Eficacia de los tratamientos farmacologicos del tabaquismo

Eisenberg MJ, Filion KB, Yavin D, Bélisle P, Mottillo S, Joseph L et al. Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ 2008; 179: 135-144. R TC PDF

Introducción

En estos momentos se dispone de diferentes abordajes farmacológicos para tratar el tabaquismo, entre los que se encuentran la nicotina en diferentes formas de administración, el bupropion y la vareniclina. En esta situación es importante comparar la eficacia de los diferentes tratamientos.

Objetivo

Revisar sistemáticamente los ensayos clínicos del tratamiento farmacológico del tabaquismo para resumir su eficacia, comparar directamente la eficacia de la vareniclina y el bupropion y comparar indirectamente la eficacia de los 7 tratamientos farmacológicos disponibles para el tabaquismo.

Perfil del estudio

Tipo de estudio: Metaanálisis
Área del estudio: Tratamiento
Ámbito del estudio: Comunitario

Métodos

Se llevó a cabo una busqueda en la US Centers for Disease Control and Prevention´s Tobacco Information and Prevention database, PubMed, EMBASE y la Cochrane Library para localizar los estudios publicados en inglés sobre la eficacia de 7 modalidades terapéuticas: vareniclina, bupropion y cinco presentaciones de la nicotina (chicle, inhalador, spray nasal, comprimidos y parche). Se incluyeron en el análisis los ensayos clínicos doble ciego controlados con placebo que proporcionaron medidas bioquímicas de abstinencia a los 6 y 12 meses. Se incluyeron los estudios en los que los participantes habían recibido tratamientos complementarios siempre que la intensidad fuese la misma en el grupo intervención y en el grupo placebo.
Se excluyeron los estudios abiertos y aquellos en los que el objetivo del tratamiento era reducir el consumo de cigarrillos o aumentar la tasa de abandonos espontáneos en personas que no querían dejar de fumar, así como los que se llevaron a cabo en personas con enfermedades crónicas. Se distinguió entre la abstinencia continua (la que se mantuvo desde el abandono hasta el último seguimiento) y la abstinencia puntual (en la semana anterior a la visita de seguimiento). Los resultados se valoraron según el principio de intención de tratar.

Resultados

Se incluyeron en el análisis 69 estudios, con cerca de 33.000 participantes (fig. 1). Los tratamientos estudiados fueron parches de nicotina (30 esturios), chicles de nicotina (22), bupropion (16), vareniclina (13), comprimidos de nicotina (6), spray nasal de nicotina (4) e inhalador de nicotina (4).

Figura 1. Proceso de selección de los estudios.

Las tasas de abandono globales fueron bajas (fig. 2), especialmente si sólo se tomaban en consideración las abstinencias mantenidas a los 12 meses.

Figura 2. Tasas de abandonos globales.

En el analisis principal todos los tratamientos fueron más eficaces que el placebo (fig. 3). En los estudios en los que se compararon directamente, la vareniclina fue superior al bupropion (odds ratio 2,18; IC95% 1,09 a 4,08).

Figura 3. Eficacia global de los diferentes tratamientos farmacológicos sobre la odds de abandono del tabaco.

Los datos relativos a la seguridad de los tratamientos fueron difíciles de analizar puesto que se recogieron de forma muy diferente en los distintos estudios, de forma que la tasa de eventos adversos en el grupo placebo oscilaba entre el 4 y el 85%. En cualquier caso, las reacciones graves registrados fueron raras.

Conclusiones

Los autores concluyen que todas las presentaciones de nicotina analizadas, la vareniclina y el bupropion son más eficaces que el placebo para promover la abstinencia de tabaco a los 6 y 12 meses y que la vaneclina parece más eficaz que el bupropion.

Conflictos de interés

Varios de los autores han recibido honorarios de diferentes laboratorios farmacéuticos. Financiado por los Canadian Institutes of Health Research.

Comentario

En estos momentos los clínicos disponen de un amplio arsenal para tratar la dependencia de la nicotina, por lo que en el momento de instaurar un tratamiento es importante conocer su eficacia relativa y su perfil de efectos adversos.

En este metaanálisis se han incluido sólo ensayos clínicos controlados en los que se confirmó la abstinencia mediante análisis, por lo que todos los estudios eran de elevada calidad. Los resultados de este estudio demuestran que todos los fármacos en el mercado son moderadamente eficaces, en lo que coinciden con otros metaanálisis previos, pero las poblaciones estudiadas estaban muy seleccionadas, por lo que es probable que su efectividad en condiciones reales sea menor.

