Patient & Survivor Care

ORLANDO – Pediatricians need to be positioned to offer survivor care to the more than 80% of pediatric cancer patients who now survive their disease, according to Dr. Melissa Hudson.

"We have in excess of 479,000 individuals living in the United States diagnosed with cancer before the age of 21 ... and we know with those numbers increasing, you will be increasingly seeing them in your practices," Dr. Hudson, director of the cancer survivorship division, department of oncology at St. Jude Children’s Research Hospital, Memphis, Tenn., said at the annual meeting of the American Academy of Pediatrics.

Health-related issues that affect these cancer survivors include the risk for recurrence, potential late effects of treatment, and psychosocial effects related to the cancer experience, Importantly, health care needs in these patients change over time and across the spectrum of care. Ideally, pediatricians will provide these patients with risk-based survivor care that includes health education, anticipatory guidance based on cancer history and specific cancer-related health risks, and cancer and other health screening and surveillance as recommended based on the patient’s specific treatment exposures, she said.

In particular, patients need to be educated about the impact of their health behaviors on cancer-related health risk and about effective self-management of chronic health conditions.

The common chronic conditions that follow cancer often can impact growth and development – including linear growth, skeletal maturation, intellectual functioning, emotional and social maturation, and sexual development.

Recently published data from the St. Jude Lifetime Cohort Study showed that 95.5% of nearly 1,700 adult survivors of pediatric cancer had at least 1 chronic health condition by age 45 years, and nearly 81% had a serious disabling or life-threatening condition (J. Clin. Oncol. 2013;31:4242-51). Data from the retrospective Childhood Cancer Survivor Study similarly showed that, compared with population controls, survivors have a higher rate of premature mortality, largely from subsequent malignancies, which confer a 15-fold excess risk of death; cardiac conditions, which confer a sevenfold excess risk of death; and pulmonary conditions, which confer a nearly ninefold excess risk of death.

Survivor care also needs to consider that treatment-related issues, ongoing cancer risk, and the cancer experience in general can combine to have important psychosocial effects

Mental health factors can include body image issues, adverse effects of the cancer experience on educational and vocational goals, and late cognitive effects. Survivors also face insurance discrimination and access to care issues due to financial issues associated with medical bills and under- or unemployment.

Many survivors also struggle with ongoing symptoms such as fatigue, disrupted sleep, memory problems, concentration issues, and chronic pain; some have difficulty living independently because of the severity of these symptoms, and the effects can have a negative impact on social interactions with family and friends.

"We need to help them achieve access to resources to optimize their quality of life," Dr. Hudson said.

When cancer survivors return to primary care, they should present with a treatment summary. If they don’t, one should be requested from the cancer treatment center to help guide care, she said.

Become familiar with practice guidelines for caring for survivors of childhood cancers, and be prepared to work with either the oncology care center to help facilitate the transition to pediatric care, she said.

The Children’s Oncology Group (COG), a consortium of medical research institutions, provides numerous tools for care providers and patients. Dr. Hudson, who co-chaired the task force that established the care guidelines, said that they provide recommendations for screening and management of late effects that can arise in pediatric cancer survivors. These patient education handouts can be printed free of charge and many are available in Spanish and French as well as in English. An updated version (4.0) of the COG guidelines is pending release by early 2014, Dr. Hudson said.

Dr. Hudson reported having no disclosures.

ORLANDO – Pediatricians need to be positioned to offer survivor care to the more than 80% of pediatric cancer patients who now survive their disease, according to Dr. Melissa Hudson.

"We have in excess of 479,000 individuals living in the United States diagnosed with cancer before the age of 21 ... and we know with those numbers increasing, you will be increasingly seeing them in your practices," Dr. Hudson, director of the cancer survivorship division, department of oncology at St. Jude Children’s Research Hospital, Memphis, Tenn., said at the annual meeting of the American Academy of Pediatrics.

Health-related issues that affect these cancer survivors include the risk for recurrence, potential late effects of treatment, and psychosocial effects related to the cancer experience, Importantly, health care needs in these patients change over time and across the spectrum of care. Ideally, pediatricians will provide these patients with risk-based survivor care that includes health education, anticipatory guidance based on cancer history and specific cancer-related health risks, and cancer and other health screening and surveillance as recommended based on the patient’s specific treatment exposures, she said.

