In vitro susceptibilities of aerobic and facultatively anaerobic gram-negative bacilli isolated from patients with intra-abdominal infections worldwide: 2005 results from Study for Monitoring Antimicrobial Resistance Trends (SMART).

BACKGROUND: The Study for Monitoring Antimicrobial Resistance Trends (SMART) is examining aerobic and facultatively anaerobic gram-negative bacilli (GNB) isolated from intra-abdominal infections. This report summarizes the 2005 annual data. METHODS: During 2005, 76 medical centers in 31 countries in five regions collected intra-abdominal GNB for antimicrobial susceptibility testing using broth microdilution according to the Clinical and Laboratory Standards Institute guidelines. RESULTS: A total of 5,476 unique aerobic and facultatively anaerobic GNB were isolated. Enterobacteriaceae accounted for 86% (4,711) of the total isolates. Among the 12 antimicrobial agents tested, the carbapenems and amikacin were the most reliably active against the Enterobacteriaceae, whereas ampicillin/sulbactam most often was the least active. Escherichia coli was the species most commonly isolated, at 48% (2,654). Extended-spectrum beta-lactamases (ESBLs) were detected phenotypically in 12% (325/2,329) of E. coli and 18% (151/856) of Klebsiella spp. In general, ESBL producers demonstrated lower susceptibility to the majority of the antibiotics than the non-producers; however, ESBL producers usually were susceptible to the carbapenems tested. CONCLUSIONS: In 2005, antibiotic resistance continued to be a problem among GNB isolated from intra-abdominal infections, with the highest resistance rates observed in the Asia/Pacific region. Imipenem-cilastatin, ertapenem, and amikacin were the agents most consistently active in vitro against the Enterobacteriaceae isolated.

Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine.

BACKGROUND: The quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle vaccine was 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18. Vaccine efficacy is thought to be mediated by humoral immunity. Here, we analyze the effect of the baseline characteristics of subjects on vaccine-induced immune responses. METHODS: Immunogenicity data from 12,343 subjects 9-26 years old randomized to quadrivalent HPV vaccine or placebo in phase 2/3 studies were analyzed. Covariates examined were day 1 HPV serostatus, age, race/ethnicity, region of residence, lactation status, hormonal contraceptive usage, smoking status, Pap test diagnosis, immunosuppressant or anti-inflammatory agent use, and number of sex partners. Anti-HPV responses were summarized as serum anti-HPV-6, -11, -16, or -18 geometric mean titers 1 month after dose 3. RESULTS: Age at vaccination initiation was inversely proportional to the vaccine-induced anti-HPV response. Vaccination of subpopulations of subjects who were seropositive at day 1 to a vaccine HPV type resulted in more robust anti-HPV responses to that type, compared with those in subjects who were seronegative at baseline. Anti-HPV responses were comparable among the remaining demographic subgroups. CONCLUSIONS: The immunogenicity of quadrivalent HPV vaccine was comparable among subjects with differing baseline characteristics. These data support vaccination with quadrivalent HPV vaccine across a broad range of baseline subject characteristics.

Bowel colonization with vancomycin-resistant enterococci after antimicrobial therapy for intra-abdominal infections: observations from 2 randomized comparative clinical trials of ertapenem therapy.

The impact of different antimicrobial regimens for intra-abdominal infections on the frequency of bowel colonization with vancomycin-resistant enterococci (VRE) was examined in 2 randomized open-label trials of intra-abdominal infection comparing piperacillin-tazobactam or ceftriaxone/metronidazole with ertapenem. In these short-term studies, overall rates of bowel colonization with VRE were generally comparable after treatment with piperacillin-tazobactam, ceftriaxone/metronidazole, or ertapenem.

Usefulness of either or both left and right bundle branch block at baseline or during follow-up for predicting death in patients following acute myocardial infarction.

