Meeting News Coverage

Cardiometabolic Health Congress highlights latest research on CVD, diabetes, obesity

BOSTON — The latest innovative research in diabetes, hypertension, lipids, obesity and thrombosis was analyzed by experts at the Cardiometabolic Health Congress.

Robert H. Eckel, MD, FAHA, professor of medicine, physiology and biophysics and the Charles A. Boettcher II chair in atherosclerosis at University of Colorado Anschutz Medical Campus and past president of the American Heart Association, said the trials selected for discussion are those that offer useful information that can be employed in day-to-day practice.

Update on diabetes

Data continue to amass on CV risks related to drugs for the treatment of diabetes, according to Jay S. Skyler, MD, MACP.

As an example, a recent examination of a component of the secondary endpoint of the SAVOR-TIMI 53 trial found that patients assigned the dipeptidyl-peptidase IV inhibitor saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) had a higher rate of hospitalization for HF compared with those assigned placebo at 180 days (HR=1.8; 95% CI, 1.29-2.55), 360 days (HR=1.46; 95% CI, 1.15-1.88) and 720 days (HR=1.27; 95% CI, 1.07-1.51)

“[The higher rate of hospitalization] was seen early on and continued to be seen,” Skyler, professor of medicine, pediatrics and psychology at the University of Miami Miller School of Medicine and deputy director for clinical and academic programs at the Diabetes Research Institute, Miami, said during a presentation. “The increased risk was highest among those with elevated levels of natriuretic peptide, prior HF or chronic kidney disease.”

In contrast, Skyler said an evaluation of the EXAMINE trial of alogliptin (Nesina, Takeda Pharmaceuticals), another DPP-IV inhibitor, demonstrated no effect on any HF endpoints, including hospitalization for HF.

The two trials presented conflicting results on DPP-IV inhibition in this patient population. “Why one [trial demonstrated risk] and the other didn’t, I have no clue,” he said.

Another important study for physicians who care for patients with diabetes was an analysis of the ACCORD trial showing that intensive glucose control was associated with a lower rate of MI compared with standard glucose control. Patients in the analysis assigned intensive control also had, or showed a trend toward, lower rates of coronary revascularization and unstable angina, he said.

Advances in hypertension

Physicians who care for patients with hypertension learned recently from an analysis from the Nurses’ Health Study showing that hypertensive women had a higher risk for psoriasis compared with normotensive women who did not use any hypertensive medications. This finding was consistent regardless of whether women with hypertension used medication, Keith C. Ferdinand, MD, FACC, FAHA, professor of clinical medicine and cardiology at Tulane University School of Medicine, New Orleans, said. This analysis also suggested a trend toward an association between beta-blocker use and psoriasis in women, he said.

Keith C. Ferdinand

Keith Ferdinand

“There have now been several studies that suggest that these inflammatory conditions are related to [CV] risk and, specifically for psoriasis, an increase in [BP],” he said.

Ferdinand also discussed several other studies of note on sodium intake and risk for BP. “There seems to be an increase in [BP] with higher degrees of sodium; it increases with age,” he said. For example, one study found elevated CV risk when sodium levels were too high or too low. However, a meta-analysis reported that 1.65 million CV deaths in 2010 could be attributed to sodium consumption above 2 g/day.

Recent developments in lipids

One of the most important developments in lipid control in recent years is the advent of PCSK9 inhibitors, which have so far demonstrated high levels of LDL reduction, Christie M. Ballantyne, MD, FACC, professor of medicine, chief of cardiology and CV research, and director of the Center for Cardiovascular Disease Prevention at Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, said here.

Christie M. Ballantyne, MD

Christie M. Ballantyne

“There are multiple outcome studies ongoing,” including ODYSSEY Outcomes for alirocumab (Sanofi/Regeneron), FOURIER for evolocumab (Amgen), and SPIRE-1 and SPIRE-2 for bococizumab (Pfizer), he said. “Some [studies of] other inhibitors are in early phases.”

Also of note is the emergence of ETC-1002 (Esperion Therapeutics), which is designed to inhibit ATP-citrate lyase and activates AMP-activated protein kinase, Ballantyne said. In the ETC-1002-006 study, patients assigned ETC-1002 had a 32% reduction in LDL after 8 weeks, compared with 3.3% for those assigned placebo (P=.0001), he said.

Progress in obesity

Publication of the STAMPEDE trial marks an important development for the treatment of obese patients. In that study, obese patients with type 2 diabetes who underwent bariatric surgery had improved glycemic control at 3 years compared with patients who received intensive medical management, according to Eckel. While the primary endpoint of STAMPEDE was an “impressive” target of HbA1c ≤6%, it was achieved by 5% of the medical therapy group compared with 37.5% of the gastric bypass group (P<.001) and 24.5% of the sleeve gastrectomy group (P=.012) at 3 years, he said.