In particular, patients need to be educated about the impact of their health behaviors on cancer-related health risk and about effective self-management of chronic health conditions.

The common chronic conditions that follow cancer often can impact growth and development – including linear growth, skeletal maturation, intellectual functioning, emotional and social maturation, and sexual development.

Recently published data from the St. Jude Lifetime Cohort Study showed that 95.5% of nearly 1,700 adult survivors of pediatric cancer had at least 1 chronic health condition by age 45 years, and nearly 81% had a serious disabling or life-threatening condition (J. Clin. Oncol. 2013;31:4242-51). Data from the retrospective Childhood Cancer Survivor Study similarly showed that, compared with population controls, survivors have a higher rate of premature mortality, largely from subsequent malignancies, which confer a 15-fold excess risk of death; cardiac conditions, which confer a sevenfold excess risk of death; and pulmonary conditions, which confer a nearly ninefold excess risk of death.

Survivor care also needs to consider that treatment-related issues, ongoing cancer risk, and the cancer experience in general can combine to have important psychosocial effects

Mental health factors can include body image issues, adverse effects of the cancer experience on educational and vocational goals, and late cognitive effects. Survivors also face insurance discrimination and access to care issues due to financial issues associated with medical bills and under- or unemployment.

Many survivors also struggle with ongoing symptoms such as fatigue, disrupted sleep, memory problems, concentration issues, and chronic pain; some have difficulty living independently because of the severity of these symptoms, and the effects can have a negative impact on social interactions with family and friends.

"We need to help them achieve access to resources to optimize their quality of life," Dr. Hudson said.

When cancer survivors return to primary care, they should present with a treatment summary. If they don’t, one should be requested from the cancer treatment center to help guide care, she said.

Become familiar with practice guidelines for caring for survivors of childhood cancers, and be prepared to work with either the oncology care center to help facilitate the transition to pediatric care, she said.

The Children’s Oncology Group (COG), a consortium of medical research institutions, provides numerous tools for care providers and patients. Dr. Hudson, who co-chaired the task force that established the care guidelines, said that they provide recommendations for screening and management of late effects that can arise in pediatric cancer survivors. These patient education handouts can be printed free of charge and many are available in Spanish and French as well as in English. An updated version (4.0) of the COG guidelines is pending release by early 2014, Dr. Hudson said.

Dr. Hudson reported having no disclosures.

ORLANDO – Pediatricians need to be positioned to offer survivor care to the more than 80% of pediatric cancer patients who now survive their disease, according to Dr. Melissa Hudson.

"We have in excess of 479,000 individuals living in the United States diagnosed with cancer before the age of 21 ... and we know with those numbers increasing, you will be increasingly seeing them in your practices," Dr. Hudson, director of the cancer survivorship division, department of oncology at St. Jude Children’s Research Hospital, Memphis, Tenn., said at the annual meeting of the American Academy of Pediatrics.

Health-related issues that affect these cancer survivors include the risk for recurrence, potential late effects of treatment, and psychosocial effects related to the cancer experience, Importantly, health care needs in these patients change over time and across the spectrum of care. Ideally, pediatricians will provide these patients with risk-based survivor care that includes health education, anticipatory guidance based on cancer history and specific cancer-related health risks, and cancer and other health screening and surveillance as recommended based on the patient’s specific treatment exposures, she said.

In particular, patients need to be educated about the impact of their health behaviors on cancer-related health risk and about effective self-management of chronic health conditions.

The common chronic conditions that follow cancer often can impact growth and development – including linear growth, skeletal maturation, intellectual functioning, emotional and social maturation, and sexual development.

Recently published data from the St. Jude Lifetime Cohort Study showed that 95.5% of nearly 1,700 adult survivors of pediatric cancer had at least 1 chronic health condition by age 45 years, and nearly 81% had a serious disabling or life-threatening condition (J. Clin. Oncol. 2013;31:4242-51). Data from the retrospective Childhood Cancer Survivor Study similarly showed that, compared with population controls, survivors have a higher rate of premature mortality, largely from subsequent malignancies, which confer a 15-fold excess risk of death; cardiac conditions, which confer a sevenfold excess risk of death; and pulmonary conditions, which confer a nearly ninefold excess risk of death.