Sin embargo, las dudas sobre la eficacia relativa de los tratamientos se mantiene, puesto que en muy pocos estudios han llevado a cabo comparaciones directas entre unos y otros fármacos y sacar conclusiones comparando los resultados de estudios llevados a cabo en diferentes poblaciones puede resultar arriesgado, dado que una parte de las diferencias observadas pueden deberse a las características de las poblaciones, de las medidas de abstinencia utilizadas y a los distintos periodos de seguimiento como lo demuestran las diferencias en los resultados de los grupos placebo.
Del perfil de seguridad relativo de los diferentes fármacos tampoco se pueden sacar grandes conclusiones. Aunque la tolerancia de todos ellos en los ensayos clínicos fue aceptable, se han descrito efectos adversos importantes postcomercialización en el caso de la vareniclina (trastornos neuropsiquiátricos) y del bupropion (trastornos neuropsiquiátricos y convulsiones). Por último, no hay que olvidar que la mayor parte de los fumadores abandonan el hábito sin necesidad de tratamientos farmacológicos, por lo que el tratamiento se debe basar en el consejo antitabaco.

Bibliografía

1. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al for the Varenicline Phase 3 Study Group. Varenicline, an {alpha}4beta2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation: A Randomized Controlled Trial. JAMA 2006; 296: 47-55. R TC PDF RC
2. Oncken C, Gonzales D, Nides M, Rennard S, Watsky E, Billing CB et al. Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation. Arch Intern Med 2006; 166: 1571-1577. R TC (s) PDF (s)
3. Andrew Molyneux. ABC of smoking cessation. Nicotine replacement therapy. BMJ 2004; 328: 454-456. TC PDF

Autor

Manuel Iglesias Rodal. Correo electrónico: mrodal@menta.net.

Crisis en atencion primaria

The editors asked several experts to share their perspectives on the crisis in U.S. primary care. Their articles, which address this crisis from six different angles, follow. We also brought the five U.S. contributors together for a roundtable discussion of the problems and potential solutions for training, practice, compensation, and systemic change. A video of the discussion and reader comments can be seen at www.nejm.org.

Primary care has been one of the best jobs in medicine, and it can be again. In fact, primary care must recapture its attraction for the next generation's best trainees — or the chaos and inefficiency of U.S. health care will only worsen.

The challenges are formidable, for there are so many reasons for young physicians to go into other fields. Many physicians graduate from medical school with staggering debts, and procedure-oriented specialties offer higher potential incomes. The work of primary care is itself overwhelming. Primary care physicians often go home worried that they may have made mistakes, or dispirited because they did not complete their work.

But as Treadway's story reminds us, failure is not an option. Throughout their lives, but particularly at the end, patients want and need physicians who focus on the people who have diseases, not just the diseases that they have.

Redesigning Primary Care In a video roundtable discussion moderated by Dr. Thomas Lee, four experts in primary care and related policy explore the crisis, as well as possible solutions for training, practice, compensation, and systemic change.

And when people want and need something, the market usually gives it to them. Right now, patients throughout the UnitedStates are having difficulty finding primary care physicians, so incomes for such practitioners will probably rise as health care organizations struggle to meet the demand for primary care. At the delivery system where I work, we are actively discussingquestions such as how high primary care salaries need to be, where the money to pay them will come from, and how quicklyhigher incomes might work to expand the primary care pipeline.

These questions are difficult to answer, because money is only part of the problem and therefore can be only part of the solution. We have to figure out how to make the job of primary care doable once again. We have to learn how to surround primary care physicians with teams that help them care for their populations of patients, as Bodenheimer argues in his article, and we have to equip them with systems such as electronic medical records to help them manage the flood of information that moves through their offices every day. And, as Goroll suggests in his article, we have to develop payment policies that make these innovations sustainable.

Many organizations have found that when they increase payments to primary care physicians, the physicians respond by reducing the number of patients they see. These physicians, it turns out, place a higher priority on trying to do a good job andhaving a sane life than on making a higher income. The message they're sending is that more money will not be enough to revitalize primary care.

Revitalization will take something more like reinvention, and it will demand creativity and flexibility from all parties — including primary care physicians themselves. These physicians need to learn to work in teams and adjust to the notion that much of primary care can be delivered by nonphysician team members, some of whom are located in nontraditional settings, such aslimited-service clinics in retail stores.

In this collection of articles, Starfield describes some of the major policy issues that must be addressed as the U.S. health care system develops a stronger primary care focus, and Roland suggests that there are some features of primary care in the United Kingdom that might warrant adaptation. As we test new concepts in the years ahead, primary care will undoubtedly changedramatically. But if we are successful and wise, these changes should allow key aspects of being a primary care physician toremain the same.

Primary care doctors should once again feel a deep sense of satisfaction when they leave their offices or patients' homes after helping people through difficult times. They should be able to leave work thinking not of their income, or of unanswered phone calls, or of test results that they might have overlooked. They should go home thinking, "This is what I was meant to do."

No potential conflict of interest relevant to this article was reported.

Source Information

Dr. Lee is network president at Partners HealthCare System, Boston, and an associate editor of the Journal.

Crisis en atencion primaria

The editors asked several experts to share their perspectives on the crisis in U.S. primary care. Their articles, which address this crisis from six different angles, follow. We also brought the five U.S. contributors together for a roundtable discussion of the problems and potential solutions for training, practice, compensation, and systemic change. A video of the discussion and reader comments can be seen at www.nejm.org.

