Kathleen McCarroll

Comparative study of ibuprofen lysine and acetaminophen in patients with postoperative dental pain

This single-dose, double-blind, parallel-group, single-site study compared ibuprofen lysine 400 mg with acetaminophen 1000 mg and placebo in 240 patients with moderate-to-severe postoperative dental pain. The relative onset of analgesic response, overall analgesic efficacy, duration of effect, and safety were assessed over a 6-hour postdose period. Analgesic efficacy was assessed by patient self-rating of pain intensity, pain relief, time to meaningful pain relief, need for additional analgesic medication, and patient global evaluation. Both ibuprofen lysine 400 mg and acetaminophen 1000 mg were significantly (P < or = 0.05) more effective than placebo. Ibuprofen lysine had a significantly (P < or = 0.05) faster onset of action with greater peak and overall analgesic effect than did effect than did acetaminophen. All treatments were generally well tolerated.

Effect of Rizatriptan and Other Triptans on the Nausea Symptom of Migraine: A Post Hoc Analysis

Objective.—To compare the effects of oral rizatriptan, sumatriptan, naratriptan, and zolmitriptan on the relief and emergence of nausea during a migraine attack.

Ertapenem Therapy for Community-Acquired Pneumonia in the Elderly

Objectives: To compare the efficacy and safety of ertapenem, 1u2003g once a day, with ceftriaxone, 1u2003g once a day, for treatment of the subgroup of patients aged 65 and older with community‐acquired pneumonia (CAP) requiring parenteral therapy.

Restoring Migraine Sufferers’ Ability to Function Normally: A Comparison of Rizatriptan and Other Triptans in Randomized Trials

Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Methods: Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale (‘normal’, ‘mild impairment’, ‘severe impairment’, ‘requires bedrest’) at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Results: Most patients in each trial and treatment group had some level of disability at baseline (range = 94–100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). Conclusion: In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan.

Sum of Pain Intensity Differences (SPID) in migraine trials. A comment based on four rizatriptan trials

Sum of Pain Intensity Difference (SPID) is an outcome measure that summarizes treatment response over a clinically relevant period. SPID is widely reported in clinical trials of analgesics but has been little used in migraine trials. We compared SPID over 2 h with the standard migraine outcome measures of pain-free at 2 h and headache relief at 2 h using data from four published clinical trials of rizatriptan in migraine patients. In assessing treatment response (rizatriptan and sumatriptan versus placebo, rizatriptan versus sumatriptan, within-treatment dose effects), SPID usually yielded similar results to the more easily understood pain-free measure.

Rizatriptan: Pharmacological Differences from Sumatriptan and Clinical Results

SUMMARY Rizatriptan and sumatriptan are selective 5-HT1B/1D receptor agonists for the acute treatment of migraine. For oral formulations, the time to maximum plasma concentration is reached earlier with rizatriptan than with sumatriptan (1u2009h versus 2–2.5u2009h) and rizatriptan has greater bioavailability than sumatriptan (45% versus 15%). These pharmacological advantages appear to translate into a faster onset of action and a better overall response for oral rizatriptan versus oral sumatriptan. The two drugs have been directly compared in randomized, double-blind, placebo-controlled clinical trials of patients with moderate or severe migraine attacks. Rizatriptan 10u2009mg was generally superior to sumatriptan on a measure of time-to-pain-relief within 2u2009h, where pain relief was defined as a reduction of pain to mild or none (odds ratio for rizatriptan versus sumatriptan 100u2009mgu2009=u20091.21; odds ratios for rizatriptan 10u2009mg versus sumatriptan 50u2009mgu2009=u20091.14 and 1.10 in two studies). Rizatriptan 10u2009mg was also superior to sumatriptan on the International Headache Society recommended endpoint of the percentage of patients pain free at 2u2009h (40% for rizatriptan 10u2009mg, 33% for sumatriptan 100u2009mg, and 35% for sumatriptan 50u2009mg). Further advantages for rizatriptan were seen on stringent outcome measures of the percentage of patients who were completely free of all symptoms at 2u2009h, patient satisfaction with medication at 2u2009h, and 24-h sustained pain-free response. 5-HT1B/1D receptor agonists are contraindicated in patients with coronary artery disease because of their potential to cause vasoconstriction. In clinical trials which excluded such patients, rizatriptan and sumatriptan were both well-tolerated. The most common side-effects on both drugs occurred in <10% of patients and consisted of dizziness, drowsiness, and asthenia/fatigue. The adverse events were usually mild or moderate in severity and short-lasting.