Results of the analysis were published in the journal Advances In Therapy in an article titled, “Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.“
IPF patients are typically older, male, and have a history of smoking — all of which are also risk factors for heart disease. Indeed, cardiovascular disease is a common, and serious, disorder among people with IPF.
Esbriet, marketed by Genentech, became one of the first treatments approved for IPF by the U.S. Food and Drug Administration (FDA) in 2014. However, the effects of this medication in terms of heart health have never been thoroughly assessed. That’s where the new study comes in.
Researchers evaluated data from three previous clinical trials (NCT00287716, NCT00287729, and NCT01366209) that included information on 1,247 people with IPF. Among them, 623 were treated with Esbriet (2,403 mg/day), while 624 received placebo. The two groups were similar in terms of demographics: the average age was 68 years, almost three-quarters (74%) were male, and most were previous (63.4%) or current (2.0%) smokers.
Rates of other risk factors, like high blood pressure, were similar between the two groups. Also similar were usage rates for other heart-related medications, including blood thinners and cholesterol-lowering drugs.
Participants were followed up for a median of approximately one year.
“Aside from older age and male sex, the most common CV [cardiovascular] risk factors at baseline were smoking, hypertension, obesity, hypercholesterolemia, and hyperlipidemia,” the researchers said.
The results showed no statistically significant differences between the Esbriet group and the placebo group in rates of serious cardiac events (1.8% vs. 2.9%).
Non-fatal heart attacks (0.5% vs. 0.8%), and non-fatal stroke (0.6% vs. 1.0%) also occurred at comparable rates between the two groups. So did the rate of bleeding events (3.7% vs. 4.3%) and death due to cardiovascular disease (0.5% vs. 0.8%). There was no difference, between the two groups, in terms of time to the first serious cardiac or bleeding event.
Furthermore, taking Esbriet in combination with other heart-related medications was beneficial for all therapies analyzed with just one exception. The researchers found there was no statistical benefit for taking the anticoagulant heparin with, as compared to without, Esbriet.
“The benefit of pirfenidone [Esbriet] on clinical outcomes did not appear to be adversely impacted by use of several concomitant CV [cardiovascular] medication classes, including warfarin, antiplatelet agents, and statins,” the researchers said.
Overall, the data suggested that taking Esbriet, along with the simultaneous use of cardiovascular medications, does not increase the risk of cardiac problems in people with IPF.
The team noted, however, that additional research with more participants is needed to fully understand the benefits and risks of using Esbriet in combination with other heart medications.
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