Primary care has been one of the best jobs in medicine, and it can be again. In fact, primary care must recapture its attraction for the next generation's best trainees — or the chaos and inefficiency of U.S. health care will only worsen.
The challenges are formidable, for there are so many reasons for young physicians to go into other fields. Many physicians graduate from medical school with staggering debts, and procedure-oriented specialties offer higher potential incomes. The work of primary care is itself overwhelming. Primary care physicians often go home worried that they may have made mistakes, or dispirited because they did not complete their work.
But as Treadway's story reminds us, failure is not an option. Throughout their lives, but particularly at the end, patients want and need physicians who focus on the people who have diseases, not just the diseases that they have.

Redesigning Primary Care In a video roundtable discussion moderated by Dr. Thomas Lee, four experts in primary care and related policy explore the crisis, as well as possible solutions for training, practice, compensation, and systemic change.

And when people want and need something, the market usually gives it to them. Right now, patients throughout the UnitedStates are having difficulty finding primary care physicians, so incomes for such practitioners will probably rise as health care organizations struggle to meet the demand for primary care. At the delivery system where I work, we are actively discussingquestions such as how high primary care salaries need to be, where the money to pay them will come from, and how quicklyhigher incomes might work to expand the primary care pipeline.
These questions are difficult to answer, because money is only part of the problem and therefore can be only part of the solution. We have to figure out how to make the job of primary care doable once again. We have to learn how to surround primary care physicians with teams that help them care for their populations of patients, as Bodenheimer argues in his article, and we have to equip them with systems such as electronic medical records to help them manage the flood of information that moves through their offices every day. And, as Goroll suggests in his article, we have to develop payment policies that make these innovations sustainable.
Many organizations have found that when they increase payments to primary care physicians, the physicians respond by reducing the number of patients they see. These physicians, it turns out, place a higher priority on trying to do a good job andhaving a sane life than on making a higher income. The message they're sending is that more money will not be enough to revitalize primary care.
Revitalization will take something more like reinvention, and it will demand creativity and flexibility from all parties — including primary care physicians themselves. These physicians need to learn to work in teams and adjust to the notion that much of primary care can be delivered by nonphysician team members, some of whom are located in nontraditional settings, such aslimited-service clinics in retail stores.
In this collection of articles, Starfield describes some of the major policy issues that must be addressed as the U.S. health care system develops a stronger primary care focus, and Roland suggests that there are some features of primary care in the United Kingdom that might warrant adaptation. As we test new concepts in the years ahead, primary care will undoubtedly changedramatically. But if we are successful and wise, these changes should allow key aspects of being a primary care physician toremain the same.
Primary care doctors should once again feel a deep sense of satisfaction when they leave their offices or patients' homes after helping people through difficult times. They should be able to leave work thinking not of their income, or of unanswered phone calls, or of test results that they might have overlooked. They should go home thinking, "This is what I was meant to do."
No potential conflict of interest relevant to this article was reported.

Source Information
Dr. Lee is network president at Partners HealthCare System, Boston, and an associate editor of the Journal.

Crisis en atencion primaria

The editors asked several experts to share their perspectives on the crisis in U.S. primary care. Their articles, which address this crisis from six different angles, follow. We also brought the five U.S. contributors together for a roundtable discussion of the problems and potential solutions for training, practice, compensation, and systemic change. A video of the discussion and reader comments can be seen at www.nejm.org.

Primary care has been one of the best jobs in medicine, and it can be again. In fact, primary care must recapture its attraction for the next generation's best trainees — or the chaos and inefficiency of U.S. health care will only worsen.

The challenges are formidable, for there are so many reasons for young physicians to go into other fields. Many physicians graduate from medical school with staggering debts, and procedure-oriented specialties offer higher potential incomes. The work of primary care is itself overwhelming. Primary care physicians often go home worried that they may have made mistakes, or dispirited because they did not complete their work.

But as Treadway's story reminds us, failure is not an option. Throughout their lives, but particularly at the end, patients want and need physicians who focus on the people who have diseases, not just the diseases that they have.

Redesigning Primary Care In a video roundtable discussion moderated by Dr. Thomas Lee, four experts in primary care and related policy explore the crisis, as well as possible solutions for training, practice, compensation, and systemic change.

And when people want and need something, the market usually gives it to them. Right now, patients throughout the UnitedStates are having difficulty finding primary care physicians, so incomes for such practitioners will probably rise as health care organizations struggle to meet the demand for primary care. At the delivery system where I work, we are actively discussingquestions such as how high primary care salaries need to be, where the money to pay them will come from, and how quicklyhigher incomes might work to expand the primary care pipeline.

These questions are difficult to answer, because money is only part of the problem and therefore can be only part of the solution. We have to figure out how to make the job of primary care doable once again. We have to learn how to surround primary care physicians with teams that help them care for their populations of patients, as Bodenheimer argues in his article, and we have to equip them with systems such as electronic medical records to help them manage the flood of information that moves through their offices every day. And, as Goroll suggests in his article, we have to develop payment policies that make these innovations sustainable.

