Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy.

Introduction: Nicotine replacement therapy (NRT) aids smoking reduction and cessation. Although NRT is effective and safe, some smokers may achieve high nicotine levels. The purpose of this study was to determine the incidence and severity of nicotine-related adverse events in subjects with levels of cotinine, a metabolite of nicotine, that increased by >50% compared with baseline smoking in controlled clinical trials of NRT.

[Improved product characteristics of nicotine gums: an unexplored area for higher compliance with nicotine replacement therapy].

Objective: To assess consumer acceptance of new flavoured nicotine gums in comparison with existing nicotinegums.

Method: A total of 607 adult smokers who intended to cut down or give up smoking were included in two randomised, single-blind, central location, acceptance tests. A new fruit-flavoured nicotine gum (Gum A = Nicorette Freshfruit) was compared with an existing fruit-flavoured nicotine gum (Gum B = Nicotinell fruit), and a new menthol-flavoured gum (Gum N = Nicorette Icy White) was compared with two existing mint-flavoured gums (Gum M = Nicotinell mint; Gum Q = NiQuitin mint).

Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler.

Background: Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. This finding has increased interest in smoking reduction as an interim step towards complete cessation.

Methods: This multi-center, double-blind placebo-controlled study evaluated the efficacy and safety of nicotine 4 mg gum or nicotine 10 mg inhaler in helping smokers (N = 314) to reduce or quit smoking.

Effects of sleep loss in men and women with insufficient sleep suffering from chronic disease: a model for supportive nursing care.

This study evaluated self-reported subjective health and effects of sleep loss according to perceived interfering cognitive anxiety related to falling asleep in patients with and without insufficient sleep and gender differences in these aspects 5 years after coronary artery bypass graft and transluminal coronary angioplasty. A total of 145 patients, five years after intervention, responded to a mailed questionnaire. Nearly 60% had severe combined sleep disturbances; 35.

Influence on coagulation activity by subcutaneous LMW heparin as an adjuvant treatment to fibrinolysis in acute myocardial infarction.

In this study, which includes 101 patients with acute ST segment-elevated myocardial infarction, we investigated the influence on the increased coagulation activity after streptokinase treatment by adding low-molecular-weight (LMW) heparin or placebo and the relation between the coagulation activity and ischemic episodes, coronary patency, and mortality. The expected increase of prothrombin fragment 1+2 (F1+2), thrombin-antithrombin (TAT), and D-dimer were significantly attenuated at 2, 6, and 18 h (D-dimer only at 18 h) in the dalteparin group compared to placebo. Ischemic episodes during the first 24 h appeared significantly more often in patients with F1+2 levels above the median at 18 h.

Smoking reduction in smokers compliant to a smoking cessation trial with nicotine patch.

The aim of this retrospective analysis was to assess the extent of smoking reduction in smokers who were compliant to a smoking cessation trial with nicotine patch, and failed to completely quit smoking. Out of 297 smokers in total, 237 participants received active treatment (60 received placebo). Eighty treated subjects attended all the scheduled visits and were classified as either abstainers (nonsmokers), regular smokers or occasional smokers.

Sociodemographic predictors of success in smoking intervention.

Aim: To examine the role of sociodemographic factors as predictors of sustained smoking cessation for the population who volunteer to participate in intervention programmes.

Method: Data for the 3575 smokers who participated in the CEASE (collaborative European anti-smoking evaluation) trial, a European multicentred study that used transdermal nicotine patches as an adjunct to smoking cessation in the chest clinic, were analysed. The effects of age, sex, smoking habit, socioeconomic status (housing conditions, education, and employment), disease, smoking habits of relatives, and baseline markers of tobacco use on sustained smoking cessation (self-reported abstinence and expired carbon monoxide < 10 parts per million) were assessed using logistic regression modelling (odds ratio (OR), 95% confidence interval (CI)).

Plasma concentrations of reputed tumor-associated soluble CD44 isoforms (v5 and v6) in smokers are dose related and decline on smoking cessation.

There is some evidence to suggest that smoking may affect circulating levels of CD44 (sCD44) molecules. Therefore, we investigated the effect of smoking on the circulating level of sCD44 by comparing the change in total sCD44, sCD44v5, and sCD44v6 concentrations over 1 year in a group of people who quit smoking (n = 30) and a control group of people who continued to smoke (n = 30). Smoking status and compliance were monitored by analysis of plasma cotinine and expired CO levels and also by self-reported tobacco use.

Dramatic decline in circulating intercellular adhesion molecule-1 concentration on quitting tobacco smoking.

The concentration of soluble ICAM-1 (sICAM-1) is significantly elevated in smokers, but it is unclear if smoking is the direct cause of elevated sICAM-1 levels, if the relationship between smoking and sICAM-1 level is dose-dependent, and if smoking cessation may lead to a decline in sICAM-1. We sought to clarify the relationship between smoking and sICAM-1 in a group of smokers who quit smoking for 1 year (n = 30) and a control group who continued to smoke (n = 30). A dose-dependent relationship between plasma sICAM-1 concentration and daily cigarette consumption (P = 0.

