Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes

Abstract

Objective: To describe return to normal function, productivity, and satisfaction of patients with moderate or severe migraine attacks treated with combined sumatriptan/naproxen sodium, sumatriptan alone, naproxen sodium alone, or placebo.

Patients, design, and setting: Patients in 2 identical, US, phase 3, randomized, double-blind, parallel-group, placebo-controlled, single-dose, multicenter studies treated a single moderate or severe migraine attack with sumatriptan/naproxen sodium (85 mg sumatriptan formulated with RT Technology and 500 mg naproxen sodium in a single-tablet formulation), sumatriptan, naproxen sodium, or placebo.

Main outcome measures: Ability to function (not impaired, mildly impaired, severely impaired, or required bed rest) was collected in diary cards completed immediately prior to treatment, every 30 minutes for the first 2 hours, and hourly from 2 to 24 hours while awake. Patients completed the Productivity Assessment Questionnaire (PAQ) 24 hours after study drug administration. The Patient Perception of Migraine Questionnaire (PPMQ) was administered at screening and 24 hours post treatment to capture patient satisfaction.

Results: Compared with the other groups, the sumatriptan/naproxen sodium group reported significantly higher levels of normal or mildly impaired functioning as early as 2 and 4 hours after dosing. They also demonstrated greater reductions in workplace productivity loss compared with placebo in both studies, and were consistently more satisfied with their treatment compared with patients in other treatment groups and compared with their usual medications.

Conclusions: Treatment with sumatriptan/naproxen sodium allowed significantly more subjects to return to normal or mildly impaired functioning more quickly, and sumatriptan/naproxen sodium patients were significantly more satisfied with their treatment compared with other treatment groups. Overall productivity loss was significantly reduced following use of sumatriptan/naproxen sodium.

Figures

Figure 1

Proportion of patients reporting normal functioning or mild impairment from baseline to 5 hours post treatment. † P < .001; ‡ P < .005 – The number of patients in the sumatriptan/naproxen sodium group who were functioning normally (ie, not impaired) was compared at 1 through 5 hours with the other treatment groups with a Cochran-Mantel-Haenszel test with pooled investigator site (small sites pooled) as the strata. Sample sizes (301)(302): placebo (382)(360); naproxen (364)(356); sumatriptan (361)(361); sumatriptan/naproxen (361)(364)

Figure 2

Proportion of patients reporting normal functioning at each hour following treatment.* Normal functioning = not impaired response on ability to function measure *Patients who reported normal functioning at initial dosing were excluded from these analyses. n (301)(302): placebo (355)(328); naproxen (345)(331); sumatriptan (338)(333); sumatriptan/naproxen (342)(341)

Figure 3

Mean productivity loss during 24 hours post treatment. *P < .05 compared with sumatriptan/naproxen sodium Lost workplace productivity = (hours missed from work) + ([100 – “% effectiveness at work”]/100) × (hours worked with symptoms) Lost nonpaid activities time = (hours missed from nonwork activities) + ([100 – “% effectiveness at nonwork activities”]/100) × (hours continued nonwork activities with symptoms)

Figure 4

Percentage of subjects satisfied/very satisfied with treatment 24 hours post dosing. *P ≤ .001; #P < .01; †P < .05

Figure 5

Change in the percent of subjects satisfied/very satisfied with study treatment compared with previous treatment. *Figure 5 shows the absolute difference in percentage of subjects satisfied/very satisfied with previous treatment at baseline compared with the percentage of subjects satisfied/very satisfied with study medication at 24 hours post dosing. Example for “Pain Relief” Study 1: Subjects in the sumatriptan/naproxen sodium group were more satisfied/very satisfied with sumatriptan/naproxen sodium (53%) than with their previous treatment (48%) by 5 percentage points (53% − 48% = 5%).