Artículo de Revisión Sinergia entre edulcorantes no calóricos y el ácido fumárico Mauricio Restrepo Gallego Ingeniero de Alimentos – Corporación Universitaria Lasallista, Especialista en Pedagogía y Psicología, profesor delprograma de Ingeniería de Alimentos, Facultad de Ingenierías de la Corporación Universitaria LasallistaCorrespondencia: Mauricio Restrepo Gallego, email:
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VersionjlsmallThe summary of product characteristics (SPC) for bupropion (Zyban®) has been updated since publication of the accompanying Bulletin. The initial dosage regimen has been modified and new safety precautions have been added to the SPC. It is important to consult the current SPC for full prescribing information. (The rINN has also been changed from amfebutamone to bupropion.) WeMeReC Bulletin
Providing independent prescribing information to general practitioners and pharmacists in Wales Bupropion (Zyban) for smoking cessation
Cigarette smoking is the greatest cause of preventable death and disability in Wales. It is responsible forapproximately one-fifth of deaths1,2 and an estimated ♦ Bupropion can be an effective smoking cessation cost to health services of £70 million per annum. 2 aid in appropriately selected patients who receive The effects of environmental tobacco smoke (passive smoking) are additional to this. The overall cost ofsmoking to society is even greater.
♦ Bupropion has only been studied in relatively heavy smokers who were otherwise healthy.
Government policy to combat smoking aims to Trials of bupropion were conducted in volunteers prevent people, especially children, from starting to motivated to stop smoking, and treatment was smoke; to help adult smokers to stop, particularly combined with a structured support programme.
pregnant women and those in lower socio-economicgroups; and to raise awareness of the dangers ♦ Bupropion has not been studied in subjects below associated with passive smoking. Approximately 18 years of age, those who are pregnant or breast- one-quarter of the adult population in Wales smokes:1 feeding, or those with serious or unstable medical reducing this figure has been set as a national ♦ Bupropion has been compared with a nicotine Smoking cessation is beneficial regardless of age or patch for smoking cessation in one trial; results smoking history.3 In a 12-month period, about one in three smokers will attempt to stop,2 of whom only 3%will be abstinent after 12 months using willpoweralone.4 Supportive measures (including provision of This bulletin does not review all smoking cessation self-help materials, and advice and counselling from therapies but provides clinical information on the use health professionals) are effective in improving of bupropion [amfebutamone (rINN)]. Bupropion cessation rates.5 These are cost-effective healthcare hydrochloride sustained-release (Zyban) is licensed in interventions4 and guidelines for integrating effective the UK for use with motivational support as an aid to smoking cessation measures through the healthcare smoking cessation in nicotine-dependent patients.
Increased knowledge of the effect of nicotine on The use of nicotine replacement therapy (NRT) can neurotransmitters, and links between nicotine- raise success rates one and a half to two-fold over dependence and depression, has led to the investigation those achieved with motivational support alone (some of many pharmacological agents, including level of support was always offered in the clinical antidepressants, to aid smoking cessation.8 trials of NRT).5 The various nicotine products are Observational reports and two early trials suggested equally effective, with product choice primarily that bupropion, an atypical antidepressant (used in the influenced by personal preference. However, even USA), may be effective. Bupropion has dopaminergic with NRT, the majority of dependent smokers rarely and noradrenergic properties but the precise succeed in their first attempt to give up, many have to mechanism by which bupropion aids smoking make several attempts and many never succeed.
cessation is not firmly established.
Published by the Welsh Medicines Resource Centre, Llandough Hospital, Penarth, Vale of Glamorgan CF64 2XX. Tel: 029 – 2071 6117 WeMeReC Bulletin Vol. 7 No. 2, October 2000 1 Efficacy of bupropion: two clinical trials
Two randomised, double-blind, placebo-controlled, (6 weeks after the target quit date) and at 3, 6 and 12 multi-centre trials of bupropion for smoking cessation months. End-of-treatment and 12-month point- have been conducted in the USA. The trials were prevalence rates and 6-week continuous abstinence rates conducted in adult volunteers who smoked at least 15 are presented in Table 1 (trial 1). Continuous abstinence cigarettes per day and were motivated to stop.9,10 rates at 12 months were not reported.
Subjects had no current depression. Other exclusionsincluded recent use of NRT, a history of, or In the second study of 893 subjects, sustained-release predisposition to seizures, eating disorders, pregnancy or bupropion 300 mg was compared with a nicotine 21-mg breast-feeding, drug or alcohol abuse, dermatological patch and a combination of bupropion and the patch.10 disorders and serious or unstable medical or psychiatric Bupropion treatment began 1 week before the target quit date and continued for a further 8 weeks. Patch treatmentbegan on the target quit date and continued for Both year-long studies included a treatment phase, with 8 weeks, however, the dose was reduced in the final 2 day 8 usually set as the “target quit date”. Subjects received supportive advice before starting treatment andindividual 10-15 minute counselling sessions were Point-prevalence rates for smoking cessation were provided each week during treatment. Subjects were also calculated for 6 and 12 months. The results at telephoned 3 days after the target quit date. During the 12 months are given in Table 1 along with follow-up period there were a further four counselling 12-month continuous abstinence rates (trial 2).
sessions and monthly telephone calls.
