Prusogliptin add-on to metformin safe and effective in T2D

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Key clinical point: Prusogliptin as an add-on therapy to metformin was superior to metformin monotherapy in improving glycemic control and was safe and well tolerated in patients with type 2 diabetes mellitus (T2D) inadequately controlled with metformin.

 

Major finding: At week 24, prusogliptin + metformin vs metformin + placebo led to significantly higher reductions in glycated hemoglobin (least squares mean change [LSM] 0.70% vs 0.07%; P < .001), fasting plasma glucose (LSM 0.63 vs 0.07 mmol/L; P  =  .025), and 2-hour postprandial plasma glucose (LSM 2.43 vs 0.70 mmol/L; P < .001) levels, with the incidence of adverse events being similar between the treatment groups.

 

Study details: Findings are from a 24-week, superiority, phase 3 trial including 206 patients with T2D with blood glucose levels inadequately controlled on metformin who were randomly assigned to receive prusogliptin + metformin (n = 138) or placebo + metformin (n = 68).

 

Disclosures: This study was funded by the CSPC Zhongqi Pharmaceutical Technology Co., Ltd. Some authors are employees of CSPC Zhongqi Pharmaceutical Technology.

 

Source: Xu J et al. Efficacy and safety of DBPR108 (prusogliptin) as an add-on to metformin therapy in patients with type 2 diabetes mellitus: A 24-week, multi-center, randomized, double-blind, placebo-controlled, superiority, phase III clinical trial. Diabetes Obes Metab. 2022 (Jul 6). Doi: 10.1111/dom.14810

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Key clinical point: Prusogliptin as an add-on therapy to metformin was superior to metformin monotherapy in improving glycemic control and was safe and well tolerated in patients with type 2 diabetes mellitus (T2D) inadequately controlled with metformin.

 

Major finding: At week 24, prusogliptin + metformin vs metformin + placebo led to significantly higher reductions in glycated hemoglobin (least squares mean change [LSM] 0.70% vs 0.07%; P < .001), fasting plasma glucose (LSM 0.63 vs 0.07 mmol/L; P  =  .025), and 2-hour postprandial plasma glucose (LSM 2.43 vs 0.70 mmol/L; P < .001) levels, with the incidence of adverse events being similar between the treatment groups.

 

Study details: Findings are from a 24-week, superiority, phase 3 trial including 206 patients with T2D with blood glucose levels inadequately controlled on metformin who were randomly assigned to receive prusogliptin + metformin (n = 138) or placebo + metformin (n = 68).

 

Disclosures: This study was funded by the CSPC Zhongqi Pharmaceutical Technology Co., Ltd. Some authors are employees of CSPC Zhongqi Pharmaceutical Technology.

 

Source: Xu J et al. Efficacy and safety of DBPR108 (prusogliptin) as an add-on to metformin therapy in patients with type 2 diabetes mellitus: A 24-week, multi-center, randomized, double-blind, placebo-controlled, superiority, phase III clinical trial. Diabetes Obes Metab. 2022 (Jul 6). Doi: 10.1111/dom.14810

Key clinical point: Prusogliptin as an add-on therapy to metformin was superior to metformin monotherapy in improving glycemic control and was safe and well tolerated in patients with type 2 diabetes mellitus (T2D) inadequately controlled with metformin.

 

Major finding: At week 24, prusogliptin + metformin vs metformin + placebo led to significantly higher reductions in glycated hemoglobin (least squares mean change [LSM] 0.70% vs 0.07%; P < .001), fasting plasma glucose (LSM 0.63 vs 0.07 mmol/L; P  =  .025), and 2-hour postprandial plasma glucose (LSM 2.43 vs 0.70 mmol/L; P < .001) levels, with the incidence of adverse events being similar between the treatment groups.

 

Study details: Findings are from a 24-week, superiority, phase 3 trial including 206 patients with T2D with blood glucose levels inadequately controlled on metformin who were randomly assigned to receive prusogliptin + metformin (n = 138) or placebo + metformin (n = 68).

 

Disclosures: This study was funded by the CSPC Zhongqi Pharmaceutical Technology Co., Ltd. Some authors are employees of CSPC Zhongqi Pharmaceutical Technology.