Many organizations have found that when they increase payments to primary care physicians, the physicians respond by reducing the number of patients they see. These physicians, it turns out, place a higher priority on trying to do a good job andhaving a sane life than on making a higher income. The message they're sending is that more money will not be enough to revitalize primary care.

Revitalization will take something more like reinvention, and it will demand creativity and flexibility from all parties — including primary care physicians themselves. These physicians need to learn to work in teams and adjust to the notion that much of primary care can be delivered by nonphysician team members, some of whom are located in nontraditional settings, such aslimited-service clinics in retail stores.

In this collection of articles, Starfield describes some of the major policy issues that must be addressed as the U.S. health care system develops a stronger primary care focus, and Roland suggests that there are some features of primary care in the United Kingdom that might warrant adaptation. As we test new concepts in the years ahead, primary care will undoubtedly changedramatically. But if we are successful and wise, these changes should allow key aspects of being a primary care physician toremain the same.

Primary care doctors should once again feel a deep sense of satisfaction when they leave their offices or patients' homes after helping people through difficult times. They should be able to leave work thinking not of their income, or of unanswered phone calls, or of test results that they might have overlooked. They should go home thinking, "This is what I was meant to do."

No potential conflict of interest relevant to this article was reported.

Source Information

Dr. Lee is network president at Partners HealthCare System, Boston, and an associate editor of the Journal.

Rosiglitazona y Riesgo Cardiovascular

Long-term Risk of Cardiovascular Events With Rosiglitazone

A Meta-analysis

Sonal Singh, MD; Yoon K. Loke, MBBS, MD; Curt D. Furberg, MD, PhD 

JAMA. 2007;298:1189-1195.

Context  Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes.

Objective  To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality.

Data Sources  We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007.

Study Selection  Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events.

Data Extraction  Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years).

Results  Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09;95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among thetrials for these end points (I² = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascularmortality).

Conclusion  Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.

Author Affiliations: Department of Medicine (Dr Singh) and Division of Public Health Sciences (Dr Furberg), Wake Forest University School of Medicine, Winston-Salem, North Carolina; and School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Loke).

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Rosiglitazona y Riesgo Cardiovascular

Long-term Risk of Cardiovascular Events With Rosiglitazone

A Meta-analysis

Sonal Singh, MD; Yoon K. Loke, MBBS, MD; Curt D. Furberg, MD, PhD 

JAMA. 2007;298:1189-1195.

Context  Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes.

Objective  To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality.

Data Sources  We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007.

Study Selection  Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events.

Data Extraction  Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years).

Results  Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09;95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among thetrials for these end points (I² = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascularmortality).

Conclusion  Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.

Author Affiliations: Department of Medicine (Dr Singh) and Division of Public Health Sciences (Dr Furberg), Wake Forest University School of Medicine, Winston-Salem, North Carolina; and School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Loke).

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Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: A Meta-analysis of Randomized Trials
, , , and 
JAMA. ;298():1180-1188. 
FULL TEXT  

Cardiovascular Risk and the Thiazolidinediones: Deja Vu All Over Again?
and 
JAMA. ;298():1216-1218. 
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Intensive Glucose Control in Type 2 Diabetes
Jenny-Avital et al.
NEJM 2008;359:1519-1521.
FULL TEXT  

Rosiglitazone and pioglitazone in the treatment of diabetes mellitus
Odom et al.
Am J Health Syst Pharm 2008;65:1846-1850.
FULL TEXT  

Rosiglitazone Treatment Reduces Diabetic Neuropathy in Streptozotocin-Treated DBA/2J Mice
Wiggin et al.
Endocrinology 2008;149:4928-4937.
ABSTRACT | FULL TEXT  

Thiazolidinediones in Type 2 Diabetes: A Cardiology Perspective
Khanderia et al.
The Annals of Pharmacotherapy 2008;42:1466-1474.
ABSTRACT | FULL TEXT  

The Peroxisome Proliferator-Activated Receptor-{gamma} Agonist Pioglitazone Represses Inflammation in a Peroxisome Proliferator-Activated Receptor-{alpha}-Dependent Manner In Vitro and In Vivo in Mice
Orasanu et al.
J Am Coll Cardiol 2008;52:869-881.
ABSTRACT | FULL TEXT  

Pharmacological Differences of Glitazones: Does Peroxisome Proliferator-Activated Receptor-{alpha} Activation Make the Difference?
Kintscher
J Am Coll Cardiol 2008;52:882-884.
FULL TEXT  

Obese Mice Lacking Inducible Nitric Oxide Synthase Are Sensitized to the Metabolic Actions of Peroxisome Proliferator-Activated Receptor-{gamma} Agonism
Dallaire et al.
Diabetes 2008;57:1999-2011.
ABSTRACT | FULL TEXT  

