LONDON—A simple, straightforward protocol for management of medication-overuse headache (MOH) has established its clinical utility in the large joint European/Latin American COMOESTAS study. "These findings confirm the efficacy, the usability worldwide, and the low economic cost of detoxifying patients with medication-overuse headache," Cristina Tassorelli, MD, PhD, said in presenting the COMOESTAS data at the Third European Headache and Migraine Trust International Congress.
The protocol used in COMOESTAS (Continuous Monitoring of Medication-Overuse Headache in Europe and Latin America: Development and Standardization of an Alert and Decision Support System) consists of abrupt detoxification, patient education, early initiation of individualized prophylactic therapy, and regular scheduled follow-up by one dedicated physician guided by electronic support. Patients maintain an electronic medical diary, which automatically signals their physician if they are in danger of relapsing, explained Dr. Tassorelli, a neurologist at the University of Pavia in Italy.
MOH occurs when patients with chronic headache, most often migraine without aura, experience a worsening of their headaches and respond by using more and more acute medication—triptans or NSAIDs—which in turn paradoxically exacerbates their headache pattern. MOH is defined by the occurrence of headache on at least 15 days per month coupled with use of triptans on 10 or more days per month or NSAIDs on at least 15 days per month.
MOH is treatable via detoxification but typically has a relapse rate of 30% to 40% within the following six months. The COMOESTAS protocol, in contrast, had a six-month relapse rate of 10%. It is designed as a first-line intervention for MOH patients who have not undergone detoxification.
“Three-quarters of first-timers will do well with this approach. It’s a good tool for stratifying patients: If they relapse, then they need a more intensive multidisciplinary approach,” Dr. Tassorelli explained.
In a separate presentation, COMOESTAS coinvestigator Lars Bendtsen, MD, PhD, reported that the management protocol proved successful not only in terms of the primary outcome measures of reduced headache frequency and fewer days per month of acute medication use, but also from the standpoint of reduced depression, anxiety, and disability, along with improved quality of life.
Among 519 COMOESTAS participants who completed six months of follow-up at centers in Spain, Italy, Denmark, Germany, Argentina, and Chile, the mean number of headache days per month decreased from 23.6 at baseline to 9.8. Days of acute drug therapy likewise decreased.
Moreover, quality of life, as assessed using the Migraine Disability Assessment score, improved from 59.8 to 25.5. The mean Hospital Anxiety and Depression Scale (HADS) depression score decreased from 6.6 at baseline to 4.1, while the HADS anxiety score dropped from 9.3 to 7.1. All of these differences were statistically significant and clinically meaningful, commented Dr. Bendtsen of the University of Copenhagen.
Dr. Tassorelli noted that detoxification in the COMOESTAS study could be carried out on either an inpatient or outpatient basis, depending on local practice. The six-month results were similar, regardless of the detoxification setting, meaning that outpatient detoxification, which is vastly less expensive, is clearly the winning strategy.
The COMOESTAS protocol began with a detailed explanation of the vicious cycle of MOH and advice to the patient to abruptly stop the overused medication. Rescue medication could be used on days 1 through 7 to combat withdrawal headaches, with the drug, dose, and route of administration to be chosen from a menu based on the patient’s medical history and headache characteristics. Options included various antiemetics, acetaminophen, and naproxen. Preventive therapy was started within the first seven days. The options were propranolol, atenolol, metoprolol, valproic acid, topiramate, candesartan, flunarizine, and amitriptyline. The selection was based on comorbid conditions, patient preference, and side effect profiles. Acute headache medication was permitted beginning on day 8 for a maximum of two days per week. The inviolable rule was that patients could not use the same drug that they previously had overused.
European Headache Federation president and COMOESTAS coinvestigator Rigmor Højland Jensen, MD, PhD, called special attention to the importance of detoxifying patients with MOH. “This is something we can do starting Monday morning. We don’t have to have a bag full of new drugs. We can do a lot for these patients now,” said Dr. Jensen, Professor of Neurology at the University of Copenhagen.
—Bruce Jancin