 

Source: Xu J et al. Efficacy and safety of DBPR108 (prusogliptin) as an add-on to metformin therapy in patients with type 2 diabetes mellitus: A 24-week, multi-center, randomized, double-blind, placebo-controlled, superiority, phase III clinical trial. Diabetes Obes Metab. 2022 (Jul 6). Doi: 10.1111/dom.14810

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Initiating semaglutide improves outcomes in patients on high daily doses of insulin

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Key clinical point: Initiation of semaglutide in patients with type 2 diabetes mellitus (T2D) on high daily doses of insulin at baseline led to a significant improvement in glycemic control, body weight, and reduction in total daily dose (TDD) of insulin.

 

Major finding: From baseline to 6 months, the TDD of insulin (183 ± 98 to 143 ± 99 units, respectively), glycated hemoglobin level (8.9% ± 1.3% to 7.6% ± 1.5%, respectively), and body weight (123.9 ± 23.5 to 118.9 ± 22.9 kg, respectively; all P < .001) reduced significantly in patients on high daily doses of insulin who received semaglutide.

 

Study details: Findings are from a retrospective analysis including 72 patients with T2D on high TDD of insulin (100 units) who were prescribed semaglutide.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Meyer J et al. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2022 (Jul 1). Doi: 10.1177/10600280221107381

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Key clinical point: Initiation of semaglutide in patients with type 2 diabetes mellitus (T2D) on high daily doses of insulin at baseline led to a significant improvement in glycemic control, body weight, and reduction in total daily dose (TDD) of insulin.

 

Major finding: From baseline to 6 months, the TDD of insulin (183 ± 98 to 143 ± 99 units, respectively), glycated hemoglobin level (8.9% ± 1.3% to 7.6% ± 1.5%, respectively), and body weight (123.9 ± 23.5 to 118.9 ± 22.9 kg, respectively; all P < .001) reduced significantly in patients on high daily doses of insulin who received semaglutide.

 

Study details: Findings are from a retrospective analysis including 72 patients with T2D on high TDD of insulin (100 units) who were prescribed semaglutide.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Meyer J et al. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2022 (Jul 1). Doi: 10.1177/10600280221107381

Key clinical point: Initiation of semaglutide in patients with type 2 diabetes mellitus (T2D) on high daily doses of insulin at baseline led to a significant improvement in glycemic control, body weight, and reduction in total daily dose (TDD) of insulin.

 

Major finding: From baseline to 6 months, the TDD of insulin (183 ± 98 to 143 ± 99 units, respectively), glycated hemoglobin level (8.9% ± 1.3% to 7.6% ± 1.5%, respectively), and body weight (123.9 ± 23.5 to 118.9 ± 22.9 kg, respectively; all P < .001) reduced significantly in patients on high daily doses of insulin who received semaglutide.

 

Study details: Findings are from a retrospective analysis including 72 patients with T2D on high TDD of insulin (100 units) who were prescribed semaglutide.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Meyer J et al. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2022 (Jul 1). Doi: 10.1177/10600280221107381

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DPP4 inhibitor ups risk for cholecystitis in T2D

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Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors significantly increased the risk for the composite of gallbladder or biliary diseases and cholecystitis but not for cholelithiasis and biliary diseases in patients with type 2 diabetes (T2D), especially those with a longer treatment duration.

 

Major finding: Compared with placebo or non-incretin drugs, DPP4 inhibitors were associated with a significantly higher risk for composite of gallbladder or biliary diseases (odds ratio [OR] 1.22; 95% CI 1.04-1.43) and cholecystitis (OR 1.43; 95% CI 1.14-1.79), but not for cholelithiasis (OR 1.08; 95% CI 0.83-1.39) and biliary diseases (OR 1.00; 95% CI 0.68-1.47), and the association remained significant with the long-term (26 weeks) use of DPP4 inhibitors.

 

Study details: The data come from a systematic review and pairwise meta-analysis of 82 randomized trials including 104,833 patients with T2D.

 

Disclosures: This study was partially supported by Beijing Natural Science Foundation, National Natural Science Foundation of China, and others. The authors declared receiving support from the funding institutions.

 

Source: He L et al. Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials BMJ. 2022;377:e068882 (Jun 28). Doi: 10.1136/bmj-2021-068882

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Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors significantly increased the risk for the composite of gallbladder or biliary diseases and cholecystitis but not for cholelithiasis and biliary diseases in patients with type 2 diabetes (T2D), especially those with a longer treatment duration.

