Biomedical subjects

Jerome Goldstein

Publications and source records attributed to Jerome Goldstein.

11 recordsLinked to original sources

PubMed2006

Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study.

OBJECTIVE: Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. METHODS: Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. RESULTS: There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). CONCLUSION: AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

Acetaminophen↗

PubMed2006

Stimulant use and HIV risk behavior: the influence of peer support group participation.

This study examines 12-step groups for recovery from methamphetamine and cocaine use that are attended by men having sex with men and the impact of attendance on HIV risk behavior. Participants in Crystal Meth Anonymous and other 12-step groups were interviewed up to 3 months since their last substance use. Sixty-two initial interviews, and ethnographic observations, were conducted. With entry into the program, mean reported sexual partners fell from around seven to one per month and the proportion having unprotected anal intercourse declined from 70% to 24%. HIV-positive men were more likely than HIV-negative men to report unprotected anal intercourse when using stimulants but less likely in recovery. Qualitative data suggest a transition from cocaine to methamphetamine in Chicago, and that reduction in partners is due to fear of relapsing in sexual situations rather than program teachings. These programs do however facilitate discussions around drug use and sexual issues.

Adult↗

PubMed2005

Aspirin is efficacious for the treatment of acute migraine.

BACKGROUND: More than 50% of migraine sufferers rely on over-the-counter medications for the treatment of migraine. Along with other over-the-counter products, aspirin is considered by the US Headache Consortium to be an option for first-line migraine treatment. This study assessed the efficacy and tolerability of aspirin versus placebo for the acute treatment of a single acute attack of migraine. METHODS: This prospective, randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy of a single, 1000-mg dose of aspirin for the treatment of acute moderate to severe migraine, with or without aura. Subjects recorded all study evaluations in a diary at baseline and at .5, 1, 2, 3, 4, 5, 6, and 24 hours after treatment. Pain was rated on a 4-point ordinal scale from no pain to severe pain. The primary efficacy end point was headache response at 2 hours. Secondary efficacy parameters included reduction of nausea, photophobia and phonophobia, pain intensity difference, and headache recurrence at 24 hours. RESULTS: Of 485 subjects enrolled, 409 took study medication and 401 treated a confirmed migraine attack (201 with aspirin and 200 with placebo). Baseline demographic and migraine characteristics were not significantly different between groups. The 2-hour headache response rate was 52% with aspirin versus 34% with placebo (P<.001). Aspirin was significantly more effective than placebo for pain reduction beginning 1 hour after dosing (P<.001) and continuing throughout the 6-hour evaluation period. Significantly (P<.05), more subjects were pain free from the 1-hour evaluation through the 6-hour evaluation. Of the aspirin-treated subjects, 20% were pain free at 2 hours versus only 6% of placebo-treated subjects. At 24 hours, the headache recurrence rate was 21.8% for aspirin (23 of 105 subjects) and 27.7% for placebo (19 of 68 subjects). Only 34% of aspirin-treated subjects needed rescue medication at 24 hours compared with 52% of placebo-treated subjects (P<.001). Aspirin was well tolerated, and adverse events were not significantly different between groups. CONCLUSIONS: This study demonstrates that aspirin is safe and effective for treatment of acute migraine in appropriately selected patients.

Acute Disease↗

PubMed2005

Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial.

OBJECTIVE: To address the need for a rigorous, direct comparison of prescription and over-the-counter (OTC) migraine drugs and to expand the database on early treatment of migraine. BACKGROUND: Most people who experience migraine use OTC medications to treat their symptoms, but no head-to-head clinical trials comparing these agents with prescription migraine therapies have been published. In addition, even though most migraineurs treat early in the attack, few studies have been conducted to reflect this treatment pattern. METHODS: We compared a combination of nonprescription migraine medication (acetaminophen 500 mg, aspirin 500 mg, and caffeine 130 mg) with a prescription migraine product (50 mg sumatriptan) in a randomized, controlled clinical trial in which subjects treated at the first sign of a migraine attack. Subjects who reported vomiting during more than 20% of migraine episodes or who required bedrest during more than 50% of migraine episodes were excluded from the study. Of the 188 subjects randomized, 171 took study medication and were included in the analysis. CONCLUSION: The combination of acetaminophen, aspirin, and caffeine was significantly more effective (P > .05) than sumatriptan in the early treatment of migraine, as shown by superiority in summed pain intensity difference, pain relief, pain intensity difference, response, sustained response, relief of associated symptoms, use of rescue medication, disability relief, and global assessments of effectiveness. An additional, larger clinical trial is needed to confirm these results.

