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Specialists hail new era in hemophilia treatment
“It’s an amazing time to be a hemophilia provider,” Alice D. Ma, MD, University of North Carolina at Chapel Hill hematologist and bleeding disorder specialist, said in an interview. “There are real options, and it’s very exciting.”
But the drugs come with quirks that hematologists must understand, hemophilia specialists cautioned, and stubborn insurers pose significant obstacles to appropriate care. Also, new generations of medications in development offer both hope and more questions.
By far, the biggest game changer in hemophilia A is a monoclonal antibody called emicizumab (Hemlibra), first approved by the Food and Drug Administration for hemophilia A patients with factor VIII inhibitors and then in 2018 for those without factor VIII inhibitors.
“It’s just been getting a bigger and bigger slice of market share as patients and parents really buy in to how great that product is,” Dr. Ma said. “I do not have any hemophilia A patients with factor VIII inhibitors who aren’t on it. That’s just kind of a no-brainer, no ifs, ands, or buts.”
About 50%-60% of her noninhibitor patients with hemophilia A take the drug, she said.
According to its manufacturer, Genentech, the drug “acts like a bridge, bringing factor IXa and factor X together to allow the blood coagulation process to continue without needing to replace factor VIII.”
Since emicizumab is not a blood factor, Dr. Ma said, it doesn’t cross-react with antibodies or inhibitors. “The other thing that is pretty amazing is that it’s given subcutaneously as opposed to intravenously. It’s given under the skin, kind of like an insulin shot, rather than into a vein.”
Prophylaxis treatments did exist for patients with hemophilia A prior to emicizumab, University of North Carolina at Chapel Hill hematologist and blood disorder specialist Nigel S. Key, MB, ChB, said in an interview. But the treatments didn’t stop all bleeding. “We never really kept them under control,” he said, adding that patients needed to get infusions several times a week. “It was cumbersome and took a lot of compliance, a lot of effort to do it.
Thanks to emicizumab, adult patients don’t have to put on tourniquets and stick butterfly needles into their own veins anymore, and parents no longer need to regularly give factor infusions to their children every 2-3 days, Dr. Ma said. Instead, doses may be required just once a week.
Not every patient is eager to embrace emicizumab
Emicizumab isn’t necessarily an easy sell. Home-care company pharmacies don’t get reimbursed as much for providing emicizumab, compared with factor infusions, Dr. Ma said, and some of these companies are urging parents to not accept the drug for their kids.
Prior experience can also make people wary. According to Dr. Ma, one of her patients – a 62-year-old man – was reluctant to take factor because he’d gotten infected with HIV from an infusion. “For guys of that certain age, factor was death. It was poison, so you tried really hard not to take it.”
The patient now regrets not taking emicizumab earlier. He told Dr. Ma that his joints “do feel better than when I took factor regularly,” and “he really thinks that it has made his hemophilia recede into the background of his life, which is pretty, pretty nice.”
In fact, Dr. Ma said, he dropped a 7-pound rock on his foot but did not need to take factor or be hospitalized because of bleeding. Instead, he simply “watched a bruise form and then get better.”
As for challenges beyond convincing patients to take emicizumab, Dr. Ma said that insurers can may still refuse to pay for it in noninhibitor patients. “Some of them say you have to fail a regular clotting factor to be able to take Hemlibra,” she said, noting that she finds this viewpoint intolerable.
Hemlibra is remarkably expensive, but treatment of bleeds is also pricey. A 2021 study found that median 6-month hemostatic treatment costs in hemophilia A patients fell from more than $176,000 to barely $128,000 after they started taking the drug.
There’s another hitch. Some hematologists don’t realize that the drug can throw off certain coagulation readings. Dr. Ma recalled that a patient with hemophilia A went to a different healthcare facility for a gall bladder operation, and hematology fellows there failed to adjust his factor VIII level – an extraordinarily high 400%, suggesting high coagulation – to reflect his use of emicizumab.
“My patient bled severely and could have lost his life,” Dr. Ma said.
Despite gains, hemophilia B remains hard to treat
The much rarer hemophilia B (the type that affected members of European royal families who descended from Queen Victoria) has proved more difficult to treat than hemophilia A. An estimated 1 in 5,600 males in the United States are born with hemophilia A, compared with 1 in 19,300 males born with hemophilia B. The conditions rarely affect females.
Recombinant factor IX products that replace a missing protein have been improved and can now be given every 7 or 14 days, instead of twice a week, Dr. Key said. As for the future, so-called rebalancing therapies are in phase 3 trials and look promising: “Instead of trying to beef up the proclotting proteins, you’re trying to knock down the anticlotting proteins. ‘Rebalancing’ is a good way to think of it.”
These treatments are also agnostic – like Hemlibra – to the presence of inhibitors, he said.
These drugs could be available within a few years, Dr. Key said. “The major concern is always going to be a risk of thrombosis or clotting. Some of that has only become apparent through clinical trials and require a return to the drawing board to redesign the dosing to hit the safe, sweet spot that prevents bleeds but doesn’t cause clots.”
Dr. Ma agreed that clots are a significant risk from rebalancing agents. “I don’t know that I would put a factor IX patient without an inhibitor on a rebalancing therapy, because we already have pretty darn good therapies for them,” she said. However, factor IX patients with inhibitors do need better treatments, “and we’re all looking forward to the next approved drugs there.”
Hoopla for gene therapy, with questions, as well
The prospect of gene therapy for hemophilia, meanwhile, continues to draw attention as phase 3 trials continue. Potentially, gene therapy could be given just once to patients with hemophilia A or hemophilia B and provide bleeding control indefinitely, Dr. Ma said.
However, Dr. Key wondered whether gene therapy may be useful in hemophilia A, since emicizumab has worked so well. “I just don’t see the tsunami of patients who are wanting to undergo gene therapy in the first few years. I think there’ll be relatively slow uptake due to a lot of factors, including reimbursement.”
Hematologist Amar H. Kelkar, MD, of Dana-Farber Cancer Institute in Boston, is also skeptical that a groundswell of patients will embrace gene therapy, even if one-time treatment lasts for years. Current treatments are working well for many patients, Dr. Kelkar said in an interview, “and comfort with novel therapies may be slow within the community, especially if the treatment effect is expected to be transient. This is the same community that was hit hard by contaminated blood products during the HIV crisis, so it may be hard to convince a large number of patients to adopt a new type of therapy. There’s also the issue of the projected high upfront cost of gene therapies. Of course, I’d love to be wrong, especially if cost issues for the patients can be mitigated.”
Moving forward, both Dr. Ma and Dr. Key urged hematologists to send their hemophilia patients to Hemophilia Treatment Centers so they can get specialized care. There are about 140 of these federally funded centers around the country, according to the National Hemophilia Foundation. Many are located in children’s hospitals.
