Alternate statin-dosing protocol shows significant reductions in LDL and total cholesterol in previously statin-intolerant women.
Although statins have been found effective in treating coronary artery disease, adherence is often problematic because of side effects, including muscle pain and weakness, which prevent high-risk patients from receiving the optimal benefit from statin therapy. Despite the prevalence of this problem, the tolerability and effectiveness of alternate dosing in statin therapy has not been evaluated extensively.
Monday at the American Heart Association Scientific Sessions 2010, lead authors Margo Minissian, ACNP, and Noel Bairey Merz, MD, of the Women’s Heart Center at Cedars-Sinai Heart Institute in Los Angeles, presented results from a study that was designed to evaluate the effectiveness of a nurse practitioner (NP) alternate statin-dosing protocol to increase the adherence, tolerance, and reduction of lipid levels.
“What we had classified as statin-intolerant was not being able to tolerate daily, dosing so they had tried something else. Because they weren’t able to take an initial statin, they will sometimes be classified as statin-intolerant, really before they’ve tried other medications in the statin category,” Minissian said.
Researchers analyzed 15 women who tolerated alternate dosing who had prior statin intolerance. Women with prior statin intolerance were placed on rosuvastatin, torvastatin, pravastatin, or simvastatin for the reduction of total cholesterol, or low-density lipoprotein (LDL-C). Rosuvastatin was used most often because it has a half-life of 30 hours compared to others with typical half lives of four hours, Minissian said.
Patients were started on twice-weekly statin dosing for four weeks then titrated up one day a week as tolerated. Fasting baseline and follow-up lipid levels were obtained by chart review. Fifteen female patients were evaluated with a mean age of 62 and a mean BMI of 26. Overall, 60% had coronary artery disease, 60% had hypertension, 7% had diabetes, and 47% had a history of smoking.
Before initiating the NP alternate dosing protocol, 93% were intolerant to two or more statins with myalgias. Using the alternate dosing protocol, researchers found a mean 32% reduction in LDL -- to 84 from their highest previous mean LDL level of 134. The study authors also found a statistically significant 20% reduction in total cholesterol after starting the alternate dosing protocol. The number one side effect was a myalgia or muscle ache.
“Most patients want to take the drug you put them on, especially if they are afraid and they have chronic chest pain. I find that if I’m willing to work with patients, they are very willing to work with me,” Minissian said. “This study is important for nurses, especially nurse practitioners managing chronic disease states. Many of the women have ischemic heart disease as their diagnosis so they have a need to be on a statin.”
Minissian said that “It makes good logical sense that a little bit of statin is better than no statin at all. All of these women told me they can’t take a statin. The results are profound for someone who has obstructive coronary artery disease or ischemic heart disease. You could potentially save the life of someone who said they were unable to tolerate a statin.”