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1.  Safety and Tolerability of Varenicline Tartrate (Champix®/Chantix®) for Smoking Cessation in HIV-Infected Subjects: A Pilot Open-Label Study 
AIDS Patient Care and STDs  2012;26(1):12-19.
Abstract
The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix®, Pfizer, Saint-Laurent, QC, Canada or Chantix®, Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p=0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9–12 was 42% (95% confidence interval [CI]: 26–58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.
doi:10.1089/apc.2011.0199
PMCID: PMC3242617  PMID: 22007690
2.  The Christmas season as a risk factor for chronic obstructive pulmonary disease exacerbations 
BACKGROUND
Epidemics of hospitalization for chronic obstructive pulmonary disease (COPD) occur annually during the Christmas holidays, and COPD exacerbations commonly coincide with respiratory viral infections.
OBJECTIVE
To compare the incidence and determinants of COPD exacerbations occurring between the Christmas holiday period and the remainder of the winter season.
METHODS
Seventy-one subjects with COPD of mixed severity faxed daily symptom diaries to a computer monitoring system from December 1, 2006, to April 30, 2007. Possible exacerbations prompted a home visit for assessment, spirometry and specimen collection for virological testing.
RESULTS
Study subjects submitted a total of 95.4% of possible daily symptom diary sheets by fax. Of 114 possible COPD exacerbations detected using the faxed diaries, 110 met the Anthonisen criteria for true exacerbations. A total of 47 exacerbations (mean 6.7/week) occurred during the Christmas holiday period, while 63 exacerbations (mean 4.3/week) occurred during the remainder of winter. Of the Christmas period exacerbations and of those in the balance of winter, 21 (44%) and 20 (32%), respectively, coincided with respiratory viral infections.
CONCLUSIONS
The incidence of COPD exacerbations during the Christmas period was greater than during the rest of winter in 2006/2007 and peaked immediately before Christmas – in contrast to hospital presentation for COPD, which peaked during the Christmas week. No clear role of respiratory viral infections in the increased rate of exacerbations during the Christmas period was established in the present study. COPD patients were highly compliant with daily symptom reporting using faxed daily diaries, which permitted nearly complete detection of all exacerbations that occurred at incidence.
PMCID: PMC3006150  PMID: 21165349
Christmas; COPD; Epidemiology; Respiratory viruses
3.  Inhaler blues? 
doi:10.1503/cmaj.111-2025
PMCID: PMC3050957  PMID: 21398255
4.  Asthma that is unresponsive to usual care 
doi:10.1503/cmaj.090089
PMCID: PMC2802604  PMID: 19825927
5.  Evaluation of a novel method to assess corticosteroid responsiveness in chronic obstructive pulmonary disease 
Annals of Thoracic Medicine  2010;5(4):232-237.
BACKGROUND:
Some patients with chronic obstructive pulmonary disease (COPD) may benefit from oral steroid therapy. These steroid-responsive patients are diagnosed based on laboratory spirometry. We hypothesize that daily, home-based spirometry is a better tool.
METHODS:
Thirty patients with COPD underwent a single-blinded study, with a crossover design. They received 2 weeks of placebo followed by 2 weeks of prednisone therapy (40 mg/day). Laboratory spirometry was done at the beginning and end of the study and daily home-based spirometry was done twice a day.
RESULTS:
Analysis of variance model was used. The variability of the median day-to-day forced expiratory volume in 1 s (FEV1) was 72.5 mL (25th percentile of 40 mL and 75th percentile of 130 mL). The daily FEV1 variation was 70 mL (25th percentile of 50 mL and 75th percentile of 100 mL). The overall laboratory FEV1 variability was larger after the steroid course (P < 0.001), but not clinically significant. The variability was not significant postplacebo treatment compared with the baseline values. For home-based spirometry, steroid treatment was not significantly different. The majority (97%) completed more than 80% of the measurements. Ninety percent of the performed tests were considered acceptable. Only 53% of the tests were considered accurate. Overall both laboratory and home-based measurements did not show significant association between airway responsiveness and dyspnea or exercise capacity.
CONCLUSION:
Twice-daily home measurements of FEV1 might be better than the conventional approach to identify steroid responsive COPD patients. However, this finding was only statistically but not clinically significant. Therefore, we would not recommend this approach to identify COPD patients with steroid responsiveness.
doi:10.4103/1817-1737.69114
PMCID: PMC2954378  PMID: 20981184
COPD; corticosteroids; home spirometry; responsiveness; variability
6.  Best practices for smoking cessation interventions in primary care 
BACKGROUND:
In Canada, smoking is the leading preventable cause of premature death. Family physicians and nurse practitioners are uniquely positioned to initiate smoking cessation. Because smoking is a chronic addiction, repeated, opportunity-based interventions are most effective in addressing physical dependence and modifying deeply ingrained patterns of beliefs and behaviour. However, only a small minority of family physicians provide thorough smoking cessation counselling and less than one-half offer adjunct support to patients.
