Simple solutions exist for patient compliance issues

Medical Device Daily Contributing Writer

CHICAGO – Some 40 million Americans have arthritis, and 100 million have low back pain. Another 100 million NSAID (non-steroidal anti-inflammatory drug) prescriptions are written each year for pain; 30% of which are for ibuprofen. Some 30% of patients taking NSAIDs will develop an ulcer; 100,000 of them will be hospitalized, and 20,000 of them will die.

So how is the pain managed without ulcers sneaking into the digestive tract? One way would be to have the patient take a gastro-protective agent along with the NSAID. The problem is that only 30% of the prescriptions written for NSAIDS are accompanied with a prescription for a gastro-protective drug.

The bigger problem is that patients don't comply even if given the prescription for the gastro-protective agent. Patients readily take their NSAID because should they forget to do so, the pain will remind them. But ulcers develop painlessly and without symptoms until the ulcer has progressed to the point of bleeding.

So it is only human nature to forget to take the drug that will prevent ulcers when there are no reminders until it is too late. If deaths from the gastrointestinal effects of NSAIDS were tabulated separately in the National Vital Statistics reports, these effects would equate to the 15th most common cause of death in the U.S.

At the 56th annual Digestive Disease Week (DDW) meeting held here, the first thing you notice (well, can't miss) when entering the enormous lakeside McCormick Place convention hall complex are end-to-end, tall banners draped alongside both halls promoting "Connect To Protect," an education program to educate physicians on risks associated with NSAID use.

Co-sponsored by the the American Gastroenterological Association (AGA; Bethesda, Maryland) and Horizon Therapeutics (Northbrook, Illinois), "Connect to Protect" was designed to increase awareness about the gastrointestinal (GI) risks associated with the use of NSAIDs such as ibuprofen, and to highlight the connection between NSAID use and GI risks.

The goal was to encourage patients and physicians to connect more often about ways to avoid NSAID-induced ulcers, including but not limited to GI protective co-therapy.

Horizon Therapeutics is a late-stage, privately held biopharmaceutical company that has developed an innovative proprietary combination drug of the most prescribed NSAID, ibuprofen, and the most potent H2 antagonist, famotidine, commonly referred to as Pepcid. By combining the two drugs, patients cannot take their ibuprofen without its accompanying gastro-protective agent; insuring patient compliance.

Two poster presentations on this drug and one oral presentation were made here, each demonstrating pain reduction with gastric acid suppression. Loren Laine, MD, of the University of Southern California (Los Angeles) Keck School of Medicine, presented "Does High-Dose Famotidine Reduce Gastric and Duodenal Ulcers in NSAID Users?"

The oral presentation included data from more than 1,300 patients who participated in the REDUCE 1 or REDUCE 2 study, whose primary objective was to compare patients treated with ibuprofen alone to patients treated with the combination drug to see if there was a difference in the development of ulcers over the course of the 24 week study.

Both groups had endoscopies at weeks 1, 8, 16 and 24. The single tablet combination ibuprofen-famotidine cohort developed significantly fewer endoscopically diagnosed gastric and/or duodenal ulcers than the group treated with ibuprofen alone.

"NSAIDS, such as ibuprofen, are among the most widely used drugs in the world," said Laine. "[They] are effective at treating pain, but they also increase the risk of developing ulcers in the stomach or intestines and the risk of developing ulcer complications, such as bleeding. Patients at increased risk of gastrointestinal ulcers may benefit from protective co-therapy, although many such patients do not receive or adhere to this co-therapy."

Now that the trials have been completed, Horizon will be submitting its data to the FDA and European Medicines Agency, with hopes of being on the market in late 2010 to early 2011. Who would have thought by combining a pain med with a gastro-protective agent there are hopes of eliminating 20,000 deaths a year?

Another life-threatening problem that depends on patient compliance is that of pediatric patients who have had a liver transplant and must take their meds religiously in order to avoid a rejection. Tamir Miloh, MD, assistant professor in pediatric hepatology and surgery, Mount Sinai Hospital (New York), took a look at the effectiveness of sending text messages to his patients in order to improve adherence and reduce organ rejection events.

Missing medication is especially dangerous since their bodies can reject the transplanted liver after only two missed doses of medication; and delayed timing of taking their meds causes wide fluctuations in the level of the medication in their bloodstream. Because young people are generally technologically savvy, Miloh sought to determine if sending text messages would result in improved compliance.

Forty-one young people with an average age of 15 were sent text messages at predetermined times reminding them to take their medication and were given 30 minutes to respond back that they had in fact taken the medication. If not, their caregiver was sent a text message.

To determine the effectiveness, he compared the number of rejections the year prior to the study with the number during the year of the study. In the prior year, there were 12 out of 41 patients who experienced a rejection event that required hospitalization due to improper medication dosage.

One year into this study, only two of the 41 patients have experienced a rejection event. "The implications for this study are vast because this practice could be used for any other chronic disease," said Miloh, who is currently conducting another randomized study with more patients.

Patient compliance not only saves lives, but also provides significant cost savings by avoiding unnecessary hospitalizations and expensive treatments to correct an avoidable problem. Cell phones are a lot less expensive than a liver transplant.