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Headache


Figure 3: Efficacy of Cambia® Sachets in Acute Migraine— Co-primary Endpoint Data from US IMPACT Study


US study: efficacy results for co-primary endpoint


60 70


50 40 30 20 10


0


Pain-free response at two hours


Nausea-free at two hours


Cambia


Photophobia-free at two hours


Placebo


*p<0.001; †p<0.002. IMPACT = International Pain Assessment Clinical Trial. Source: Lipton et al., 2010.36


Figure 4: Efficacy of Cambia® Sachets in Acute Migraine— Secondary Endpoint Data from US IMPACT Study


US study: secondary endpoint


60 70


50 40 30 20 10


0


Sustained pain-free*


Headache response rates†


Cambia Recurrence‡ Placebo


*Subjects who were pain-free at two hours with no use of rescue medication or recurrence of pain for up to 24 hours post-treatment; †At two hours; ‡Subjects who were pain-free at two hours post-dose and had a recurrence defined as mild, moderate or severe pain and/or taking rescue medication within 24 hours.


** Headache response rates continued to favor Cambia over placebo at 24 hours. *** Reduction in disability also favored Cambia over placebo at 24 hours. IMPACT = International Pain Assessment Clinical Trial. Source: Lipton et al., 2010.36


A Clinician’s Perspective on Cambia® Use From the point of view of a practitioner working in a multidisciplinary headache clinic where patients range from those with episodic migraine to chronic migraine, as well as those with other forms of primary and secondary headaches, NSAIDs have been a standard option for headache treatment in addition to, or instead of, the use of triptans for acute treatment. However, the speed of effect of NSAIDs compared with triptans has been a limiting factor in their use. Since Cambia has been available, it has become a significant part of the treatment armamentarium and has differentiated itself from other, slower options. Cambia’s rapid onset of pain relief makes it a good first-line medication choice for acute migraine attacks. It should be noted that although most practice is based on evidenced-based medicine, some of the following illustrations are based on real-world experience within a busy headache clinic.


142


Restoration of function†


64.7 % n=222


41.6 %** p<0.001


19.0 % n=65


7.2 % n=25


n=144 29.0 %


24.0 % n=10 n=21


n=114 33.2 %


16.1 %*** n=56


Phonophobia-free at two hours


n=222 64.7 %†


52.7 % n=183


40.5 %* n=139


25.1 %* n=86


10.1 % n=35


27.4 % n=95


44.3 %* n=152


27.4 % n=95


From a personal perspective, Cambia is included in the ‘brown bag’ of medications for patients to try instead of triptans as a primary treatment for headache relief. Patients seem to prefer a non-triptan option and appreciate it when data is shared with them demonstrating relief as soon as 15 minutes after dosing with a 15-minute peak absorption for Cambia versus diclofenac pills at one hour time points. Patients intuitively know the benefit of early treatment and the expression, ‘If I can catch it in time, I have a better chance of getting relief with medication’, is often heard. One can reassure them that this medication is not only rapid in absorption for early treatment but has good efficacy even if headache has reached moderate to severe intensity as demonstrated in both FDA-approved trials.


Although all NSAIDs have a small but real increased risk for cardiovascular disease and Cambia is prescribed with the warning that the risk may increase with duration of use,40


medications such as


triptans have an absolute contraindication in patients with cardiovascular disease. This situation makes Cambia a very useful alternative to triptans in that it can deliver efficacy similar to triptans with significantly reduced cardiovascular risk.


Like all NSAIDs, Cambia increases the risk of adverse gastrointestinal (GI) events, including bleeding, ulceration, and perforation of the stomach or intestine wall. Older patients are at greater risk. Renal papillary necrosis and other renal injury may also occur with long-term use of NSAIDs. Patients at risk include older people, those taking diuretics or angiotensin-converting enzyme inhibitors, those with renal impairment, heart failure, or liver impairment.


Many of the patients one sees in the clinic overuse caffeinated medication leading to the phenomenon of caffeine withdrawal headache, causing them to develop headache as soon as the effects of each dose dissipates.41,42


One of the most common forms of the


medications in question is caffeinated, powdered aspirin. It is of great benefit to be able to offer a powdered substitute that provides a sense of comfort and familiarity that patients may not have with pills. Half the battle of success is patient confidence in the medication they are using.


It has been noted that patients are often given tapers of medication to compensate for withdrawal headache or status migrainosus, a headache that persists for more than 72 hours.6


dexamethasone is a common choice for such instances,43–45


A steroid taper with prednisone or but many


patients express intolerance to steroids, either from steroid-induced side effects (mania, insomnia, GI distress, etc.) or have conditions such as diabetes where steroids, could exacerbate the primary condition. Using Cambia in such instances with a strategy of one dose twice daily for three days followed by a daily dose for three days has proved useful in the author’s experience. As with steroid tapers, the employment of a less sedating anti-emetic such as metoclopramide with the taper and/or an antihistamine such as hydroxyzine can be beneficial, depending on the situation of the patient. Finally, combined therapies, which act on multiple target sites, may confer improved efficacy and symptom relief for patients with migraine. Considerable evidence is available that justifies the use of NSAIDs in combination with triptans.46–51


US NEUROLOGY


Patients (%)


Patients (%)


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