 

Major finding: Compared with placebo or non-incretin drugs, DPP4 inhibitors were associated with a significantly higher risk for composite of gallbladder or biliary diseases (odds ratio [OR] 1.22; 95% CI 1.04-1.43) and cholecystitis (OR 1.43; 95% CI 1.14-1.79), but not for cholelithiasis (OR 1.08; 95% CI 0.83-1.39) and biliary diseases (OR 1.00; 95% CI 0.68-1.47), and the association remained significant with the long-term (26 weeks) use of DPP4 inhibitors.

 

Study details: The data come from a systematic review and pairwise meta-analysis of 82 randomized trials including 104,833 patients with T2D.

 

Disclosures: This study was partially supported by Beijing Natural Science Foundation, National Natural Science Foundation of China, and others. The authors declared receiving support from the funding institutions.

 

Source: He L et al. Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials BMJ. 2022;377:e068882 (Jun 28). Doi: 10.1136/bmj-2021-068882

Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors significantly increased the risk for the composite of gallbladder or biliary diseases and cholecystitis but not for cholelithiasis and biliary diseases in patients with type 2 diabetes (T2D), especially those with a longer treatment duration.

 

Major finding: Compared with placebo or non-incretin drugs, DPP4 inhibitors were associated with a significantly higher risk for composite of gallbladder or biliary diseases (odds ratio [OR] 1.22; 95% CI 1.04-1.43) and cholecystitis (OR 1.43; 95% CI 1.14-1.79), but not for cholelithiasis (OR 1.08; 95% CI 0.83-1.39) and biliary diseases (OR 1.00; 95% CI 0.68-1.47), and the association remained significant with the long-term (26 weeks) use of DPP4 inhibitors.

 

Study details: The data come from a systematic review and pairwise meta-analysis of 82 randomized trials including 104,833 patients with T2D.

 

Disclosures: This study was partially supported by Beijing Natural Science Foundation, National Natural Science Foundation of China, and others. The authors declared receiving support from the funding institutions.

 

Source: He L et al. Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials BMJ. 2022;377:e068882 (Jun 28). Doi: 10.1136/bmj-2021-068882

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SGLT2i vs GLP-1RA or DPP4i lowers the risk for new-onset AF in T2D

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Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) use was associated with a lower risk for new-onset atrial fibrillation (AF) in patients with type 2 diabetes (T2D) compared with the use of either glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

 

Major finding: Use of SGLT2i was associated with a lower risk for new-onset AF compared with the use of DPP4i (hazard ratio [HR] 0.90; P  =  .0028) or GLP-1RA (HR 0.74; P  =  .0007), with no significant difference being observed between the risk associated with GLP-1RA and DPP4i (HR 1.01; P  =  .8980).

 

Study details: This was a retrospective cohort study that included 344,893, 44,370, and 393,100 patients with T2D and without preexisting AF who were treated with SGLT2i, GLP-1RA, and DPP4i, respectively.

 

Disclosures: This study was supported by grants from the Ministry of Science and Technology and Chang Gung Memorial Hospital, Linkou, Taiwan. The authors declared no competing interests.

 

Source: Chan YH et al. The risk of incident atrial fibrillation in patients with type 2 diabetes treated with sodium glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, and dipeptidyl peptidase-4 inhibitors: A nationwide cohort study. Cardiovasc Diabetol. 2022;21:118 (Jun 28). Doi: 10.1186/s12933-022-01549-x

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Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) use was associated with a lower risk for new-onset atrial fibrillation (AF) in patients with type 2 diabetes (T2D) compared with the use of either glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

 

Major finding: Use of SGLT2i was associated with a lower risk for new-onset AF compared with the use of DPP4i (hazard ratio [HR] 0.90; P  =  .0028) or GLP-1RA (HR 0.74; P  =  .0007), with no significant difference being observed between the risk associated with GLP-1RA and DPP4i (HR 1.01; P  =  .8980).

 

Study details: This was a retrospective cohort study that included 344,893, 44,370, and 393,100 patients with T2D and without preexisting AF who were treated with SGLT2i, GLP-1RA, and DPP4i, respectively.

 

Disclosures: This study was supported by grants from the Ministry of Science and Technology and Chang Gung Memorial Hospital, Linkou, Taiwan. The authors declared no competing interests.