Survivor care also needs to consider that treatment-related issues, ongoing cancer risk, and the cancer experience in general can combine to have important psychosocial effects

Mental health factors can include body image issues, adverse effects of the cancer experience on educational and vocational goals, and late cognitive effects. Survivors also face insurance discrimination and access to care issues due to financial issues associated with medical bills and under- or unemployment.

Many survivors also struggle with ongoing symptoms such as fatigue, disrupted sleep, memory problems, concentration issues, and chronic pain; some have difficulty living independently because of the severity of these symptoms, and the effects can have a negative impact on social interactions with family and friends.

"We need to help them achieve access to resources to optimize their quality of life," Dr. Hudson said.

When cancer survivors return to primary care, they should present with a treatment summary. If they don’t, one should be requested from the cancer treatment center to help guide care, she said.

Become familiar with practice guidelines for caring for survivors of childhood cancers, and be prepared to work with either the oncology care center to help facilitate the transition to pediatric care, she said.

The Children’s Oncology Group (COG), a consortium of medical research institutions, provides numerous tools for care providers and patients. Dr. Hudson, who co-chaired the task force that established the care guidelines, said that they provide recommendations for screening and management of late effects that can arise in pediatric cancer survivors. These patient education handouts can be printed free of charge and many are available in Spanish and French as well as in English. An updated version (4.0) of the COG guidelines is pending release by early 2014, Dr. Hudson said.

Dr. Hudson reported having no disclosures.

SAN ANTONIO – Adopting a standard exercise program resulted in a clinically meaningful 30% reduction in aromatase inhibitor-associated joint pain in breast cancer patients who participated in a year-long randomized trial.

The exercise prescription utilized in the HOPE (Hormones and Physical Exercise) trial was what’s recommended in national guidelines both for cancer survivors and healthy adults: 150 minutes per week of at least moderate-intensity aerobic activity, such as brisk walking, along with two strength-training sessions per week, Melinda L. Irwin, Ph.D., explained at the San Antonio Breast Cancer Symposium.

The HOPE studies enrolled 121 postmenopausal women who had stage 1-3, hormone receptor–positive breast cancers and were physically inactive and overweight yet physically able to exercise. At enrollment, they were experiencing moderate aromatase inhibitor (AI)–associated joint pain, defined as a score of 5-7 on the 0-10 Brief Pain Inventory (BPI), after about 18 months on the medication. Roughly two-thirds of participants had no history of joint pain prior to starting AI therapy; the rest reported the AI exacerbated their preexisting joint pain. Subjects were randomized to the exercise program or to usual care, which included written information about the importance of exercise.

The primary study endpoint was the 12-month change in BPI worst pain score, which dropped by an average of 30% among the exercise group. This translated to an improvement in pain level from moderate at baseline to mild at follow-up. In addition, BPI scores rating pain severity and pain interference improved by about 20%. In contrast, patients in the usual care control group experienced a slight increase in BPI scores in all three domains over time, added Dr. Irwin, co-leader of the cancer prevention and control research program at Yale University Cancer Center, New Haven, Conn.

This degree of improvement in joint pain is greater than reported in studies of glucosamine, acupuncture, or vitamin D supplementation, she noted.

The improvement in pain scores in the exercise group was greater at 12 months than at 3 or 6, suggesting that a year-long exercise program is probably necessary to see sustained reduction in joint pain.

At 12 months of follow-up, women in the exercise group averaged 159 minutes of physical activity per week, 110 minutes more than controls. Compliance with the supervised exercise program was notably good, with women attending an average of 70% of the twice-weekly small-group strength-training sessions.

In addition to the improvement in AI-related arthralgias, the exercise group experienced ancillary benefits: a mean 6.5% improvement in peak oxygen consumption, or VO₂ max, compared with baseline, along with a 3% reduction in body weight.

HOPE was the first randomized trial to examine the effects of exercise on AI side effects in breast cancer patients. The impetus for the study was the recognition that arthralgias are the most common reason for poor adherence to and discontinuation of AI therapy. Up to 20% of breast cancer patients discontinue their AI within the first year. And both early discontinuation and poor adherence have been shown to be predictive of increased mortality risk.