Best Practices for Lowering the Risk of Cardiovascular Disease in Diabetes
Triplitt and Alvarez
Diabetes Spectr. 2008;21:177-189.
ABSTRACT | FULL TEXT  

Treating Elderly People with Diabetes and Stages 3 and 4 Chronic Kidney Disease
Abaterusso et al.
CJASN 2008;3:1185-1194.
ABSTRACT | FULL TEXT  

Patient-Important Outcomes in Registered Diabetes Trials
Gandhi et al.
JAMA 2008;299:2543-2549.
ABSTRACT | FULL TEXT  

Screening Adults for Type 2 Diabetes: A Review of the Evidence for the U.S. Preventive Services Task Force
Norris et al.
ANN INTERN MED 2008;148:855-868.
ABSTRACT | FULL TEXT  

Regulation of Macrophage Functions by PPAR-{alpha}, PPAR-{gamma}, and LXRs in Mice and Men
Rigamonti et al.
Arterioscler. Thromb. Vasc. Bio. 2008;28:1050-1059.
ABSTRACT | FULL TEXT  

Induction of CXCR2 Receptor by Peroxisome Proliferator-Activated Receptor {gamma} in Human Macrophages
Rigamonti et al.
Arterioscler. Thromb. Vasc. Bio. 2008;28:932-939.
ABSTRACT | FULL TEXT  

Diabetic retinopathy and risk of heart failure.
Cheung et al.
J Am Coll Cardiol 2008;51:1573-1578.
ABSTRACT | FULL TEXT  

PROactive: time for a critical appraisal
Betteridge et al.
Eur Heart J 2008;29:969-983.
ABSTRACT | FULL TEXT  

Glitazones in type 2 diabetes: an update
DTB 2008;46:25-29.
ABSTRACT | FULL TEXT  

Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone
Dahabreh
Clin Trials 2008;5:116-120.
ABSTRACT  

The year in atherothrombosis.
Sanz et al.
J Am Coll Cardiol 2008;51:944-955.
FULL TEXT  

Peroxisome Proliferator-Activated Receptor-{gamma}-Mediated Effects in the Vasculature
Duan et al.
Circ. Res. 2008;102:283-294.
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Management of Type 2 Diabetes -- Polling Results
Halperin et al.
NEJM 2008;358:e8-e8.
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Projecting future drug expenditures--2008
Hoffman et al.
Am J Health Syst Pharm 2008;65:234-253.
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New Drugs for the Treatment of Diabetes: Part II: Incretin-Based Therapy and Beyond
Inzucchi and McGuire
Circulation 2008;117:574-584.
ABSTRACT | FULL TEXT  

New Drugs for the Treatment of Diabetes Mellitus: Part I: Thiazolidinediones and Their Evolving Cardiovascular Implications
McGuire and Inzucchi
Circulation 2008;117:440-449.
FULL TEXT  

Glucose-lowering therapy after myocardial infarction: more questions than answers
Radke and Schunkert
Eur Heart J 2008;29:141-143.
FULL TEXT  

Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes 
Nathan et al.
Diabetes Care 2008;31:173-175.
FULL TEXT  

Standards of Medical Care in Diabetes--2008
American Diabetes Association
Diabetes Care 2008;31:S12-S54.
FULL TEXT  

Thiazolidinediones and Cardiovascular Outcomes in Older Patients With Diabetes
Lipscombe et al.
JAMA 2007;298:2634-2643.
ABSTRACT | FULL TEXT  

A Crash Course in Stats
Kirkman
DOC News 2007;4:2-2.
FULL TEXT  

Thiazolidinediones and Increased MI Risk: A Class Effect?
Journal Watch Cardiology 2007;2007:3-3.
FULL TEXT  

Cardiovascular Risk and the Thiazolidinediones: Deja Vu All Over Again?
Solomon and Winkelmayer
JAMA 2007;298:1216-1218.
FULL TEXT  

Thiazolidinediones and Heart Disease Risk
JWatch General 2007;2007:2-2.
FULL TEXT  

Rosiglitazona y Riesgo Cardiovascular

Long-term Risk of Cardiovascular Events With Rosiglitazone

A Meta-analysis

Sonal Singh, MD; Yoon K. Loke, MBBS, MD; Curt D. Furberg, MD, PhD 

JAMA. 2007;298:1189-1195.

Context  Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes.

Objective  To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality.

Data Sources  We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007.

Study Selection  Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events.

Data Extraction  Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years).

Results  Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09;95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among thetrials for these end points (I² = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascularmortality).

Conclusion  Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.

Author Affiliations: Department of Medicine (Dr Singh) and Division of Public Health Sciences (Dr Furberg), Wake Forest University School of Medicine, Winston-Salem, North Carolina; and School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Loke).

