$18.5M NIH grant to link NSAID benefit and risk

NSAIDs (nonsteroidal anti-inflammatory drugs) are commonly used for pain, both over-the-counter and prescription, but they don't all work for everyone, and a few people end up with severe side effects. The National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) has created the Personalized NSAID Therapeutics Consortium (Pentacon), awarding an $18.5 million grant to the international group, to find markers that could tag who would benefit, and who is at risk.

NSAIDs, such as ibuprofen, are now so commonly used that pretty much everyone has a strip in a handbag or desk drawer for that next headache, and more than 30 million Americans take OTC or prescription NSAIDs every day. These drugs make up the third-largest part of the pain market, and worldwide sales reached $9.3 billion in 2007. But for some people these very useful and popular drugs are limited by the side effects, from mild stomach upsets to life-threatening bleeding in the gut. And for some, even worse--Merck's ($MRK) Vioxx (rofecoxib), an NSAID targeting the enzyme COX-2, was voluntarily withdrawn from the market in 2004 after heart attacks, heart failure and strokes in a small proportion of patients.

"There's a great need to understand how people differ in their response to NSAIDs and how their use might be tailored to the needs and susceptibilities of the individual patient," says Garret FitzGerald of the Perelman School of Medicine at the University of Pennsylvania, who is heading up Pentacon.

The Pentacon project will involve 42 scientists from 22 institutions, and will use so-called "omics" technologies--genomics, proteomics and metabolomics--to find markers that explain how and why the drugs work (or don't work), allowing doctors to pick out the right drugs for the right patients, and use alternatives when the risks are too high.

"Hopefully this work will reduce to the level of an app, where a practitioner can enter information--a person's clinical details, with genomic and epigenomic data, for example, and after a test dose, drug levels and metabolic response--to receive an answer to whether you should be on an NSAID, and if so, which one, at what dose and whether you should keep taking it," says FitzGerald.

- read the press release