Hemophilia treatment now requires a subspecialty degree of knowledge that’s difficult for a hematologist in general practice to master, Dr. Ma said. “If you have a patient with hemophilia, and you’re in private practice for general hematology/oncology, please send them to a Hemophilia Treatment Center for something like a once-a-year check-in to make sure that the patient is getting comprehensive care.”
Dr. Ma discloses relationships with Takeda (research funding and consultation). Dr. Key discloses relationships with BioMarin and Takeda (advisory board), Novo Nordisk (grants review committee), and Uniqure (steering committee). Dr. Kelkar has no disclosures.
“It’s an amazing time to be a hemophilia provider,” Alice D. Ma, MD, University of North Carolina at Chapel Hill hematologist and bleeding disorder specialist, said in an interview. “There are real options, and it’s very exciting.”
But the drugs come with quirks that hematologists must understand, hemophilia specialists cautioned, and stubborn insurers pose significant obstacles to appropriate care. Also, new generations of medications in development offer both hope and more questions.
By far, the biggest game changer in hemophilia A is a monoclonal antibody called emicizumab (Hemlibra), first approved by the Food and Drug Administration for hemophilia A patients with factor VIII inhibitors and then in 2018 for those without factor VIII inhibitors.
“It’s just been getting a bigger and bigger slice of market share as patients and parents really buy in to how great that product is,” Dr. Ma said. “I do not have any hemophilia A patients with factor VIII inhibitors who aren’t on it. That’s just kind of a no-brainer, no ifs, ands, or buts.”
About 50%-60% of her noninhibitor patients with hemophilia A take the drug, she said.
According to its manufacturer, Genentech, the drug “acts like a bridge, bringing factor IXa and factor X together to allow the blood coagulation process to continue without needing to replace factor VIII.”
Since emicizumab is not a blood factor, Dr. Ma said, it doesn’t cross-react with antibodies or inhibitors. “The other thing that is pretty amazing is that it’s given subcutaneously as opposed to intravenously. It’s given under the skin, kind of like an insulin shot, rather than into a vein.”
Prophylaxis treatments did exist for patients with hemophilia A prior to emicizumab, University of North Carolina at Chapel Hill hematologist and blood disorder specialist Nigel S. Key, MB, ChB, said in an interview. But the treatments didn’t stop all bleeding. “We never really kept them under control,” he said, adding that patients needed to get infusions several times a week. “It was cumbersome and took a lot of compliance, a lot of effort to do it.
Thanks to emicizumab, adult patients don’t have to put on tourniquets and stick butterfly needles into their own veins anymore, and parents no longer need to regularly give factor infusions to their children every 2-3 days, Dr. Ma said. Instead, doses may be required just once a week.
Not every patient is eager to embrace emicizumab
Emicizumab isn’t necessarily an easy sell. Home-care company pharmacies don’t get reimbursed as much for providing emicizumab, compared with factor infusions, Dr. Ma said, and some of these companies are urging parents to not accept the drug for their kids.
Prior experience can also make people wary. According to Dr. Ma, one of her patients – a 62-year-old man – was reluctant to take factor because he’d gotten infected with HIV from an infusion. “For guys of that certain age, factor was death. It was poison, so you tried really hard not to take it.”
The patient now regrets not taking emicizumab earlier. He told Dr. Ma that his joints “do feel better than when I took factor regularly,” and “he really thinks that it has made his hemophilia recede into the background of his life, which is pretty, pretty nice.”
In fact, Dr. Ma said, he dropped a 7-pound rock on his foot but did not need to take factor or be hospitalized because of bleeding. Instead, he simply “watched a bruise form and then get better.”
As for challenges beyond convincing patients to take emicizumab, Dr. Ma said that insurers can may still refuse to pay for it in noninhibitor patients. “Some of them say you have to fail a regular clotting factor to be able to take Hemlibra,” she said, noting that she finds this viewpoint intolerable.
Hemlibra is remarkably expensive, but treatment of bleeds is also pricey. A 2021 study found that median 6-month hemostatic treatment costs in hemophilia A patients fell from more than $176,000 to barely $128,000 after they started taking the drug.
There’s another hitch. Some hematologists don’t realize that the drug can throw off certain coagulation readings. Dr. Ma recalled that a patient with hemophilia A went to a different healthcare facility for a gall bladder operation, and hematology fellows there failed to adjust his factor VIII level – an extraordinarily high 400%, suggesting high coagulation – to reflect his use of emicizumab.
“My patient bled severely and could have lost his life,” Dr. Ma said.
Despite gains, hemophilia B remains hard to treat
The much rarer hemophilia B (the type that affected members of European royal families who descended from Queen Victoria) has proved more difficult to treat than hemophilia A. An estimated 1 in 5,600 males in the United States are born with hemophilia A, compared with 1 in 19,300 males born with hemophilia B. The conditions rarely affect females.
Recombinant factor IX products that replace a missing protein have been improved and can now be given every 7 or 14 days, instead of twice a week, Dr. Key said. As for the future, so-called rebalancing therapies are in phase 3 trials and look promising: “Instead of trying to beef up the proclotting proteins, you’re trying to knock down the anticlotting proteins. ‘Rebalancing’ is a good way to think of it.”
These treatments are also agnostic – like Hemlibra – to the presence of inhibitors, he said.
These drugs could be available within a few years, Dr. Key said. “The major concern is always going to be a risk of thrombosis or clotting. Some of that has only become apparent through clinical trials and require a return to the drawing board to redesign the dosing to hit the safe, sweet spot that prevents bleeds but doesn’t cause clots.”
Dr. Ma agreed that clots are a significant risk from rebalancing agents. “I don’t know that I would put a factor IX patient without an inhibitor on a rebalancing therapy, because we already have pretty darn good therapies for them,” she said. However, factor IX patients with inhibitors do need better treatments, “and we’re all looking forward to the next approved drugs there.”
Hoopla for gene therapy, with questions, as well
The prospect of gene therapy for hemophilia, meanwhile, continues to draw attention as phase 3 trials continue. Potentially, gene therapy could be given just once to patients with hemophilia A or hemophilia B and provide bleeding control indefinitely, Dr. Ma said.
However, Dr. Key wondered whether gene therapy may be useful in hemophilia A, since emicizumab has worked so well. “I just don’t see the tsunami of patients who are wanting to undergo gene therapy in the first few years. I think there’ll be relatively slow uptake due to a lot of factors, including reimbursement.”
Hematologist Amar H. Kelkar, MD, of Dana-Farber Cancer Institute in Boston, is also skeptical that a groundswell of patients will embrace gene therapy, even if one-time treatment lasts for years. Current treatments are working well for many patients, Dr. Kelkar said in an interview, “and comfort with novel therapies may be slow within the community, especially if the treatment effect is expected to be transient. This is the same community that was hit hard by contaminated blood products during the HIV crisis, so it may be hard to convince a large number of patients to adopt a new type of therapy. There’s also the issue of the projected high upfront cost of gene therapies. Of course, I’d love to be wrong, especially if cost issues for the patients can be mitigated.”
