Gender Differences In Efficacy Research Articles

Effect of gender and age on bDMARD efficacy for axial spondyloathritis patients: a meta-analysis of randomized controlled trials.

To study the therapeutic variations of biological and targeted synthetic disease-modifying antirheumatic drugs(b/tsDMARDs) between genders and across age stages in axial spondyloarthritis (axSpA) patients through meta-analysis. Randomized controlled trials (RCTs), published by Pubmed, Scopus, and Embase before August 10, 2023, testing the efficiency of b/tsDMARDs in axSpA, were searched and systematically reviewed. The Assessment of Spondyloarthritis International Society ≥40% improvement (ASAS40) response was used as the primary outcome of treatment response. : Only one study meet the inclusion criteria was related to tsDMARD, which was excluded from further data combination. Nine studies of bDMARDs, with the involvement of 4127 patients, were included for final analysis. When compared with placebo, both males (OR = 3.14; 95%CI, 2.66-3.70) and females (2.32; 1.82-2.82), younger (4.00; 2.50-6.40) and older (2.21; 1.15-4.22) patients, presented significantly better responses to bDMARDs. Besides, the efficacies were more evident in males (1.89; 1.56-2.30) and younger patients (2.07; 1.42-3.02). Subgroup analysis revealed that gender difference in efficacy was more obvious in non-radiographic-axSpA (nr-axSpA) patients (Pheterogeneity=0.03, I2=78.1%). Moreover, males with radiographic-axSpA (r-axSpA) and nr-axSpA shared similar responses to bDMARDs (Pheterogeneity=0.87, I2=0%), while females with r-axSpA showed greater response than those with nr-axSpA (Pheterogeneity=0.005, I2=87.4%). BioDMARDs were efficient in all axSpA patients regardless of gender or age stage. However, the treatment responses were more evident in male and younger patients. Besides, females with r-axSpA had greater responses than those with nr-axSpA, whereas no relevant difference was observed in males, indicating that the gender difference on efficacy was larger in nr-axSpA patients.

Naturalistic examination of the anxiolytic effects of medical cannabis and associated gender and age differences in a Canadian cohort

BackgroundThe aim of the current study was to examine patterns of medical cannabis use in those using it to treat anxiety and to investigate if the anxiolytic effects of cannabis were impacted by gender and/or age.MethodsPatient-reported data (n = 184 participants, 61% female, 34.7 ± 8.0 years) was collected through the Strainprint® app. Tracked sessions were included if the method of administration was inhalation, treatment was for anxiety and the product used was dried flower. The final analyzed dataset encompassed three of the most commonly utilized dried flower products in anxiety sessions. Independent sample t-tests were used. The core analysis examined within subject changes overtime (pre-medication to post-medication) and interactions between time with two candidate moderators [gender (male, female) and age (18–29, 30–39, and 40 + years old)] by using analysis of variance (ANOVA). For significant main effects of interactions, post hoc tests were conducted using a Bonferroni correction. A secondary analysis examined differences in proportion of emotives endorsed as a function of gender or age using chi-square test of independence.ResultsCannabis consumption resulted in a significant decrease in anxiety scores among both males and females (average efficacy of 50%) and efficacy was similar across the three cultivars. However, gender differences in efficacy were identified in two of the cultivars. All age groups experienced significant reductions in their anxiety post cannabis consumption; however, the 40 + year old group had significantly less efficacy than the other groups. The overall optimal dosing for the entire cohort was 9–11 inhalations for males and 5–7 inhalations for females, with some variation in dosing across the different cultivars, genders and age groups.ConclusionsWe found all three cultivars had significant anxiolytic effects and were well-tolerated. Some limitations of the study are the moderate sample size, self-reported diagnosis of anxiety, unknown comorbidities and experience with cannabis, whether other drugs or cannabis products were used, and restriction to solely inhaled administration. We suggest that the gender and age differences in optimal dosing could support both healthcare practitioners and patients initiate medical cannabis treatment for anxiety.

Gender Differences in Academic Efficacy across STEM Fields

Cultural processes can reduce self-selection into math and science fields, but it remains unclear how confidence in computer science develops, where women are currently the least represented in STEM (science, technology, engineering, and mathematics). Few studies evaluate both computer skills and self-assessments of skill. In this paper, we evaluate gender differences in efficacy across three STEM fields using a data set of middle schoolers, a particularly consequential period for academic pathways. Even though girls and boys do not significantly differ in terms of math grades and have similar levels of computer skill, the gender gap in computer efficacy is twice as large as the gap for math. We offer support for disaggregation of STEM fields, so the unique meaning making around computing can be addressed.