The HOPE results received an enthusiastic audience reception. Physicians were particularly impressed with the 70% exercise adherence rate over the course of a year. They asked how they can keep their previously sedentary patients’ commitment to regular exercise from waning after an initial burst of enthusiasm, as so often happens.

Dr. Irwin replied that adherence to lifestyle change is always a challenge. Social support is quite helpful. The exercise group in HOPE received a paid gym membership and met in small groups with a personal trainer twice weekly.

"The women really bonded with each other. And there are now a growing number of free programs throughout the country, which give cancer survivors a start on an exercise program with a free gym membership for several months. For example, the Livestrong Foundation has partnered with the YMCA to offer free exercise programs for cancer survivors at local Ys," she said.

The HOPE trial was funded by the National Cancer Institute. Dr. Irwin reported having no financial conflicts of interest.

[email protected]

SAN ANTONIO – Adopting a standard exercise program resulted in a clinically meaningful 30% reduction in aromatase inhibitor-associated joint pain in breast cancer patients who participated in a year-long randomized trial.

The exercise prescription utilized in the HOPE (Hormones and Physical Exercise) trial was what’s recommended in national guidelines both for cancer survivors and healthy adults: 150 minutes per week of at least moderate-intensity aerobic activity, such as brisk walking, along with two strength-training sessions per week, Melinda L. Irwin, Ph.D., explained at the San Antonio Breast Cancer Symposium.

The HOPE studies enrolled 121 postmenopausal women who had stage 1-3, hormone receptor–positive breast cancers and were physically inactive and overweight yet physically able to exercise. At enrollment, they were experiencing moderate aromatase inhibitor (AI)–associated joint pain, defined as a score of 5-7 on the 0-10 Brief Pain Inventory (BPI), after about 18 months on the medication. Roughly two-thirds of participants had no history of joint pain prior to starting AI therapy; the rest reported the AI exacerbated their preexisting joint pain. Subjects were randomized to the exercise program or to usual care, which included written information about the importance of exercise.

The primary study endpoint was the 12-month change in BPI worst pain score, which dropped by an average of 30% among the exercise group. This translated to an improvement in pain level from moderate at baseline to mild at follow-up. In addition, BPI scores rating pain severity and pain interference improved by about 20%. In contrast, patients in the usual care control group experienced a slight increase in BPI scores in all three domains over time, added Dr. Irwin, co-leader of the cancer prevention and control research program at Yale University Cancer Center, New Haven, Conn.

This degree of improvement in joint pain is greater than reported in studies of glucosamine, acupuncture, or vitamin D supplementation, she noted.

The improvement in pain scores in the exercise group was greater at 12 months than at 3 or 6, suggesting that a year-long exercise program is probably necessary to see sustained reduction in joint pain.

At 12 months of follow-up, women in the exercise group averaged 159 minutes of physical activity per week, 110 minutes more than controls. Compliance with the supervised exercise program was notably good, with women attending an average of 70% of the twice-weekly small-group strength-training sessions.

In addition to the improvement in AI-related arthralgias, the exercise group experienced ancillary benefits: a mean 6.5% improvement in peak oxygen consumption, or VO₂ max, compared with baseline, along with a 3% reduction in body weight.

HOPE was the first randomized trial to examine the effects of exercise on AI side effects in breast cancer patients. The impetus for the study was the recognition that arthralgias are the most common reason for poor adherence to and discontinuation of AI therapy. Up to 20% of breast cancer patients discontinue their AI within the first year. And both early discontinuation and poor adherence have been shown to be predictive of increased mortality risk.

The HOPE results received an enthusiastic audience reception. Physicians were particularly impressed with the 70% exercise adherence rate over the course of a year. They asked how they can keep their previously sedentary patients’ commitment to regular exercise from waning after an initial burst of enthusiasm, as so often happens.

Dr. Irwin replied that adherence to lifestyle change is always a challenge. Social support is quite helpful. The exercise group in HOPE received a paid gym membership and met in small groups with a personal trainer twice weekly.

"The women really bonded with each other. And there are now a growing number of free programs throughout the country, which give cancer survivors a start on an exercise program with a free gym membership for several months. For example, the Livestrong Foundation has partnered with the YMCA to offer free exercise programs for cancer survivors at local Ys," she said.

The HOPE trial was funded by the National Cancer Institute. Dr. Irwin reported having no financial conflicts of interest.

