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.
Where to Use
•Treatment of reflux esophagitis (RE)
•Treatment of gastric ulcer (GU)
•Treatment of duodenal ulcer (DU)
•Prevention of reoccurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration
•Prevention of reoccurrence of gastric ulcer or duodenal ulcer during NSAIDs administration.
•Adjunct to Helicobacter pylori (H. pylori) eradication associated with: Gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage cancer or Helicobacter Pylori gastritis.
How to Use
•Reflux esophagitis (erosive esophagitis)
The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 4 weeks. However, when the effect is insufficient, treatment may be continued for up to 8 weeks.
•Gastric ulcer: The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 8 weeks.
•Duodenal ulcer: The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 6 weeks.
•Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration. The usual dose is 10 mg of vonoprazan once a day.
•Adjunct to Helicobacter pylori eradication: Usually, the following 3 drugs are orally administered at the same time twice daily for 7 days: 20 mg vonoprazan, 750 mg amoxicillin hydrate, and 200 mg clarithromycin. The dose of clarithromycin may be appropriately increased as required; however, the upper limit is 400 mg twice daily or physician judgement.
When Helicobacter pylori eradication treatment with 3 drugs consisting of a proton pump inhibitor, amoxicillin hydrate, and clarithromycin fails, alternative treatment with the following 3 drugs is recommended; 20 mg vonoprazan, 750 mg amoxicillin hydrate, and 250 mg metronidazole, orally administered at the same time twice daily for 7 days. The doses of antibiotic should follow the respective label recommendations for H. pylori eradication.
Special Patient Populations
Elderly Patients:
Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, vonoprazan should be carefully administered.
Paediatric Patients:
Vonoprazan has not been studied in patients under 18 years of age.
Impaired Renal Function:
a.Healing of Erosive Esophagitis:
The recommended dosage of Vonoprazan in adult patients with renal impairment is described in Table 1 below.
Safety Advice
Use in Special Populations (Such as Pregnant Women, Lactating Women, Paediatric Patients, Geriatric Patients, etc.)
Pregnancy
No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are pregnant. In a rat toxicology study, embryo-foetal toxicity was observed following exposure of more than approximately 28 times of the exposure (AUC) at the maximum clinical dose (40 mg/day) of vonoprazan. As a precaution, vonoprazan should not be administered to women who are or may be pregnant, unless the expected therapeutic benefit is thought to outweigh any possible risk.
Lactation
No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are lactating are lactating. It is unknown whether vonoprazan is excreted in human milk. In animal studies it has been shown that vonoprazan was excreted in milk. During treatment with vonoprazan, nursing should be avoided if the administration of this drug is necessary for the mother.
Pediatric use
The safety and effectiveness of vonoprazan is not established in pediatric patients.
Geriatric use
No overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.
No clinically meaningful differences in the pharmacokinetics of vonoprazan are predicted in patients 65 years of age and older compared to younger adult patients.
Renal Impairment
Healing of Erosive Esophagitis: No dosage adjustment of vonoprazan is recommended in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Dosage reduction is recommended in patients with severe renal impairment (eGFR < 30 mL/min). Maintenance of Healed Erosive Esophagitis: No dosage adjustment of vonoprazan is recommended in patients with any degree of renal impairment. Treatment of H. pylori Infection: Use of vonoprazan is not recommended for the treatment of H. pylori infection in patients with severe renal impairment (eGFR < 30 mL/min).
Hepatic Impairment
Healing of Erosive Esophagitis: No dosage adjustment of vonoprazan is recommended in patients with mild hepatic impairment (Child-Pugh A). Dosage reduction is recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). Maintenance of Healed Erosive Esophagitis: No dosage adjustment of vonoprazan for the maintenance of healed erosive esophagitis is recommended in patients with any degree of hepatic impairment. Treatment of H. pylori Infection: Use of vonoprazan is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C).
Effects on ability to drive and use machines
The influence of vonoprazan on the ability to drive or use machines is unknown.
Side Effects
Contraindications
•Vonoprazan is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of Vonoprazan. Reactions have included anaphylactic shock.
•Vonoprazan is contraindicated with rilpivirine-containing products.
•For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Vonoprazan, refer to the Contraindications section of the corresponding prescribing information.
Special Warnings and Precautions for Use
Presence of Gastric Malignancy
In adults, symptomatic response to therapy with Vonoprazan does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in patients who have a suboptimal response or an early symptomatic relapse after completing treatment with Vonoprazan. In older patients, also consider endoscopy.
Acute Tubulointerstitial Nephritis
Aute tubulointerstitial nephritis (TIN) has been reported with Vonoprazan. If suspected, discontinue Vonoprazan and evaluate patients with suspected acute TIN.
