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Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration.

ABSTRACT: Anti-inflammatory and pain therapies have been associated with blood pressure (BP) destabilization. Hence, the effects on BP of sumatriptan/naproxen sodium in fixed-dose combination, sumatriptan 85 mg, and naproxen sodium 500 mg administered intermittently for the acute treatment of migraine attacks were assessed. Patients with migraine with or without aura and no history of hypertension were randomized to sumatriptan/naproxen sodium (n=135), sumatriptan (n=136), or naproxen sodium (n=136) to treat migraine attacks for 6 months in a double-blind, parallel-group trial. Following a treated migraine attack, patients performed 2 consecutive days of self-measured BPs beginning ≥24 hours after the last dose of study medication and transmitted them by a transtelephonic modem. The primary end point was the change from baseline in self-measured BP at 6 months. Changes in self-measured BP from baseline to 6 months for sumatriptan/naproxen sodium were -2.1/-1.5 mm Hg (95% confidence intervals, -3.4 to -0.8 for systolic and -2.6 to -0.3 for diastolic). Mean changes from baseline in self-measured BP did not differ among the 3 treatment groups. Additional categorical analyses did not show increases from baseline with sumatriptan/naproxen sodium relative to either of the monotherapy groups. Intermittent acute migraine treatment with sumatriptan/naproxen sodium for up to 6 months was associated with clinically insignificant decreases in self-measured BP that were similar to those with sumatriptan or naproxen alone in normotensive patients with migraine.

SUBMITTER: White WB

PROVIDER: S-EPMC8108967 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The goal of this study was to use protein array analysis to investigate temporal regulation of stimulated cytokine expression in trigeminal ganglia and the spinal trigeminal nucleus in response to co-treatment of sumatriptan and naproxen sodium or individual drug.Activation of neurons and glia in trigeminal ganglia and the spinal trigeminal nucleus leads to increased levels of cytokines that promote peripheral and central sensitization, which are key events in migraine pathology. While recent clinical studies have provided evidence that a combination of sumatriptan and naproxen sodium is more efficacious in treating migraine than either drug alone, it is not well understood why the combination therapy is superior to monotherapy.Male Sprague-Dawley rats were left untreated (control), injected with capsaicin, or pretreated with sumatriptan/naproxen, sumatriptan, or naproxen for 1 hour prior to capsaicin. Trigeminal ganglia and the spinal trigeminal nucleus were isolated 2 and 24 hours after capsaicin or drug treatment, and levels of 90 proteins were determined using a RayBio® Label-Based Rat Antibody Array (RayBiotech, Norcross, GA, USA).Capsaicin stimulated a >3-fold increase in expression of the majority of cytokines in trigeminal ganglia at 2 hours that was sustained at 24 hours. Significantly, treatment with sumatriptan/naproxen almost completely abolished the stimulatory effects of capsaicin at 2 and 24 hours. Capsaicin stimulated >3-fold expression of more proteins in the spinal trigeminal nucleus at 24 hours when compared to 2 hours. Similarly, sumatriptan/naproxen abolished capsaicin stimulation of proteins in the spinal trigeminal nucleus at 2 hours and greatly suppressed protein expression 24 hours post-capsaicin injection. Interestingly, treatment with sumatriptan alone suppressed expression of different cytokines in trigeminal ganglia and the spinal trigeminal nucleus than repressed by naproxen sodium.We found that the combination of sumatriptan/naproxen was effective in blocking capsaicin stimulation of pro-inflammatory proteins implicated in the development of peripheral and central sensitization in response to capsaicin activation of trigeminal neurons. Based on our findings that sumatriptan and naproxen regulate expression of different proteins in trigeminal ganglia and the spinal trigeminal nucleus, we propose that these drugs function on therapeutically distinct cellular targets to suppress inflammation and pain associated with migraine.

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Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration.

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