[email protected]

SAN ANTONIO – Adopting a standard exercise program resulted in a clinically meaningful 30% reduction in aromatase inhibitor-associated joint pain in breast cancer patients who participated in a year-long randomized trial.

The exercise prescription utilized in the HOPE (Hormones and Physical Exercise) trial was what’s recommended in national guidelines both for cancer survivors and healthy adults: 150 minutes per week of at least moderate-intensity aerobic activity, such as brisk walking, along with two strength-training sessions per week, Melinda L. Irwin, Ph.D., explained at the San Antonio Breast Cancer Symposium.

The HOPE studies enrolled 121 postmenopausal women who had stage 1-3, hormone receptor–positive breast cancers and were physically inactive and overweight yet physically able to exercise. At enrollment, they were experiencing moderate aromatase inhibitor (AI)–associated joint pain, defined as a score of 5-7 on the 0-10 Brief Pain Inventory (BPI), after about 18 months on the medication. Roughly two-thirds of participants had no history of joint pain prior to starting AI therapy; the rest reported the AI exacerbated their preexisting joint pain. Subjects were randomized to the exercise program or to usual care, which included written information about the importance of exercise.

The primary study endpoint was the 12-month change in BPI worst pain score, which dropped by an average of 30% among the exercise group. This translated to an improvement in pain level from moderate at baseline to mild at follow-up. In addition, BPI scores rating pain severity and pain interference improved by about 20%. In contrast, patients in the usual care control group experienced a slight increase in BPI scores in all three domains over time, added Dr. Irwin, co-leader of the cancer prevention and control research program at Yale University Cancer Center, New Haven, Conn.

This degree of improvement in joint pain is greater than reported in studies of glucosamine, acupuncture, or vitamin D supplementation, she noted.

The improvement in pain scores in the exercise group was greater at 12 months than at 3 or 6, suggesting that a year-long exercise program is probably necessary to see sustained reduction in joint pain.

At 12 months of follow-up, women in the exercise group averaged 159 minutes of physical activity per week, 110 minutes more than controls. Compliance with the supervised exercise program was notably good, with women attending an average of 70% of the twice-weekly small-group strength-training sessions.

In addition to the improvement in AI-related arthralgias, the exercise group experienced ancillary benefits: a mean 6.5% improvement in peak oxygen consumption, or VO₂ max, compared with baseline, along with a 3% reduction in body weight.

HOPE was the first randomized trial to examine the effects of exercise on AI side effects in breast cancer patients. The impetus for the study was the recognition that arthralgias are the most common reason for poor adherence to and discontinuation of AI therapy. Up to 20% of breast cancer patients discontinue their AI within the first year. And both early discontinuation and poor adherence have been shown to be predictive of increased mortality risk.

The HOPE results received an enthusiastic audience reception. Physicians were particularly impressed with the 70% exercise adherence rate over the course of a year. They asked how they can keep their previously sedentary patients’ commitment to regular exercise from waning after an initial burst of enthusiasm, as so often happens.

Dr. Irwin replied that adherence to lifestyle change is always a challenge. Social support is quite helpful. The exercise group in HOPE received a paid gym membership and met in small groups with a personal trainer twice weekly.

"The women really bonded with each other. And there are now a growing number of free programs throughout the country, which give cancer survivors a start on an exercise program with a free gym membership for several months. For example, the Livestrong Foundation has partnered with the YMCA to offer free exercise programs for cancer survivors at local Ys," she said.

The HOPE trial was funded by the National Cancer Institute. Dr. Irwin reported having no financial conflicts of interest.

[email protected]

This report details the case of a 65-year-old man who was diagnosed with multiple myeloma in 2006 and since 2009, has attempted to control the progression of his disease with the most powerful available treatment regimens, including bortezomib-based regimens, for both induction and consolidation therapy followed by autologous stem-cell transplants. Subsequently, because the patient was deemed treatment refractory, treatment with the newly approved carfilzomib was initiated. Coincidentally, the patient developed acute kidney injury, evidenced by tenfold rise in his creatinine levels, 2 weeks after the initiation of carfilzomib.

Click on the PDF icon at the top of this introduction to read the full article.

