 4 (denoting moderate-to-severe pruritus).
A higher proportion of patients in the seladelpar group experienced a biochemical response compared to those in the placebo group (61.7% vs. 20.0%). Additionally, a larger percentage of patients who were treated with seladelpar saw normalization of alkaline phosphatase levels in comparison to those who received a placebo (25.0% vs. 0%). Seladelpar also led to a more significant decrease in pruritus numerical rating scale scores than the placebo (-3.2 vs. -1.7).
Therefore, it can be concluded that the proportion of patients achieving a biochemical response and normalization of alkaline phosphatase was significantly higher with seladelpar compared to placebo. Additionally, seladelpar demonstrated a significant reduction in pruritus for primary biliary cholangitis patients experiencing moderate-to-severe pruritus at the baseline.
A recent study suggests that seladelpar notably decreased pruritus in individuals with moderate to severe pruritus at the baseline. The study’s findings were published in The New England Journal of Medicine.
In this phase 3, double-blind, placebo-controlled trial, a total of 193 patients (who had an inadequate response to or had a previous medical history of adverse side effects with ursodeoxycholic acid) were randomly assigned in a 2:1 ratio to either receive oral seladelpar at a daily dose of 10 mg or placebo. The primary endpoint of the study was a biochemical response, characterized by an alkaline phosphatase level < 1.67 times the upper limit of normal, showing a reduction of 15% or greater from the baseline, and a normal total bilirubin level by the end of the 12th month. Key secondary endpoints included the normalization of alkaline phosphatase level at 12th month and the change in pruritus numerical rating scale score from baseline to 6th month among patients with a baseline score of at least 4 (denoting moderate-to-severe pruritus).
A higher proportion of patients in the seladelpar group experienced a biochemical response compared to those in the placebo group (61.7% vs. 20.0%). Additionally, a larger percentage of patients who were treated with seladelpar saw normalization of alkaline phosphatase levels in comparison to those who received a placebo (25.0% vs. 0%). Seladelpar also led to a more significant decrease in pruritus numerical rating scale scores than the placebo (-3.2 vs. -1.7).
Therefore, it can be concluded that the proportion of patients achieving a biochemical response and normalization of alkaline phosphatase was significantly higher with seladelpar compared to placebo. Additionally, seladelpar demonstrated a significant reduction in pruritus for primary biliary cholangitis patients experiencing moderate-to-severe pruritus at the baseline.
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