Search

The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥ 10 cigarettes/day) with ≥ 1 prior quit attempt (≥ 2 weeks) using varenicline and no quit attempts in ≤ 3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers.

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

Background: Hospital admission is a time when patients are sickest and also often encountering an entirely new set of caregivers. As a result, understanding and documenting a patient's care preferences at hospital admission is critically important., Objective: To understand factors associated with documentation of care planning discussions in patients admitted to general medical services at 6 academic medical centers., Design: Observational cohort study using data collected during the Multicenter Hospitalist Study, conducted between July 1, 2002 and June 30, 2004., Setting: Prospective trial enrolling patients admitted to general medicine services at 6 university-based teaching hospitals., Patients: Patients were eligible for this study if they were 18 years of age or older, admitted to a hospitalist or nonhospitalist physician, and able to give informed consent., Measurements: Presence of chart documentation that the admitting team had discussed care plans with the patient within the first 24 hours of hospitalization. Notations such as "full code" were not counted as a discussion, whereas notations such as "discussed care wishes and plan with patient" were counted., Results: A total of 17,097 patients over the age of 18 gave informed consent and completed an interview and chart abstraction; of these, 1776 (10.3%) had a code status discussion (CD) documented in the first 24 hours of their admission. Patients with a CD were older (69 years vs. 56 years, P < 0.0001), more often white (52.8% vs. 43.3%, P < 0.0001), and more likely to have cancer (19.8% vs. 11.4%, P < 0.0001), or depression (35.1% vs. 30.9%, P < 0.0001). There was marked variability in CD documentation across sites of enrollment (2.8%-24.9%, P < 0.0001). Despite strong associations seen in unadjusted comparisons, in multivariable models many socioeconomic factors, functional status, comorbid illness, and documentation of a surrogate decision maker were only moderately associated with a CD (adjusted odds ratios all less than 2.0). However, patients' site of enrollment (odds ratios 1.74-5.14) and informal notations describing prehospital care wishes (eg, orders for "do not resuscitate"/"do not intubate;" odds ratios 3.22-11.32 compared with no preexisting documentation) were powerfully associated with CD documentation. Site remained a powerful influence even in patients with no documented prehospital wishes., Limitations: Our results are derived from a relatively small number of academic sites, and we cannot connect documentation differences to differences in patient outcomes., Conclusions: Documentation of a CD at admission was more strongly associated with informal documentation of prehospital care wishes and where the patient was hospitalized than legal care planning documents (such as durable power of attorney), or comorbid illnesses. Efforts to improve communication between hospitalists and their patients might target local documentation practices and culture., ((c) 2008 Society of Hospital Medicine.)

Background: Many persons who attempt to quit smoking have made previous unsuccessful attempts to quit with pharmacologic aids. An understanding of the impact of these previous attempts to quit is vital for selecting medications that may be more successful in a future attempt to quit. In particular, the effect of repeated use of bupropion SR (Zyban; INN, amfebutamone) on abstinence rates has not been studied previously., Methods: This was a multicenter, randomized, double-blind, placebo-controlled study in 450 smokers who had previously used bupropion in a smoking cessation attempt. The study consisted of a screening phase, a 12-week treatment phase, and a follow-up at month 6. Participants made regular clinic visits throughout the treatment phase during which they received brief counseling sessions to encourage abstinence from smoking. The primary end point was continuous abstinence from smoking from weeks 4 through 7. Secondary efficacy end points were examined throughout the treatment phase and at follow-up after 6 months., Results: In participants receiving bupropion SR, 27% (61 of 226) remained abstinent throughout the period from weeks 4 through 7 compared with 5% (11 of 224) of participants receiving placebo (P <.001). Significantly (P <.001) more participants who received bupropion SR during the treatment phase remained continuously abstinent from the start of week 4 through month 6 (27 of 226; 12%) compared with participants who received placebo (5 of 224; 2%). Eleven participants receiving placebo (5%) and 19 participants receiving bupropion SR (8%) stopped taking the study medication because of an adverse event., Conclusions: Bupropion SR is an effective medication for retreatment of smokers who have used bupropion SR previously.

The behavior of golden hamster blastocysts was studied in vitro by continuous time-lapse videomicrography and computer imaging, during and immediately following escape from the zona pellucida. This study revealed numerous small cytoplasmic trophectoderm projections (TEPs) approximately 18 microns long that penetrated the zona pellucida both radically and tangentially and appeared to be actively involved in zona escape in vitro. After escape from their zonae, some blastocysts moved across the culture dish by an endogenous means of locomotion, most likely involving activity of the small TEPs. Several hours after zona escape, embryos expressed large TEPs up to 46 microns long that moved in an undulating manner and showed rapid cycles of extension and retraction; the timing of their appearance suggested that these TEPs are normally involved in attachment to the uterine epithelium. Embryos fixed in utero, during the developmental interval between zona loss and embryo attachment, exhibited large TEPs similar in morphology to those expressed by cultured blastocysts. These observations document for the first time that mammalian blastocysts are capable of endogenous locomotion, confirm TEPs as components of normal blastocyst activity, reveal that there are two kinds of TEPs that differ temporally and morphologically, and extend earlier reports of TEP activity in guinea-pig embryos to the hamster.

We have tested the fire-resistance of a new endotracheal tube designed for use in laser surgery of the upper aerodigestive tract. This Teflon/metallic-wrapped silicone tube seems capable of withstanding occasional, accidental pulsed laser impact at power settings used clinically (1 to 10 watts) without fire. On rare occasions when continuous mode is used, the tube seems capable of withstanding at least several seconds of continuous irradiation at clinical power settings without igniting. When used with other recommended safety procedures, this tube should minimize the risk of endotracheal tube fire from accidental laser impact.