“Moreover, if you look at the average number of medications, there were major impacts of both bariatric approaches compared to medical therapy alone,” Eckel said.

Also of note are studies of aspiration therapy for obese patients, Eckel said. Thus far, there are data on three small proof-of-principle United States trials, he said. In those trials, patients aspirated between 18% and 29% of calories after each meal, depending on how large the meal was and how long after the meal aspiration occurred. Almost all patients assigned aspiration therapy achieved at least 25% excess weight loss at 52 weeks, compared to approximately 25% of controls, he said.

New data on thrombosis

The recent presentation of data from the ATLANTIC study at the European Society of Cardiology Congress in August represents an important advance for the treatment of thrombosis, Deepak L. Bhatt, MD, MPH, FACC, FAHA, FESC, professor of medicine at Harvard Medical School and executive director of the interventional cardiovascular program at the Brigham and Women’s Hospital Heart and Vascular Center, said.

Deepak L. Bhatt, MD, MPH

Deepak L. Bhatt

ATLANTIC enrolled patients with STEMI planned for PCI. Most endpoints revealed no difference between ticagrelor (Brilinta, AstraZeneca) administered pre-hospital or in-hospital; however, definite stent thrombosis up to 30 days was observed less often in the pre-hospital ticagrelor group (OR=0.19; 95% CI, 0.04-0.86). “We need to be cautious. [Definite stent thrombosis] is a secondary endpoint — one of many,” said Bhatt, who is chief medical editor of Cardiology Today’s Intervention. “[There was] no excess in major bleeding seen with ticagrelor pretreatment, so if you’re going to be using ticagrelor anyway in that patient with STEMI undergoing primary PCI, there is certainly no harm in doing it a little bit earlier, and potentially some benefit.”

Bhatt also said the TRA 2P TIMI 50 study of vorapaxar (Zontivity, Merck), recently approved by the FDA for reduction of atherothrombotic events in patients with a history of MI or peripheral artery disease, has important implications. “It is a new way of inhibiting platelets with an oral medication,” he said. – by Erik Swain

For more information:

Ballantyne CM, Bhatt DL, Eckel RH, Ferdinand KC and Skyler JS. Late-Breaking Clinical Trials and FDA Update. Presented at: Cardiometabolic Health Congress; Oct. 22-25, 2014; Boston.

Disclosure: Ballantyne, Bhatt, Eckel, Ferdinand and Skyler report financial relationships with various pharmaceutical companies.

BOSTON — The latest innovative research in diabetes, hypertension, lipids, obesity and thrombosis was analyzed by experts at the Cardiometabolic Health Congress.

Robert H. Eckel, MD, FAHA, professor of medicine, physiology and biophysics and the Charles A. Boettcher II chair in atherosclerosis at University of Colorado Anschutz Medical Campus and past president of the American Heart Association, said the trials selected for discussion are those that offer useful information that can be employed in day-to-day practice.

Update on diabetes

Data continue to amass on CV risks related to drugs for the treatment of diabetes, according to Jay S. Skyler, MD, MACP.

As an example, a recent examination of a component of the secondary endpoint of the SAVOR-TIMI 53 trial found that patients assigned the dipeptidyl-peptidase IV inhibitor saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) had a higher rate of hospitalization for HF compared with those assigned placebo at 180 days (HR=1.8; 95% CI, 1.29-2.55), 360 days (HR=1.46; 95% CI, 1.15-1.88) and 720 days (HR=1.27; 95% CI, 1.07-1.51)

“[The higher rate of hospitalization] was seen early on and continued to be seen,” Skyler, professor of medicine, pediatrics and psychology at the University of Miami Miller School of Medicine and deputy director for clinical and academic programs at the Diabetes Research Institute, Miami, said during a presentation. “The increased risk was highest among those with elevated levels of natriuretic peptide, prior HF or chronic kidney disease.”

In contrast, Skyler said an evaluation of the EXAMINE trial of alogliptin (Nesina, Takeda Pharmaceuticals), another DPP-IV inhibitor, demonstrated no effect on any HF endpoints, including hospitalization for HF.

The two trials presented conflicting results on DPP-IV inhibition in this patient population. “Why one [trial demonstrated risk] and the other didn’t, I have no clue,” he said.

Another important study for physicians who care for patients with diabetes was an analysis of the ACCORD trial showing that intensive glucose control was associated with a lower rate of MI compared with standard glucose control. Patients in the analysis assigned intensive control also had, or showed a trend toward, lower rates of coronary revascularization and unstable angina, he said.

Advances in hypertension

Physicians who care for patients with hypertension learned recently from an analysis from the Nurses’ Health Study showing that hypertensive women had a higher risk for psoriasis compared with normotensive women who did not use any hypertensive medications. This finding was consistent regardless of whether women with hypertension used medication, Keith C. Ferdinand, MD, FACC, FAHA, professor of clinical medicine and cardiology at Tulane University School of Medicine, New Orleans, said. This analysis also suggested a trend toward an association between beta-blocker use and psoriasis in women, he said.