This report details the case of a 65-year-old man who was diagnosed with multiple myeloma in 2006 and since 2009, has attempted to control the progression of his disease with the most powerful available treatment regimens, including bortezomib-based regimens, for both induction and consolidation therapy followed by autologous stem-cell transplants. Subsequently, because the patient was deemed treatment refractory, treatment with the newly approved carfilzomib was initiated. Coincidentally, the patient developed acute kidney injury, evidenced by tenfold rise in his creatinine levels, 2 weeks after the initiation of carfilzomib.

Click on the PDF icon at the top of this introduction to read the full article.

This report details the case of a 65-year-old man who was diagnosed with multiple myeloma in 2006 and since 2009, has attempted to control the progression of his disease with the most powerful available treatment regimens, including bortezomib-based regimens, for both induction and consolidation therapy followed by autologous stem-cell transplants. Subsequently, because the patient was deemed treatment refractory, treatment with the newly approved carfilzomib was initiated. Coincidentally, the patient developed acute kidney injury, evidenced by tenfold rise in his creatinine levels, 2 weeks after the initiation of carfilzomib.

Click on the PDF icon at the top of this introduction to read the full article.

Mindfulness can be described as an attentive awareness of the reality of things in the present moment that can impart power when coupled with a clear comprehension of what is taking place, or put another way, as a calm awareness of body, mind, and spirit supporting analysis that can lead to wisdom. Although many of us promote this practice to our patients to help them more fully live their days whether few or many, it is worth considering how this consciousness could help us, practicing oncologists, through the challenging changes we currently face in our clinical practices and to more fully participate in the transitions to high-quality cancer care, as was recently outlined in a report by the Institute of Medicine.¹

*Click on the link to the left for a PDF of the full article.   

Mindfulness can be described as an attentive awareness of the reality of things in the present moment that can impart power when coupled with a clear comprehension of what is taking place, or put another way, as a calm awareness of body, mind, and spirit supporting analysis that can lead to wisdom. Although many of us promote this practice to our patients to help them more fully live their days whether few or many, it is worth considering how this consciousness could help us, practicing oncologists, through the challenging changes we currently face in our clinical practices and to more fully participate in the transitions to high-quality cancer care, as was recently outlined in a report by the Institute of Medicine.¹

*Click on the link to the left for a PDF of the full article.   

Mindfulness can be described as an attentive awareness of the reality of things in the present moment that can impart power when coupled with a clear comprehension of what is taking place, or put another way, as a calm awareness of body, mind, and spirit supporting analysis that can lead to wisdom. Although many of us promote this practice to our patients to help them more fully live their days whether few or many, it is worth considering how this consciousness could help us, practicing oncologists, through the challenging changes we currently face in our clinical practices and to more fully participate in the transitions to high-quality cancer care, as was recently outlined in a report by the Institute of Medicine.¹

*Click on the link to the left for a PDF of the full article.   

As I write this editorial, we who practice medicine face many challenges. Our internal and external environments are changing, and we are asked to do more with less, but we have better tools to perform that work. We have health care reform, which has been met with such opposition that our government temporarily shutdown in October and faced potential default on the national debt. Although it is uncertain to what degree health care reform will succeed at its primary objectives – the provision of services to the underserved and cost control – it is clear that there are changes ahead that will have an impact on our care delivery. Because many states did not embrace Medicaid, it remains unclear how meaningful care will be provided. The technical challenges in registering for the health care exchanges partnered with the very small penalty for not enrolling are likely to precipitate lower-than-anticipated use of the exchanges, which could result in adverse selection of a sicker patient population, and increase proportional costs for patients enrolled in the health care exchanges. How will we manage this change better?

*Click on the link to the left for a PDF of the full article.  

As I write this editorial, we who practice medicine face many challenges. Our internal and external environments are changing, and we are asked to do more with less, but we have better tools to perform that work. We have health care reform, which has been met with such opposition that our government temporarily shutdown in October and faced potential default on the national debt. Although it is uncertain to what degree health care reform will succeed at its primary objectives – the provision of services to the underserved and cost control – it is clear that there are changes ahead that will have an impact on our care delivery. Because many states did not embrace Medicaid, it remains unclear how meaningful care will be provided. The technical challenges in registering for the health care exchanges partnered with the very small penalty for not enrolling are likely to precipitate lower-than-anticipated use of the exchanges, which could result in adverse selection of a sicker patient population, and increase proportional costs for patients enrolled in the health care exchanges. How will we manage this change better?