 

Source: Chan YH et al. The risk of incident atrial fibrillation in patients with type 2 diabetes treated with sodium glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, and dipeptidyl peptidase-4 inhibitors: A nationwide cohort study. Cardiovasc Diabetol. 2022;21:118 (Jun 28). Doi: 10.1186/s12933-022-01549-x

Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) use was associated with a lower risk for new-onset atrial fibrillation (AF) in patients with type 2 diabetes (T2D) compared with the use of either glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

 

Major finding: Use of SGLT2i was associated with a lower risk for new-onset AF compared with the use of DPP4i (hazard ratio [HR] 0.90; P  =  .0028) or GLP-1RA (HR 0.74; P  =  .0007), with no significant difference being observed between the risk associated with GLP-1RA and DPP4i (HR 1.01; P  =  .8980).

 

Study details: This was a retrospective cohort study that included 344,893, 44,370, and 393,100 patients with T2D and without preexisting AF who were treated with SGLT2i, GLP-1RA, and DPP4i, respectively.

 

Disclosures: This study was supported by grants from the Ministry of Science and Technology and Chang Gung Memorial Hospital, Linkou, Taiwan. The authors declared no competing interests.

 

Source: Chan YH et al. The risk of incident atrial fibrillation in patients with type 2 diabetes treated with sodium glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, and dipeptidyl peptidase-4 inhibitors: A nationwide cohort study. Cardiovasc Diabetol. 2022;21:118 (Jun 28). Doi: 10.1186/s12933-022-01549-x

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Semaglutide improves glycemic control in patients with prediabetes

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Key clinical point: Once-weekly semaglutide plus lifestyle intervention significantly improved glucose parameters with a greater likelihood of achieving normoglycemia compared with placebo in patients with baseline prediabetes.

 

Major finding: Semaglutide vs placebo led to a significant reduction in the glycated hemoglobin level, fasting plasma glucose level, and homeostasis model assessment of insulin resistance (all P < .01), in addition to a significant increase in the proportion of patients experiencing normoglycemia (STEP 1: 84.1% vs 47.8%; STEP 3: 89.5% vs 55.0%; STEP 4: 89.8% vs 70.4%; P < .0001).

 

Study details: This was a post hoc analysis data of the STEP 1, 3, and 4 trials including 1536 patients with prediabetes who were randomly assigned to received semaglutide or placebo.

 

Disclosures: The STEP trials were funded by Novo Nordisk. Some authors declared receiving personal fees, speaker fees, advisory or consulting fees, and research funding or other support from various organizations. Three authors are employees and shareholders of Novo Nordisk.

 

Source: Perreault L et al. Changes in glucose metabolism and glycemic status with once-weekly subcutaneous semaglutide 2.4 mg among participants with prediabetes in the STEP program. Diabetes Care. 2022 (Jul 5). Doi: 10.2337/dc21-1785

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Key clinical point: Once-weekly semaglutide plus lifestyle intervention significantly improved glucose parameters with a greater likelihood of achieving normoglycemia compared with placebo in patients with baseline prediabetes.

 

Major finding: Semaglutide vs placebo led to a significant reduction in the glycated hemoglobin level, fasting plasma glucose level, and homeostasis model assessment of insulin resistance (all P < .01), in addition to a significant increase in the proportion of patients experiencing normoglycemia (STEP 1: 84.1% vs 47.8%; STEP 3: 89.5% vs 55.0%; STEP 4: 89.8% vs 70.4%; P < .0001).

 

Study details: This was a post hoc analysis data of the STEP 1, 3, and 4 trials including 1536 patients with prediabetes who were randomly assigned to received semaglutide or placebo.

 

Disclosures: The STEP trials were funded by Novo Nordisk. Some authors declared receiving personal fees, speaker fees, advisory or consulting fees, and research funding or other support from various organizations. Three authors are employees and shareholders of Novo Nordisk.

 

Source: Perreault L et al. Changes in glucose metabolism and glycemic status with once-weekly subcutaneous semaglutide 2.4 mg among participants with prediabetes in the STEP program. Diabetes Care. 2022 (Jul 5). Doi: 10.2337/dc21-1785

Key clinical point: Once-weekly semaglutide plus lifestyle intervention significantly improved glucose parameters with a greater likelihood of achieving normoglycemia compared with placebo in patients with baseline prediabetes.

 

Major finding: Semaglutide vs placebo led to a significant reduction in the glycated hemoglobin level, fasting plasma glucose level, and homeostasis model assessment of insulin resistance (all P < .01), in addition to a significant increase in the proportion of patients experiencing normoglycemia (STEP 1: 84.1% vs 47.8%; STEP 3: 89.5% vs 55.0%; STEP 4: 89.8% vs 70.4%; P < .0001).