Megestrol acetate in advanced, progressive, hormone-insensitive cancer. Effects on the quality of life: a placebo-controlled, randomised, multicentre trial.

A randomised double-blind placebo-controlled multicentre trial was performed to investigate the effects of megestrol acetate (MA) on the quality of life (QoL), appetite, weight and survival of patients with advanced, incurable, hormone-insensitive cancer. QoL was assessed at the start of treatment and at 4, 8 and 12 weeks, using the EORTC-QLQ-C30 instrument. 255 patients were randomised to 320 mg of MA daily or placebo for 12 weeks.

Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society.

The Collaborative European Anti-Smoking Evaluation (CEASE) was a European multicentre, randomized, double-blind placebo controlled smoking cessation study. The objectives were to determine whether higher dosage and longer duration of nicotine patch therapy would increase the success rate. Thirty-six chest clinics enrolled a total of 3,575 smokers.

Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up.

Objective: To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.

Design: Placebo controlled, double blind trial.

Setting: Reykjavik health centre.

Transurethral incision versus resection of the prostate for small to medium benign prostatic hyperplasia.

Objective: To compare the effects of transurethral incision and resection of the prostate in patients with small to medium benign prostatic hyperplasia.

Patients And Methods: Patients were assessed preoperatively using the Madsen-Iversen symptom score, post- void residual urine volume, urinary flow and cystoscopy. Those eligible for the study were randomized to undergo either transurethral incision or resection of the prostate.

Prognostic importance of p15INK4B and p16INK4 gene inactivation in childhood acute lymphocytic leukemia.

Purpose: The present study explores the prognostic importance of p16INK4/p15INK4B gene inactivation in childhood acute lymphocytic leukemia (ALL).

Materials And Methods: Cells from 79 pediatric ALL patients were investigated for inactivation of the p15INK4B and p16INK4 genes or loss of heterozygosity (LOH) for chromosome 9p markers by use of Southern hybridization, restriction fragment length polymorphism (RFLP) analysis, microsatellite analysis as well as single-strand conformation polymorphism (SSCP) analysis, and nucleotide sequencing of the p15INK4B and p16INK4 genes. Genetic data were correlated to clinical outcome and established prognostic factors.

Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch.

Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement. We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values.

Dose effects and predictors of outcome in a randomized trial of transdermal nicotine patches in general practice.

The transdermal nicotine patch has proved an effective aid to smoking cessation. The ease of securing good compliance gives it a potential advantage over nicotine gum as an adjunct to brief advice and support in primary care settings where the major public health impact is obtained. In a preliminary report of half the sample of a randomized placebo controlled trial, we showed the patch to be effective in a general practice setting.

Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial.

Background: Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day. Hence, nicotine replacement therapy by way of gum, patch, or spray has been advocated. The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch.

On the use of the WHO handicap classification in a population study of 73- and 76-year-old men and women.

The WHO ICIDH classification of handicap was used in a population sample studied at 73 (n = 504) and 76 (n = 649) years of age. In the sample, there was either no handicap at all or the degree of handicap was generally low. In most handicap categories, however, the grades increased from 73 to 76 years.

Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches.

Objectives: (a) To evaluate the efficacy of transdermal nicotine patches as an aid to stopping smoking when used as an adjunct to brief advice and support in a general practice setting; (b) to see whether an increase in nicotine patch dosage enhances the rate of initial cessation.

Design: Randomised double blind placebo controlled parallel group study with one year of follow up.

Setting: 30 general practices in 15 English counties.

Diagnostic methods in the detection of prostate cancer: a study of a randomly selected population of 2,400 men.

We investigated the value of digital rectal examination, transrectal ultrasonography and prostatic specific antigen (PSA) analysis as aids in general clinical practice and in the early detection of prostate cancer. Of a randomly selected population of 2,400 men 55 to 70 years old who were offered examination with digital rectal examination, transrectal ultrasound and PSA analysis, 1,782 (74%) accepted and prostate cancer was detected in 65 (3.6%).

Early treatment with thrombolysis and beta-blockade in suspected acute myocardial infarction: results from the TEAHAT Study.

Independent trials of early administration of beta-blockers and thrombolytic agents have shown beneficial effects on both short- and long-term prognoses in acute myocardial infarction (AMI). The effects of a combination of the two strategies have not been thoroughly documented. Three hundred and fifty-two patients, of less than 75 years of age, with chest pain indicative of AMI, and onset less than 2 h and 45 min before first examination, were randomized to treatment with rt-PA or placebo.

Prehospital thrombolysis in suspected acute myocardial infarction: results from the TEAHAT Study.

In a randomized, double-blind study, rt-PA vs. placebo treatment in early suspected acute myocardial infarction (AMI) was evaluated in patients both in hospital and prehospitally. The inclusion criteria were as follows: (a) age less than 75 years; and (b) chest pain indicative of AMI, of no longer than 2.