Moving forward, both Dr. Ma and Dr. Key urged hematologists to send their hemophilia patients to Hemophilia Treatment Centers so they can get specialized care. There are about 140 of these federally funded centers around the country, according to the National Hemophilia Foundation. Many are located in children’s hospitals.
Hemophilia treatment now requires a subspecialty degree of knowledge that’s difficult for a hematologist in general practice to master, Dr. Ma said. “If you have a patient with hemophilia, and you’re in private practice for general hematology/oncology, please send them to a Hemophilia Treatment Center for something like a once-a-year check-in to make sure that the patient is getting comprehensive care.”
Dr. Ma discloses relationships with Takeda (research funding and consultation). Dr. Key discloses relationships with BioMarin and Takeda (advisory board), Novo Nordisk (grants review committee), and Uniqure (steering committee). Dr. Kelkar has no disclosures.
“It’s an amazing time to be a hemophilia provider,” Alice D. Ma, MD, University of North Carolina at Chapel Hill hematologist and bleeding disorder specialist, said in an interview. “There are real options, and it’s very exciting.”
But the drugs come with quirks that hematologists must understand, hemophilia specialists cautioned, and stubborn insurers pose significant obstacles to appropriate care. Also, new generations of medications in development offer both hope and more questions.
By far, the biggest game changer in hemophilia A is a monoclonal antibody called emicizumab (Hemlibra), first approved by the Food and Drug Administration for hemophilia A patients with factor VIII inhibitors and then in 2018 for those without factor VIII inhibitors.
“It’s just been getting a bigger and bigger slice of market share as patients and parents really buy in to how great that product is,” Dr. Ma said. “I do not have any hemophilia A patients with factor VIII inhibitors who aren’t on it. That’s just kind of a no-brainer, no ifs, ands, or buts.”
About 50%-60% of her noninhibitor patients with hemophilia A take the drug, she said.
According to its manufacturer, Genentech, the drug “acts like a bridge, bringing factor IXa and factor X together to allow the blood coagulation process to continue without needing to replace factor VIII.”
Since emicizumab is not a blood factor, Dr. Ma said, it doesn’t cross-react with antibodies or inhibitors. “The other thing that is pretty amazing is that it’s given subcutaneously as opposed to intravenously. It’s given under the skin, kind of like an insulin shot, rather than into a vein.”
Prophylaxis treatments did exist for patients with hemophilia A prior to emicizumab, University of North Carolina at Chapel Hill hematologist and blood disorder specialist Nigel S. Key, MB, ChB, said in an interview. But the treatments didn’t stop all bleeding. “We never really kept them under control,” he said, adding that patients needed to get infusions several times a week. “It was cumbersome and took a lot of compliance, a lot of effort to do it.
Thanks to emicizumab, adult patients don’t have to put on tourniquets and stick butterfly needles into their own veins anymore, and parents no longer need to regularly give factor infusions to their children every 2-3 days, Dr. Ma said. Instead, doses may be required just once a week.
Not every patient is eager to embrace emicizumab
Emicizumab isn’t necessarily an easy sell. Home-care company pharmacies don’t get reimbursed as much for providing emicizumab, compared with factor infusions, Dr. Ma said, and some of these companies are urging parents to not accept the drug for their kids.
Prior experience can also make people wary. According to Dr. Ma, one of her patients – a 62-year-old man – was reluctant to take factor because he’d gotten infected with HIV from an infusion. “For guys of that certain age, factor was death. It was poison, so you tried really hard not to take it.”
The patient now regrets not taking emicizumab earlier. He told Dr. Ma that his joints “do feel better than when I took factor regularly,” and “he really thinks that it has made his hemophilia recede into the background of his life, which is pretty, pretty nice.”
In fact, Dr. Ma said, he dropped a 7-pound rock on his foot but did not need to take factor or be hospitalized because of bleeding. Instead, he simply “watched a bruise form and then get better.”
As for challenges beyond convincing patients to take emicizumab, Dr. Ma said that insurers can may still refuse to pay for it in noninhibitor patients. “Some of them say you have to fail a regular clotting factor to be able to take Hemlibra,” she said, noting that she finds this viewpoint intolerable.
Hemlibra is remarkably expensive, but treatment of bleeds is also pricey. A 2021 study found that median 6-month hemostatic treatment costs in hemophilia A patients fell from more than $176,000 to barely $128,000 after they started taking the drug.
There’s another hitch. Some hematologists don’t realize that the drug can throw off certain coagulation readings. Dr. Ma recalled that a patient with hemophilia A went to a different healthcare facility for a gall bladder operation, and hematology fellows there failed to adjust his factor VIII level – an extraordinarily high 400%, suggesting high coagulation – to reflect his use of emicizumab.
“My patient bled severely and could have lost his life,” Dr. Ma said.
Despite gains, hemophilia B remains hard to treat
The much rarer hemophilia B (the type that affected members of European royal families who descended from Queen Victoria) has proved more difficult to treat than hemophilia A. An estimated 1 in 5,600 males in the United States are born with hemophilia A, compared with 1 in 19,300 males born with hemophilia B. The conditions rarely affect females.
Recombinant factor IX products that replace a missing protein have been improved and can now be given every 7 or 14 days, instead of twice a week, Dr. Key said. As for the future, so-called rebalancing therapies are in phase 3 trials and look promising: “Instead of trying to beef up the proclotting proteins, you’re trying to knock down the anticlotting proteins. ‘Rebalancing’ is a good way to think of it.”
These treatments are also agnostic – like Hemlibra – to the presence of inhibitors, he said.
These drugs could be available within a few years, Dr. Key said. “The major concern is always going to be a risk of thrombosis or clotting. Some of that has only become apparent through clinical trials and require a return to the drawing board to redesign the dosing to hit the safe, sweet spot that prevents bleeds but doesn’t cause clots.”
Dr. Ma agreed that clots are a significant risk from rebalancing agents. “I don’t know that I would put a factor IX patient without an inhibitor on a rebalancing therapy, because we already have pretty darn good therapies for them,” she said. However, factor IX patients with inhibitors do need better treatments, “and we’re all looking forward to the next approved drugs there.”
Hoopla for gene therapy, with questions, as well
The prospect of gene therapy for hemophilia, meanwhile, continues to draw attention as phase 3 trials continue. Potentially, gene therapy could be given just once to patients with hemophilia A or hemophilia B and provide bleeding control indefinitely, Dr. Ma said.
However, Dr. Key wondered whether gene therapy may be useful in hemophilia A, since emicizumab has worked so well. “I just don’t see the tsunami of patients who are wanting to undergo gene therapy in the first few years. I think there’ll be relatively slow uptake due to a lot of factors, including reimbursement.”
