Ranolazine (Ranexa, Gilead) is an effective anti-anginal therapy in patients with refractory angina; however, at one year only 59 percent of patients remained on the drug, according to a scientific poster that will be presented at the American College of Cardiology (ACC) Scientific Sessions in New Orleans, April 1-3.
Patients with refractory angina, who have chronic chest pain but are not candidates for revascularization, have limited therapeutic options and significant limitations in their quality of life, the study authors wrote. Conversely, patients with chronic angina are often candidates for a procedure.
Ranolazine is approved for patients with chronic stable angina but has not been studied in refractory angina. The prospective Ranolazine Refractory Angina Registry Trial was designed to evaluate the safety, tolerability and effectiveness in RA patients.
"Refractory angina is a challenging and increasingly common clinical problem. These patients are often identified as 'no option patients' due to the lack of treatment choices," explained the study's senior author Timothy D. Henry, MD, interventional cardiologist at Minneapolis Heart Instituteฎ at Abbott Northwestern Hospital in Minneapolis.
In order to assess ranolazine for this patient population, the researchers enrolled 100 consecutive patients with class 3 or class 4 angina who were not candidates for revascularization.
The drug was found to be effective in more than 80 percent of patients, but at one year, only 59 percent of the patients remained on ranolazine. Of those remaining on ranolazine, 56 percent had at least a two class improvement in angina.
In the 41 patients who discontinued ranolazine usage, the reasons included: side effects which ranged from lightheadedness, numbness, tingling and constipation (15 patients); major adverse cardiac events, including heart attack (seven patients) or death (two patients); cost (five patients); ineffective (six patients); cost and ineffective (three patients); and for unknown reasons (two patients).
Henry said an approximate 40 percent discontinuation rate is fairly congruent with other medication discontinuation rates, such as statins and antiplatelet therapies. "In challenging economic times, cost is unfortunately going to play a larger role in the medication adherence," he said. "In this study, cost resulted in almost 10 percent of these patients to stop taking the medication." According to the American Academy of Family Physicians, a regimen of 500 mg orally twice-daily ranolazine costs approximately $206 a month.
Also, hospitalization due to angina was similar in the group that discontinued the medication and those patients that remained on ranolazine (32.5 percent versus 32.8 percent, respectively). "The high rate of hospitalization was not surprising but it was disappointing that an effective anti-anginal medication did not decrease the hospitalization rate," Henry said.
"Overall, we found that ranolazine is about 85 percent effective," Henry said. "These findings indicate that ranolazine is a reasonable choice for refractory angina, but it also demonstrates how difficult it can be to treat refractory angina."
The study was funded by the Minneapolis Heart Institute Foundation, in addition to a research grant from CV Therapeutics, the original developer of ranolazine, which was later purchased by Gilead.
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