RELATED ARTICLES

Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: A Meta-analysis of Randomized Trials
, , , and 
JAMA. ;298():1180-1188. 
FULL TEXT  

Cardiovascular Risk and the Thiazolidinediones: Deja Vu All Over Again?
and 
JAMA. ;298():1216-1218. 
FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Intensive Glucose Control in Type 2 Diabetes
Jenny-Avital et al.
NEJM 2008;359:1519-1521.
FULL TEXT  

Rosiglitazone and pioglitazone in the treatment of diabetes mellitus
Odom et al.
Am J Health Syst Pharm 2008;65:1846-1850.
FULL TEXT  

Rosiglitazone Treatment Reduces Diabetic Neuropathy in Streptozotocin-Treated DBA/2J Mice
Wiggin et al.
Endocrinology 2008;149:4928-4937.
ABSTRACT | FULL TEXT  

Thiazolidinediones in Type 2 Diabetes: A Cardiology Perspective
Khanderia et al.
The Annals of Pharmacotherapy 2008;42:1466-1474.
ABSTRACT | FULL TEXT  

The Peroxisome Proliferator-Activated Receptor-{gamma} Agonist Pioglitazone Represses Inflammation in a Peroxisome Proliferator-Activated Receptor-{alpha}-Dependent Manner In Vitro and In Vivo in Mice
Orasanu et al.
J Am Coll Cardiol 2008;52:869-881.
ABSTRACT | FULL TEXT  

Pharmacological Differences of Glitazones: Does Peroxisome Proliferator-Activated Receptor-{alpha} Activation Make the Difference?
Kintscher
J Am Coll Cardiol 2008;52:882-884.
FULL TEXT  

Obese Mice Lacking Inducible Nitric Oxide Synthase Are Sensitized to the Metabolic Actions of Peroxisome Proliferator-Activated Receptor-{gamma} Agonism
Dallaire et al.
Diabetes 2008;57:1999-2011.
ABSTRACT | FULL TEXT  

Best Practices for Lowering the Risk of Cardiovascular Disease in Diabetes
Triplitt and Alvarez
Diabetes Spectr. 2008;21:177-189.
ABSTRACT | FULL TEXT  

Treating Elderly People with Diabetes and Stages 3 and 4 Chronic Kidney Disease
Abaterusso et al.
CJASN 2008;3:1185-1194.
ABSTRACT | FULL TEXT  

Patient-Important Outcomes in Registered Diabetes Trials
Gandhi et al.
JAMA 2008;299:2543-2549.
ABSTRACT | FULL TEXT  

Screening Adults for Type 2 Diabetes: A Review of the Evidence for the U.S. Preventive Services Task Force
Norris et al.
ANN INTERN MED 2008;148:855-868.
ABSTRACT | FULL TEXT  

Regulation of Macrophage Functions by PPAR-{alpha}, PPAR-{gamma}, and LXRs in Mice and Men
Rigamonti et al.
Arterioscler. Thromb. Vasc. Bio. 2008;28:1050-1059.
ABSTRACT | FULL TEXT  

Induction of CXCR2 Receptor by Peroxisome Proliferator-Activated Receptor {gamma} in Human Macrophages
Rigamonti et al.
Arterioscler. Thromb. Vasc. Bio. 2008;28:932-939.
ABSTRACT | FULL TEXT  

Diabetic retinopathy and risk of heart failure.
Cheung et al.
J Am Coll Cardiol 2008;51:1573-1578.
ABSTRACT | FULL TEXT  

PROactive: time for a critical appraisal
Betteridge et al.
Eur Heart J 2008;29:969-983.
ABSTRACT | FULL TEXT  

Glitazones in type 2 diabetes: an update
DTB 2008;46:25-29.
ABSTRACT | FULL TEXT  

Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone
Dahabreh
Clin Trials 2008;5:116-120.
ABSTRACT  

The year in atherothrombosis.
Sanz et al.
J Am Coll Cardiol 2008;51:944-955.
FULL TEXT  

Peroxisome Proliferator-Activated Receptor-{gamma}-Mediated Effects in the Vasculature
Duan et al.
Circ. Res. 2008;102:283-294.
ABSTRACT | FULL TEXT  

Management of Type 2 Diabetes -- Polling Results
Halperin et al.
NEJM 2008;358:e8-e8.
FULL TEXT  

Projecting future drug expenditures--2008
Hoffman et al.
Am J Health Syst Pharm 2008;65:234-253.
ABSTRACT | FULL TEXT  

New Drugs for the Treatment of Diabetes: Part II: Incretin-Based Therapy and Beyond
Inzucchi and McGuire
Circulation 2008;117:574-584.
ABSTRACT | FULL TEXT  

New Drugs for the Treatment of Diabetes Mellitus: Part I: Thiazolidinediones and Their Evolving Cardiovascular Implications
McGuire and Inzucchi
Circulation 2008;117:440-449.
FULL TEXT  

Glucose-lowering therapy after myocardial infarction: more questions than answers
Radke and Schunkert
Eur Heart J 2008;29:141-143.
FULL TEXT  

Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes 
Nathan et al.
Diabetes Care 2008;31:173-175.
FULL TEXT  

Standards of Medical Care in Diabetes--2008
American Diabetes Association
Diabetes Care 2008;31:S12-S54.
FULL TEXT  