Bupropion and the combined treatment were associatedwith significantly higher abstinence rates than the End-points included point-prevalence abstinence rates, nicotine patch. The combined treatment appeared which were based on the numbers of subjects who had superior to, but not significantly better than, bupropion not smoked for the previous week. Carbon monoxide alone. With the nicotine patch, only the continuous abstinence rate differed significantly compared with self-reports of smoking abstinence. Continuous abstinence rates were based on the numbers of subjectswho reported not smoking since the target quit date and In the first trial, weight gain during treatment in subjects who had negative carbon monoxide measurements at all who were continuously abstinent (n=103) was preceding clinic visits. In addition to abstinence rates, significantly lower with bupropion 300 mg (1.5 kg) body weight and symptoms of depression and withdrawal compared with placebo (2.9 kg). This difference had were monitored. The results were analysed on an diminished at 6 months. In the second trial, weight gain intent-to-treat basis; subjects who did not complete the in subjects at week 7 (n=666) was lower but not studies were considered to be smoking. Approximately significantly different in the bupropion group (1.7 kg) 35% of subjects in both studies did not participate for a compared with the placebo group (2.1 kg).
Withdrawal symptoms were experienced by subjects receiving bupropion 300 mg but not to the same degree as sustained-release bupropion taken at daily doses of 100 by those receiving placebo. Bupropion had no effect on mg, 150 mg and 300 mg (150 mg twice daily) for 7 measures of depressive symptoms in either trial.
weeks.9 Point-prevalence or 7-day abstinence rates weredetermined at the end of treatment Table 1 Smoking cessation rates*
Point-prevalence (7-day abstinence) rates
Continuous abstinence rates
* Differences between rates for bupropion and placebo are statistically significant in both trial 19 and trial 2.10 2 WeMeReC Bulletin Vol. 7 No. 2, October 2000 In the trials, dry mouth and insomnia were common suspected adverse reactions, including serious reactions, adverse events that were reported significantly more have been reported to the CSM. Bupropion carries the t frequently with bupropion than with placebo. In the first symbol; all suspected adverse reactions should be trial, 37 (6%) subjects withdrew because of adverse reported through the Yellow Card Scheme to CSM events (8 receiving placebo); tremor, headaches, rash and urticaria were the most common reasons.9 In the secondtrial, 79 (8.8%) subjects withdrew because of adverse Bupropion and smoking cessation have the potential to events, with a significantly higher percentage affect the metabolism of drugs by cytochrome enzymes withdrawing in the groups receiving bupropion (57 and there are a number of medicines that can potentially subjects in total) than in the placebo group (6 subjects).10 affect blood levels of bupropion. The summary of Serious adverse events included three cases of rash and product characteristics should be consulted about pruritus, one of which occurred with shortness of breath potential interactions between bupropion and other One of the main concerns with bupropion use, which Patients with recent myocardial infarction or unstable arose during post-marketing experience in the USA, is heart disease were not included in clinical trials of the incidence of seizures. The incidence of seizures is bupropion, so care is advised in these groups. There have approximately 0.1%,11 with risk strongly associated with been reports of cardiovascular effects, including the presence of predisposing factors. Higher doses of tachycardia, hypertension and postural hypotension, in bupropion are associated with a greater risk of seizures.
patients receiving bupropion.11 In the second trial,10 newor worsening hypertension was reported more frequently, Bupropion is contra-indicated in patients with a current although not significantly so, in subjects receiving or previous diagnosis of a seizure disorder or bulimia or bupropion combined with the nicotine patch than in those anorexia nervosa, a history of bipolar disorder or those receiving placebo. In patients receiving combination taking monoamine oxidase inhibitors. Bupropion is also treatment, caution must be exercised and blood pressure contra-indicated in patients with severe hepatic cirrhosis.