Clostridioides difficile-Associated Diarrhoea
Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridioides difficile-associated diarrhea (CDAD), especially in hospitalized patients. Vonoprazan, another drug that blocks the proton pump to inhibit gastric acid production, may also increase the risk of CDAD. Consider CDAD in patients with diarrhoea that does not improve. Use the shortest duration of Vonoprazan appropriate to the condition being treated.
CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Vonoprazan, refer to Warnings and Precautions section of the corresponding prescribing information.
Bone Fracture
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term therapy (a year or longer). Bone fracture, including osteoporosis-related fracture, has also been reported with vonoprazan. Use the shortest duration of Vonoprazan appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.
Severe Cutaneous Adverse Reactions
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with Vonoprazan. Discontinue Vonoprazan at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
Vitamin B12 (Cobalamin) Deficiency
Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin B12 deficiency has been reported postmarketing with vonoprazan. If clinical symptoms consistent with Vitamin B12 deficiency are observed in patients treated with Vonoprazan consider further workup.
Hypomagnesemia and Mineral Metabolism
Hypomagnesemia has been reported postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.
Consider monitoring magnesium levels prior to initiation of Vonoprazan and periodically in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of hypomagnesemia (e.g., digoxin), or drugs that may cause hypomagnesemia (e.g., diuretics). Treatment of hypomagnesemia may require magnesium replacement and discontinuation of Vonoprazan.
Consider monitoring magnesium and calcium levels prior to initiation of Vonoprazan and periodically while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing Vonoprazan.
Interactions with Diagnostic Investigations for Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily discontinue Vonoprazan treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Fundic Gland Polyps
Use of Vonoprazan is associated with a risk of fundic gland polyps that increases with long-term use, especially beyond one year. Fundic gland polyps have been reported with vonoprazan in clinical trials and post-marketing use with PPIs. Most patients who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of Vonoprazan appropriate to the condition being treated.
Drug Interactions:
Table 5 and Table 6 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Vonoprazan and instructions for preventing or managing them.
These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with Vonoprazan.
A recent study demonstrated that for patients at risk of renal injury undergoing coronary angiography for acute coronary syndromes (ACS), a short (5-day) regimen of once-daily inorganic nitrate resulted in decreased contrast-induced nephropathy (CIN), enhanced kidney outcomes at 3 months, and reduced major adverse cardiovascular events (MACE) at 1 year when compared with individuals who received a placebo. This study’s results were published in the European Heart Journal.
The NITRATE-CIN trial was a double-blind, randomized, placebo-controlled trial that included a total of 640 patients. These patients were randomized to receive either once daily potassium nitrate (n= 319; 12 mmol) or placebo (n= 321; potassium chloride) capsules for a period of 5 days. The primary endpoint of the trial was the incidence of CIN based on KDIGO criteria. Secondary outcomes measured included kidney function (eGFR) at 3 months, rates of procedural myocardial infarction, and MACE at 12 months.
Inorganic nitrate treatment led to a significant decrease in the rates of CIN compared to the placebo (9.1% vs 30.5%). This difference remained even after adjusting for baseline creatinine levels and diabetes status. Additionally, the use of inorganic nitrate exhibited positive outcomes in secondary outcomes, including a lower incidence of procedural myocardial infarction (2.7% vs 12.5%), improved renal function at 3 months (between-group change in estimated glomerular filtration rate of 5.17), and a reduced occurrence of MACE at 1 year (9.1% vs. 18.1%) compared to the placebo group.
Thus, it can be concluded that a 5-day regimen of once-daily inorganic nitrate may be beneficial for patients undergoing coronary angiography for ACS. This treatment resulted in a decrease in CIN, improved kidney outcomes at 3 months, and reduced MACE at 1 year compared to those who received a placebo.
A recent study demonstrated that for patients at risk of renal injury undergoing coronary angiography for acute coronary syndromes (ACS), a short (5-day) regimen of once-daily inorganic nitrate resulted in decreased contrast-induced nephropathy (CIN), enhanced kidney outcomes at 3 months, and reduced major adverse cardiovascular events (MACE) at 1 year when compared with individuals who received a placebo. This study’s results were published in the European Heart Journal.
The NITRATE-CIN trial was a double-blind, randomized, placebo-controlled trial that included a total of 640 patients. These patients were randomized to receive either once daily potassium nitrate (n= 319; 12 mmol) or placebo (n= 321; potassium chloride) capsules for a period of 5 days. The primary endpoint of the trial was the incidence of CIN based on KDIGO criteria. Secondary outcomes measured included kidney function (eGFR) at 3 months, rates of procedural myocardial infarction, and MACE at 12 months.