Thiazolidinediones and Cardiovascular Outcomes in Older Patients With Diabetes
Lipscombe et al.
JAMA 2007;298:2634-2643.
ABSTRACT | FULL TEXT  

A Crash Course in Stats
Kirkman
DOC News 2007;4:2-2.
FULL TEXT  

Thiazolidinediones and Increased MI Risk: A Class Effect?
Journal Watch Cardiology 2007;2007:3-3.
FULL TEXT  

Cardiovascular Risk and the Thiazolidinediones: Deja Vu All Over Again?
Solomon and Winkelmayer
JAMA 2007;298:1216-1218.
FULL TEXT  

Thiazolidinediones and Heart Disease Risk
JWatch General 2007;2007:2-2.
FULL TEXT  

Screening para la depresion detecta multiples comorbilidades

El objetivo de este estudio realizado por investigadores de Australia y España fue reportar las características básicas del Diagnóstico, Manejo y Resultados de la Depresión en Atención Primaria (DIAMOND). Fue un estudio de cohorte, prospectivo y longitudinal que se inició en Enero de 2005 y discutió las implicaciones para la depresión en atención médica general. El estudio incluyó a pacientes adultos con síntomas depresivos identificados a través de tamizaje con la Escala de Depresión del Centro de Estudios Epidemiológicos (CES-D = 16). Se seleccionaron 30 pacientes al azar de la práctica general. El resultado principal fue el estado de depresión según el Cuestionario de Salud del Paciente (PHQ). 

Al inicio del estudio, 47% eran casados, 21% vivían solos, el 36% recibía una pensión o beneficio, el 15% no estaban en condiciones de trabajo, el 23% informó riesgo a la bebida, 32% eran fumadores, 39% utilizaban antidepresivos y el 19% utilizaba sedantes. 27% satisfechos según los criterios actuales para el síndrome depresivo mayor (MDS) en el PHQ, mientras que en el 52% había síntomas persistentes de depresión, y en el 22% había síntomas transitorios depresivos, con una duración de un par de semanas, como máximo. De los que cumplían con los criterios para MDS, el 49% también fueron clasificados con síndrome de ansiedad, 40% reportó abuso sexual infantil, 57% reportó abuso físico infantil, el 42% había en algún momento miedo de su pareja, y el 72% informó de una condición física crónica; el 84% estaba recibiendo atención de salud mental (ya sea que estaba tomando antidepresivos o consultaba con un profesional de la salud específicamente para la atención de salud mental) en comparación con el 66% de aquellos con persistencia de síntomas depresivos y el 57% con síntomas transitorios de depresión.

Los investigadores concluyeron: "Este método de cribado de síntomas depresivos, en la práctica general, identifica a un grupo de pacientes con múltiples comorbilidades sustanciales - psiquiátricas, físicas y sociales que coexisten con los síntomas depresivos, lo que plantea desafíos para el manejo de la depresión en la práctica general. " 

Otro estudio que muestra que hay mucho más psicopatología entre los pacientes que a menudo no se conocen en la práctica general y que pueden ser detectados por medio del cribado. La presentación de informes de abusos es aterrador.

MJA Junio 16 2008; 188 (12 Suppl): S119-S125 © 2008 The Medical Journal of Australia

¿Qué se identifica cuando se lleva a cabo el cribado de la depresión en la práctica general? Línea de base de los resultados de diagnóstico, el manejo y el desenlace de la Depresión en Atención Primaria (Diamond) estudio longitudinal. Jane M Gunn, Gail P Gilchrist and Patty Chondros et al. Correspondencia a: Jane M Gunn: j.gunn@unimelb.edu.au 

Eficacia de los tratamientos farmacologicos del tabaquismo

Eisenberg MJ, Filion KB, Yavin D, Bélisle P, Mottillo S, Joseph L et al. Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ 2008; 179: 135-144. R TC PDF

Introducción

En estos momentos se dispone de diferentes abordajes farmacológicos para tratar el tabaquismo, entre los que se encuentran la nicotina en diferentes formas de administración, el bupropion y la vareniclina. En esta situación es importante comparar la eficacia de los diferentes tratamientos.

Objetivo

Revisar sistemáticamente los ensayos clínicos del tratamiento farmacológico del tabaquismo para resumir su eficacia, comparar directamente la eficacia de la vareniclina y el bupropion y comparar indirectamente la eficacia de los 7 tratamientos farmacológicos disponibles para el tabaquismo.

Perfil del estudio

Tipo de estudio: Metaanálisis

Área del estudio: Tratamiento

Ámbito del estudio: Comunitario

Métodos

Se llevó a cabo una busqueda en la US Centers for Disease Control and Prevention´s Tobacco Information and Prevention database, PubMed, EMBASE y la Cochrane Library para localizar los estudios publicados en inglés sobre la eficacia de 7 modalidades terapéuticas: vareniclina, bupropion y cinco presentaciones de la nicotina (chicle, inhalador, spray nasal, comprimidos y parche). Se incluyeron en el análisis los ensayos clínicos doble ciego controlados con placebo que proporcionaron medidas bioquímicas de abstinencia a los 6 y 12 meses. Se incluyeron los estudios en los que los participantes habían recibido tratamientos complementarios siempre que la intensidad fuese la misma en el grupo intervención y en el grupo placebo.