It should be used with caution in patients with hepaticimpairment and renal insufficiency. A lower dose (150 The trials of bupropion for smoking cessation did not mg daily) is recommended in these patients, and in the include patients with depression. The efficacy of bupropion for smoking cessation in the trials was notassociated with an antidepressant effect, and a subgroup Because bupropion can lower the seizure threshold, it analysis of the first trial found bupropion was equally should be administered with extreme caution in patients effective in patients with or without a history of major who may already be predisposed to a lower seizure depression.16 Bupropion is not licensed in the UK for use threshold or a higher risk of seizures. For example, in the management of depression and depression may patients with a history of head trauma, those with central occur during its use for smoking cessation.17 nervous system tumours, or those taking medicines suchas antipsychotics, antidepressants, theophylline or Discontinuation reactions were not observed in the trials systemic steroids. It should be used with caution in the of bupropion but gradual dose reduction may be presence of alcohol abuse, the abrupt withdrawal of considered.11 As a centrally-acting drug, bupropion can alcohol or benzodiazepines, the use of stimulants or affect the ability to perform tasks requiring judgement or anorectic products, and diabetes treated with motor and cognitive skills. Dizziness and light- headedness have been reported, and patients startingbupropion should be cautioned about driving and using Relatively rare but serious adverse effects reported with bupropion include hypersensitivity reactions, serumsickness-like reactions, erythema multiforme and Stevens Bupropion has not been evaluated in subjects below 18 Johnson syndrome.11-15 Since bupropion has become years of age and its safety in pregnant or lactating women has not been established. Bupropion has not been studiedbeyond 9 weeks for use as an aid to smoking cessation.
WeMeReC Bulletin Vol. 7 No. 2, October 2000 1 Prescribing bupropion
Healthcare professionals providing smoking cessation Bupropion is available in 150-mg sustained-release advice in primary care should ask about smoking at
tablets. The recommended dosage is 150 mg taken daily every opportunity; advise all smokers to stop; assist the
for 3 days, increasing to 150 mg twice daily. Doses smoker to stop and arrange follow-up.6 Before
should be taken at least 8 hours apart. As it takes about prescribing bupropion, GPs should be confident that 1 week for steady-state blood levels of bupropion to be patients are committed to quitting and be able to provide, reached, patients should start the tablets while they are or refer patients to, a source of face-to-face counselling.
still smoking and set a “target quit date” within thesecond week, usually day 8 of treatment. Treatment Help with assessment of patients’ motivation and should be stopped after 7 weeks if no effect is observed.
provision of support may be available locally throughcommunity pharmacies or smoking cessation clinics.
Health authorities and some local health groups have Information on how to contact your local smoking issued guidelines on prescribing bupropion. These cessation co-ordinator can be obtained from the national telephone helpline. Additional telephone counselling for 1 month only. A second prescription should be issued patients is available through this national helpline.
only with counselling and assessment of tolerability andcompliance.
Smokers Helpline for Wales: 0800 169-0-169 Cost
Zyban costs £85.70 for a 2-month course of treatment.
The manufacturer of bupropion is also advertising a Costs associated with counselling should also be support programme that provides patients with self-help considered. Comparisons with nicotine replacement materials and access to telephone counselling. Contact therapy are difficult as costs associated with nicotine details are provided in the patient information leaflet.
products vary considerably depending on the formulationand dose used, and the route of supply.
1. Digest of Welsh statistics 1999. The National Assembly for
9. Hurt RD et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997; 337: 2. Promoting health and well being: a consultation document.
March 2000. Health Promotion Division, The National 10. Jorenby DE et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation.
3. Peto R et al. Smoking, smoking cessation, and lung cancer N Engl J Med 1999; 340: 685-691. Correction: N Engl J in the UK since 1950: combination of national statistics with two case-control studies. BMJ 2000; 321: 323-329.
11. Zyban summary of product characteristics. GlaxoWellcome 4. Parrott S et al. A guidence for commissioners on the cost- effectiveness of smoking cessation interventions. Thorax 12. Tripathi A, Greenberger PA. Bupropion hydrochloride induced serum sickness-like reaction. Ann Allergy Asthma 5. Lancaster T et al. Effectiveness of interventions to help people stop smoking: findings from the Cochrane Library.
13. Peloso PM, Baillie C. Serum sickness-like reaction with 6. Raw M et al. Smoking cessation guidelines for health 14. Yolles JC et al. Serum sickness induced by bupropion. Ann professionals. A guide to effective smoking cessation interventions for the health care system. Thorax 1998; 53 15. McCollom RA et al. Bupropion-induced serum sickness-like reaction. Ann Pharmacother 2000; 34: 471-473.
7. Raw M et al. Smoking cessation: evidence based 16. Hayford KE et al. Efficacy of bupropion for smoking cessation recommendations for the healthcare system. BMJ 1999; 318: in smokers with a former history of major depression or alcoholism. Br J Psychiatry 1999; 174: 173-178.
8. Benowitz NL, Peng MW. Non-nicotine pharmacotherapy for 17. Patten CA et al. Development of depression during placebo- smoking cessation. Mechanisms and prospects. CNS Drugs controlled trials of bupropion for smoking cessation: case reports. J Clin Psychiatry 1999; 60: 436-441.
The manufacturer’s summary of product characteristics should be consulted for full prescribing information.
Prescribing in pregnancy is the topic for the next WeMeReC bulletin
and GP distance-learning module. These will be issued in November.
WeMeReC Bulletin Vol. 7 No. 2, October 2000 3
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