Acetaminophen↗

PubMed2004

Efficacy of diclofenac sodium softgel 100 mg with or without caffeine 100 mg in migraine without aura: a randomized, double-blind, crossover study.

OBJECTIVE: A phase II, randomized, double-blind, crossover study was designed to evaluate the efficacy of 100-mg diclofenac sodium softgel (formulated using ProSorb technology) with or without 100-mg caffeine versus placebo in migraineurs during migraine attacks. BACKGROUND: Diclofenac has been demonstrated to be an effective migraine treatment in several placebo-controlled studies. A rapidly absorbed softgel of diclofenac has been shown to be effective in the rapid relief of acute pain, and may have advantages in migraine treatment. In addition, caffeine has consistently been shown to increase both the efficacy and speed of onset of concurrently administered analgesics. The ability of caffeine to both enhance and accelerate analgesic effects has been documented with a variety of different medications (ie, aspirin, acetaminophen, ibuprofen, and ergotamine). METHODS: The 3-period crossover study was designed to compare diclofenac softgel 100 mg, diclofenac softgel 100 mg plus caffeine 100 mg, and placebo in the acute treatment of migraine. Subjects treated one moderate or severe attack with each study medication. The primary efficacy parameter was the percentage of subjects with headache relief at 60 minutes as defined by a reduction of headache severity from moderate or severe at baseline to absent or mild compared with placebo. Though the sample size estimate required that 72 subjects treat 3 separate attacks, 51 subjects treated 1 migraine attack, 44 treated 2 attacks, and 39 treated 3 attacks. Results.-In the placebo group, 6 (14%) of 43 subjects reported headache relief at 60 minutes versus 12 (27%) of 45 subjects in the diclofenac softgel group, and 19 (41%) of 46 subjects in the diclofenac softgel plus caffeine group. Differences were statistically significant for the diclofenac softgel plus caffeine group versus placebo (odds ratio, 4.2; 95% confidence interval, 1.3 to 13.7). Rescue medication was used by 27 (63%) of 43 subjects treated with placebo, 15 (33%) of 45 subjects treated with diclofenac softgel, and 14 (30%) of 46 subjects treated with diclofenac softgel plus caffeine. This result is highly statistically significant (chi22= 11.56, P=.003). Both the diclofenac plus caffeine (P <.03) and diclofenac only (P <.03) groups were significantly different from the placebo group in terms of the visual analog scale score at 60 minutes. CONCLUSIONS: The major finding of the present study is that diclofenac softgel plus caffeine produces statistically significant benefits relative to placebo at 60 minutes. Diclofenac softgel alone did not differ significantly from placebo, perhaps due to limits in sample size. Nonsignificant trends support the analgesic adjuvant benefit of caffeine when added to diclofenac softgels.

Adolescent↗

PubMed2004

Randomized, placebo-controlled comparison of early use of frovatriptan in a migraine attack versus dosing after the headache has become moderate or severe.