Se excluyeron los estudios abiertos y aquellos en los que el objetivo del tratamiento era reducir el consumo de cigarrillos o aumentar la tasa de abandonos espontáneos en personas que no querían dejar de fumar, así como los que se llevaron a cabo en personas con enfermedades crónicas. Se distinguió entre la abstinencia continua (la que se mantuvo desde el abandono hasta el último seguimiento) y la abstinencia puntual (en la semana anterior a la visita de seguimiento). Los resultados se valoraron según el principio de intención de tratar.

Resultados

Se incluyeron en el análisis 69 estudios, con cerca de 33.000 participantes (fig. 1). Los tratamientos estudiados fueron parches de nicotina (30 esturios), chicles de nicotina (22), bupropion (16), vareniclina (13), comprimidos de nicotina (6), spray nasal de nicotina (4) e inhalador de nicotina (4).

Figura 1. Proceso de selección de los estudios.

Las tasas de abandono globales fueron bajas (fig. 2), especialmente si sólo se tomaban en consideración las abstinencias mantenidas a los 12 meses.

Figura 2. Tasas de abandonos globales.

En el analisis principal todos los tratamientos fueron más eficaces que el placebo (fig. 3). En los estudios en los que se compararon directamente, la vareniclina fue superior al bupropion (odds ratio 2,18; IC95% 1,09 a 4,08).

Figura 3. Eficacia global de los diferentes tratamientos farmacológicos sobre la odds de abandono del tabaco.

Los datos relativos a la seguridad de los tratamientos fueron difíciles de analizar puesto que se recogieron de forma muy diferente en los distintos estudios, de forma que la tasa de eventos adversos en el grupo placebo oscilaba entre el 4 y el 85%. En cualquier caso, las reacciones graves registrados fueron raras.

Conclusiones

Los autores concluyen que todas las presentaciones de nicotina analizadas, la vareniclina y el bupropion son más eficaces que el placebo para promover la abstinencia de tabaco a los 6 y 12 meses y que la vaneclina parece más eficaz que el bupropion.

Conflictos de interés

Varios de los autores han recibido honorarios de diferentes laboratorios farmacéuticos. Financiado por los Canadian Institutes of Health Research.

Comentario

En estos momentos los clínicos disponen de un amplio arsenal para tratar la dependencia de la nicotina, por lo que en el momento de instaurar un tratamiento es importante conocer su eficacia relativa y su perfil de efectos adversos.

En este metaanálisis se han incluido sólo ensayos clínicos controlados en los que se confirmó la abstinencia mediante análisis, por lo que todos los estudios eran de elevada calidad. Los resultados de este estudio demuestran que todos los fármacos en el mercado son moderadamente eficaces, en lo que coinciden con otros metaanálisis previos, pero las poblaciones estudiadas estaban muy seleccionadas, por lo que es probable que su efectividad en condiciones reales sea menor.

Sin embargo, las dudas sobre la eficacia relativa de los tratamientos se mantiene, puesto que en muy pocos estudios han llevado a cabo comparaciones directas entre unos y otros fármacos y sacar conclusiones comparando los resultados de estudios llevados a cabo en diferentes poblaciones puede resultar arriesgado, dado que una parte de las diferencias observadas pueden deberse a las características de las poblaciones, de las medidas de abstinencia utilizadas y a los distintos periodos de seguimiento como lo demuestran las diferencias en los resultados de los grupos placebo.

Del perfil de seguridad relativo de los diferentes fármacos tampoco se pueden sacar grandes conclusiones. Aunque la tolerancia de todos ellos en los ensayos clínicos fue aceptable, se han descrito efectos adversos importantes postcomercialización en el caso de la vareniclina (trastornos neuropsiquiátricos) y del bupropion (trastornos neuropsiquiátricos y convulsiones). Por último, no hay que olvidar que la mayor parte de los fumadores abandonan el hábito sin necesidad de tratamientos farmacológicos, por lo que el tratamiento se debe basar en el consejo antitabaco.

Bibliografía

1. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al for the Varenicline Phase 3 Study Group. Varenicline, an {alpha}4beta2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation: A Randomized Controlled Trial. JAMA 2006; 296: 47-55. R TC PDF RC
2. Oncken C, Gonzales D, Nides M, Rennard S, Watsky E, Billing CB et al. Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation. Arch Intern Med 2006; 166: 1571-1577. R TC (s) PDF (s)
3. Andrew Molyneux. ABC of smoking cessation. Nicotine replacement therapy. BMJ 2004; 328: 454-456. TC PDF

Autor

Manuel Iglesias Rodal. Correo electrónico: mrodal@menta.net.