The presence or onset of bundle branch block (BBB) is associated with increased mortality in patients after acute myocardial infarction (AMI). The risk increases with age. We assessed the prognostic power of BBB patterns for predicting clinical outcomes in patients after high-risk AMI. In the OPTIMAAL trial, the effects of losartan versus captopril were compared in 5,477 patients with heart failure and/or evidence of left ventricular dysfunction after MI. The association between clinical outcomes and the presence of left or right BBB at randomization (median 3 days after AMI) or occurring during follow-up (mean 2.7 years) was assessed using Cox regression models. At randomization, 8% of patients (n = 438) showed BBB patterns; 3.7% (n = 203) showed left BBB and 4.3% (n = 235) showed right BBB patterns. In patients with left BBB, there was an increased risk of all-cause death and cardiovascular death. In patients with right BBB, there was increased risk of sudden cardiac death/resuscitated cardiac arrest. During follow-up, another 4.9% (n = 272) developed BBB patterns; 2.8% (n = 153) developed left BBB and 2.17% (n = 119) developed right BBB. Left BBB was associated with increased risk for all-cause death, cardiovascular death, and sudden cardiac death/resuscitated cardiac arrest, whereas right BBB was related to increased risk of sudden cardiac death/resuscitated cardiac arrest. In conclusion, our results confirm and quantify previous observations showing substantially increased mortality in patients with BBB patterns at baseline or occurring soon after AMI.

In vitro susceptibilities of aerobic and facultative Gram-negative bacilli isolated from patients with intra-abdominal infections in the Asia-Pacific region: 2004 results from SMART (Study for Monitoring Antimicrobial Resistance Trends).

In the 2004 Study for Monitoring Antimicrobial Resistance Trends (SMART), 14 centres from six countries in Asia-Pacific collected 1198 unique aerobic and facultative Gram-negative bacilli from intra-abdominal infections for susceptibility testing to 12 antimicrobial agents. Enterobacteriaceae comprised 82% of the total isolates. Escherichia coli was the most commonly isolated species (43%). Resistance rates were generally higher in Enterobacteriaceae isolated from Asian centres than those isolated from Oceania centres. There was little difference in susceptibility rates between community- and hospital-acquired Enterobacteriaceae for carbapenems. Extended-spectrum beta-lactamase (ESBL)-producers typically had a more resistant profile than non-ESBL-producers, but were usually susceptible to carbapenems. Of the antimicrobial agents tested, carbapenems were the most reliably active in vitro against Enterobacteriaceae recovered from patients in Asia-Pacific with intra-abdominal infections.

In vitro susceptibilities of aerobic and facultatively anaerobic Gram-negative bacilli isolated from patients with intra-abdominal infections worldwide: 2004 results from SMART (Study for Monitoring Antimicrobial Resistance Trends).

OBJECTIVES: SMART (Study for Monitoring Antimicrobial Resistance Trends) is an ongoing study to monitor worldwide antimicrobial resistance trends among aerobic and facultatively anaerobic Gram-negative bacilli (GNB) isolated from intra-abdominal infections. This 2004 report summarizes the most recently completed annual data from SMART. METHODS: During 2004, 81 medical centres from 28 countries in five global regions collected intra-abdominal GNB for antimicrobial susceptibility testing using broth microdilution according to the Clinical and Laboratory Standards Institute guidelines. RESULTS: A total of 6156 unique aerobic and facultatively anaerobic GNB were isolated from intra-abdominal infections. Enterobacteriaceae composed 86% of the total isolates. Among the 12 antimicrobial agents tested, the carbapenems and amikacin were the most consistently active against the Enterobacteriaceae. Escherichia coli was the most commonly isolated species (48%), and the susceptibility rate to the quinolones was lowest in Asia/Pacific and Latin America. Extended-spectrum beta-lactamases (ESBLs) were detected phenotypically in 10% of E. coli, 17% of Klebsiella spp. and 22% of Enterobacter spp. worldwide, representing a slight increase over the two previous years. ESBL producers typically had a more antibiotic-resistant profile than non-ESBL producers but were usually susceptible to the carbapenems. CONCLUSIONS: Antimicrobial resistance among GNB isolated from intra-abdominal infections continued to be a problem worldwide in 2004, with the highest rates of resistance overall in the Asia/Pacific region. The carbapenems and amikacin were the most consistently active agents in vitro against Enterobacteriaceae isolated from intra-abdominal infections worldwide.

In vitro susceptibilities of Escherichia coli isolated from patients with intra-abdominal infections worldwide in 2002-2004: results from SMART (Study for Monitoring Antimicrobial Resistance Trends).