Hematologist Amar H. Kelkar, MD, of Dana-Farber Cancer Institute in Boston, is also skeptical that a groundswell of patients will embrace gene therapy, even if one-time treatment lasts for years. Current treatments are working well for many patients, Dr. Kelkar said in an interview, “and comfort with novel therapies may be slow within the community, especially if the treatment effect is expected to be transient. This is the same community that was hit hard by contaminated blood products during the HIV crisis, so it may be hard to convince a large number of patients to adopt a new type of therapy. There’s also the issue of the projected high upfront cost of gene therapies. Of course, I’d love to be wrong, especially if cost issues for the patients can be mitigated.”
Moving forward, both Dr. Ma and Dr. Key urged hematologists to send their hemophilia patients to Hemophilia Treatment Centers so they can get specialized care. There are about 140 of these federally funded centers around the country, according to the National Hemophilia Foundation. Many are located in children’s hospitals.
Hemophilia treatment now requires a subspecialty degree of knowledge that’s difficult for a hematologist in general practice to master, Dr. Ma said. “If you have a patient with hemophilia, and you’re in private practice for general hematology/oncology, please send them to a Hemophilia Treatment Center for something like a once-a-year check-in to make sure that the patient is getting comprehensive care.”
Dr. Ma discloses relationships with Takeda (research funding and consultation). Dr. Key discloses relationships with BioMarin and Takeda (advisory board), Novo Nordisk (grants review committee), and Uniqure (steering committee). Dr. Kelkar has no disclosures.
No effect of red meat diet on T2D risk factors, says meta-analysis
Key clinical point: A diet containing red meat did not have any significant effect on most glycemic and insulinemic risk factors associated with type 2 diabetes (T2D), but it led to a significant reduction in postprandial glucose level compared with a diet containing less or no red meat.
Major finding: A diet with vs without or less meat had no significant effect on insulin sensitivity (standardized mean difference [SMD] −0.11; 95% CI −0.39 to 0.16), insulin resistance (SMD 0.11; 95% CI −0.24 to 0.45), fasting glucose level (SMD 0.13; 95% CI −0.04 to 0.29), and fasting insulin level (SMD 0.08; 95% CI −0.16 to 0.32), but it significantly reduced the postprandial glucose level (SMD −0.44; P < .001).
Study details: Findings are from a meta-analysis of 21 randomized controlled trials that evaluated the association between red meat intake and T2D risk.
Disclosures: This study was funded by the Beef Checkoff. Three authors declared being employees of Midwest Biomedical Research (USA), which received research funding from Beef Checkoff and National Pork Board.
Source: Sanders LM et al. Red meat consumption and risk factors for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2022 (May 5). Doi: 10.1038/s41430-022-01150-1
Key clinical point: A diet containing red meat did not have any significant effect on most glycemic and insulinemic risk factors associated with type 2 diabetes (T2D), but it led to a significant reduction in postprandial glucose level compared with a diet containing less or no red meat.
Major finding: A diet with vs without or less meat had no significant effect on insulin sensitivity (standardized mean difference [SMD] −0.11; 95% CI −0.39 to 0.16), insulin resistance (SMD 0.11; 95% CI −0.24 to 0.45), fasting glucose level (SMD 0.13; 95% CI −0.04 to 0.29), and fasting insulin level (SMD 0.08; 95% CI −0.16 to 0.32), but it significantly reduced the postprandial glucose level (SMD −0.44; P < .001).
Study details: Findings are from a meta-analysis of 21 randomized controlled trials that evaluated the association between red meat intake and T2D risk.
Disclosures: This study was funded by the Beef Checkoff. Three authors declared being employees of Midwest Biomedical Research (USA), which received research funding from Beef Checkoff and National Pork Board.
Source: Sanders LM et al. Red meat consumption and risk factors for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2022 (May 5). Doi: 10.1038/s41430-022-01150-1
Key clinical point: A diet containing red meat did not have any significant effect on most glycemic and insulinemic risk factors associated with type 2 diabetes (T2D), but it led to a significant reduction in postprandial glucose level compared with a diet containing less or no red meat.
Major finding: A diet with vs without or less meat had no significant effect on insulin sensitivity (standardized mean difference [SMD] −0.11; 95% CI −0.39 to 0.16), insulin resistance (SMD 0.11; 95% CI −0.24 to 0.45), fasting glucose level (SMD 0.13; 95% CI −0.04 to 0.29), and fasting insulin level (SMD 0.08; 95% CI −0.16 to 0.32), but it significantly reduced the postprandial glucose level (SMD −0.44; P < .001).
Study details: Findings are from a meta-analysis of 21 randomized controlled trials that evaluated the association between red meat intake and T2D risk.
Disclosures: This study was funded by the Beef Checkoff. Three authors declared being employees of Midwest Biomedical Research (USA), which received research funding from Beef Checkoff and National Pork Board.
Source: Sanders LM et al. Red meat consumption and risk factors for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2022 (May 5). Doi: 10.1038/s41430-022-01150-1
Cotadutide is safe and effective in overweight and obese T2D patients
Key clinical point: Cotadutide vs placebo was safe and effective in reducing body weight, glycated hemoglobin (HbA1c) level, and fasting plasma glucose level in patients with type 2 diabetes mellitus (T2D) and overweight or obesity.
Major finding: Percent decrease in body weight (mean difference [MD] 3.31; 95% CI 2.76-3.38) and glucose area under the plasma concentration curve (MD 30.15; 95% CI 23.18-37.12) and reduction in HbA1c (MD 0.68; 95% CI 0.58-0.79) and fasting plasma glucose (MD 31.31 mg/dL; 95% CI 22.59-40.04) levels over time were higher with cotadutide than placebo. Treatment-emergent serious adverse events were not significantly different between the treatment groups.
Study details: Findings are from a meta-analysis of eight randomized controlled trials including 1259 patients with T2D (body mass index 22-40 kg/m2) who received cotadutide (n = 890), placebo (n = 259), or other interventions (n = 110).
Disclosures: The study was funded by the Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.
Source: Ali MM et al. Impact of Cotadutide drug on patients with type 2 diabetes mellitus: a systematic review and meta-analysis BMC Endocr Disord. 2022;22:113 (Apr 29). Doi: 10.1186/s12902-022-01031-5
Key clinical point: Cotadutide vs placebo was safe and effective in reducing body weight, glycated hemoglobin (HbA1c) level, and fasting plasma glucose level in patients with type 2 diabetes mellitus (T2D) and overweight or obesity.
Major finding: Percent decrease in body weight (mean difference [MD] 3.31; 95% CI 2.76-3.38) and glucose area under the plasma concentration curve (MD 30.15; 95% CI 23.18-37.12) and reduction in HbA1c (MD 0.68; 95% CI 0.58-0.79) and fasting plasma glucose (MD 31.31 mg/dL; 95% CI 22.59-40.04) levels over time were higher with cotadutide than placebo. Treatment-emergent serious adverse events were not significantly different between the treatment groups.
