To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ERS: Bupropion Safe and Effective for People with Cardiovascular Disease URL: http://www.pslgroup.com/dg/206E76.htm Doctor's Guide September 24, 2001
By Cameron Johnston Special to DG News
BERLIN, GERMANY -- September 24, 2001 -- Research results suggest that bupropion hydrochloride (Zyban SR, GlaxoSmithkline) can be used safely and effectively in people with coronary artery disease.
Cardiovascular disease has been listed as a possible contraindication for using the smoking cessation drug buproprion since the drug was first introduced almost five years ago.
Research presented yesterday (September 23) at the European Respiratory Society (ERS) meeting, in Berlin, Germany, suggests that those concerns might be unfounded.
The drug not only appears to be well-tolerated among hard-core smokers, but over the length of a 52-week trial, there were no significant effects on heart rate or blood pressure, even among subjects who had documented history of cardiovascular disease.
Dr. Pietr van Spiegel of the Stotervaart Hospital, in Amsterdam, the Netherlands, discussed a study in which 502 highly-motivated smokers in eight countries, including the United States and New Zealand, took bupropion 150 mg b.i.d for seven weeks of active treatment, the way the drug is intended to be used, and then they were followed up for a further 45 weeks, or a 52-week total.
These patients had good reason to want to stop smoking Dr. van Spiegel said, as a large number of them had significant co-morbidities: 49 had had a previous myocardial infarction, 42 had had cardiac surgery, including coronary artery bypass grafting, 35 had documented angina. Thirty-seven percent had hypertension, 15 percent had chronic obstructive pulmonary disease, and 14 percent had diabetes.
The patient's mean age was 56 years, and they all scored above 7 on the Fagerstrom Test for Nicotine Dependence.
The important part of the study, apart from confirming what other investigators have already shown - namely that bupropion is effective at helping motivated individuals stop smoking if they want to - is that there were few cardiovascular or other events among the study participants.
In fact, while 64 percent of subjects in the study group reported some form of adverse event, 58 percent in the placebo group did. Moreover, 51 percent in the study group had drug related adverse events, compared with 39 percent in the control group. And while this figure seems high at first glance, it is in keeping with what has been seen in previous studies, Dr. van Spiegel said.
Of eight serious adverse events that occurred, five were during active treatment, one was after treatment, and two were in the placebo group.
Five percent of the study group withdrew from the investigation, but half of those quit for reasons unrelated to the study drug.
Also, there were no clinically significant changes in mean heart rate or blood pressure for the study subjects over the course of the trial.
The complete abstinence rate at four weeks was 43 percent in the bupropion group compared with 19 percent in the control group (OR =3.27). At weeks four to 12 the abstinence rate was 34 percent versus 15 percent, and at 26 weeks, the abstinence rate was 27 percent versus 11 percent (OR = 3.09).
Although this was a one-year study, the full year's data was not completed until mid-September and therefore had not been analyzed before the study was presented at the ERS meeting.
Dr. van Spiegel said the results of this study suggest that bupropion can be used safely and effectively in people with coronary artery disease, despite the fact that so many of them had other co-morbidities, and that as they were long-term smokers, their arteries would probably have been ripe for some kind of cardiovascular event. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.