OBJECTIVE: To evaluate whether frovatriptan would provide greater relief if given early during a migraine attack. RESEARCH DESIGN AND METHODS: Adults with a history of migraine of at least 1 year, and who had 2-8 headaches in the previous month were recruited from 19 US centres for a prospective, placebo-controlled crossover study over 2 migraine attacks. Dose 1 was taken at the onset of mild migraine headache, Dose 2 was taken at least 2 h later if the headache progressed to moderate/severe. Patients were randomized to receive Dose 1 frovatriptan then Dose 2 placebo or Dose 1 placebo followed by Dose 2 frovatriptan. Treatment order was reversed for the second attack. This schedule enabled a comparison of frovatriptan with placebo and a comparison of early and later treatment with frovatriptan. MAIN OUTCOME MEASURES: Freedom from pain at 2 h for frovatriptan versus placebo as Dose 1; use of Dose 2 and/or rescue medication, pain severity, functional impairment and headache recurrence. RESULTS: In 241 patients who each treated 2 migraine attacks, Dose 1 frovatriptan was more effective than placebo in terms of the proportion of patients who were pain free at 2 h (28% vs 20%, p = 0.04). This benefit was sustained up to 4 h post-dose (p = 0.003). Early use of frovatriptan significantly reduced re-medication (p < 0.001). Twenty-four-hour headache recurrence was low in both early (4%) and later use (6%) groups. Sustained pain-free response occurred in 40% of frovatriptan early use patients compared with 31% of later use patients (p < 0.05). Early use prevented headache progression: 69%-78% had mild/no headache 2-4 h after Dose 1 frovatriptan compared with 54%-63% taking Dose 1 placebo (p < 0.001). Early use reduced pain burden and functional disability (p < or = 0.001). More patients rated early use of frovatriptan as excellent or good (57% vs 46%). CONCLUSIONS: Early use of frovatriptan resulted in a higher, earlier and sustained pain-free response, prevented progression to moderate/severe headache and reduced pain burden and functional disability.

Adult↗

PubMed2003

Real-world experiences in migraine therapy with rizatriptan.

OBJECTIVE: To evaluate the effectiveness of rizatriptan for acute migraine treatment and patient satisfaction with the drug in usual clinical practice settings. BACKGROUND: Although rizatriptan has been shown to effectively relieve migraine symptoms in clinical trials, we wished to assess its utility in typical patient care settings. Design.-Multicenter, open-label design involving the patients of practicing clinicians. METHODS: Adult migraineurs treated two migraine attacks with either rizatriptan 10-mg standard tablets or rizatriptan 10-mg orally disintegrating tablets in a crossover manner. Participants had not taken rizatriptan previously and chose which formulation to take first. Patients reported their treatment experiences via an interactive voice response system approximately 24 hours after treatment. Prior migraine treatment experiences were reported by patients on a baseline questionnaire completed at participating clinics. We used conditional logistic regression analysis adjusted for treatment sequences to test the statistical significance of comparisons with results recorded on the baseline questionnaire. RESULTS: Of the 5388 patients enrolled, 3953 (73%) completed at least one follow-up and 3183 (59%) completed two follow-up reports. Patients reported the following outcomes for attacks treated with the rizatriptan tablet and orally disintegrating tablet formulations, respectively, compared with their prior responses to oral usual care medications (P <.05 in all comparisons with baseline data): onset of pain relief within 30 minutes postdose: 18% and 23% versus 16%; no or mild headache 2 hours postdose: 66% and 67% versus 37%; largely symptom-free within 2 hours postdose: 52% and 54% versus 35%; return to usual activities within 2 hours postdose: 50% and 51% versus 31%; and very or somewhat satisfied with treatment: 72% and 74% versus 53%. CONCLUSIONS: In this "real-world" setting involving a patient population selected by clinicians, rizatriptan appeared to offer better treatment outcomes than those from prior treatments with other oral migraine medications.

Acute Disease↗

PubMed2003

Frovatriptan: a review.