Study details: Findings are from a meta-analysis of eight randomized controlled trials including 1259 patients with T2D (body mass index 22-40 kg/m2) who received cotadutide (n = 890), placebo (n = 259), or other interventions (n = 110).
Disclosures: The study was funded by the Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.
Source: Ali MM et al. Impact of Cotadutide drug on patients with type 2 diabetes mellitus: a systematic review and meta-analysis BMC Endocr Disord. 2022;22:113 (Apr 29). Doi: 10.1186/s12902-022-01031-5
Key clinical point: Cotadutide vs placebo was safe and effective in reducing body weight, glycated hemoglobin (HbA1c) level, and fasting plasma glucose level in patients with type 2 diabetes mellitus (T2D) and overweight or obesity.
Major finding: Percent decrease in body weight (mean difference [MD] 3.31; 95% CI 2.76-3.38) and glucose area under the plasma concentration curve (MD 30.15; 95% CI 23.18-37.12) and reduction in HbA1c (MD 0.68; 95% CI 0.58-0.79) and fasting plasma glucose (MD 31.31 mg/dL; 95% CI 22.59-40.04) levels over time were higher with cotadutide than placebo. Treatment-emergent serious adverse events were not significantly different between the treatment groups.
Study details: Findings are from a meta-analysis of eight randomized controlled trials including 1259 patients with T2D (body mass index 22-40 kg/m2) who received cotadutide (n = 890), placebo (n = 259), or other interventions (n = 110).
Disclosures: The study was funded by the Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.
Source: Ali MM et al. Impact of Cotadutide drug on patients with type 2 diabetes mellitus: a systematic review and meta-analysis BMC Endocr Disord. 2022;22:113 (Apr 29). Doi: 10.1186/s12902-022-01031-5
Metformin may protect against age-related macular degeneration in T2D
Key clinical point: In patients with type 2 diabetes mellitus (T2D) for ≥10 years, metformin use vs no use was significantly associated with a lower risk for any and early age-related macular degeneration (AMD) but not late AMD.
Major finding: A significant association was observed between metformin use and any AMD (adjusted odds ratio [aOR] 0.24) and early AMD (aOR 0.17; both P < .0001), but not late AMD (P = .0619). Prolonged use (>5 years) and high cumulative dose (>3500 g) of metformin reduced AMD risk (Ptrend = .0007).
Study details: This retrospective study included 324 patients aged ≥50 years diagnosed with T2D for ≥10 years, of which 209 were metformin users and 115 were metformin nonusers.
Disclosures: This study was funded by Hospital Youth Research Fund of China-Japan
Friendship Hospital and Beijing University of Chemical Technology-China-Japan Friendship Hospital Biomedical Translational Engineering Research Center Joint Fund. The authors declared no competing interests.
Source: Jiang J et al. Association between metformin use and the risk of age-related macular degeneration in patients with type 2 diabetes: A retrospective study. BMJ Open. 2022;12:e054420 (Apr 26). Doi: 10.1136/bmjopen-2021-054420
Key clinical point: In patients with type 2 diabetes mellitus (T2D) for ≥10 years, metformin use vs no use was significantly associated with a lower risk for any and early age-related macular degeneration (AMD) but not late AMD.
Major finding: A significant association was observed between metformin use and any AMD (adjusted odds ratio [aOR] 0.24) and early AMD (aOR 0.17; both P < .0001), but not late AMD (P = .0619). Prolonged use (>5 years) and high cumulative dose (>3500 g) of metformin reduced AMD risk (Ptrend = .0007).
Study details: This retrospective study included 324 patients aged ≥50 years diagnosed with T2D for ≥10 years, of which 209 were metformin users and 115 were metformin nonusers.
Disclosures: This study was funded by Hospital Youth Research Fund of China-Japan
Friendship Hospital and Beijing University of Chemical Technology-China-Japan Friendship Hospital Biomedical Translational Engineering Research Center Joint Fund. The authors declared no competing interests.
Source: Jiang J et al. Association between metformin use and the risk of age-related macular degeneration in patients with type 2 diabetes: A retrospective study. BMJ Open. 2022;12:e054420 (Apr 26). Doi: 10.1136/bmjopen-2021-054420
Key clinical point: In patients with type 2 diabetes mellitus (T2D) for ≥10 years, metformin use vs no use was significantly associated with a lower risk for any and early age-related macular degeneration (AMD) but not late AMD.
Major finding: A significant association was observed between metformin use and any AMD (adjusted odds ratio [aOR] 0.24) and early AMD (aOR 0.17; both P < .0001), but not late AMD (P = .0619). Prolonged use (>5 years) and high cumulative dose (>3500 g) of metformin reduced AMD risk (Ptrend = .0007).
Study details: This retrospective study included 324 patients aged ≥50 years diagnosed with T2D for ≥10 years, of which 209 were metformin users and 115 were metformin nonusers.
Disclosures: This study was funded by Hospital Youth Research Fund of China-Japan
Friendship Hospital and Beijing University of Chemical Technology-China-Japan Friendship Hospital Biomedical Translational Engineering Research Center Joint Fund. The authors declared no competing interests.
Source: Jiang J et al. Association between metformin use and the risk of age-related macular degeneration in patients with type 2 diabetes: A retrospective study. BMJ Open. 2022;12:e054420 (Apr 26). Doi: 10.1136/bmjopen-2021-054420
Metformin protects against poor functional outcomes in patients with first ever stroke and T2D
Key clinical point: Patients with first-ever stroke and type 2 diabetes mellitus (T2D) who receive metformin treatment (MT) show lower stroke severity, case fatality, and disability rates.
Major finding: MT vs non-MT group had a lower rate of in-hospital case fatality (odds ratio [OR] 0.63; 95% CI 0.47-0.84), 12-month case fatality (OR 0.69; 95% CI 0.50-0.88), and 12-month disability (OR 0.83; 95% CI 0.70-0.95).
Study details: The data come from a prospective, hospital-based cohort study including 7587 patients with first-ever stroke and T2D, of which 3593 (47.36%) received MT (MT group) and 3994 (52.64%) did not receive MT (non-MT group).
Disclosures: This study was supported by the National Major Public Health Service Projects, Chinese Academy of Medical Sciences Innovation Fund for Medical Science, Natural Science Foundation of Tianjin, and China Postdoctoral Science Foundation, among others. The authors declared no conflicts of interest.
Source: Tu WJ et al. Metformin use is associated with low risk of case fatality and disability rates in first-ever stroke patients with type 2 diabetes. Ther Adv Chronic Dis. 2022 (Apr 19). Doi: 10.1177/20406223221076894
Key clinical point: Patients with first-ever stroke and type 2 diabetes mellitus (T2D) who receive metformin treatment (MT) show lower stroke severity, case fatality, and disability rates.