Gender difference in efficacy of intra-aortic balloon pump in acute myocardial infarction patients complicating with cardiogenic shock

Objective: To investigate the effect of gender on the efficacy of intra-aortic balloon pump(IABP) applied in patients with cardiogenic shock complicated by acute myocardial infarction(AMI). Methods: A total of 209 patients diagnosed as cardiogenic shock complicated by AMI admitted in Fuwai Hospital from June 2012 to May 2018 were enrolled in our study. We collected the data from medical records and investigated their clinical manifestation and laboratory examination and IABP support, as well as 28-day (from diagnosis of cardiogenic shock) mortality retrospectively. Kaplan-Meier survival analysis was used to compare the 28-day survival rates of patients of different genders/with or without IABP treatment. Adjustment for age, systolic blood pressure, ST segment elevation myocardial infarction, dual antiplatelet, coma, APACHEⅡ score and SAPSⅡ score, Cox regression analysis was used to detect the affect of IABP treatment on the risk of all-cause mortality in different crowd, and using Z test to evaluate the modification effect of gender on IABP treatment efficacy. Results: A total of 209 patients were included in this study, with 148 males (80 (54.05%) cases received IABP support) and 61 females (22 (36.06%) cases received IABP support). A total of 102 patients received IABP treatment. The 28-day survival rate of male patients was higher than that of females (39.2% (58/148) vs. 26.2% (16/61), Log-rank P=0.034). The 28-day survival rate of patients receiving IABP was significantly higher than that of non-IABP groups (46.1% (47/102) vs. 25.2% (27/107), Log-rank P=0.001 7). Among female patients, there was no statistically significant difference in 28-day survival rate between those who received IABP and those who did not receive IABP (P=0.889). While in male patients, the 28-day survival rate of those who received IABP was higher than that of those who did not receive IABP (51.2% (41/80) vs. 25.0% (17/68), P=0.001). The survival rate of male patients treated with IABP was higher than that of male patients who did not receive IABP, female patients who did not receive IABP and female patients who received IABP (all P<0.05). After multiple regression analysis and adjustment of confounding factors, it was found that IABP implantation can significantly reduce the 28-day mortality risk in male patients (HR=0.44, 95%CI 0.25-0.77 P=0.004). While it had no inpact on the death risk in female patients(P= 0.401). The impact of IABP implantation in patients of different genders was significantly different (Z=-2.32, P=0.020). Conclusion: In AMI patients complicating cardiogenic shock, there is a gender difference in the impact of IABP implantation on the 28-day mortality risk, and protective effects are seen only in men.

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

BackgroundConcerns exist that women are underrepresented in trials of cardiovascular medications. ObjectivesThe authors sought to examine women’s participation and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications. MethodsOn the basis of publicly available FDA reviews, the authors assessed enrollment of women in trials supporting 36 drug approvals from 2005 to 2015. Prevalence-corrected estimates for the participation of women were calculated as the percentage of women among trial participants divided by the percentage of women in the disease population (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting similar representation of women in the trial and disease population. Sex differences in efficacy and safety were assessed. ResultsThe proportion of women enrolled ranged from 22% to 81% (mean 46%). The calculated PPR by disease area was within or above the desirable range for atrial fibrillation (0.8 to 1.1), hypertension (0.9), and pulmonary arterial hypertension (1.4); PPR was <0.8 for heart failure (0.5 to 0.6), coronary artery disease (0.6), and acute coronary syndrome/myocardial infarction (0.6). The authors found little indication of clinically meaningful gender differences in efficacy or safety. Gender differences in efficacy or safety were described in labeling for 4 drugs. ConclusionsWomen were well represented in trials of drugs for hypertension and atrial fibrillation, and overrepresented for pulmonary arterial hypertension. Representation of women fell below a PPR of 0.8 for trials in heart failure, coronary artery disease, and acute coronary syndrome. Minimal gender differences in drug efficacy and safety profiles were observed.

Gender Differences in Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation: Systematic Review and Network Meta-analysis.