Frovatriptan is a potent 5-HT(1B/1D) receptor agonist and has the highest 5-HT(1B) potency in the triptan class. preclinical pharmacology studies demonstrated that frovatriptan is apparently cerebro-selective. In clinical pharmacology studies, frovatriptan was shown to have a long-terminal elimination half-life of 26 h and to be well-tolerated across a broad dose range of 1-100 mg. Frovatriptan has no inhibiting or inducing effects on cytochrome P450 isoenzymes and is only slightly bound to plasma proteins; thus it has a low potential for drug interactions. No dosage adjustments are necessary based on age or renal or hepatic impairment. Efficacy studies show significantly higher response rates compared with placebo and the lowest reported range of headache recurrence rates in the triptan class. Safety studies show a side effect profile similar to placebo. The combination of cerebro-selectivity, long half-life, reliable efficacy, low recurrence rates and good tolerability make frovatriptan a valuable new choice for acute treatment of migraine. Frovatriptan may be particularly well suited to patients with migraine of long duration, those prone to recurrence and those troubled by "triptan-type" side effects.

Administration, Oral↗

PubMed2002

Frovatriptan for the acute treatment of migraine: a dose-finding study.

OBJECTIVE: To determine the optimal dose and tolerability of frovatriptan in the acute treatment of migraine. BACKGROUND: Frovatriptan has a distinctive pharmacological and pharmacokinetic profile compared with sumatriptan. A previous study has shown that frovatriptan doses of 2.5, 5, 10, 20, and 40 mg are equally effective in relieving headache with no evidence of a dose-response relationship. The incidence of adverse events tended to increase with doses of 10 mg and above. METHODS: This study was a randomized, double-blind, placebo-controlled, parallel-group multicenter trial. Patients (n=635) took a single oral dose of placebo or frovatriptan, 0.5, 1, 2.5, or 5 mg, at the onset of a moderate or severe migraine headache and recorded headache intensity, functional impairment, and migraine-associated symptoms over 24 hours. RESULTS: Frovatriptan 2.5 mg produced clinically and statistically significant headache relief 2 hours post-dose, whereas the effect of lower doses was not significantly different from that of placebo at that time point. The 2.5-mg dose also produced significant symptom relief and improvement in functional impairment. All doses of frovatriptan were well tolerated, and the majority of adverse events were of mild or moderate severity. CONCLUSION: It is concluded that the 2.5-mg dose of frovatriptan offers optimal efficacy and tolerability in the treatment of acute migraine. Higher doses do not appear to confer greater efficacy and are associated with an increased incidence of adverse effects.

Administration, Oral↗

PubMed2002

Dose range-finding studies with frovatriptan in the acute treatment of migraine.

OBJECTIVE: To determine the optimum dose of frovatriptan for the acute treatment of migraine. BACKGROUND: Frovatriptan is a new triptan developed for the acute treatment of migraine. The dose-response characteristics and safety of frovatriptan have been investigated across a broad range of doses from 0.5 to 40 mg. DESIGN: Two randomized, placebo-controlled, double-blind, parallel-group trials, with a total of 1453 patients, were performed to determine the optimal dose of the 5-HT(B/1D)agonist, frovatriptan, for the acute treatment of migraine. The dose ranges studied were 2.5 to 40 mg in the high-dose study and 0.5 to 5 mg in the low-dose study. RESULTS: At 2 hours postdosing for initial moderate or severe headache (International Headache Society grades 2 or 3), there was an approximate two-fold difference in the proportion of patients taking frovatriptan doses of 2.5 to 40 mg with mild or no headache compared to placebo. Frovatriptan doses of 0.5 mg and 1 mg were not more effective than placebo at 2 hours postdose, and 2.5 mg was identified as the lowest effective dose for the relief of migraine and accompanying symptoms. Above 2.5 mg, no dose-response relationship was observed for any efficacy parameters. There was an increase in the incidence of adverse events from 10 mg and above, but the vast majority were rated as mild in severity and did not impact upon tolerability in a significant manner. CONCLUSIONS: Frovatriptan was well tolerated throughout the dose range of 0.5 to 40 mg. The 2.5-mg dose confers the optimal balance of efficacy and tolerability for the acute treatment of migraine.

Acute Disease↗

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↗