Over-the-counter Painkiller Associated With Increased Risk of Heart Problems

Highlights:

In a larger, randomized, controlled study, a common painkiller diclofenac has been linked to episodes of heart attacks and strokes compared to other painkillers.
Researchers suggest not allowing diclofenac to be available over the counter, and add an appropriate warning about its potential risks when it is prescribed.

The painkiller diclofenac was associated with an increased risk of cardiovascular events like heart attacks and strokes compared to use of no drug, paracetamol, or other traditional painkillers, says researchers from the Aarhus University Hospital in Denmark.

The study is published in The BMJ.

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‘Individuals starting on the traditional painkiller diclofenac are showing a relative increased risk of major adverse heart problems prompting researchers to say that it is time to acknowledge diclofenac’s potential health risk and to reduce its use.’

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Diclofenac is a common, widely used traditional non-steroidal anti-inflammatory drug, otherwise known as NSAID, used for treating pain and inflammation. However, until now, the cardiovascular risks of diclofenac and other traditional NSAIDs have not been compared in large randomized controlled trials.

Since it is available over the counter in most countries that makes its cardiovascular risk of public health and vital clinical importance, the European Medicines Agency has asked for a safety testing of diclofenac.

Study - Examining Cardiovascular Risks of Initiating Diclofenac

The study estimated the cardiovascular risks among patients who started on diclofenac versus patients who did not use any NSAIDs, who used the traditional NSAIDs, and those who used paracetamol, a non-NSAID painkiller.

The results for an entire period of 10 years were obtained from the Danish national registry data for more than 6.3 million adults who had filled out prescription records continuously for at least a year before study entry in January 1996.

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The average age of participants who initiated NSAIDs was 46 to 49 years, whereas it was 56 years for the participants who began paracetamol. The participants were divided into groups of people having low, moderate, and high baseline cardiovascular risk.

The results clearly pointed that starting diclofenac during the 10 year study period from 1996 to 2016 was linked to an increased rate of major adverse cardiovascular events like irregular heartbeat or flutter, ischemic stroke, heart failure, and heart attack within a month compared to starting ibuprofen or naproxen (traditional NSAIDs) or paracetamol.

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Heart attack is the death of the heart muscle due to loss of blood supply. Heart disease is the leading cause of death in the United States. Other names for heart attack include acute myocardial infarction, coronary thrombosis, and coronary occlusion.

The risk was seen in men and women of all ages and also at low strengths of diclofenac.

Compared to not having any NSAIDs, starting diclofenac caused an increased rate of cardiac death.

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Starting diclofenac caused an increased risk of upper gastrointestinal bleeding compared to people who started without any NSAIDs and ibuprofen or paracetamol but not with naproxen.

Next, they analyzed the results based on baseline cardiovascular risk. Compared to ibuprofen starters, diclofenac starters had one, seven, and sixteen additional events among patients at low, moderate and high baseline risk respectively.

Compared to naproxen starters, diclofenac starters had one, seven, and ten additional events among patients at low, moderate and high baseline risk respectively.

Compared to paracetamol starters, diclofenac starters had three, eight, and one additional event among patients at low, moderate and high baseline risk respectively.

Compared to having no NSAIDs, diclofenac starters had four, fourteen, and thirty-nine additional events among patients at low, moderate and high baseline risk respectively.

Two points to note in this study are -

# Although the relative risk (disease risk compared to other drugs) increases, the absolute risk (the risk that diclofenac will definitely cause cardiovascular events to happen) is low.
Also, the study is observational, and we cannot conclude cause and effect.

However, the study's sample size is larger than most previous studies combined and provides strong evidence to guide clinical decision making.

"Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite potential side effects," they write. "Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs," they conclude.

References:

NSAIDs: Do they increase my risk of heart attack and stroke? - (https://www.mayoclinic.org/diseases-conditions/heart-attack/expert-answers/nsaids-heart-attack-stroke/faq-20147557)
NSAIDs and the Risk of Heart Problems and Stroke - (https://www.arthritis.org/living-with-arthritis/treatments/medication/drug-types/nsaids/nsaids-heart-attack-stroke-risk.php)

Source-Medindia