Studies indicate that women with atrial fibrillation (AF) are less likely to receive anticoagulants despite their higher risk of stroke compared with men. To evaluate whether the efficacy and safety of direct oral anticoagulants (DOACs) differ in women with AF as compared with men. Our secondary aim was to examine gender differences regarding the safety and efficacy of specific DOACs. MEDLINE, EMBASE, Cochrane, and ClinicalTrials.gov were searched through March 2017. Randomized clinical trials that reported on major bleeding and stroke with DOACs in women and men with AF were included. Meta-analysis and network meta-analysis was performed. Five trials met the inclusion criteria. Among 66 389 patients, 37.8% were women. Women treated with DOACs were at higher risk of stroke and systemic embolism compared with men (RR = 1.19; 95% CI = 1.04-1.35; I2 = 10%) but there was a significantly lower risk of major bleeding in women compared with men (RR = 0.86; 95% CI = 0.78-0.94; I2 = 0%). Network meta-analyses suggested differences between various DOACs in men and women. Patient-level data enabling control for differences in baseline risk and head-to-head comparisons between DOACs were not available. Relevance to Patient Care and Clinical Practice: Undertreatment with DOACs among women cannot be justified. Women treated with DOACs had a lower rate of major bleeding and higher rate of stroke and systemic emboli compared with men. Further investigation of DOACs, including differences between the DOACs in specific populations is warranted.

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem.

Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either short-or long-term differences in efficacy and safety. To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. CLINCIAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525.

Gender Difference in Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation or Venous Thromboembolism: A Systematic Review and a Meta-Analysis of the Literature.

Limited information exists on gender-related differences in the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs). To assess the safety and efficacy of direct oral anticoagulants (DOACs)/NOACs in men and women pooling data from randomized controlled trials on the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) and on the acute and extended treatment of venous thromboembolism (VTE). MEDLINE and EMBASE databases were searched up to June 2014. The efficacy outcome was defined as the prevention of stroke and systemic embolism (AF studies), or as the prevention of recurrent VTE or VTE-related death (VTE studies). The safety outcome was defined as the occurrence of major and/or clinically relevant non-major bleeding. Differences in the efficacy and safety outcomes were expressed as risk ratio (RR) with pertinent 95% confidence intervals (95% CI). A total of 13 studies (> 100,000 patients) were included. DOACs appeared to have a similar efficacy and safety compared with vitamin K antagonists in female and male patients treated for nonvalvular AF and acute VTE. In the extended treatment of VTE NOACs had a RR of bleeding of 4.97 (95% CI 1.06, 23.41) in males and 1.33 (95% CI 0.63, 2.83) in females compared with placebo (subgroup difference chi-square test: 2.25, p = 0.13). No gender-related difference in the efficacy and safety of NOACs in patients with AF or acute VTE was found. A trend toward an increased risk of bleeding in male patients as compared with female patients was detected in the extended treatment of VTE.

Analysis of Gender Differences in the Efficacy of Psoriasis Treatment Modalities Resulting in Clearance

Background/Objective Characterize gender differences in efficacy of psoriasis treatments, as this has not been well studied. Methods In this retrospective cohort study, data were collected on patients with psoriasis seen at Tufts Medical Center between 2008 and 2014. Treatment courses lasting ≥ 4 weeks in patients with baseline moderate to severe psoriasis were included. Clearance was defined as an S-MAPA (simple measure for assessing psoriasis activity, the product of body surface area and physician global assessment) ≤ 3. Results Of the 172 biologic treatment courses, 81 (47%) resulted in clearance, 56% of females and 39% of males (RR=1.43, p=0.032). Women were more likely to clear on infliximab (88% compared to 27% of males, RR=3.21, p=0.02) despite a significantly higher baseline S-MAPA in females in this subgroup (166.63 versus 94.86 in men, p=0.05). There was no statistically significant gender difference in clinical outcomes for patients on conventional systemics or combination treatment courses. Conclusion Clinical outcomes are better for biologics, especially infliximab, in females compared to males with moderate to severe psoriasis. Further investigation of possible biologic or pharmacokinetic explanations for this finding is warranted.

