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Deepak L. Bhatt
NEW ORLEANS – Treatment with SGLT2 inhibitor dapagliflozin has reduced the number of hospitalizations badociated with heart failure in patients with a wide range of left ventricular ejection fractions and could offer even better benefits with lower CV mortality and mortality in patients with reduced ejection fraction, researchers at the American College of Scientific Session in Cardiology reported.
In all of the DECLARE-TIMI 58 CV results, dapagliflozin 10 mg (Farxiga, AstraZeneca) reduced the composite endpoint of CV death and hospitalization for heart failure in 4 patients. years, mainly because of the reduction in the number of hospitalizations for heart failure, in a large population of patients 2 diabetes.
"However, the impact of basic LVEF and the clinical benefit of SGLT2 inhibitors are unknown," Eri T. Kato, MD, doctorate cardiologist from Kyoto University in Japan, said during the presentation of the last-minute clinical trial.
New subbadysis
The prespecified subbadysis was to examine the clinical benefit of dapagliflozin in patients with and without HFrEF.
Of the 17,160 patients with type 2 diabetes and established or multiple risk factors for atherosclerotic CVD included in the DECLARE-TIMI 58 trial, baseline EF was available out of 5,202. Initially, 88.4% were Had no history of HF, 7.7% had HF without reduced FE and 3.9% had HFrEF, defined as an EF less than 45%.
Patients with dapagliflozin badigned to HFrEF were 38% less likely to be hospitalized for heart failure or to die from CV, compared to those receiving placebo (HR = 0.62, 95% CI, 0, 45-.86). According to the researchers, this was a significantly greater reduction than the 12% decrease in the probability of events in patients without HFrEF (HR = 0.88, 95% CI, 0%). , 76-1.02). The effect of dapagliflozin on treatment was similar in patients with HF without known EF (HR = 0.88, 95% CI, 0.66-1.17) and those without HF ( HR = 0.88, 95% CI, 0.74 to 3.03), the researchers wrote a simultaneous publication in Circulation.
Treatment with dapagliflozin reduced the rate of hospitalizations for heart failure among all patients, regardless of EF or HF status at the start of the study, according to the results.
In addition, patients with dapagliflozin badigned to HFrEF had a 45% lower CV death rate (HR = 0.55, 95% CI, 0.34-0.9) and an all-cause mortality rate (HR). = 0.59, 95% CI, 0.4-0.88) versus placebo. According to Kato, researchers have not observed these benefits in patients without HFrEF.
"A subgroup mortality benefit in this trial with a neutral overall effect on mortality should be interpreted with caution," Kato said during the presentation.
"The ejection fraction is a powerful tool"
The large DECLARE-TIMI 58 trial was conducted at 882 sites in 33 countries.
This new badysis, presented in CAC 2019, is the first to examine whether the benefits of dapaliflozin can be predicted on the basis of the LVEF.
Inhibitors of SGLT2 have drawn attention to the reduction of cardiovascular risk, empagliflozin (Jardiance, Boehringer Ingelheim / Eli Lilly) gaining an expanded indication in 2017. More recently, canagliflozin (Invokana, Janssen) has also obtained an expanded indication from the FDA for a risk reduction CV diabetes type 2.
At present, dapagliflozin is not indicated to reduce the risk of cardiovascular events, CV death or hospitalization due to heart failure.
"The use of dapagliflozin, an inhibitor of SGLT2, is beneficial in reducing the number of hospitalizations for heart failure in patients with a wide range of left ventricular ejection fraction, but patients with a reduced ejection fraction could derive an even greater benefit, "Kato said in a press release. "The clinical implication of this discovery is that the ejection fraction is a powerful tool for identifying the most at-risk individuals who may benefit particularly from SGLT2 inhibitors."
Talk with Cardiology today Deepak L. Bhatt, MD, MPH, A DECLARE-TIMI 58 trial researcher said: "It is encouraging to see diabetes trials presented at cardiology meetings such as: [ACC 2019].
"Trials currently underway in diabetic or non-diabetic RF patients and on obtaining SGLT2 inhibitors or a placebo should help determine who benefits most from the inhibition of SGLT2, "he said. "These are exciting data for cardiologists, diabetologists, primary care physicians and, ultimately, we hope for the benefit of patients and the care provided to patients."
Additional badyzes from DECLARE-TIMI 58 are planned. Kato noted that several other ongoing trials are investigating SGLT2 inhibitors in patients with heart failure, which should provide additional information in this population. These trials include Dapa-HF and EMPEROR-Reduced in the HFrEF and DELIVER population, PRESERVED-HF and EMPEROR-conserved in the HFpEF population. – by Katie Kalvaitis
Reference s :
Kato ET. Last Minute Clinical Trials IV. Presented at: Scientific Session of the American College of Cardiology; March 16-18, 2019; New Orleans.
Kato ET, et al. Circulation. 2019; doi: 10.1161 / CIRCULATIONAHA.119.040130.
Disclosure : The DECLARE-TIMI 58 study was funded by AstraZeneca.
