Biomedical subjects

Carolyn R Sikes

Publications and source records attributed to Carolyn R Sikes.

4 recordsLinked to original sources

PubMed2005

In vivo disintegration profiles of encapsulated and nonencapsulated sumatriptan: gamma scintigraphy in healthy volunteers.

The goal of this exploratory pilot study was to use gamma scintigraphy to evaluate, under physiological conditions, disintegration profiles of encapsulated and nonencapsulated formulations of 100 mg sumatriptan. Using a crossover design, healthy volunteers (n = 10) ingested 100-mg doses of sumatriptan tablets radiolabeled with 111Indium, as well as encapsulated sumatriptan tablets that were prepared similarly, then placed within a gelatin capsule and backfilled with an excipient blend radiolabeled with 99mTechnetium. A gamma camera recorded scintigraphic images until 5 hours postdose. Initial disintegration of the gelatin capsule was observed at a mean (range) of 5 minutes (1-11 minutes); disintegration was complete within 14 minutes (5-24 minutes). For nonencapsulated versus encapsulated tablets, the mean (+/- standard deviation) time to initial disintegration (6 +/- 5 minutes vs 8 +/- 5 minutes) and time to complete disintegration (18 +/- 14 minutes vs 16 +/- 7 minutes) were comparable. Results of this study demonstrate that encapsulated and nonencapsulated sumatriptan have equivalent in vivo dissolution rates.

Adult↗

PubMed2003

Comparative efficacy of eletriptan 40 mg versus sumatriptan 100 mg.

OBJECTIVE: To confirm the efficacy advantage of eletriptan 40 mg over sumatriptan 100 mg. Background.-Eletriptan 80 mg has demonstrated significantly greater efficacy when compared to both sumatriptan 50 mg and 100 mg in two studies. Eletriptan 40 mg demonstrated significantly greater efficacy than sumatriptan 100 mg in one previous trial. METHODS: Two thousand one hundred thirteen patients with a diagnosis of migraine according to International Headache Society criteria were randomized using a double-blind, double-dummy, parallel-group design, and treated for a single migraine attack with either eletriptan 40 mg, sumatriptan 100 mg, or placebo. The primary endpoint was 2-hour headache response. Secondary endpoints included headache response rates at 1 hour, pain-free rates, absence of associated symptoms, functional response at 1 and 2 hours, and sustained headache response. RESULTS: Headache response rates at 2 hours postdose were significantly higher for eletriptan 40 mg (67%) than for sumatriptan 100 mg (59%; P <.001) and placebo (26%; P <.0001). Eletriptan 40 mg consistently showed significant (P <.01) efficacy over sumatriptan 100 mg across secondary clinical outcomes, including 1-hour headache response; 2-hour pain-free response; absence of nausea, photophobia, and phonophobia; functional improvement; use of rescue medication; treatment acceptability; and sustained headache response (P <.05). Overall, treatment-related adverse events were low, nausea being the only adverse event with an incidence of 2% or higher (4.9% with eletriptan, 4.2% sumatriptan, 2.8% placebo). CONCLUSION: This trial confirmed that eletriptan 40 mg offers superior efficacy in treating migraine pain and associated symptoms and in restoring patient functioning when compared with sumatriptan 100 mg.

Acute Disease↗

PubMedDate not supplied

Severe vascular events in migraine patients.

OBJECTIVE: To estimate rates of vascular events in relation to dispensing of triptans and ergot alkaloids among migraineurs, and to compare these rates with those of nonmigraineurs. CONTEXT: It has been speculated that the use of triptans or ergot alkaloid drugs might increase risk of ischemic events through vasoconstriction. DESIGN: A retrospective cohort study of 130,411 migraineurs and 130,411 age-, sex-, and health plan-matched nonmigraineurs who were members of UnitedHealthcare during 1995 through 1999. The data source for this study was Ingenix's research database containing pharmacy and medical claims for UnitedHealthcare members, and the National Death Index. MAIN OUTCOME MEASURES: Incidence of cardiovascular and cerebrovascular events and mortality. RESULTS: Migraineurs and nonmigraineurs had identical rates of myocardial infarction: 1.4 per 1000 person-years. Migraineurs were 67% more likely to suffer a stroke than nonmigraineurs (adjusted relative risk [RR] 1.67, 95% confidence interval [CI] 1.31-2.13), and had higher rates of unstable angina and transient ischemic attacks. There was no increase in risk of myocardial infarction with current (adjusted RR 0.80, 95% CI 0.58-1.11) or recent (adjusted RR 1.15, 95% CI 0.71-1.87) triptan use. Neither current (adjusted RR 0.90, 95% CI 0.64-1.26) nor recent (adjusted RR 0.84, 95% CI 0.46-1.55) triptan use was associated with risk of stroke. Current users of ergot alkaloids were somewhat more likely to have a stroke than other migraineurs (adjusted RR 1.49, 95% CI 0.93-2.41), but there was no dose-response relationship. CONCLUSIONS: Use of triptans is not associated with increased risk of any ischemic events, including myocardial infarction and stroke, or mortality. Consistent with previous studies, migraineurs in general have an elevated risk of stroke, but not myocardial infarction, compared with nonmigraineurs.

Adult↗

PubMedDate not supplied

Eletriptan in migraine patients reporting unsatisfactory response to rizatriptan.

OBJECTIVE: The objective of this open-label study was to evaluate the efficacy of switching patients who had a previous unsatisfactory response to rizatriptan to eletriptan 40 mg. Background.-The characteristics of individual migraine patients can vary tremendously and can have a significant impact on treatment outcomes. In addition, clinical experience has demonstrated that the triptans are not identical or interchangeable and that patients who respond poorly or who are dissatisfied with one agent can derive benefit by being switched to another agent within the triptan class. METHODS: Patients were eligible if they met International Headache Society criteria for migraine, with a frequency of 1 to 6 migraine attacks per month, and had documented "unsatisfactory treatment response" to rizatriptan within the past year (54% on the melt formulation; 46% on tablets). Reasons for dissatisfaction with rizatriptan (>1 could be cited) included inadequate (84%) or slow onset (50%) of pain relief, high recurrence rate (69%), and lack of improvement in associated symptoms (60%). One hundred twenty-three patients were eligible for treatment. Patients were instructed to take eletriptan 40 mg as soon as they were certain that their headache was a migraine, regardless of level of pain severity (8% treated headaches that were mild). RESULTS: Headache response at 2 hours (first-attack data) was 64%. Absence of nausea (from baseline to 2 hours) increased from 50% to 78%, absence of photophobia from 30% to 72%, and absence of phonophobia from 39% to 77%. Functional response at 2 hours was 63%, with 41% of patients reporting normal functioning. Treatment with eletriptan 40 mg was associated with a 27% to 40% reduction in migraine attack-related functional impairment, as measured by the PQ-7. Recurrence rates were 36.6%. Overall, 72% of patients rated eletriptan as a "good-to-excellent" treatment, and 78% reported overall satisfaction with the degree of headache relief. CONCLUSION: The results of this study suggest that eletriptan is an efficacious treatment option for patients who are dissatisfied with their response to rizatriptan.

Adult↗