OBJECTIVE:
To identify the key steps family physicians and nurse practitioners can take to strengthen effective smoking cessation interventions for their patients.
METHODS:
A multidisciplinary panel of health care practitioners involved with smoking cessation from across Canada was convened to discuss best practices derived from international guidelines, including those from the United States, Europe, and Australia, and other relevant literature. The panellists subsequently refined their findings in the form of the present article.
RESULTS:
The present paper outlines best practices for brief and effective counselling for, and treatment of, tobacco addiction. By adopting a simple series of questions, taking 30 s to 3 min to complete, health care professionals can initiate smoking cessation interventions. Integrating these strategies into daily practice provides opportunities to significantly improve the quality and duration of patients’ lives.
CONCLUSION:
Tobacco addiction is the most important preventable cause of morbidity and mortality in Canada. Family physicians, nurse practitioners and other front-line health care professionals are well positioned to influence and assist their patients in quitting, thereby reducing the burden on both personal health and the public health care system.
PMCID: PMC2734439  PMID: 19707607
Behavioural intervention; Smoking cessation; Tobacco
7.  Chronic obstructive pulmonary disease 
BMJ : British Medical Journal  2007;334(7597):798.
doi:10.1136/bmj.39084.666736.94
PMCID: PMC1852053  PMID: 17431268
8.  Effect of smoking on lung function, respiratory symptoms and respiratory diseases amongst HIV-positive subjects: a cross-sectional study 
Background
Smoking prevalence in human immunodeficiency virus (HIV) positive subjects is about three times of that in the general population. However, whether the extremely high smoking prevalence in HIV-positive subjects affects their lung function is unclear, particularly whether smoking decreases lung function more in HIV-positive subjects, compared to the general population. We conducted this study to determine the association between smoking and lung function, respiratory symptoms and diseases amongst HIV-positive subjects.
Results
Of 120 enrolled HIV-positive subjects, 119 had an acceptable spirogram. Ninety-four (79%) subjects were men, and 96 (81%) were white. Mean (standard deviation [SD]) age was 43.4 (8.4) years. Mean (SD) of forced expiratory volume in one second (FEV1) percent of age, gender, race and height predicted value (%FEV1) was 93.1% (15.7%). Seventy-five (63%) subjects had smoked 24.0 (18.0) pack-years. For every ten pack-years of smoking increment, %FEV1 decreased by 2.1% (95% confidence interval [CI]: -3.6%, -0.6%), after controlling for gender, race and restrictive lung function (R2 = 0.210). The loss of %FEV1 in our subjects was comparable to the general population. Compared to non-smokers, current smokers had higher odds of cough, sputum or breathlessness, after adjusting for highly active anti-retroviral therapy (HAART) use, odds ratio OR = 4.9 (95% CI: 2.0, 11.8). However respiratory symptom presence was similar between non-smokers and former smokers, OR = 1.0 (95% CI: 0.3, 2.8). All four cases of COPD (chronic obstructive pulmonary disease) had smoked. Four of ten cases of restrictive lung disease had smoked (p = 0.170), and three of five asthmatic subjects had smoked (p = 1.000).
Conclusions
Cumulative cigarette consumption was associated with worse lung function; however the loss of %FEV1 did not accelerate in HIV-positive population compared to the general population. Current smokers had higher odds of respiratory symptoms than non-smokers, while former smokers had the same odds of respiratory symptoms as non-smokers. Cigarette consumption was likely associated with more COPD cases in HIV-positive population; however more participants and longer follow up would be needed to estimate the effect of smoking on COPD development. Effective smoking cessation strategies are required for HIV-positive subjects.
doi:10.1186/1742-6405-7-6
PMCID: PMC2853483  PMID: 20298614
9.  Tobacco control and nicotine addiction in Canada: Current trends, management and challenges 
Despite a significant decrease in tobacco use over the past four decades, cigarette smoking remains the leading preventable cause of death and disease in Canada. Nicotine addiction, unequal access to available support programs and gaps in continuity of health care are recognized as the main barriers to smoking cessation. To overcome these obstacles and to reach the Federal Tobacco Control Strategy goal of reducing smoking prevalence in Canada from 19% to 12% by 2011, several Canadian health care organizations developed extensive sets of recommendations. Improved access to affordable pharmacotherapies and behavioural counselling, better training of health care professionals and the addition of systemic cessation measures appear to be the key components in all of the proposed recommendations.