Gender and Anti-thrombotic Therapy: from Biology to Clinical Implications

Cardiovascular diseases actually remain the leading cause of death and morbidity in Western countries, and it is the most common cause of death in American women accounting for about one third of all deaths. Women remain underrepresented in published trial literature relative to their disease prevalence. Strong evidence do exists demonstrating gender differences in efficacy (ischemic risk) and safety (bleeding risk) associated with antithrombotic treatment, mostly related to different values of body mass, and renal function in women than men. Several data show a higher platelet reactivity in females and a higher prevalence of high platelet reactivity on aspirin and clopidogrel therapy. In primary prevention, the use of aspirin is associated with a higher reduction of risk for ischemic stroke in females and for myocardial infarction in males. In the setting of ACS, female gender is associated with a significantly higher risk of bleeding. In summary, there are some gender-related aspects of guidance in the complex spectrum of the net clinical benefit related to antithrombotic treatment.

Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle‐of‐the‐night awakening in insomnia

Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet (ZST) formulation. Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender. In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST (females: 15.7 and 8.6 min, respectively, vs. 27.7 min [placebo]; males: 19.0 and 12.7 min vs. 29.0 min [placebo]) with no significant gender differences. In the outpatient study, subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average (females: 37.3 vs. 59.4 min, p < 0.0001; males: 38.6 vs. 55.1 min, p ≤ 0.01). There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening. In the outpatient study, weekly usage of ZST and placebo by both genders declined throughout the study. Morning alertness following dosing nights improved in both genders, although significant only in females. In both studies, there were no gender differences in adverse events. Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders, with no gender differences in efficacy and safety.

Gender difference in efficacy of corticosteroid therapy for left ventricular function in cardiac sarcoidosis

Gender difference in efficacy of corticosteroid therapy for left ventricular function in cardiac sarcoidosis

Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo‐controlled trial

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Desmopressin orally disintegrating tablet (ODT) 60-240 μg has proved an effective and well-tolerated antidiuretic treatment in male and female patients with nocturia. The main adverse event is hyponatraemia. Recent studies suggest that female patients are more sensitive to desmopressin ODT, achieving the same efficacy at lower doses than male patients. The study demonstrates the efficacy of desmopressin ODT in male and female Japanese patients with nocturia. It provides further evidence that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males. Tailoring the dose according to gender provides an improved therapeutic window with the benefits of a decreased risk of hyponatraemia without compromising efficacy. To establish the dose-response efficacy of desmopressin in a Japanese patient population for the treatment of nocturia. To explore gender differences in sensitivity to desmopressin in Japanese patients with nocturia. A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted. Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg. The dose-response relationship of pharmacodynamic variables measured after a single dose of desmopressin administered to water-loaded subjects (treatment period 1) was compared with the primary clinical endpoint of change from baseline in mean number of nocturnal voids, after 28 days of desmopressin treatment (treatment period 2). A total of 116 patients were treated in treatment period 1 of whom 113 qualified for treatment period 2, and 111 completed the study. In treatment period 1 a dose-response relationship was observed, both overall and in each gender group. Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo. Female patients were found to be more sensitive to desmopressin; DOA in female patients was longer than in male patients after desmopressin 25 and 50 μg. Extrapolation suggests that male patients require ∼58 μg to achieve similar DOA to females receiving 25 μg. A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo. Similar dose-response relationships were also seen when the data were analysed by gender. Desmopressin ODT was well tolerated with no serious or severe adverse events. A dose-response relationship for desmopressin ODT was shown in a population of Japanese patients with nocturia. The study suggests that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males, indicating a gender-specific therapeutic window with a decreased risk of hyponatraemia without compromising efficacy on reduction of nocturnal voids. Further dose-finding studies are planned to confirm the recommended dose for the treatment of nocturia in a Japanese patient population.

Long‐term durability of the response to desmopressin in female and male nocturia patients