*Click on the link to the left for a PDF of the full article.  

As I write this editorial, we who practice medicine face many challenges. Our internal and external environments are changing, and we are asked to do more with less, but we have better tools to perform that work. We have health care reform, which has been met with such opposition that our government temporarily shutdown in October and faced potential default on the national debt. Although it is uncertain to what degree health care reform will succeed at its primary objectives – the provision of services to the underserved and cost control – it is clear that there are changes ahead that will have an impact on our care delivery. Because many states did not embrace Medicaid, it remains unclear how meaningful care will be provided. The technical challenges in registering for the health care exchanges partnered with the very small penalty for not enrolling are likely to precipitate lower-than-anticipated use of the exchanges, which could result in adverse selection of a sicker patient population, and increase proportional costs for patients enrolled in the health care exchanges. How will we manage this change better?

*Click on the link to the left for a PDF of the full article.  

The three smoking cessation agents bupropion, varenicline, and nicotine replacement therapy did not raise the risk of serious adverse cardiovascular events in a network meta-analysis of 63 randomized clinical trials reported online Dec. 9 in Circulation.

This finding held true in the main analysis that included 30,508 patients attempting to quit smoking, in a subgroup analysis of the highest-risk patients who had a history of conditions predisposing them to cardiovascular events, and in a sensitivity analysis that broke down cardiovascular events by type and seriousness.

©thinkstockphotos.com

"Given the current findings of low risk of serious CVD events attributed to smoking cessation pharmacotherapies, combined with the well-established CVD and mortality risks of continued smoking, the benefits of use would seem to outweigh the risks," said Edward J. Mills, Ph.D., of the Stanford (Calif.) Prevention Research Center, and his associates.

The investigators performed the meta-analysis because recent reports have raised concerns that these agents may raise cardiovascular risks. They used a statistical technique known as network meta-analysis to examine both direct, head-to-head comparison studies and indirect evidence, "thus increasing the power and interpretability of a comparative analysis."

They included any randomized clinical trial of any of the three pharmacotherapies that were of any duration and that reported on any cardiovascular events. Dr. Mills and his colleagues then considered two separate definitions of cardiovascular events: the first was any such event, including minor occurrences such as palpitations, and the second was only major adverse cardiovascular events as defined by the Food and Drug Administration, which is "considered to be a more stringent definition of important patient outcomes."

A total of 19 of the randomized clinical trials assessed nicotine replacement therapy against placebo, 27 assessed bupropion against placebo, 18 assessed varenicline against placebo, 1 assessed high-dose nicotine replacement therapy against placebo, 1 assessed combination nicotine replacement therapy against a control condition, 2 assessed bupropion against varenicline, 3 assessed bupropion against nicotine replacement therapy, and 1 assessed varenicline against nicotine replacement therapy.

Both a pairwise meta-analysis and the network meta-analysis demonstrated that none of the three pharmacotherapies raised the risk of major adverse cardiovascular events. Bupropion appeared to exert a protective effect against both minor and major events, while varenicline showed no harmful or beneficial effect at all concerning minor or major cardiovascular events.

"Nicotine replacement therapy, the most widely used pharmacotherapy for smoking cessation, was associated with an increase in cardiovascular events that was driven by lower-risk events" such as palpitations and tachycardia, which are "well known and largely benign" effects of nicotine replacement, Dr. Mills and his associates said (Circulation 2013 Dec. 9 [doi:10.1161/circulationaha.113.003961]).

"Concerns about adverse cardiovascular events need to be balanced with the consistent evidence for the benefit of smoking cessation, and patients should be counseled about what adverse events may be associated with smoking cessation therapies, the symptoms associated with the withdrawal period from cigarettes, and symptoms that may be due to existing cardiovascular diseases," the investigators added.

This study was supported by the Canadian Institutes of Health Research, the U.S. National Institutes of Health, and the California Tobacco-Related Disease Research Program. Dr. Mills reported ties to Merck; Pfizer, maker of Chantix (varenicline); Novartis; Takeda; and GlaxoSmithKline, maker of Zyban (bupropion); and his associates reported ties to Pfizer.

