Arthritis Biotechnology Clinical Trials Pharmaceuticals Prescriptions

New Study Shows Common NSAIDs can cause more Harm than Good

Many patients around the world, are prescribed non-steroidal anti-inflammatory drugs (called NSAIDs) for the treatment of painful conditions, fever and inflammation. But the treatment also comes with side effects, including the risk of ulcers and increased blood pressure. A major new study from Denmark complied new research that demonstrated that a common arthritis medicine is particularly dangerous for heart patients.

The study also uncovered that older types of arthritis medicine, which have not previously been in focus, also appear to be dangerous for the heart. The study, which was carried out in collaboration between 14 European universities and hospitals, including a number of leading European heart specialists, was published in the most prestigious European journal of heart medicine, European Heart Journal.

“It’s been well-known for a number of years that newer types of NSAIDs – what are known as COX-2 inhibitors, increase the risk of heart attacks. For this reason, a number of these newer types of NSAIDs have been taken off the market again. We can now see that some of the older NSAID types, particularly Diclofenac, are also associated with an increased risk of heart attack and apparently to the same extent as several of the types that were taken off the market,” says Morten Schmidt, MD and PhD from Aarhus University, who is in charge of the research project.

Global Issue Around the World

Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, are NSAIDs which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.

Late last year, a new NSAID candidate KIT-302 from Kitov Pharmaceuticals showed good promise as a combination pill that simultaneously treats joint pain and elevated levels of blood pressure. Kitov’s NSAID is a combination of celecoxib and the calcium channel blocker amlodipine.  In Kitov’s phase 3 study, this combination was documented to lower blood pressure better than amlodipine alone, thus enhancing the cardiovascular safety of the amlodipine. In contrast, and consistent with multiple prior publications, celecoxib alone raised blood pressure: An effect that correlates with an increased adverse cardiovascular event rate.

“The primary efficacy of the trial was to show that a combination of the two components of KIT-302, lowers daytime systolic blood pressure by at least 50 percent. Recognizing the cardiovascular dangers associated with NSAID use, Kitov has been working to bring a safer NSAID to market for the past three years,” explained Kitov’s Chairman and Chief Medical Officer, Dr, Paul Waymack.

“Many European countries consume more of these drugs than Denmark. But we can still do better and it’s often the case that paracetamol, physiotherapy, mild opioids or other types of NSAIDs with less risk for the heart would be better for the patients. Of course, the recommendations that have been introduced following our study and its review of the heart-related risks are a big step in the right direction in relation to patient safety,” says Morten Schmidt.