To explore the durability of efficacy and gender differences during chronic administration of desmopressin in nocturia. This pooled analysis of three short-term efficacy studies, with extensions, of desmopressin administered as orally disintegrating tablet (ODT) or solid tablet in nocturia treatment, comprised 351 patients completing 40-56 weeks' treatment. Efficacy endpoints of change in number of nocturnal voids and duration of initial undisturbed sleep period from baseline were analyzed to determine response durability and gender differences. The mean decrease in number of nocturnal voids during short-term treatment was maintained and further reduced during the long term. At 52 weeks, the mean decrease in number of nocturnal voids from baseline reached 1.4-2.1 voids for desmopressin ODT 25-100 µg. Following 40-week tablet treatment, the decrease in number of nocturnal voids was 0.8-1.5 for desmopressin 100-400 µg. The mean decrease in nocturnal voids (25-50 µg ODT) was greater for females than males. For females, the improvement in initial period of undisturbed sleep was 2.5-3 hr for desmopressin ODT 25-100 µg, compared with 1.3-2.6 hr for males. No gender difference in efficacy was seen in the tablet studies. The decrease in nocturnal voids and improvement in sleep with short-term desmopressin treatment were maintained throughout long-term treatment. A durable gender difference in efficacy in favor of females was observed with desmopressin ODT 25 µg. Further, large-scale long-term trials are needed to confirm the durability of efficacy with gender-specific doses of desmopressin.

Pharmacological treatment of disruptive behavior in Smith–Magenis syndrome

Smith-Magenis syndrome (SMS) is a complex genetic syndrome caused by an interstitial deletion of chromosome 17p11.2. Children and adults with SMS appear to have unique neurobehavioral problems that include: sleep disturbance, self-injurious and maladaptive behaviors, stereotypies, and sensory integration disorders. We gathered retrospective psychotropic use information from parents or other caregivers of 62 individuals with SMS who were asked about use of psychotropic medication from a list of commonly used psychiatric medications. For those drugs identified, respondents were asked to rate the experience with the particular medication using a likert-type scale. Drugs were grouped into seven main categories: (1) stimulants; (2) antidepressants; (3) antipsychotics; (4) sleep aides; (5) mood stabilizers; (6) alpha 2 agonists; and (7) benzodiazepines. Relative frequencies, means and standard deviations pertaining to age and medication effect were derived for each medication category. Six of the seven medication categories examined showed no meaningful deviations from the "no change" score. The benzodiazepine group showed a mild detrimental effect. There were no gender differences in efficacy. Use of psychotropic medication started early in life (mean age 5 years), particularly with sleep aides. Although no medication category was identified as efficacious in SMS, all the categories reported herein may be considered as an option for brief symptomatic relief.

Gender-based analyses of intervention outcome in non-ST segment elevation acute coronary syndrome

To investigate the impact of gender on outcomes in patients with non-ST segment elevation acute coronary syndrome undergoing intervention treatment. In a multi-center randomized trial, the patients diagnosed as non-ST segment elevation acute coronary syndrome were randomly assigned to undergo early intervention (coronary angiography ≤ 24 h after randomization) or delayed intervention (coronary angiography ≥ 36 h after randomization). The primary outcome was a composite of death, myocardial infarction or stroke at 180 days. The secondary outcomes were death, myocardial infarction, refractory ischemia, stroke or revascularization at 180 days. Among 815 patients (545 males, 270 females), the incidences of primary and secondary outcome were equivalent for both genders (P > 0.05). Males of the early intervention group had a greater incidence of the primary outcome (7.1% vs 14.8%, P = 0.00). The secondary outcome was a composite of death, myocardial infarction or refractory ischemia occurring in 12.5% of males in early intervention group and 21.2% in delayed intervention group. Significant difference existed (P = 0.00). The incidence of another secondary outcome as a composite of death, myocardial infarction, refractory ischemia, stroke or revascularization was equivalent for males in early intervention group and delayed intervention group (26.8% vs 32.4%, P > 0.05). The incidences of primary outcome (12.6% vs 14.3%, P > 0.05) and secondary outcome (18.5% vs 23.5% P > 0.05; 28.5% vs 27.7% P > 0.05) were equivalent for females in early intervention group and delayed intervention group (P > 0.05). Patients with non-ST segment elevation acute coronary syndrome undergoing intervention demonstrate no significant gender differences in efficacy and safety. Early intervention reduces the rate of myocardial infarction for males, but it is not superior to delayed intervention for females.

Extended treatment of older cigarette smokers

Tobacco dependence treatments achieve abstinence rates of 25-30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers > or = 50 years of age, and to determine if gender differences in efficacy existed. Open randomized clinical trial. A free-standing, smoking treatment research clinic. A total of 402 smokers of > or = 10 cigarettes per day, all 50 years of age or older. Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability). Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104. The most clinically important findings were significant main effects for treatment condition, time and the treatment x time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found. Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT.