The present article provides an overview of the current approaches to smoking cessation in Canada, describes the remaining challenges, and outlines recent recommendations that are geared toward not only tobacco control but also overall improvement in long-term health outcomes.
PMCID: PMC2687843  PMID: 19262909
Nicotine addiction; Respiratory health; Smoking cessation
10.  Asthma worsenings: Approaches to prevention and management from the Asthma Worsenings Working Group 
Most asthma patients prescribed maintenance asthma therapies still experience periods of asthma worsenings characterized by daytime or nighttime symptoms, or an increased need for rescue medication. In fact, these episodes are highly prevalent even in patients with well-controlled disease. Published literature suggests that asthma worsenings likely represent a window of opportunity during which patients could intervene early to prevent exacerbations or further deterioration of asthma symptoms. However, current evidence suggests that most patients fail to respond or to self-manage appropriately during these periods.
To address the issue of asthma worsenings, an interdisciplinary committee of respirologists, allergists, family physicians, pharmacists and certified asthma educators from across Canada developed a practical definition of asthma worsenings and provided approaches to the prevention and management of these episodes based on current literature. To date, combination inhaled corticosteroid/long-acting beta-agonist therapy, particularly single inhaler maintenance and reliever therapy, appears to be an effective strategy for preventing asthma worsenings and exacerbations. Addressing the potential barriers to appropriate patient self-management of asthma worsenings, such as failure to adequately identify and respond to worsenings, low expectations for controlling asthma, low health literacy and poor patient-health care professional communication, are also critical to the successful prevention and management of these episodes. Finally, an interdisciplinary team approach involving patients and their families, certified asthma educators, primary care physicians, pharmacists and specialists is likely to have the greatest impact on the identification, prevention and management of asthma worsenings.
PMCID: PMC3486700  PMID: 19129942
Asthma worsenings; Education; Exacerbations; Inhaled corticosteroids; Long-acting beta-agonists
11.  Coccidioides Immitis: Two Cases of Misidentified Mycosis 
In the present report, two cases of pulmonary coccidioidomycosis that caused a diagnostic confusion are presented. The first case was initially misdiagnosed as nonsmall cell carcinoma, and both cases were initially misidentified as blastomycosis because of the presence of an atypical morphological form of Coccidioides immitis.
PMCID: PMC2679575  PMID: 18949109
Coccidioides immitis; Pulmonary mycosis
13.  Canadian economic evaluation of budesonide-formoterol as maintenance and reliever treatment in patients with moderate to severe asthma 
OBJECTIVES:
To compare the cost-effectiveness of budesonide-formoterol in a single inhaler used as both maintenance and reliever medication versus clinician-directed titration of salmeterol-fluticasone as maintenance medication, plus salbutamol taken as needed, in controlling asthma in adults and adolescents.
METHODS:
A Canadian economic evaluation was conducted based on the results of a large (n=2143), open-label, randomized, controlled effectiveness trial in which health resource use was prospectively collected. The primary outcome measurement was the time to the first severe exacerbation. Costs included direct medical costs (physician and emergency room visits, hospitalizations, asthma drug costs, etc) and productivity (absenteeism). The time horizon was one year, which corresponded to the duration of the clinical trial. Prices were obtained from 2005 Canadian sources. Both health care and societal perspectives were considered, and deterministic univariate sensitivity analyses were conducted.
RESULTS:
In the clinical trial, budesonide-formoterol as maintenance and reliever treatment was superior to salmeterol-fluticasone with respect to the time to the first severe exacerbation, overall rate of exacerbations and use of as-needed reliever medication. The annualized rate of severe exacerbations was 0.24 events/patient in the budesonide-formoterol arm and 0.31 events/patient in the salmeterol-fluticasone arm (P=0.0025). From a health care perspective, the mean cost per patient-year was $1,315 in the budesonide-formoterol arm versus $1,541 in the salmeterol-fluticasone arm. From a societal perspective, the mean cost per patient-year was $1,538 in the budesonide-formoterol arm and $1,854 in the salmeterol-fluticasone arm. Budesonide-formoterol was dominant (more effective and less expensive) in the base case analysis from both perspectives. The results were robust under sensitivity testing.
CONCLUSIONS:
The strategy that allows budesonide-formoterol to be used in a single inhaler as both maintenance and reliever medication proved to be more effective and less expensive than a strategy of clinician-directed titration of salmeterol-fluticasone with salbutamol as reliever therapy.