Major finding: MT vs non-MT group had a lower rate of in-hospital case fatality (odds ratio [OR] 0.63; 95% CI 0.47-0.84), 12-month case fatality (OR 0.69; 95% CI 0.50-0.88), and 12-month disability (OR 0.83; 95% CI 0.70-0.95).
Study details: The data come from a prospective, hospital-based cohort study including 7587 patients with first-ever stroke and T2D, of which 3593 (47.36%) received MT (MT group) and 3994 (52.64%) did not receive MT (non-MT group).
Disclosures: This study was supported by the National Major Public Health Service Projects, Chinese Academy of Medical Sciences Innovation Fund for Medical Science, Natural Science Foundation of Tianjin, and China Postdoctoral Science Foundation, among others. The authors declared no conflicts of interest.
Source: Tu WJ et al. Metformin use is associated with low risk of case fatality and disability rates in first-ever stroke patients with type 2 diabetes. Ther Adv Chronic Dis. 2022 (Apr 19). Doi: 10.1177/20406223221076894
Key clinical point: Patients with first-ever stroke and type 2 diabetes mellitus (T2D) who receive metformin treatment (MT) show lower stroke severity, case fatality, and disability rates.
Major finding: MT vs non-MT group had a lower rate of in-hospital case fatality (odds ratio [OR] 0.63; 95% CI 0.47-0.84), 12-month case fatality (OR 0.69; 95% CI 0.50-0.88), and 12-month disability (OR 0.83; 95% CI 0.70-0.95).
Study details: The data come from a prospective, hospital-based cohort study including 7587 patients with first-ever stroke and T2D, of which 3593 (47.36%) received MT (MT group) and 3994 (52.64%) did not receive MT (non-MT group).
Disclosures: This study was supported by the National Major Public Health Service Projects, Chinese Academy of Medical Sciences Innovation Fund for Medical Science, Natural Science Foundation of Tianjin, and China Postdoctoral Science Foundation, among others. The authors declared no conflicts of interest.
Source: Tu WJ et al. Metformin use is associated with low risk of case fatality and disability rates in first-ever stroke patients with type 2 diabetes. Ther Adv Chronic Dis. 2022 (Apr 19). Doi: 10.1177/20406223221076894
Weight change influences hip fracture risk in T2D
Key clinical point: Body weight gain and loss are significantly associated with a higher risk for hip fracture in patients with type 2 diabetes (T2D), irrespective of the body mass index.
Major finding: Compared with stable weight, body weight loss of ≥10% (adjusted hazard ratio [aHR] 1.605; 95% CI 1.493-1.725) and 5%-10% (aHR 1.237; 95% CI 1.177-1.300) and gain of ≥10% (aHR 1.457; 95% CI 1.318-1.612) and 5%-≤10% (aHR 1.234; 95% CI 1.156-1.318) were associated with a higher risk for hip fracture.
Study details: Findings are from a nationwide cohort study including 1,447,579 patients aged >40 years with T2D who reported 11,848 hip fracture events.
Disclosures: The study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.
Source: Lee SW et al. Weight change and the risk of hip fractures in patients with type 2 diabetes: A nationwide cohort study. Osteoporos Int. 2022 (Apr 19). Doi: 10.1007/s00198-022-06398-8
Key clinical point: Body weight gain and loss are significantly associated with a higher risk for hip fracture in patients with type 2 diabetes (T2D), irrespective of the body mass index.
Major finding: Compared with stable weight, body weight loss of ≥10% (adjusted hazard ratio [aHR] 1.605; 95% CI 1.493-1.725) and 5%-10% (aHR 1.237; 95% CI 1.177-1.300) and gain of ≥10% (aHR 1.457; 95% CI 1.318-1.612) and 5%-≤10% (aHR 1.234; 95% CI 1.156-1.318) were associated with a higher risk for hip fracture.
Study details: Findings are from a nationwide cohort study including 1,447,579 patients aged >40 years with T2D who reported 11,848 hip fracture events.
Disclosures: The study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.
Source: Lee SW et al. Weight change and the risk of hip fractures in patients with type 2 diabetes: A nationwide cohort study. Osteoporos Int. 2022 (Apr 19). Doi: 10.1007/s00198-022-06398-8
Key clinical point: Body weight gain and loss are significantly associated with a higher risk for hip fracture in patients with type 2 diabetes (T2D), irrespective of the body mass index.
Major finding: Compared with stable weight, body weight loss of ≥10% (adjusted hazard ratio [aHR] 1.605; 95% CI 1.493-1.725) and 5%-10% (aHR 1.237; 95% CI 1.177-1.300) and gain of ≥10% (aHR 1.457; 95% CI 1.318-1.612) and 5%-≤10% (aHR 1.234; 95% CI 1.156-1.318) were associated with a higher risk for hip fracture.
Study details: Findings are from a nationwide cohort study including 1,447,579 patients aged >40 years with T2D who reported 11,848 hip fracture events.
Disclosures: The study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.
Source: Lee SW et al. Weight change and the risk of hip fractures in patients with type 2 diabetes: A nationwide cohort study. Osteoporos Int. 2022 (Apr 19). Doi: 10.1007/s00198-022-06398-8
Quadruple therapy as attractive as once-weekly GLP-1RA therapy in poorly controlled T2D
Key clinical point: Treatment intensification with quadruple therapy showed similar glucose lowering efficacy as once weekly glucagon-like peptide-1 receptor agonist (GLP-1RA)-based triple therapy in patients with poorly controlled type 2 diabetes mellitus (T2D). However, low C-peptide levels reduced the therapeutic efficacy of GLP-1RA therapy but not quadruple therapy.
Major finding: At 24 weeks, both quadruple and GLP-1RA-based triple therapies significantly reduced glycated hemoglobin level (both therapies: mean reduction −1.1%; P < .001); however, the glucose-lowering effects of GLP-1RA vs quadruple therapy were weaker in patients with low C-peptide levels (mean −0.1% vs −1.3%; P = .04).
Study details: Findings are from a real-world study including 96 patients with poorly controlled T2D refractory to triple oral therapy who underwent treatment intensification with quadruple oral therapy (n = 50) or once-weekly GLP-1RA-based triple therapy (n = 46).
Disclosures: The study received no specific funding. The authors declared no conflicts of interest.
Source: Kim M et al. the efficacy of treatment intensification by quadruple oral therapy compared to GLP-1RA therapy in poorly controlled type 2 diabetes mellitus patients: A real-world data study. Diabetes Metab J. 2022 (Apr 29). Doi: 10.4093/dmj.2021.0373
Key clinical point: Treatment intensification with quadruple therapy showed similar glucose lowering efficacy as once weekly glucagon-like peptide-1 receptor agonist (GLP-1RA)-based triple therapy in patients with poorly controlled type 2 diabetes mellitus (T2D). However, low C-peptide levels reduced the therapeutic efficacy of GLP-1RA therapy but not quadruple therapy.
