Samara Rosenfeld

 was originally published on HCPLive.com.

Findings of a recent study suggest empagliflozin is associated with a decreased risk of hospitalization for heart failure and a similar risk of myocardial infarction or stroke in routine clinical care.

The findings were presented as part of the 

American Diabetes Association’s (ADA’s) 80th Virtual Scientific Sessions

.

In a previous trial, EMPA-REG OUTCOME, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, and hospitalization for heart failure by 35% in patients with type 2 diabetes and established cardiovascular disease. The EMPRISE study aimed to assess comparative effectiveness, safety, healthcare utilization, and cost of empagliflozin in patients with type 2 diabetes.

Elisabetta Patorno, MD, DrPH, and a team of investigators used data from Medicare and 2 US commercial claims datasets. The team collected data on empagliflozin for 5 years from August 2014-September 2019. The objective of the study was to analyze the data over 3 years from 2014-2017 to assess selected effectiveness and safety outcomes within 39,169 pairs of 1:1 propensity score-matched patients 

18 years old with type 2 diabetes initiating EMPA or a DPP-4 inhibitor (DPP-4i).

For effectiveness outcomes, the team was interested in hospitalizations for heart failure, defined as a heart failure discharge diagnosis in the primary (specific) or in any position (broad), a composite of myocardial infarction and stroke, and all-cause mortality (Medicare only). Safety outcomes included lower limb amputations, bone fractures, diabetic ketoacidosis, and acute kidney injury.

Of the more than 39,000 patients included in the study, the mean age for empagliflozin was 60.25 years old and 60.28 years old for the DPP-4i group. A majority of the patients were female in both groups (54% vs 54%). Slightly more patients had a history of cardiovascular disease in the empagliflozin group (28% vs 27.8%).

In a comparison with DPP-4i, EMPA had a reduced risk of hospitalizations for heart failure (specific, .46; .3-.73; broad, .63; .51-.77), a similar risk of myocardial infarction or stroke (HR, .89; 95% CI, .73-1.09), and a reduced risk of all-cause mortality (HR, .52; 95% CI, .36-.76) in Medicare. There was a mean follow-up of 178 days and EMPA was associated with a decreased risk of acute kidney injury (HR, .64; 95% CI, .53-.77), an increased risk of diabetic ketoacidosis (HR, 1.56; 95% CI, 1-2.44), and a similar risk of lower limb amputations and fractures.

“While the number of events in this early assessment are still small for some of the safety outcomes, the data observed in this study are consistent with the currently available information on the safety profile of empagliflozin,” Patorno and the investigators wrote.

In routine care, the effectiveness profile of empagliflozin was consistent with randomized controlled trial findings and safety outcomes similar to previously documented information.

The study, “

Effectiveness and safety of empagliflozin in routine care patients: interim results from the EMPagliflozin comparative effectIveness and SafEty (EMPRISE) study

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Findings of a recent study suggest empagliflozin is associated with a decreased risk of hospitalization for heart failure and a similar risk of myocardial infarction or stroke in routine clinical care.

ADA 2020: Decreasing Risk of Heart Failure Hospitalization With Empagliflozin 

Overweight, hypertensive patients who enrolled in a self-administered, internet-based health management program had better outcomes than patients who did not join the program, according to recent study findings.

Juan Francisco Lison, MD, PhD, and a team of colleagues investigated the efficacy in terms of body composition and blood pressure parameters of an internet-based intervention. The program had different modules and learning techniques to promote lifestyle changes including physical activity and healthy eating in patients with obesity and hypertension.

Lison, from the Department of Medicine at Cardenal Herrera University in Spain, and the investigators included adults between 18-65 years old with hypertension and who were overweight (BMI >24.9 kg/m2 and <30 kg/m2) or had type 1 obesity (BMI >29.9 kg/m2 and <35 kg/m2). The investigators defined hypertension as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, or current use of antihypertensive medication.

Patients were excluded if they had a diagnosis of diabetes, previous ischemic heart disease, cerebrovascular disease, or a severe psychiatric disorder; if they took >3 antihypertensive drugs; had physical impairments precluding participation in physical activity; received any treatment for weight loss elsewhere; or had no access to internet.

The study included 105 participants who were randomly assigned either to the three-month internet-based intervention group (55 patients) or the wait-list control group (50).

The intervention program was called “Live better,” and those in the group received usual medical care and a three-month multimedia, interactive, and self-administered online program comprised of 9 modules. The modules focused on obesity and hypertension and were presented on a webpage which aimed to progressively establish healthy eating habits and increase the patient’s physical activity levels.

Each of the first 5 modules were activated 1 per week, and modules 6-9 were activated every 2 weeks.

Modules included psychoeducation about the meaning of a healthy lifestyle and how to achieve it on a daily basis. Techniques included self-instruction, self-reinforcement, behavioral recording, and homework.

For those in the wait-list control group, patients received standard medical care focused on reducing their cardiovascular risks factors. Standard care included antihypertensive prescription; written lifestyle advice; moderate salt restriction with a list of recommended foods; a low-calorie diet; and advice for physical activity.

The team measured BMI using a body-fat analyzer and used other tests to measure secondary outcomes.

Overall, 510 participants were screened, and 105 were deemed eligible. A two-way analysis showed a significant decrease in BMI, body fat mass, and blood glucose after 3 months in the intervention group, with moderate to large effect size for BMI and body fat mass. There was a borderline significant trend (P=.05) for diastolic blood pressure and insulin.

In the wait-list control group, there was a significant increase in BMI and insulin.

In the intervention and control groups, there was a statistically significant increase in the functional capacity for aerobic exercise.

At 12-months of follow up, there were significant improvements in BMI (mean difference [MD], −.4; 95% CI, −.1 to −.6; P=.005), body fat mass (MD, −2.4; 95% CI, −1.1 to −3.6; P <.001), diastolic blood pressure (MD, −1.8; 95% CI, −.2 to −3.3; P=.03), and blood glucose levels (MD, −2; 95% CI, 0 to −4; P=.04).

Nearly 75% of the intervention group completed the nine-module program.

The findings suggested that the tailored approach for delivering lifestyle changes virtually to patients who were obese with hypertension had positive health benefits.

Additional research could investigate the acceptability and cost-effectiveness of such programs in populations with varied sociodemographic status.

Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial

Author | Samara Rosenfeld

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ADA 2020: Decreasing Risk of Heart Failure Hospitalization With Empagliflozin

Study Finds Internet Based Health Management Has Benefits