PMCID: PMC2676392  PMID: 17703241
Asthma; Budesonide-formoterol; Comparison; Economic evaluation; Salmeterol-fluticasone
14.  Implementing practice guidelines: A workshop on guidelines dissemination and implementation with a focus on asthma and COPD 
The present supplement summarizes the proceedings of the symposium “Implementing practice guidelines: A workshop on guidelines dissemination and implementation with a focus on asthma and COPD”, which took place in Quebec City, Quebec, from April 14 to 16, 2005. This international symposium was a joint initiative of the Laval University Office of Continuing Medical Education (Bureau de la Formation Médicale Continue), the Canadian Thoracic Society and the Canadian Network for Asthma Care, and was supported by many other organizations and by industrial partners. The objectives of this meeting were to examine the optimal implementation of practice guidelines, review current initiatives for the implementation of asthma and chronic obstructive pulmonary disease (COPD) guidelines in Canada and in the rest of the world, and develop an optimal strategy for future guideline implementation. An impressive group of scientists, physicians and other health care providers, as well as policy makers and representatives of patients’ associations, the pharmaceutical industry, research and health networks, and communications specialists, conveyed their perspectives on how to achieve these goals.
This important event provided a unique opportunity for all participants to discuss key issues in improving the care of patients with asthma and COPD. These two diseases are responsible for an enormous human and socioeconomic burden around the world. Many reports have indicated that current evidence-based guidelines are underused by physicians and others, and that there are many barriers to an effective translation of recommendations into day-to-day care. There is therefore a need to develop more effective ways to communicate key information to both caregivers and patients, and to promote appropriate health behaviours. This symposium contributed to the initiation of what could become the “Canadian Asthma and COPD Campaign”, aimed at improving care and, hence, the quality of life of those suffering from these diseases.
It is hoped that this event will be followed by other meetings that focus on how to improve the transfer of key recommendations from evidence-based guidelines into current care, and how to stimulate research to accomplish this.
PMCID: PMC2806791  PMID: 16552449
Asthma; COPD; Evidence-based medicine; Guidelines implementation; Practice guidelines
15.  A prospective comparison of Porta-sonic and Fisoneb ultrasonic nebulizers for administering aerosol pentamidine 
Objective:
To report patient acceptability and overall therapeutic effectiveness of two different ultrasonic nebulizers, Fisoneb and Porta-sonic, for the administration of aerosol pentamidine for Pneumocysitis carinii prophylaxis in human immunodeficiency virus (hiv)-infected individuals.
Design:
Prospective assessment of a random subgroup of 174 individuals from an inception cohort of 1093 patients attending a central aerosol pentamidine treatment centre in Toronto, Ontario.
Methods:
One hundred and seventy-four patients who had been receiving aerosolized pentamidine for more than 10 weeks using Fisoneb at 60 mg every two weeks were switched to Porta-sonic. Subjective evaluation included three standard 10 cm visual analogue scales rating cough/wheeze, aftertaste and overall preference. The individuals were also asked to compare the duration of time spent on the aerosol treatments. Objective evaluation included spirometry performed immediately before and 15 mins after pentamidine administration. Prospective surveillance of the entire cohort was preformed to record and document episodes of breakthrough P carinii pneumonia.
Results:
Porta-sonic was the overall preferred nebulizer in 82% of patients. Less time was spent on aerosol treatment using the Porta-sonic nebulizer compared with the Fisoneb in 66% of patients. The Porta-sonic nebulizer system produced less aftertaste compared with Fisoneb. Both nebulizers produced significant but modest reduction in flow rates. During the study period there was no statistically significant difference in the rates of breakthrough P carinii pneumonia between the two groups. A total of 91 episodes occurred, at a rate of 0.5 episodes per patient-month on Porta-sonic compared with 0.7 episodes per patient-month on Fisoneb (P=0.2536).
Discussion:
Aerosol pentamidine remains the proven second-line prophylaxis against P carinii pneumonia in hiv/aids for those intolerant to trimethoprim-sulphamethoxazole. Cough, bronchospasm and poor taste are side effects that may limit patient tolerance and acceptability. The results of this study show that the Porta-sonic nebulizer system significantly reduces some of these side effects and increases patient preference.
Conclusion:
This study suggests that Porta-sonic, the newer nebulizer system, with more ideal in vitro characteristics may become a favoured device in clinical practice.
PMCID: PMC3307407  PMID: 22451767
Human immunodeficiency virus; Nebulizers; Pentamidine; Pneumocystis carinii pneumonia; Prophylaxis

Results 1-15 (15)