Inorganic nitrate treatment led to a significant decrease in the rates of CIN compared to the placebo (9.1% vs 30.5%). This difference remained even after adjusting for baseline creatinine levels and diabetes status. Additionally, the use of inorganic nitrate exhibited positive outcomes in secondary outcomes, including a lower incidence of procedural myocardial infarction (2.7% vs 12.5%), improved renal function at 3 months (between-group change in estimated glomerular filtration rate of 5.17), and a reduced occurrence of MACE at 1 year (9.1% vs. 18.1%) compared to the placebo group.
Thus, it can be concluded that a 5-day regimen of once-daily inorganic nitrate may be beneficial for patients undergoing coronary angiography for ACS. This treatment resulted in a decrease in CIN, improved kidney outcomes at 3 months, and reduced MACE at 1 year compared to those who received a placebo.
A recent study found that initial oral treprostinil improved survival while those who started treprostinil after a clinical worsening in the placebo group and tolerated the drug for up to 48 weeks, enjoyed substantial functional gains. This study was published in the journal, Advances in Therapy.
This trial was an open-label extension (OLE) of the FREEDOM-EV study which enrolled 470 patients who had experienced an investigator-assessed clinical worsening event. All OLE participants were kept on open-label oral treprostinil. Those participants who had previously been assigned to placebo or previously assigned treprostinil, continued with the dose titration. Assessments included measured N-terminal pro-brain natriuretic peptide (NT-proBNP) at week 48, functional class, and 6-min walk distance (6MWD) at 12-week intervals. Survival was studied using the Kaplan-Meier analysis while hazard ratio (HR) was measured using Cox proportional hazards.
At the end of the study, it was seen that initial administration of oral treprostinil reduced mortality. Those who were randomized to the placebo group and initiated on oral treprostinil after clinical worsening, showed a reduction in NT-proBNP of - 778 pg/mL, functional class shifts, and 6MWD improvements of + 84 m when compared to the OLE baseline. Modest trends were observed in those participants who were initially assigned placebo and did not show clinical worsening and also those participants who were on the study drug without clinical worsening but continued with the drug through week 48.
Based on the above results, it can be concluded that with initial treprostinil, improved survival in the entire data set may be observed while those participants in the placebo arm, who were kept on treprostinil after a clinical worsening and tolerated the drug at week 48, may exhibit substantial functional gains.
A recent study found that initial oral treprostinil improved survival while those who started treprostinil after a clinical worsening in the placebo group and tolerated the drug for up to 48 weeks, enjoyed substantial functional gains. This study was published in the journal, Advances in Therapy.
This trial was an open-label extension (OLE) of the FREEDOM-EV study which enrolled 470 patients who had experienced an investigator-assessed clinical worsening event. All OLE participants were kept on open-label oral treprostinil. Those participants who had previously been assigned to placebo or previously assigned treprostinil, continued with the dose titration. Assessments included measured N-terminal pro-brain natriuretic peptide (NT-proBNP) at week 48, functional class, and 6-min walk distance (6MWD) at 12-week intervals. Survival was studied using the Kaplan-Meier analysis while hazard ratio (HR) was measured using Cox proportional hazards.
At the end of the study, it was seen that initial administration of oral treprostinil reduced mortality. Those who were randomized to the placebo group and initiated on oral treprostinil after clinical worsening, showed a reduction in NT-proBNP of - 778 pg/mL, functional class shifts, and 6MWD improvements of + 84 m when compared to the OLE baseline. Modest trends were observed in those participants who were initially assigned placebo and did not show clinical worsening and also those participants who were on the study drug without clinical worsening but continued with the drug through week 48.
Based on the above results, it can be concluded that with initial treprostinil, improved survival in the entire data set may be observed while those participants in the placebo arm, who were kept on treprostinil after a clinical worsening and tolerated the drug at week 48, may exhibit substantial functional gains.
According to a recent study, the pulmonary hypertension (pH) due to left heart disease (LHD) noninvasive nomogram demonstrates exceptional diagnostic value and clinical applicability, enabling a more precise assessment of the risk of pH in individuals with LHD. This study’s results were published in the journal, Heart & Lung.
In this study, a total of 361 patients with left heart disease (LHD) who had undergone right heart catheterization were enrolled. These patients were then randomly divided into two groups: a training cohort consisting of 253 patients (70%) and a validation cohort consisting of 108 patients (30%). The presence of pH was determined by a resting mean pulmonary arterial pressure (mPAP) of ≥25 mmHg, as measured through the right heart catheterization (RHC) examination. To analyze the data, the Lasso regression model was used for dimension reduction and feature selection. Subsequently, a nomogram was constructed based on multivariable logistic regression analysis.
175 individuals with left heart disease were diagnosed with pulmonary hypertension during their hospitalization, accounting for 48.5% of the sample cohort. Factors such as elevated New York Heart Association functional class, excessive resting heart rate, increased red blood cell distribution width, pulmonary artery systolic pressure, and right ventricular end-diastolic diameter assessed via echocardiography were independently linked to the prevalence of pH-LHD. The incorporation of these 5 variables in the nomogram demonstrated optimal calibration (Hosmer-Lemeshow test, P = 0.791) and strong discrimination (AUC = 0.866 [95% CI, 0.820-0.911]) for the validation set.
