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Valdecoxib for treatment of a single, acute, moderate to severe migraine headache.
Headache. 2005 Oct; 45(9):1151-62.H

Abstract

OBJECTIVE

To evaluate the analgesic efficacy and safety of a single 20- or 40-mg dose of valdecoxib compared with placebo in treatment of a single, acute, moderate or severe migraine headache, with or without aura.

BACKGROUND

Valdecoxib, an oral COX-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and treatment of primary dysmenorrhea. This study assessed the optimal dose of valdecoxib for treatment of a single, acute, moderate to severe migraine headache.

METHODS

This was a double-blind, randomized, placebo- and active-controlled, multicenter, single-dose (primary end point) and multiple-dose (secondary end point), 56-day study of valdecoxib in the treatment of a single, acute, moderate or severe migraine headache, with or without aura. Migraine headaches were diagnosed according to International Headache Society (IHS) criteria. The primary efficacy end point was headache response (defined as reduction of headache pain intensity from moderate or severe to mild or none) at 2 hours postdose. Patients assessed their headache pain intensity and presence or absence of migraine-associated nausea, vomiting, phonophobia, and photophobia at intervals from 0 to 24 hours postdose. Sumatriptan 50 mg (encapsulated, in standard method, to maintain blinding) was included as a positive control for assay sensitivity. No statistical comparisons were performed between active treatment arms (valdecoxib 20 mg, valdecoxib 40 mg, and sumatriptan 50 mg). Adverse events and safety parameters were monitored throughout the study.

RESULTS

In the intent-to-treat population of 570 patients (135 valdecoxib 20 mg, 151 valdecoxib 40 mg, 143 sumatriptan, and 141 placebo), no significant differences in baseline demographics among treatment groups were observed. The headache response rate with valdecoxib 40 mg and sumatriptan 50 mg was significantly greater than that with placebo at all time points from 2 to 24 hours postdose. With valdecoxib 20 mg, headache response rate was significantly greater than placebo from 2 to 4 hours. Significantly fewer patients treated with valdecoxib 40 mg, compared with placebo, experienced nausea, vomiting, and phonophobia at 2 hours postdose.

CONCLUSIONS

A single 40-mg dose of valdecoxib is effective and well tolerated in treatment of migraine headache pain and associated symptoms.

Authors+Show Affiliations

California Medical Clinic for Headache, Santa Monica, CA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16178945

Citation

Kudrow, David, et al. "Valdecoxib for Treatment of a Single, Acute, Moderate to Severe Migraine Headache." Headache, vol. 45, no. 9, 2005, pp. 1151-62.
Kudrow D, Thomas HM, Ruoff G, et al. Valdecoxib for treatment of a single, acute, moderate to severe migraine headache. Headache. 2005;45(9):1151-62.
Kudrow, D., Thomas, H. M., Ruoff, G., Ishkanian, G., Sands, G., Le, V. H., & Brown, M. T. (2005). Valdecoxib for treatment of a single, acute, moderate to severe migraine headache. Headache, 45(9), 1151-62.
Kudrow D, et al. Valdecoxib for Treatment of a Single, Acute, Moderate to Severe Migraine Headache. Headache. 2005;45(9):1151-62. PubMed PMID: 16178945.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Valdecoxib for treatment of a single, acute, moderate to severe migraine headache. AU - Kudrow,David, AU - Thomas,H Mikel, AU - Ruoff,Gary, AU - Ishkanian,Gary, AU - Sands,George, AU - Le,Vu H, AU - Brown,Mark T, PY - 2005/9/24/pubmed PY - 2006/3/1/medline PY - 2005/9/24/entrez SP - 1151 EP - 62 JF - Headache JO - Headache VL - 45 IS - 9 N2 - OBJECTIVE: To evaluate the analgesic efficacy and safety of a single 20- or 40-mg dose of valdecoxib compared with placebo in treatment of a single, acute, moderate or severe migraine headache, with or without aura. BACKGROUND: Valdecoxib, an oral COX-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and treatment of primary dysmenorrhea. This study assessed the optimal dose of valdecoxib for treatment of a single, acute, moderate to severe migraine headache. METHODS: This was a double-blind, randomized, placebo- and active-controlled, multicenter, single-dose (primary end point) and multiple-dose (secondary end point), 56-day study of valdecoxib in the treatment of a single, acute, moderate or severe migraine headache, with or without aura. Migraine headaches were diagnosed according to International Headache Society (IHS) criteria. The primary efficacy end point was headache response (defined as reduction of headache pain intensity from moderate or severe to mild or none) at 2 hours postdose. Patients assessed their headache pain intensity and presence or absence of migraine-associated nausea, vomiting, phonophobia, and photophobia at intervals from 0 to 24 hours postdose. Sumatriptan 50 mg (encapsulated, in standard method, to maintain blinding) was included as a positive control for assay sensitivity. No statistical comparisons were performed between active treatment arms (valdecoxib 20 mg, valdecoxib 40 mg, and sumatriptan 50 mg). Adverse events and safety parameters were monitored throughout the study. RESULTS: In the intent-to-treat population of 570 patients (135 valdecoxib 20 mg, 151 valdecoxib 40 mg, 143 sumatriptan, and 141 placebo), no significant differences in baseline demographics among treatment groups were observed. The headache response rate with valdecoxib 40 mg and sumatriptan 50 mg was significantly greater than that with placebo at all time points from 2 to 24 hours postdose. With valdecoxib 20 mg, headache response rate was significantly greater than placebo from 2 to 4 hours. Significantly fewer patients treated with valdecoxib 40 mg, compared with placebo, experienced nausea, vomiting, and phonophobia at 2 hours postdose. CONCLUSIONS: A single 40-mg dose of valdecoxib is effective and well tolerated in treatment of migraine headache pain and associated symptoms. SN - 0017-8748 UR - https://www.unboundmedicine.com/medline/citation/16178945/Valdecoxib_for_treatment_of_a_single_acute_moderate_to_severe_migraine_headache_ L2 - https://doi.org/10.1111/j.1526-4610.2005.00238.x DB - PRIME DP - Unbound Medicine ER -