LOS ANGELES—Clinical trial end points that focus on pain-free response—including two-hour pain-free response and sustained pain-free response—are more rigorous and better aligned with patients’ goals and expectations than end points focused on partial pain relief or delayed recurrence, according to research presented at the 54th Annual Scientific Meeting of the American Headache Society.
Clinicians’ choice of triptan for acute migraine management should take into account a large and growing body of efficacy, safety, and tolerability evidence from clinical trials, reported Stephen D. Silberstein, MD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, and his coinvestigators. Similarly, patients’ treatment goals and preferences should play a key role in therapeutic decisions and treatment choices.
Studies have shown that patients with migraine want rapid, sustained, and complete alleviation of their migraine pain. Achievement of these patient goals predicts favorable quality of life and facilitates patients’ return to normal functioning following a migraine attack.
Headache relief as an efficacy end point is defined as the percentage of patients whose headache intensity decreases within two hours. According to the International Headache Society (IHS), headache relief should be used in clinical trials not as a primary end point, but rather as a secondary end point, because of its poor alignment with patients’ treatment goals. Two-hour pain-free response is recommended by the IHS as a primary end point in migraine clinical trials. Sustained pain-free response, defined as the percentage of patients pain-free at two hours with no relapse for the next 48 hours, is “the ideal migraine treatment response and should be the ultimate goal in drug development,” according to the IHS Clinical Trials Subcommittee. This end point is simple, clinically relevant, and reflects patients’ treatment expectations.
Using two-hour pain-free response and sustained pain-free response as preferred goals, Dr. Silberstein and colleagues compared triptan treatment options. Among the oral triptans, meta-analysis data showed two-hour pain-free response in the range of 23% to 38% of patients, while two-hour pain-free response with subcutaneous sumatriptan was achieved in 60.7% of patients. Similarly, 24-hour sustained pain-free response with oral triptans was seen in 11% to 26% of patients, while 24-hour sustained pain-free response with subcutaneous sumatriptan was achieved in 35.4% of patients.
The researchers then compared time to maximum concentration (Tmax) for the various triptans (see Table). According to the researchers, clinical decision-making regarding migraine treatment options should take into account clinical trial evidence weighted toward trials that used the IHS-recommended end points of pain-free response—including two-hour pain-free response and sustained pain-free response—as well as patients’ treatment goals.
—Glenn S. Williams