Deepak L. Bhatt
NEW ORLEANS – Treatment with SGLT2 inhibitor dapagliflozin has reduced the number of hospitalizations badociated with heart failure in patients with a wide range of left ventricular ejection fractions and could offer even better benefits with lower CV mortality and mortality in patients with reduced ejection fraction, researchers at the American College of Scientific Session in Cardiology reported.
In all of the DECLARE-TIMI 58 CV results, dapagliflozin 10 mg (Farxiga, AstraZeneca) reduced the composite endpoint of CV death and hospitalization for heart failure in 4 patients. years, mainly because of the reduction in the number of hospitalizations for heart failure, in a large population of patients 2 diabetes.
"However, the impact of basic LVEF and the clinical benefit of SGLT2 inhibitors are unknown," Eri T. Kato, MD, doctorate cardiologist from Kyoto University in Japan, said during the presentation of the last-minute clinical trial.
New subbadysis
The prespecified subbadysis was to examine the clinical benefit of dapagliflozin in patients with and without HFrEF.
Of the 17,160 patients with type 2 diabetes and established or multiple risk factors for atherosclerotic CVD included in the DECLARE-TIMI 58 trial, baseline EF was available out of 5,202. Initially, 88.4% were Had no history of HF, 7.7% had a HF without reduced FE and 3.9% had HFrEF, defined as an FE less than 45%.
Patients with dapagliflozin badigned to HFrEF were 38% less likely to be hospitalized for heart failure or to die from CV, compared to those receiving placebo (HR = 0.62, 95% CI, 0, 45-.86). According to the researchers, this was a significantly greater reduction than the 12% decrease in the probability of events in patients without HFrEF (HR = 0.88, 95% CI, 0%). , 76-1.02). The effect of dapagliflozin on treatment was similar in patients with HF without known EF (HR = 0.88, 95% CI, 0.66-1.17) and those without HF ( HR = 0.88, 95% CI, 0.74 to 3.03), the researchers wrote a simultaneous publication in Circulation.
Treatment with dapagliflozin reduced the rate of hospitalizations for heart failure among all patients, regardless of EF or HF status at the start of the study, according to the results.
In addition, patients with dapagliflozin badigned to HFrEF had a 45% lower CV death rate (HR = 0.55, 95% CI, 0.34-0.9) and an all-cause mortality rate (HR). = 0.59, 95% CI, 0.4-0.88) versus placebo. According to Kato, researchers have not observed these benefits in patients without HFrEF.
"A subgroup mortality benefit in this trial with a neutral overall effect on mortality should be interpreted with caution," Kato said during the presentation.
PAGE BREAK
"The ejection fraction is a powerful tool"
The large DECLARE-TIMI 58 trial was conducted at 882 sites in 33 countries.
This new badysis, presented in CAC 2019, is the first to examine whether the benefits of dapaliflozin can be predicted on the basis of the LVEF.
Inhibitors of SGLT2 have drawn attention to the reduction of cardiovascular risk, empagliflozin (Jardiance, Boehringer Ingelheim / Eli Lilly) gaining an expanded indication in 2017. More recently, canagliflozin (Invokana, Janssen) has also obtained an expanded indication from the FDA for a risk reduction CV diabetes type 2.
At present, dapagliflozin is not indicated to reduce the risk of cardiovascular events, CV death or hospitalization due to heart failure.
"The use of dapagliflozin, an inhibitor of SGLT2, is beneficial in reducing the number of hospitalizations for heart failure in patients with a wide range of left ventricular ejection fraction, but patients with a reduced ejection fraction could derive an even greater benefit, "Kato said in a press release. "The clinical implication of this discovery is that the ejection fraction is a powerful tool for identifying the most at-risk individuals who may benefit particularly from SGLT2 inhibitors."
Talk with Cardiology today Deepak L. Bhatt, MD, MPH, A DECLARE-TIMI 58 trial researcher said: "It is encouraging to see diabetes trials presented at cardiology meetings such as: [ACC 2019].
"Trials currently underway in diabetic or non-diabetic RF patients and on obtaining SGLT2 inhibitors or a placebo should help determine who benefits most from the inhibition of SGLT2, "he said. "These are exciting data for cardiologists, diabetologists, primary care physicians and, ultimately, we hope for the benefit of patients and the care provided to patients."
Additional badyzes from DECLARE-TIMI 58 are planned. Kato noted that several other ongoing trials are investigating SGLT2 inhibitors in patients with heart failure, which should provide additional information in this population. These trials include Dapa-HF and EMPEROR-Reduced in the HFrEF and DELIVER population, PRESERVED-HF and EMPEROR-conserved in the HFpEF population. – by Katie Kalvaitis
Reference s :
Kato ET. Last Minute Clinical Trials IV. Presented at: Scientific Session of the American College of Cardiology; March 16-18, 2019; New Orleans.
Kato ET, et al. Circulation. 2019; doi: 10.1161 / CIRCULATIONAHA.119.040130.
Disclosure : The DECLARE-TIMI 58 study was funded by AstraZeneca.
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