Health Rounds: Semaglutide pill Rybelsus matches heart benefits of injectable versions
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Novo Nordisk's (NOVOb.CO), opens new tab diabetes medicine Rybelsus, an oral form of the GLP-1 drug semaglutide, provides similar cardiovascular benefits as the injectable forms of the drug, researchers reported at the American College of Cardiology scientific meeting in Chicago.
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In a trial of 9,650 patients with type 2 diabetes, who had clogged heart arteries and/or chronic kidney disease, those taking Rybelsus were overall 14% less likely to experience heart-related death, heart attack or stroke than those who received a placebo after an average follow-up of four years.
The researchers saw a 26% reduction in non-fatal heart attacks with oral semaglutide and a 12% reduction in non-fatal strokes, both of which 'are among the most common and devastating complications of diabetes,' study coauthor Dr. John Buse of the University of North Carolina School of Medicine said in a statement.
There was also a 7% lower rate of cardiovascular death with Rybelsus.
This level of risk reduction is in line with results from eight previous trials involving injectable GLP-1s, such as Novo's Ozempic and Eli Lilly's (LLY.N), opens new tab Trulicity, said study leader Dr. Darren McGuire of UT Southwestern Medical Center and Parkland Health in Dallas.
'The same cardiovascular benefits can be derived from the tablet that we've seen from the injectables before,' McGuire said in a statement.
Although the exact mechanism through which the drugs reduce cardiovascular risk is not known, their anti-inflammatory activity is thought to play a role.
The most common side effects reported in the study that was also published in The New England Journal of Medicine, opens new tab were gastrointestinal problems such as nausea, diarrhea, constipation and gas, which are also the most common side effects of injectable semaglutide.
'Semaglutide has been a mainstay of our efforts to reduce heart attack and stroke in people with diabetes,' Buse said. 'Having an oral option to deliver this highly effective therapy is a big advance.'
HEART FAILURE PATIENTS CAN STOP LIMITING FLUIDS
Heart failure patients do not benefit from restricted fluid intake, according to findings that may contradict current practice.
U.S. and European medical guidelines have long advised heart failure patients to limit their daily fluid intake to about six cups (1,500 milliliters), to help reduce fluid buildup in the lungs and extremities, but without much evidence to support this practice, researchers said at the ACC meeting.
In the trial of 504 patients with mild to moderate heart failure, there was no difference in health status after three months between individuals with unrestricted fluid intake compared with patients assigned to fluid restriction.
Nor were there any differences in safety outcomes, such as swelling or shortness of breath due to congestion from fluid overload in the body that occurs when the heart is too stiff or too weak to effectively pump blood, according to a report of the study published in Nature Medicine, opens new tab.
Patients in the fluid restriction group reported more problems with thirst, however.
There was a trend toward better health at three months among those with unrestricted fluid intake, but the difference between groups was not statistically significant and so could be due to chance.
'Our conclusion is that in patients with stable heart failure there is no need for fluid restriction,' study leader Dr. Roland van Kimmenade of Radboud University Medical Center in Nijmegen, Netherlands said in a statement.
MINIMALLY INVASIVE HEART PROCEDURES IMPROVING IN LOW-RISK PATIENTS
Physically fit patients who need heart procedures are traditionally referred for major surgery, but the benefits of minimally invasive procedures are starting to outweigh the disadvantages in these individuals, researchers reported at the ACC meeting.
In a trial called FAME 3, 1,500 relatively healthy patients with blockages in three coronary arteries, but not in the left main artery known as the 'widow maker', were recruited between 2014 and 2019.
They underwent either a percutaneous coronary intervention via a small incision through the skin, or coronary artery bypass grafting (CABG) surgery, which involves sawing through the breastbone and stopping the heart and requires weeks or months of recovery.
None of the patients was at particularly high risk for complications from open-heart surgery.
Researchers had earlier reported that one year into the study, the combined rate of death, stroke, heart attack, or need for a repeat procedure to reopen the arteries was higher in the minimally invasive group, suggesting the major surgery was still the best option for these patients.
But now, five years out, there is no significant difference in the composite of death, stroke, or heart attack between the two groups, the researchers say.
'This is the only study to compare CABG and PCI as they are currently used in cardiology – incorporating recent advances in surgical and minimally invasive techniques as well as in medical therapy – in patients with triple-vessel disease,' study leader Dr. William Fearon of Stanford University School of Medicine in California said in a statement.
Looking at the endpoints individually, rates of death and stroke were similar in the two groups, but PCI patients had higher risks for heart attack (8% vs 5%) and repeat revascularization (16% vs 8%) than the CABG group.
The narrowing of the outcomes difference between the two approaches is likely due to improved stent technology, the routine use of new techniques for selecting which arteries to treat with PCI, and greater patient adherence to medical therapy, Fearon's team said in The Lancet, opens new tab.
In a separate trial involving 1,478 relatively healthy patients who needed aortic valve replacement, rates of death or disabling stroke at five years were similar whether the valve was replaced through a small incision in the arm or via standard open-heart surgery, Dr. Michael Reardon of Houston Methodist Hospital and colleagues reported at the meeting and in the Journal of the American College of Cardiology, opens new tab.
However, in a third study of 1,618 patients who were at intermediate or high risk for surgical complications – also reported at the meeting and in the Journal of the American College of Cardiology, opens new tab - five-year outcomes were significantly better after minimally invasive procedures than after surgery, Reardon's team said.
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