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Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
FROM BMJ
Key clinical point: Patients taking high doses of certain NSAIDS had significantly higher odds of hospital admission for heart failure, compared with controls not currently taking the medications.
Major finding: The odds of hospitalization for heart failure increased by 19% overall for adults currently using certain NSAIDS and doubled for users of certain NSAIDs at high doses.
Data source: The data come from approximately 10 million hospital admissions taken from databases in the Netherlands, Italy, Germany, and the United Kingdom.
Disclosures: The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