BACKGROUND: Since 2002, the worldwide Study for Monitoring Antimicrobial Resistance Trends (SMART) has tracked resistance patterns among aerobic and facultative gram-negative bacilli isolated from patients with intra-abdominal infections. Escherichia coli has been by far the most frequently isolated species. METHODS: Antimicrobial susceptibilities for consecutive non-duplicate isolates of aerobic and facultative gram-negative bacilli recovered from intra-abdominal infections were determined by standard broth microdilution techniques. A subanalysis was performed for E. coli isolates from the first three years of the study. RESULTS: A total of 7,002 E. coli isolates were recovered, most commonly from the peritoneal cavity followed by the biliary tract. Susceptibility rates to the 12 antimicrobial agents tested differed among geographic regions, with isolates from Asia/Pacific generally having the highest resistance rates. Overall, extended-spectrum beta-lactamase (ESBL)-producers had a more antibiotic-resistant profile than non-ESBL-producers but usually were susceptible to the carbapenems and amikacin. Community-acquired E. coli strains comprised slightly more than one-half of the isolates and were susceptible to the agents tested more frequently than were hospital-acquired E. coli. CONCLUSIONS: The prevalence of antimicrobial resistance among E. coli isolated from intraabdominal infections is not inconsequential, especially in the Asia/Pacific region. The carbapenems and amikacin were consistently active in vitro against E. coli isolates worldwide, including ESBL-producers.

Head CT evaluation in clinically stable motor vehicle collision patients.

PURPOSE: To assess the utilization of non-contrast head computed tomography (HCT) in clinically stable patients who were involved in motor vehicle collisions. Our goal is to identify patients in whom HCT may be safely excluded without altering clinical outcome. METHODS: Adult, front-seat passengers were retrospectively examined. All clinically stable patients involved in motor vehicle collisions and who subsequently underwent HCT were studied to determine the factors that increased the statistical likelihood of a negative examination. Seven factors relevant to passenger safety or clinical outcomes were measured. RESULTS: Eighteen of the 206 patients who met criteria for our study had positive HCT findings. Front-seat passengers were more likely to suffer traumatic head injury than drivers. Both Glasgow Coma Scale (GCS) and Injury Severity Score (ISS) individually had statistically significant correlations with positive HCT findings. Thirteen of the 18 patients had GCS scores of 13-15. Seatbelts, rollover collisions, gender, and airbag deployment demonstrated relatively decreased predictive values. CONCLUSION: The ISS emerged as the single most reliable predictor of positive HCT findings. Regarding multiple variable effects, the combinations of ISS and patient position or GCS and patient position are the most statistically significant clinical factors in identifying patients in whom HCT may be safely excluded.

Clinical outcome of active extravasation in splenic trauma.

The purpose of this study was to determine the necessity for splenectomy in patients with active extravasation on contrast enhanced CT secondary to splenic trauma. We reviewed cases of splenic injury and classified these according to the American Association for the Surgery of Trauma (AAST) grading scale. The presence of active extravasation and associated injuries was assessed. Chart review was then performed to determine age, sex, mechanism of injury, indications for splenectomy, and clinical outcome. Of 82 cases evaluated, 12 grade I, 15 grade II, 30 grade III, 17 grade IV, and 8 grade V injuries were present. Eighteen patients were actively extravasating. Of extravasating patients, 13 eventually underwent open splenectomy or embolization and five (27.8%) were managed expectantly with success. Of grade IV injuries, 9/17 showed active extravasation, of which six underwent splenectomy. Of grade V injuries, 3/8 showed active extravasation, and all three underwent intervention. Splenectomy may not be necessary in appropriately chosen patients with active extravasation from the spleen in blunt abdominal trauma.

Efficacy of the dorzolamide/timolol fixed combination versus latanoprost in the treatment of ocular hypertension or glaucoma: combined analysis of pooled data from two large randomized observer and patient-masked studies.

In previous analyses of primary efficacy data from two randomized clinical trials, standard dosing regimens of the dorzolamide/timolol fixed combination (COSOPT) and latanoprost (XALATAN) were shown to have equivalent efficacy with regard to reduction in mean daytime diurnal intraocular pressure (IOP). We performed additional post hoc analyses of pooled data from these studies to compare further the efficacy of the two treatments. The studies used identical 3-month, parallel group, randomized, observer-masked and patient-masked, multicenter designs. Patients with a baseline IOP > or = 24 mm Hg were randomized to either the 2% dorzolamide/0.5% timolol combination eye drops twice daily (n = 273) or 0.005% latanoprost eye drops once daily (n = 271). The IOP measurements were made at 8 AM, 10 AM, 2 PM, and 4 PM at the baseline visit and then on each of the 3 monthly assessment days. The following measures were analyzed on a post hoc basis: 1) percentages of patients meeting target levels of IOP reduction; 2) mean IOP reduction in those patients with high IOP (> or =30 mmHg) at baseline; 3) mean IOP at each of the assessment time points during a day. A total of 259 patients in the dorzolamide/timolol group and 268 patients in the latanoprost group were included in the efficacy analysis. At 3 months, both treatments showed similar efficacy with regard to the percentages of patients who achieved target levels of IOP reduction (e.g., 40% IOP reduction in 15% of dorzolamide/timolol combination patients and 13% of latanoprost patients), mean IOP reduction in those patients with high IOP at baseline (dorzolamide/ timolol combination, 12.5 mmHg, latanoprost, 12.6 mmHg), and mean IOP at each time point during the day. By the measures used in this analysis, the dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP in patients with ocular hypertension or glaucoma.

Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies.

OBJECTIVE: To examine the short- and long-term efficacy and tolerability of rizatriptan 5 mg in adolescents with migraine. METHODS: Two studies were conducted in patients aged 12 to 17 years. The first study was a randomized, double-blind, placebo-controlled, single-attack study followed by a randomized, 1-year, open-label extension. The second study was a randomized, 1-year, open-label study. In the single-attack study, patients treated a moderate or severe migraine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234) or placebo (n = 242). Patients were instructed to use the study medication only on nonschool days. Headache severity, associated symptoms, and functional disability were assessed by the patient at 0.5, 1, 1.5, 2, 3, and 4 hours after the initial dose. In the 1-year studies, patients treated up to 6 migraine attacks per month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. RESULTS: In the single-attack study, the proportion of patients with pain relief at 2 hours was not significantly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer patients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significantly higher in the rizatriptan group than in the placebo group (74% vs. 58%, P = 0.022). In the multiple-attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not significantly different from that of placebo or standard care. CONCLUSIONS: Rizatriptan 5 mg was not more effective than placebo in the treatment of a single migraine attack in adolescents, but appeared to be more effective than standard care for treating multiple attacks occurring over 1 year in these patients. Rizatriptan 5 mg was well tolerated in adolescents during short-term and long-term use.

Ertapenem as initial antimicrobial monotherapy for patients with chronic obstructive pulmonary disease hospitalized with typical community-acquired pneumonia.

This report describes a post-hoc analysis of two large studies of typical community-acquired pneumonia (CAP) in hospitalized patients, focusing on demographics, disease characteristics, and outcome in patients with and without chronic obstructive pulmonary disease (COPD). In both studies, ertapenem 1 g IV daily was compared with ceftriaxone 1 g IV daily as initial antimicrobial therapy. Clinically improving patients could be switched to oral antibiotic therapy after 3 days. Of the 857 patients treated in both studies, 264 (31%) had COPD. The proportions of patients who were male, were >/=65 years of age, had a Pneumonia Severity Index of IV/V, or had Haemophilus influenzae isolated in a baseline culture were higher in patients with COPD. Streptococcus pneumoniae was the most common pathogen both in patients with and without COPD. Clinical response rates in assessable patients 7-14 days after completion of therapy for the combined treatment groups were 90% (187/208) for patients with COPD and 93% (424/456) for those without COPD (odds ratio 0.7 [95% CI, 0.4-1.2], P = 0.17). Of assessable COPD patients, 109/121 (90%) treated with ertapenem and 78/87 (90%) treated with ceftriaxone achieved a favorable clinical response (odds ratio 1.0 [95% CI, 0.6-1.8], P = 0.94). The outcome in patients with or without COPD was similar regardless of therapy. In patients with COPD as well as in the overall study population, the efficacy of ertapenem as initial antimicrobial monotherapy for patients with serious typical community-acquired pneumonia was comparable to that of ceftriaxone.

Efficacy of ertapenem against methicillin-susceptible Staphylococcus aureus in complicated skin/skin structure infections: results of a double-blind clinical trial versus piperacillin-tazobactam.

Staphylococcus aureus is the predominant pathogen in complicated skin/skin structure infections. In this analysis of a subgroup of data from a randomised, double-blind trial, the efficacy of ertapenem 1 g daily was compared with piperacillin-tazobactam 3.375 g Q6H for treatment of complicated skin/skin structure infections caused by methicillin-susceptible S. aureus (MSSA). Of the 529 treated patients in this trial, 185 (35.0%) had MSSA as a baseline pathogen. At the test of cure assessment 10-21 days post-therapy, 54 of 67 (80.6%) protocol evaluable patients in the ertapenem group and 55 of 68 (80.9%) in the piperacillin-tazobactam group were cured (odds ratio: 1.0 (95% confidence interval (CI): 0.4-2.4), P = 0.99). In both treatment groups, cure rates were higher in patients with monomicrobial than polymicrobial infections, but the difference was not significant. In this subgroup analysis of patients with MSSA complicated skin/skin structure infections, therapy with ertapenem 1 g daily was as effective as piperacillin-tazobactam 13.5 g divided in four daily doses.