Major finding: At 24 weeks, both quadruple and GLP-1RA-based triple therapies significantly reduced glycated hemoglobin level (both therapies: mean reduction −1.1%; P < .001); however, the glucose-lowering effects of GLP-1RA vs quadruple therapy were weaker in patients with low C-peptide levels (mean −0.1% vs −1.3%; P = .04).
Study details: Findings are from a real-world study including 96 patients with poorly controlled T2D refractory to triple oral therapy who underwent treatment intensification with quadruple oral therapy (n = 50) or once-weekly GLP-1RA-based triple therapy (n = 46).
Disclosures: The study received no specific funding. The authors declared no conflicts of interest.
Source: Kim M et al. the efficacy of treatment intensification by quadruple oral therapy compared to GLP-1RA therapy in poorly controlled type 2 diabetes mellitus patients: A real-world data study. Diabetes Metab J. 2022 (Apr 29). Doi: 10.4093/dmj.2021.0373
Key clinical point: Treatment intensification with quadruple therapy showed similar glucose lowering efficacy as once weekly glucagon-like peptide-1 receptor agonist (GLP-1RA)-based triple therapy in patients with poorly controlled type 2 diabetes mellitus (T2D). However, low C-peptide levels reduced the therapeutic efficacy of GLP-1RA therapy but not quadruple therapy.
Major finding: At 24 weeks, both quadruple and GLP-1RA-based triple therapies significantly reduced glycated hemoglobin level (both therapies: mean reduction −1.1%; P < .001); however, the glucose-lowering effects of GLP-1RA vs quadruple therapy were weaker in patients with low C-peptide levels (mean −0.1% vs −1.3%; P = .04).
Study details: Findings are from a real-world study including 96 patients with poorly controlled T2D refractory to triple oral therapy who underwent treatment intensification with quadruple oral therapy (n = 50) or once-weekly GLP-1RA-based triple therapy (n = 46).
Disclosures: The study received no specific funding. The authors declared no conflicts of interest.
Source: Kim M et al. the efficacy of treatment intensification by quadruple oral therapy compared to GLP-1RA therapy in poorly controlled type 2 diabetes mellitus patients: A real-world data study. Diabetes Metab J. 2022 (Apr 29). Doi: 10.4093/dmj.2021.0373
Prolonged proton pump inhibitor therapy raises the risk for T2D
Key clinical point: Prolonged treatment with proton pump inhibitors (PPI) is associated with a higher risk for type 2 diabetes (T2D), thus unnecessary prescription, particularly for long-term use, should be avoided.
Major finding: The risk for T2D was higher among patients receiving PPI for 8 weeks to 6 months (odds ratio [OR] 1.19; 95% CI 1.15-1.24), 6 months to 2 years (OR 1.43; 95% CI 1.38-1.49), and >2 years (OR 1.56; 95% CI 1.49-1.64) than those receiving PPI for <8 weeks (Ptrend < .001), particularly among younger patients and those with worse clinical complexity.
Study details: Findings are from a nested case-control study including 777,420 patients aged ≥40 years who received PPI, of which 50,535 were diagnosed with T2D and matched with control participants.
Disclosures: The study was funded by the Italian Ministry of Education, University, and Research. G Corrao declared being an advisory board member, receiving research support, and participating in numerous projects funded by various sources.
Source: Ciardullo S et al. Prolonged use of proton pump inhibitors and risk of type 2 diabetes: Results from a large population-based nested case-control study. J Clin Endocrinol Metab. 2022 (Apr 16). Doi: 10.1210/clinem/dgac231
Key clinical point: Prolonged treatment with proton pump inhibitors (PPI) is associated with a higher risk for type 2 diabetes (T2D), thus unnecessary prescription, particularly for long-term use, should be avoided.
Major finding: The risk for T2D was higher among patients receiving PPI for 8 weeks to 6 months (odds ratio [OR] 1.19; 95% CI 1.15-1.24), 6 months to 2 years (OR 1.43; 95% CI 1.38-1.49), and >2 years (OR 1.56; 95% CI 1.49-1.64) than those receiving PPI for <8 weeks (Ptrend < .001), particularly among younger patients and those with worse clinical complexity.
Study details: Findings are from a nested case-control study including 777,420 patients aged ≥40 years who received PPI, of which 50,535 were diagnosed with T2D and matched with control participants.
Disclosures: The study was funded by the Italian Ministry of Education, University, and Research. G Corrao declared being an advisory board member, receiving research support, and participating in numerous projects funded by various sources.
Source: Ciardullo S et al. Prolonged use of proton pump inhibitors and risk of type 2 diabetes: Results from a large population-based nested case-control study. J Clin Endocrinol Metab. 2022 (Apr 16). Doi: 10.1210/clinem/dgac231
Key clinical point: Prolonged treatment with proton pump inhibitors (PPI) is associated with a higher risk for type 2 diabetes (T2D), thus unnecessary prescription, particularly for long-term use, should be avoided.
Major finding: The risk for T2D was higher among patients receiving PPI for 8 weeks to 6 months (odds ratio [OR] 1.19; 95% CI 1.15-1.24), 6 months to 2 years (OR 1.43; 95% CI 1.38-1.49), and >2 years (OR 1.56; 95% CI 1.49-1.64) than those receiving PPI for <8 weeks (Ptrend < .001), particularly among younger patients and those with worse clinical complexity.
Study details: Findings are from a nested case-control study including 777,420 patients aged ≥40 years who received PPI, of which 50,535 were diagnosed with T2D and matched with control participants.
Disclosures: The study was funded by the Italian Ministry of Education, University, and Research. G Corrao declared being an advisory board member, receiving research support, and participating in numerous projects funded by various sources.
Source: Ciardullo S et al. Prolonged use of proton pump inhibitors and risk of type 2 diabetes: Results from a large population-based nested case-control study. J Clin Endocrinol Metab. 2022 (Apr 16). Doi: 10.1210/clinem/dgac231
T2D: Adding Gla-300 to GLP-1 RA improves glycemic control in real world
Key clinical point: Treatment intensification with 300 units/mL insulin glargine (Gla-300) in patients with type 2 diabetes mellitus (T2D) receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) significantly improved glycemic control without increasing the risk for hypoglycemia.
Major finding: Addition of Gla-300 to GLP-1 RA therapy significantly reduced glycated hemoglobin (HbA1c) level (mean change −0.97% ± 1.6%; P < .0001) and significantly increased the proportion of patients achieving glycemic control (HbA1c <7.0%: change 17.34%; HbA1c <8.0%: change 31.73%; both P < .001), with no significant changes in overall incidence or event rate of hypoglycemia.
