LONDON – A simple, straightforward protocol for management of medication-overuse headache 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," Dr. Cristina Tassorelli said in presenting the COMOESTAS data at the European Headache and Migraine Trust International Congress.

The protocol utilized 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 begin to slide down the slope toward relapse, explained Dr. Tassorelli, a neurologist at the University of Pavia (Italy).

Medication-overuse headache (MOH) is a common and disabling condition. It affects 1%-3% of the general population and 20%-60% of patients in specialized headache clinics. It 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 and/or NSAIDs – which in turn paradoxically exacerbates their headache pattern. MOH is defined by the occurrence of headache on at least 15 days/month coupled with use of triptans on 10 or more days/month or NSAIDs on at least 15 days/month.

MOH is treatable via detoxification but typically has a relapse rate of 30%-40% within the following 6 months. The COMOESTAS protocol, in contrast, had a 6-month relapse rate of 10%.

The COMOESTAS protocol for MOH was devised by expert consensus. It is designed as a first-line intervention for MOH patients who are detoxification-naive.

"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 Dr. Lars Bendsten 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 6 months of follow-up at centers in Spain, Italy, Denmark, Germany, Argentina, and Chile, the mean number of headache days per month fell from 23.6 at baseline to 9.8. Days of acute drug therapy dropped in sync.

Moreover, quality of life as assessed using the MIDAS (Migraine Disability Assessment Score) scale improved from 59.8 to 25.5. The mean HADS (Hospital Anxiety and Depression Scale) depression score fell 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. Bendsten 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 upon local practice. The 6-month results were closely 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 day 1 detailed explanation of the vicious cycle of MOH and advice to the patient to abruptly stop the overused medication. Rescue medication could be employed on days 1-7 to combat withdrawal headaches, with the drug, dose, and route of administration to be chosen from a menu based upon the patient’s medical history and headache characteristics. Options included a variety of antiemetics, acetaminophen, and naproxen.

Preventive therapy was started within the first 7 days. The options were propranolol, atenolol, metoprolol, valproic acid, topiramate, candesartan, flunarizine, or amitriptyline. The selection was based upon comorbid conditions, patient preference, and side effect profiles.

Acute headache medication was permitted beginning on day 8 for a maximum of 2 days per week. The inviolable rule was that patients could not use the same drug that was previously overused.

Elsewhere at the conference, European Headache Federation president and COMOESTAS coinvestigator Dr. Rigmor Højland Jensen diverged from providing an update on the therapeutic pipeline for migraine to draw 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.

The COMOESTAS project is funded by the European Commission. The investigators reported having no financial conflicts.

b.jancin@elsevier.com

Study breaks new ground in medication-overuse headache