(RxWiki News) Although diabetes can increase heart-related risks, some treatments for diabetes may pose health risks as well. A new medication, however, did not appear to heighten the likelihood of having a severe cardiac event.
To make sure that new therapies to treat type 2 diabetes are safe, the US Food and Drug Administration (FDA) requires manufacturers to demonstrate that a therapy will not result in an unacceptable increase in cardiovascular risk.
A recent investigation has found that the diabetes treatment alogliptin (brand name Nesina) did not pose additional risk to those who have been hospitalized with heart attack or unstable angina (chest pain when the heart does not get enough blood flow).
"Ask a pharmacist about side effects of your diabetes medication."
William White, MD, from the University of Connecticut School of Medicine in Farmington, Connecticut and the chair of the study's steering committee, and fellow scientists analyzed data on 5,380 diabetes patients who had acute coronary syndromes — defined here as having had a heart attack or unstable angina requiring hospitalization.
Selected from 898 centers in 49 countries, these participants were randomly assigned to receive either alogliptin or a placebo (a dummy pill that has no effect). Alogliptin has been shown to control blood sugar levels, but it does not cure diabetes.
The participants also continued to take standard-of-care treatment for type 2 diabetes and possible cardiovascular risk factors.
Depending on their kidney condition, patients received varying doses of medication — about 71 percent received 25 milligrams, 26 percent received 12.5 milligrams and about 3 percent received 6.25 milligrams daily.
Looking at the rate of cardiovascular death, heart attack and stroke collectively, the researchers observed virtually no difference between the alogliptin and placebo groups.
After an average follow-up of 18 months, and up to 40 months, the rate of cardiovascular death, heart attack and stroke among alogliptin-treated patients was 11.3 percent, compared to 11.8 percent for the placebo users.
"[The study] represents the first cardiovascular safety trial of an antidiabetic drug in patients with acute coronary syndromes,” said Dr. White in a statement.
“Hence, for those who are likely candidates for the drug in clinical practice with elevated cardiovascular risk, including those with a recent acute coronary syndrome, it is reassuring that alogliptin does not increase cardiovascular morbidity [incidence of disease] or mortality [death],” he said.
Alogliptin is an antihyperglycemic agent, meaning it counteracts high levels of blood sugar. At the end of the study, the alogliptin patients had significantly lowered their blood sugar levels (measured as glycated hemoglobin) compared with the placebo patients.
Alogliptin is in a class of medications called DPP-4 inhibitors. DPP-4 (dipeptidyl peptidase IV) is an enzyme that shuts down gastrointestinal hormones called incretins. When DDP-4 is blocked by these medications, the incretins can get back to work increasing insulin secretion and lowering blood sugar.
Registered pharmacist Jason Poquette, BPharm, RPh, told dailyRx News, “The study only compared alogliptin to placebo and not to other DPP-4 inhibitors, but I believe the study will help physicians navigate the options currently available."
Poquette advises his patients who are prescribed alogliptin to watch out for negative side effects and symptoms. “Although rare, pancreatitis can occur, which typically presents itself with severe abdominal pain and/or vomiting. Common side effects include stuffy or runny nose, as well as headache or cold symptoms. These are typically mild.
"Always check with your doctor or pharmacist before taking any additional medications while taking alogliptin,” he said.
While the investigation satisfied FDA requirements proving cardiovascular safety, the research did not find that alogliptin had any heart benefits. The authors noted that no diabetes medication has of yet been identified as beneficial to the heart.
"The findings could guide clinicians to choose among the many antidiabetic agents available when treating patients with type 2 diabetes and very high cardiovascular risk," Dr. White said.
This study was published on September 2 in The New England Journal of Medicine and presented at the European Society of Cardiology Congress. It was funded by Takeda Development Center Americas, Inc.