Study details: The data come from a retrospective analysis of 271 insulin-naive patients with T2D receiving GLP-1 RA who underwent treatment intensification with Gla-300.
Disclosures: This study was funded by Sanofi. TS Bailey declared receiving research support and consulting and speaking honoraria from various sources, including Sanofi. C Nicholls, J Gill, and J Westerbacka declared being employees and stockholders of Sanofi.
Source: Bailey TS et al. Real-world outcomes of addition of insulin glargine 300 U/mL (Gla-300) to GLP-1 RA therapy in people with type 2 diabetes: The DELIVER-G study. Diabetes Obes Metab. 2022 (May 1). Doi: 10.1111/dom.14739
Key clinical point: Treatment intensification with 300 units/mL insulin glargine (Gla-300) in patients with type 2 diabetes mellitus (T2D) receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) significantly improved glycemic control without increasing the risk for hypoglycemia.
Major finding: Addition of Gla-300 to GLP-1 RA therapy significantly reduced glycated hemoglobin (HbA1c) level (mean change −0.97% ± 1.6%; P < .0001) and significantly increased the proportion of patients achieving glycemic control (HbA1c <7.0%: change 17.34%; HbA1c <8.0%: change 31.73%; both P < .001), with no significant changes in overall incidence or event rate of hypoglycemia.
Study details: The data come from a retrospective analysis of 271 insulin-naive patients with T2D receiving GLP-1 RA who underwent treatment intensification with Gla-300.
Disclosures: This study was funded by Sanofi. TS Bailey declared receiving research support and consulting and speaking honoraria from various sources, including Sanofi. C Nicholls, J Gill, and J Westerbacka declared being employees and stockholders of Sanofi.
Source: Bailey TS et al. Real-world outcomes of addition of insulin glargine 300 U/mL (Gla-300) to GLP-1 RA therapy in people with type 2 diabetes: The DELIVER-G study. Diabetes Obes Metab. 2022 (May 1). Doi: 10.1111/dom.14739
Key clinical point: Treatment intensification with 300 units/mL insulin glargine (Gla-300) in patients with type 2 diabetes mellitus (T2D) receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) significantly improved glycemic control without increasing the risk for hypoglycemia.
Major finding: Addition of Gla-300 to GLP-1 RA therapy significantly reduced glycated hemoglobin (HbA1c) level (mean change −0.97% ± 1.6%; P < .0001) and significantly increased the proportion of patients achieving glycemic control (HbA1c <7.0%: change 17.34%; HbA1c <8.0%: change 31.73%; both P < .001), with no significant changes in overall incidence or event rate of hypoglycemia.
Study details: The data come from a retrospective analysis of 271 insulin-naive patients with T2D receiving GLP-1 RA who underwent treatment intensification with Gla-300.
Disclosures: This study was funded by Sanofi. TS Bailey declared receiving research support and consulting and speaking honoraria from various sources, including Sanofi. C Nicholls, J Gill, and J Westerbacka declared being employees and stockholders of Sanofi.
Source: Bailey TS et al. Real-world outcomes of addition of insulin glargine 300 U/mL (Gla-300) to GLP-1 RA therapy in people with type 2 diabetes: The DELIVER-G study. Diabetes Obes Metab. 2022 (May 1). Doi: 10.1111/dom.14739
Severe hypoglycemia raises the risk for QTc prolongation in T2D
Key clinical point: Severe hypoglycemia (SH) is associated with a greater risk for corrected QT (QTc) prolongation in patients with type 2 diabetes mellitus (T2D), especially in younger participants (age <61.9 years), irrespective of other risk factors.
Major finding: Patients with T2D and SH had a higher risk for QTc prolongation (adjusted risk ratio [aRR] 1.66; 95% CI 1.16-2.38), with the risk being higher in patients with 1 (aRR 1.57; 95% CI 1.04-2.39) and ≥2 (aRR 2.01; 95% CI 1.07-3.78) vs no SH episodes and the association remaining significant in younger (aRR 2.63; P = .001) but not in older (P = .170) patients.
Study details: This prospective cohort study included 8277 patients with T2D from the ACCORD study, of which 324 had ≥1 SH episodes and 517 developed QTc prolongation over a 5-year median follow-up.
Disclosures: The study received no specific funding. GC Fonarow reported being a consultant for various organizations.
Source: Kaze AD et al. Severe hypoglycemia and incidence of QT interval prolongation among adults with type 2 diabetes. J Clin Endocrinol Metab. 2022 (Apr 9). Doi: 10.1210/clinem/dgac195
Key clinical point: Severe hypoglycemia (SH) is associated with a greater risk for corrected QT (QTc) prolongation in patients with type 2 diabetes mellitus (T2D), especially in younger participants (age <61.9 years), irrespective of other risk factors.
Major finding: Patients with T2D and SH had a higher risk for QTc prolongation (adjusted risk ratio [aRR] 1.66; 95% CI 1.16-2.38), with the risk being higher in patients with 1 (aRR 1.57; 95% CI 1.04-2.39) and ≥2 (aRR 2.01; 95% CI 1.07-3.78) vs no SH episodes and the association remaining significant in younger (aRR 2.63; P = .001) but not in older (P = .170) patients.
Study details: This prospective cohort study included 8277 patients with T2D from the ACCORD study, of which 324 had ≥1 SH episodes and 517 developed QTc prolongation over a 5-year median follow-up.
Disclosures: The study received no specific funding. GC Fonarow reported being a consultant for various organizations.
Source: Kaze AD et al. Severe hypoglycemia and incidence of QT interval prolongation among adults with type 2 diabetes. J Clin Endocrinol Metab. 2022 (Apr 9). Doi: 10.1210/clinem/dgac195
Key clinical point: Severe hypoglycemia (SH) is associated with a greater risk for corrected QT (QTc) prolongation in patients with type 2 diabetes mellitus (T2D), especially in younger participants (age <61.9 years), irrespective of other risk factors.
Major finding: Patients with T2D and SH had a higher risk for QTc prolongation (adjusted risk ratio [aRR] 1.66; 95% CI 1.16-2.38), with the risk being higher in patients with 1 (aRR 1.57; 95% CI 1.04-2.39) and ≥2 (aRR 2.01; 95% CI 1.07-3.78) vs no SH episodes and the association remaining significant in younger (aRR 2.63; P = .001) but not in older (P = .170) patients.
Study details: This prospective cohort study included 8277 patients with T2D from the ACCORD study, of which 324 had ≥1 SH episodes and 517 developed QTc prolongation over a 5-year median follow-up.
Disclosures: The study received no specific funding. GC Fonarow reported being a consultant for various organizations.
Source: Kaze AD et al. Severe hypoglycemia and incidence of QT interval prolongation among adults with type 2 diabetes. J Clin Endocrinol Metab. 2022 (Apr 9). Doi: 10.1210/clinem/dgac195