Keith C. Ferdinand

Keith Ferdinand

“There have now been several studies that suggest that these inflammatory conditions are related to [CV] risk and, specifically for psoriasis, an increase in [BP],” he said.

Ferdinand also discussed several other studies of note on sodium intake and risk for BP. “There seems to be an increase in [BP] with higher degrees of sodium; it increases with age,” he said. For example, one study found elevated CV risk when sodium levels were too high or too low. However, a meta-analysis reported that 1.65 million CV deaths in 2010 could be attributed to sodium consumption above 2 g/day.

PAGE BREAK

Recent developments in lipids

One of the most important developments in lipid control in recent years is the advent of PCSK9 inhibitors, which have so far demonstrated high levels of LDL reduction, Christie M. Ballantyne, MD, FACC, professor of medicine, chief of cardiology and CV research, and director of the Center for Cardiovascular Disease Prevention at Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, said here.

Christie M. Ballantyne, MD

Christie M. Ballantyne

“There are multiple outcome studies ongoing,” including ODYSSEY Outcomes for alirocumab (Sanofi/Regeneron), FOURIER for evolocumab (Amgen), and SPIRE-1 and SPIRE-2 for bococizumab (Pfizer), he said. “Some [studies of] other inhibitors are in early phases.”

Also of note is the emergence of ETC-1002 (Esperion Therapeutics), which is designed to inhibit ATP-citrate lyase and activates AMP-activated protein kinase, Ballantyne said. In the ETC-1002-006 study, patients assigned ETC-1002 had a 32% reduction in LDL after 8 weeks, compared with 3.3% for those assigned placebo (P=.0001), he said.

Progress in obesity

Publication of the STAMPEDE trial marks an important development for the treatment of obese patients. In that study, obese patients with type 2 diabetes who underwent bariatric surgery had improved glycemic control at 3 years compared with patients who received intensive medical management, according to Eckel. While the primary endpoint of STAMPEDE was an “impressive” target of HbA1c ≤6%, it was achieved by 5% of the medical therapy group compared with 37.5% of the gastric bypass group (P<.001) and 24.5% of the sleeve gastrectomy group (P=.012) at 3 years, he said.

“Moreover, if you look at the average number of medications, there were major impacts of both bariatric approaches compared to medical therapy alone,” Eckel said.

Also of note are studies of aspiration therapy for obese patients, Eckel said. Thus far, there are data on three small proof-of-principle United States trials, he said. In those trials, patients aspirated between 18% and 29% of calories after each meal, depending on how large the meal was and how long after the meal aspiration occurred. Almost all patients assigned aspiration therapy achieved at least 25% excess weight loss at 52 weeks, compared to approximately 25% of controls, he said.

New data on thrombosis

The recent presentation of data from the ATLANTIC study at the European Society of Cardiology Congress in August represents an important advance for the treatment of thrombosis, Deepak L. Bhatt, MD, MPH, FACC, FAHA, FESC, professor of medicine at Harvard Medical School and executive director of the interventional cardiovascular program at the Brigham and Women’s Hospital Heart and Vascular Center, said.

Deepak L. Bhatt, MD, MPH

Deepak L. Bhatt

ATLANTIC enrolled patients with STEMI planned for PCI. Most endpoints revealed no difference between ticagrelor (Brilinta, AstraZeneca) administered pre-hospital or in-hospital; however, definite stent thrombosis up to 30 days was observed less often in the pre-hospital ticagrelor group (OR=0.19; 95% CI, 0.04-0.86). “We need to be cautious. [Definite stent thrombosis] is a secondary endpoint — one of many,” said Bhatt, who is chief medical editor of Cardiology Today’s Intervention. “[There was] no excess in major bleeding seen with ticagrelor pretreatment, so if you’re going to be using ticagrelor anyway in that patient with STEMI undergoing primary PCI, there is certainly no harm in doing it a little bit earlier, and potentially some benefit.”

Bhatt also said the TRA 2P TIMI 50 study of vorapaxar (Zontivity, Merck), recently approved by the FDA for reduction of atherothrombotic events in patients with a history of MI or peripheral artery disease, has important implications. “It is a new way of inhibiting platelets with an oral medication,” he said. – by Erik Swain

For more information:

Ballantyne CM, Bhatt DL, Eckel RH, Ferdinand KC and Skyler JS. Late-Breaking Clinical Trials and FDA Update. Presented at: Cardiometabolic Health Congress; Oct. 22-25, 2014; Boston.

Disclosure: Ballantyne, Bhatt, Eckel, Ferdinand and Skyler report financial relationships with various pharmaceutical companies.

    See more from Cardiometabolic Health Congress