Gender differences in efficacy of primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction

The clinical outcome of percutaneous coronary intervention (PCI) is poorer in women than that in men. This study aimed at comparing the impact of gender difference on the strategy of primary PCI in patients with acute ST-segment elevation myocardial infarction (STEMI). Two hundred and fifty-nine patients with STEMI who underwent primary PCI within 12 hours of symptom onset were enrolled. The male group consisted of 143 men aged > 55 years, and a female group included 116 women without age limitation. Procedural success was defined as residual stenosis < 20% with thrombolysis in myocardial infarction flow grade > 2 and without death, emergency bypass surgery or disabling cerebral events during the hospitalization. The rate of major adverse cardiac events (MACE), including death, nonfatal myocardial infarction and target vessel revascularization during follow-up, was recorded. Female patients were more hypertensive and diabetic and with fewer cigarette smokers than male counterparts. The prevalence of angiographic 3-vessel disease was higher in the female group, but the procedural success rate was comparable between the two groups (94.4% vs 92.2%). The occurrence rate of MACE did not differ during the hospitalization (4.2% vs 6.0%, P = 0.50), but was significantly higher in the female group during follow-up (mean (16.0 +/- 11.2) months) than that in the male group (5.4% vs 0.7%, P = 0.02). Despite a similar success rate of primary PCI and in-hospital outcomes in both genders, female patients with acute STEMI still have a worse prognosis during the long-term follow-up.

Fish consumption: efficacy among fishermen of a brochure developed for pregnant women

The risk to human consumers from contaminants in fish is often dealt with by issuing consumption advisories, or in some cases, information brochures. Normally advisories and brochures are developed and tested with anglers. We examine the efficacy of a fish consumption brochure that was developed for pregnant women on people engaged in fishing in the Newark Bay Complex. The brochures were in English and Spanish, and subjects could read and be interviewed in either language. Of the 151 people interviewed, 32% were women, 58% spoke only English, 22% spoke mainly Spanish and the rest felt comfortable with both languages. There were no differences in the percent that were present as a function of preferred language. There were significant differences in the understanding of the brochure, depending upon preferred language (and the language of the brochure). In general, anglers preferring Spanish and who read the brochure in Spanish obtained fewer of the messages correctly than those who preferred English (seven of seven questions). There were also gender differences in efficacy of the brochures; a higher percentage of female anglers thought that the fish were not safe to eat from the port and thought that eating contaminated fish from the port could harm their baby. Although the correct message was obtained by 34–100% of the anglers, depending upon the question, and 60–75% of the anglers believed the pamphlet, only 16% (Spanish‐speaking) to 47% (Bilingual) planned on changing the species of fish they eat or the method of cooking. These data suggest that a pamphlet designed for pregnant women is useful for anglers, and they can obtain the ‘correct’ message from it. However, a relatively small percentage of subjects were persuaded to change their cooking or consumption behavior. In addition to television, subjects felt that the direct approach of distributing brochures face‐to‐face was an important method of communication of fish consumers.

Gender differences in the efficacy of brief interventions with a stepped care approach in general practice patients with alcohol-related disorders

To analyse gender differences in the efficacy of stepped care brief interventions for general practice patients with alcohol problems. Data are part of "Stepped Interventions for Problem Drinkers," in which 10,803 patients from 85 general practitioners were screened using alcohol related questionnaires; 408 patients were randomized (32% were female) to a control (booklet only) or two different intervention groups: stepped care (feedback, manual, and up to three counselling sessions depending on the success of the previous intervention) and fixed care (four sessions). Response rate for the 12 months follow-up was 91.7%. Regression analysis revealed a significant effect size only in women (P = 0.039). After excluding alcohol dependents and binge drinkers, an effect size (R(2)) of 0.031 (P = 0.050) in women and an effect size (R(2)) of 0.069 (P = 0.057) in men was obtained. Among the patients in stepped care who, by the first assessment point, had reduced drinking to within safe-drinking limits, there was a tendency for females to have achieved this more often than males (40% vs. 24%; P = 0.089). In a heterogeneous sample, the intervention was only effective for women. Women tended to profit more from the first, less intensive intervention than men. When analysis was limited to those reporting "at risk" average daily consumption and "alcohol abuse," the gender differences in efficacy appeared to be less, but the study was not sufficiently powered to affirm that.