Evaluation of outpatient treatment with ertapenem in a double blind controlled clinical trial of complicated skin/skin structure infections.

OBJECTIVES: The patient characteristics and the efficacy and safety of ertapenem 1 g once daily vs. piperacillin-tazobactam 13.5 g divided Q6H were examined in patients who received outpatient parenteral antimicrobial therapy (OPAT) during a clinical trial of complicated skin/skin structure infections. METHODS: The population analyzed included 363 patients treated at US sites in a large randomized double-blind study. RESULTS: In this analysis, 146 (40%) patients at 19 (66%) sites were managed by OPAT. A lower proportion of treated patients who received OPAT had severe infection (12% vs. 20%, P=0.03). In evaluable patients managed by OPAT, 45 (83.3%) of 54 treated with ertapenem and 41 (82.0%) of 50 treated with piperacillin-tazobactam were cured at the test of cure assessment 10-21 days post-therapy (OR 1.2 (95% CI, 0.4-3.2), P=0.78). The safety profile of both drugs was generally similar; diarrhoea was the most common adverse event in both groups. CONCLUSIONS: In this trial of complicated skin/skin structure infection, OPAT was commonly used by US investigators. Among patients who received OPAT, ertapenem 1 g daily was as effective as piperacillin-tazobactam 3.375 g Q6H.

Ertapenem therapy for community-acquired pneumonia in the elderly.

OBJECTIVES: To compare the efficacy and safety of ertapenem, 1 g once a day, with ceftriaxone, 1 g once a day, for treatment of the subgroup of patients aged 65 and older with community-acquired pneumonia (CAP) requiring parenteral therapy. DESIGN: Combined data from patients aged 65 and older in two randomized, double-blind clinical trials. SETTING: Eighty international centers. PARTICIPANTS: Eight hundred fifty-seven treated patients, of whom 351 were aged 65 and older. INTERVENTIONS: Intravenous or intramuscular ertapenem or ceftriaxone with the option to switch to oral amoxicillin-clavulanate after at least 3 days of parenteral therapy. MEASUREMENTS: Clinical efficacy was assessed at completion of parenteral therapy and 7 to 14 days after all therapy had been completed (test of cure (TOC) assessment). Bacterial eradication was assessed at the TOC visit. Safety was assessed daily during study therapy and for 14 days thereafter. RESULTS: One hundred forty-eight clinically evaluable patients aged 65 and older were treated with ertapenem and 125 with ceftriaxone. Pathogens were identified in 157 (57.5%) patients (the most common being Streptococcus pneumoniae), most of which were penicillin-susceptible. Clinical cure rates were 95.9% for patients in the ertapenem group and 92.7% for patients in the ceftriaxone group at completion of parenteral therapy and 93.9% and 90.4%, respectively, at the TOC assessment. Overall bacterial eradication rates were 92.8% (77 of 83) for patients treated with ertapenem and 93.2% (69 of 74) for those treated with ceftriaxone. The most common drug-related adverse experiences in both treatment groups were diarrhea and mild to moderate elevation of serum aminotransferase levels. CONCLUSION: Ertapenem 1 g once a day was highly effective for treatment of elderly patients with CAP requiring parenteral therapy and was as effective as ceftriaxone. Ertapenem was generally well tolerated, with an overall safety profile similar to ceftriaxone.

Efficacy of ertapenem in the treatment of serious infections caused by Enterobacteriaceae: analysis of pooled clinical trial data.