 

Study details: This was a post hoc analysis data of the STEP 1, 3, and 4 trials including 1536 patients with prediabetes who were randomly assigned to received semaglutide or placebo.

 

Disclosures: The STEP trials were funded by Novo Nordisk. Some authors declared receiving personal fees, speaker fees, advisory or consulting fees, and research funding or other support from various organizations. Three authors are employees and shareholders of Novo Nordisk.

 

Source: Perreault L et al. Changes in glucose metabolism and glycemic status with once-weekly subcutaneous semaglutide 2.4 mg among participants with prediabetes in the STEP program. Diabetes Care. 2022 (Jul 5). Doi: 10.2337/dc21-1785

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T2D: Significant improvement in glycemic control with efpeglenatide

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Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

 

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

 

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

 

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

 

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

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Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

 

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

 

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

 

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

 

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

 

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

 

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

 

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

 

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

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Commentary: Treatments for IBS, August 2022

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APN Kametas scans the journals, so you don’t have to!

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
The study by El-Sahy and colleagues highlights the novel role of fecal microbiota transplant (FMT) in the treatment of irritable bowel syndrome (IBS). The safety and efficacy of this treatment was durable and provided sustained symptom relief for 3 years after FMT in this study. Those treated with donor feces had significantly lower IBS Severity Scoring System scores. Notably, patients with diarrhea-predominant IBS and those with mixed IBS had significantly higher response rates than did those with constipation-predominant IBS at 2 years post-FMT, but response rates coalesced at year 3. Those who lost clinical response at year 3 were responsive to retransplantation. This supports the idea of developing a protocol for FMT for the treatment of patients with IBS.

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues1 emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

 

Additional References

  1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277  
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Marita Kametas, MSN,  FNP-BC, CMSRN, COCN, Advanced Practice Nurse, Department of Digestive Diseases, The University of Chicago Medicine, Chicage, Illinois

APN Kametas is an active member of the Abbvie Speakers’ Bureau

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APN Kametas is an active member of the Abbvie Speakers’ Bureau

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Marita Kametas, MSN,  FNP-BC, CMSRN, COCN, Advanced Practice Nurse, Department of Digestive Diseases, The University of Chicago Medicine, Chicage, Illinois

APN Kametas is an active member of the Abbvie Speakers’ Bureau

APN Kametas scans the journals, so you don’t have to!
APN Kametas scans the journals, so you don’t have to!

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
The study by El-Sahy and colleagues highlights the novel role of fecal microbiota transplant (FMT) in the treatment of irritable bowel syndrome (IBS). The safety and efficacy of this treatment was durable and provided sustained symptom relief for 3 years after FMT in this study. Those treated with donor feces had significantly lower IBS Severity Scoring System scores. Notably, patients with diarrhea-predominant IBS and those with mixed IBS had significantly higher response rates than did those with constipation-predominant IBS at 2 years post-FMT, but response rates coalesced at year 3. Those who lost clinical response at year 3 were responsive to retransplantation. This supports the idea of developing a protocol for FMT for the treatment of patients with IBS.

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues1 emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

 

Additional References

  1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277  

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
The study by El-Sahy and colleagues highlights the novel role of fecal microbiota transplant (FMT) in the treatment of irritable bowel syndrome (IBS). The safety and efficacy of this treatment was durable and provided sustained symptom relief for 3 years after FMT in this study. Those treated with donor feces had significantly lower IBS Severity Scoring System scores. Notably, patients with diarrhea-predominant IBS and those with mixed IBS had significantly higher response rates than did those with constipation-predominant IBS at 2 years post-FMT, but response rates coalesced at year 3. Those who lost clinical response at year 3 were responsive to retransplantation. This supports the idea of developing a protocol for FMT for the treatment of patients with IBS.

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues1 emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

 

Additional References

  1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277  
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Clinical Edge Journal Scan: IBS August 2022
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CRC screening coverage continuum is complete

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In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

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In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

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Don’t let insurance policies burden GI practices

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Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

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Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

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Understanding proposed changes to Medicare payment policies

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On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

  • CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
  • Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
  • Split/shared visits policy delayed until CY 2024.
  • Payment rates for new bariatric device codes proposed.
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On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

  • CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
  • Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
  • Split/shared visits policy delayed until CY 2024.
  • Payment rates for new bariatric device codes proposed.

On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

  • CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
  • Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
  • Split/shared visits policy delayed until CY 2024.
  • Payment rates for new bariatric device codes proposed.
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