Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial.

Background: Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum.

Single-Dose and Multiple-Dose Pharmacokinetics of Nicotine 6 mg Gum.

Introduction: Under-dosing is a recognized problem with current nicotine replacement therapy (NRT). Therefore, a new 6mg nicotine gum has been developed. To compare the nicotine uptake from the 6mg gum versus currently available NRT products, two pharmacokinetic studies were performed.

Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial.

Objective: A new nicotine mouth spray was shown to be an effective stop-smoking treatment. This study was set up to examine the speed with which it relieves urges to smoke, and how it compares with nicotine lozenge in this respect.

Design: Randomised, cross-over trial that compared nicotine mouth spray 2 mg versus nicotine lozenge 2 or 4 mg.

Single-dose pharmacokinetics of nicotine when given with a novel mouth spray for nicotine replacement therapy.

Introduction: As the efficacy of nicotine replacement therapy might be improved by faster systemic nicotine uptake, a new nicotine mouth spray has been developed. The current study was performed to evaluate the single-dose pharmacokinetics of nicotine at 3 doses of the mouth spray and to compare the speed of nicotine uptake from the spray versus nicotine lozenge and gum.

Methods: In a randomized crossover study, 45 healthy adult smokers received single doses of nicotine mouth spray 1, 2, and 4 mg, nicotine lozenge 4 mg, and nicotine gum 4 mg on separate occasions.

Effect of uncertainty about population parameters on pharmacodynamics-based prediction of clinical trial power.

Clinical trial simulation (CTS) may be applied to predict power of intended drug trials on the basis of pharmacokinetic/pharmacodynamic (PKPD) drug models. The validity of such predictions will, among other factors, depend on the degree of uncertainty about population parameters entering the simulation. In the current article, we illustrate how population parameter uncertainty may be incorporated in the overall simulation model, using a worked example to demonstrate our approach.

Reduction of sleep-disordered breathing after physostigmine.

The cholinesterase inhibitor physostigmine (PHYS) was investigated in a double-blind, placebo-controlled, randomized, crossover trial of 10 male patients with moderate to severe obstructive sleep apnea. PHYS (0.12 microg/minute/kg, 7-hour infusion) reduced mean apnea/hypopnea index (AHI) by 13.

Finger plethysmography--a method for monitoring finger blood flow during sleep disordered breathing.

We investigated a non-invasive measurement for changes in finger blood flow during wakefulness and sleep. Changes in finger blood flow, reflected by pulse wave amplitude (PWA) derived from finger plethysmography, were compared with changes in forearm vascular flow assessed by venous occlusion plethysmography after intra-arterial infusion of norepinephrine (NE), phentolamine, and isoproterenol (n=15, 15, 14 subjects, respectively). Moreover, PWA was assessed during obstructive breathing during sleep (n=8 patients).

[Sleep apnea a risk factor of cardiovascular disease].

Obstructive sleep apnea (OSA) affects almost one fifth of the male and 10% of the female middle-aged population. Only one fifth of subjects with more or less severe disorder of breathing report simultaneous daytime sleepiness. There is growing research evidence for an independent association between OSA and cardiovascular disease (CVD).

Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnea: a 7-year follow-up.

The incidence of a cardiovascular disease (CVD) was explored in a consecutive sleep clinic cohort of 182 middle-aged men (mean age, 46.8 +/- 9.3; range, 30-69 years in 1991) with or without obstructive sleep apnea (OSA).

Plasma vascular endothelial growth factor in sleep apnea syndrome: effects of nasal continuous positive air pressure treatment.

Sleep apnea syndrome is associated with recurrent episodic hypoxia during sleep, which has been implicated in the development of cardiovascular morbidity. Hypoxia is the major stimulus of vascular endothelial growth factor (VEGF), which is a potent angiogenic cytokine. In the present article we describe the results of three experiments in which plasma concentrations of VEGF were measured in patients with sleep apnea.