OBJECTIVE: The efficacy of ertapenem, 1 g once a day, for treatment of adults with serious infections caused by Enterobacteriaceae was compared with ceftriaxone 1 g once a day [complicated urinary tract infection (CUTI) and community-acquired pneumonia (CAP)] or piperacillin-tazobactam, 3.375 g every 6 h (complicated intra-abdominal, complicated skin/skin structure and acute pelvic infections). PATIENTS AND METHODS: This combined analysis included the subgroup of all 1167 treated patients infected with Enterobacteriaceae from seven randomized double-blind studies. RESULTS: Escherichia coli was the most common pathogen, accounting for 65.3% of all Enterobacteriaceae. Among evaluable patients with deep tissue (intra-abdominal, skin and pelvic) infections, the combined clinical cure rates were 84.8% (223 of 263) for ertapenem and 82.9% (194 of 234) for piperacillin-tazobactam [95% confidence interval (CI) for the difference, adjusting for infection, -4.9% to 8.9%]. Cure rates by infection for ertapenem and piperacillin-tazobactam, respectively, were: intra-abdominal, 85.1% (143 of 168) and 79.9% (119 of 149); pelvic, 86.8% (46 of 53) and 94% (47 of 50); skin/skin structure, 81% (34 of 42) and 80% (28 of 35). Among patients with CUTI, microbiological cure rates were 90.5% (220 of 243) for ertapenem and 92% (196 of 213) for ceftriaxone (95% CI for the difference, -7.1% to 4.1%). In patients with CAP, clinical cure rates were 95% (19 of 20) for ertapenem and 88.9% (16 of 18) for ceftriaxone. CONCLUSION: Ertapenem therapy was as effective as either piperacillin-tazobactam or ceftriaxone for serious infections caused by Enterobacteriaceae.

Telephone screening for amnestic mild cognitive impairment.

OBJECTIVES: To evaluate the utility of telephone screening for identifying subjects with amnestic mild cognitive impairment (aMCI) for enrollment in a clinical trial and to identify which elements of the modified Telephone Interview for Cognitive Status (TICS-m) best predicted the in-clinic determination of aMCI. METHODS: Subjects aged >/=65 years with memory complaints responded to an advertisement for a clinical trial by calling a central telephone recruiting agency. To determine eligibility, subjects went through a stepwise selection procedure involving a review of major protocol inclusion and exclusion criteria, followed by administration of the Category Fluency Test (CFT) and then the TICS-m. Subjects meeting entry criteria, who obtained a score of /=24 on the Mini-Mental State Examination and a score of

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.

Further evaluation of rizatriptan in menstrual migraine: retrospective analysis of long-term data.

OBJECTIVE: To determine the long-term efficacy of oral rizatriptan 10-mg wafers in the treatment of menstrual migraine attacks. METHODS: Data from an extension study where patients with migraine used rizatriptan 10 mg to treat moderate or severe migraine attacks occurring over periods of up to 6 months were included in a retrospective analysis. Patients used a diary card to record details of each migraine attack and onset of menstruation. Attacks in women were classified as menstrual or nonmenstrual according to 3 time windows relative to onset of menstruation (day 0): -3 to +3 days (7-day window), -2 to + 2 days (5-day window), and 0 to +1 days (2-day window). The analysis looked at the efficacy of rizatriptan 10 mg by menstrual category of attack for each definition on three measures: pain relief at 2 hours (reduction of pain to mild or none), pain free at 2 hours, 24-hours sustained pain free (pain free at 2 hours with no headache recurrence and no use of additional medications from 2 to 24 hours). RESULTS: Ninety-five women used rizatriptan 10 mg to treat a total of 1,839 attacks. The percentage of menstrual attacks was 30% for the -3 to +3 days definition, 23% for the -2 to +2 days definition, and 11% for the 0 to +1 days definition. Rizatriptan 10 mg was equally effective in menstrual and nonmenstrual migraine attacks regardless of the definition used. For example, using the -3 to +3 days definition, 78% of menstrual migraine attacks were relieved at 2 hours after dosing compared with 78% of nonmenstrual attacks. Pain relief rates for the other definitions were as follows: -2 to +2 days, menstrual = 78%, nonmenstrual = 78%; 0 to +1 days, menstrual = 79%, and nonmenstrual = 78%. No differences between menstrual and nonmenstrual attacks were found for the 2-hour pain free and 24-hour sustained pain free measures for any of the three definitions. CONCLUSIONS: Rizatriptan 10-mg wafers were equally effective in the treatment of menstrual and nonmenstrual migraine attacks occurring over 6 months, regardless of the precise definition of menstrual association used and even when the outcome criteria were very stringent. These data provide further evidence that triptans are effective treatments for menstrual migraine.

Radiologic study of injection drug use complications.

The complications of injection drug use (IDU) can lead to a wide variety of clinical problems that range from complications localized to the injection site to more disseminated disease. The radiologic workup of these problems uses multiple modalities, depending on the location and type of problem to be investigated. This article discusses and illustrates some of the local and disseminated complications that can occur after IDU.