Rc. Cady et al., SUMATRIPTAN INJECTION REDUCES PRODUCTIVITY LOSS DURING A MIGRAINE ATTACK - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL, Archives of internal medicine, 158(9), 1998, pp. 1013-1018
Objective: To evaluate the impact of sumatriptan succinate injection c
ompared with placebo on productivity loss during a migraine attack in
the workplace. Design: Randomized, double-blind, placebo-controlled, p
arallel-group clinical trial. Setting: Fifteen clinical centers in the
United States. Patients: One hundred thirty-five patients 18 years an
d older diagnosed as having migraine according to International Headac
he Society criteria. Interventions: Patients self-administered sumatri
ptan injection (6 mg) or matching placebo to treat a moderate or sever
e migraine occurring within the first 4 hours of a minimum 8-hour work
shift. Main Outcome Measures: Mean productivity loss 2 hours after do
sing and across the work shift; percentages of patients returning to n
ormal work performance within 2 hours after dosing and across the work
shift; percentages of patients experiencing headache relief (reductio
n of moderate or severe predose pain to mild or no pain) 1 and 2 hours
after dosing. Results: Mean productivity loss was significantly (P le
ss than or equal to.002) lower in the sumatriptan group compared with
the placebo group both during the 2-hour postdose period (sumatriptan,
39 minutes; placebo, 54 minutes) and across the work shift (sumatript
an, 86 minutes; placebo, 168 minutes). Significantly (P<.001) greater
percentages of patients in the sumatriptan group compared with the pla
cebo group returned to normal work performance by 2 hours after dosing
(sumatriptan, 52%; placebo, 9%) and across the work shift (sumatripta
n, 66%; placebo, 18%). Significantly (P less than or equal to.001) gre
ater percentages of patients in the sumatriptan group compared with th
e placebo group experienced headache relief 1 hour after dosing (sumat
riptan, 69%; placebo, 18%) and 2 hours after dosing (sumatriptan, 79%;
placebo, 32%). Conclusion: Sumatriptan reduced migraine-associated pr
oductivity loss during a minimum 8-hour work shift by approximately 50
% compared with placebo and alleviated headache in more than three fou
rths of patients.