The above study demonstrated that the noninvasive nomogram for pH-LHD exhibits excellent diagnostic efficacy and clinical applicability, facilitating a more accurate evaluation of the pH risk in individuals with LHD.
According to a recent study, the pulmonary hypertension (pH) due to left heart disease (LHD) noninvasive nomogram demonstrates exceptional diagnostic value and clinical applicability, enabling a more precise assessment of the risk of pH in individuals with LHD. This study’s results were published in the journal, Heart & Lung.
In this study, a total of 361 patients with left heart disease (LHD) who had undergone right heart catheterization were enrolled. These patients were then randomly divided into two groups: a training cohort consisting of 253 patients (70%) and a validation cohort consisting of 108 patients (30%). The presence of pH was determined by a resting mean pulmonary arterial pressure (mPAP) of ≥25 mmHg, as measured through the right heart catheterization (RHC) examination. To analyze the data, the Lasso regression model was used for dimension reduction and feature selection. Subsequently, a nomogram was constructed based on multivariable logistic regression analysis.
175 individuals with left heart disease were diagnosed with pulmonary hypertension during their hospitalization, accounting for 48.5% of the sample cohort. Factors such as elevated New York Heart Association functional class, excessive resting heart rate, increased red blood cell distribution width, pulmonary artery systolic pressure, and right ventricular end-diastolic diameter assessed via echocardiography were independently linked to the prevalence of pH-LHD. The incorporation of these 5 variables in the nomogram demonstrated optimal calibration (Hosmer-Lemeshow test, P = 0.791) and strong discrimination (AUC = 0.866 [95% CI, 0.820-0.911]) for the validation set.
The above study demonstrated that the noninvasive nomogram for pH-LHD exhibits excellent diagnostic efficacy and clinical applicability, facilitating a more accurate evaluation of the pH risk in individuals with LHD.
A new study found that standard dose triple combination therapy of chlorthalidone 25 mg with telmisartan 80 mg plus amlodipine 5 mg was safe and effective for treating primary hypertension. This study’s results were published in the Journal of Clinical Hypertension.
This phase 3, multicenter, randomized, double-blind, active-controlled trial enrolled 374 patients. The participants were randomized to TEL/AML/CHTD group (triple combination), receiving telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg or TEL/AML group (dual combination), receiving telmisartan 40 mg/amlodipine 5 mg. This was followed by dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. Change of mean sitting systolic blood pressure (MSSBP) at week 8 was the primary endpoint of the study.
It was observed that the baseline MSSBPs/diastolic BPs were 149.9 ± 12.2/88.5 ± 10.4 mm Hg. 8 weeks post-treatment, the change of MSSBPs was found to be -19.1 ± 14.9 mm Hg (TEL/AML/CHTD) and -11.4 ± 14.7 mm Hg (TEL/AML). The achievement rates of target BP and responder rate were significantly higher in TEL/AML/CHTD. No adverse events due to medication were reported. Among the triple combination group, female patients or those aged≥ 65 years old showed a higher rate of target BP achievement than relatively young males.
Based on the above results, it was evident that the standard dose triple combination was safe and efficacious in treating primary hypertension and may be more pronounced in females or older patients.
A new study found that standard dose triple combination therapy of chlorthalidone 25 mg with telmisartan 80 mg plus amlodipine 5 mg was safe and effective for treating primary hypertension. This study’s results were published in the Journal of Clinical Hypertension.
This phase 3, multicenter, randomized, double-blind, active-controlled trial enrolled 374 patients. The participants were randomized to TEL/AML/CHTD group (triple combination), receiving telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg or TEL/AML group (dual combination), receiving telmisartan 40 mg/amlodipine 5 mg. This was followed by dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. Change of mean sitting systolic blood pressure (MSSBP) at week 8 was the primary endpoint of the study.
It was observed that the baseline MSSBPs/diastolic BPs were 149.9 ± 12.2/88.5 ± 10.4 mm Hg. 8 weeks post-treatment, the change of MSSBPs was found to be -19.1 ± 14.9 mm Hg (TEL/AML/CHTD) and -11.4 ± 14.7 mm Hg (TEL/AML). The achievement rates of target BP and responder rate were significantly higher in TEL/AML/CHTD. No adverse events due to medication were reported. Among the triple combination group, female patients or those aged≥ 65 years old showed a higher rate of target BP achievement than relatively young males.
Based on the above results, it was evident that the standard dose triple combination was safe and efficacious in treating primary hypertension and may be more pronounced in females or older patients.
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).
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