The three smoking cessation agents bupropion, varenicline, and nicotine replacement therapy did not raise the risk of serious adverse cardiovascular events in a network meta-analysis of 63 randomized clinical trials reported online Dec. 9 in Circulation.

This finding held true in the main analysis that included 30,508 patients attempting to quit smoking, in a subgroup analysis of the highest-risk patients who had a history of conditions predisposing them to cardiovascular events, and in a sensitivity analysis that broke down cardiovascular events by type and seriousness.

©thinkstockphotos.com

"Given the current findings of low risk of serious CVD events attributed to smoking cessation pharmacotherapies, combined with the well-established CVD and mortality risks of continued smoking, the benefits of use would seem to outweigh the risks," said Edward J. Mills, Ph.D., of the Stanford (Calif.) Prevention Research Center, and his associates.

The investigators performed the meta-analysis because recent reports have raised concerns that these agents may raise cardiovascular risks. They used a statistical technique known as network meta-analysis to examine both direct, head-to-head comparison studies and indirect evidence, "thus increasing the power and interpretability of a comparative analysis."

They included any randomized clinical trial of any of the three pharmacotherapies that were of any duration and that reported on any cardiovascular events. Dr. Mills and his colleagues then considered two separate definitions of cardiovascular events: the first was any such event, including minor occurrences such as palpitations, and the second was only major adverse cardiovascular events as defined by the Food and Drug Administration, which is "considered to be a more stringent definition of important patient outcomes."

A total of 19 of the randomized clinical trials assessed nicotine replacement therapy against placebo, 27 assessed bupropion against placebo, 18 assessed varenicline against placebo, 1 assessed high-dose nicotine replacement therapy against placebo, 1 assessed combination nicotine replacement therapy against a control condition, 2 assessed bupropion against varenicline, 3 assessed bupropion against nicotine replacement therapy, and 1 assessed varenicline against nicotine replacement therapy.

Both a pairwise meta-analysis and the network meta-analysis demonstrated that none of the three pharmacotherapies raised the risk of major adverse cardiovascular events. Bupropion appeared to exert a protective effect against both minor and major events, while varenicline showed no harmful or beneficial effect at all concerning minor or major cardiovascular events.

"Nicotine replacement therapy, the most widely used pharmacotherapy for smoking cessation, was associated with an increase in cardiovascular events that was driven by lower-risk events" such as palpitations and tachycardia, which are "well known and largely benign" effects of nicotine replacement, Dr. Mills and his associates said (Circulation 2013 Dec. 9 [doi:10.1161/circulationaha.113.003961]).

"Concerns about adverse cardiovascular events need to be balanced with the consistent evidence for the benefit of smoking cessation, and patients should be counseled about what adverse events may be associated with smoking cessation therapies, the symptoms associated with the withdrawal period from cigarettes, and symptoms that may be due to existing cardiovascular diseases," the investigators added.

This study was supported by the Canadian Institutes of Health Research, the U.S. National Institutes of Health, and the California Tobacco-Related Disease Research Program. Dr. Mills reported ties to Merck; Pfizer, maker of Chantix (varenicline); Novartis; Takeda; and GlaxoSmithKline, maker of Zyban (bupropion); and his associates reported ties to Pfizer.

The three smoking cessation agents bupropion, varenicline, and nicotine replacement therapy did not raise the risk of serious adverse cardiovascular events in a network meta-analysis of 63 randomized clinical trials reported online Dec. 9 in Circulation.

This finding held true in the main analysis that included 30,508 patients attempting to quit smoking, in a subgroup analysis of the highest-risk patients who had a history of conditions predisposing them to cardiovascular events, and in a sensitivity analysis that broke down cardiovascular events by type and seriousness.

©thinkstockphotos.com

"Given the current findings of low risk of serious CVD events attributed to smoking cessation pharmacotherapies, combined with the well-established CVD and mortality risks of continued smoking, the benefits of use would seem to outweigh the risks," said Edward J. Mills, Ph.D., of the Stanford (Calif.) Prevention Research Center, and his associates.

The investigators performed the meta-analysis because recent reports have raised concerns that these agents may raise cardiovascular risks. They used a statistical technique known as network meta-analysis to examine both direct, head-to-head comparison studies and indirect evidence, "thus increasing the power and interpretability of a comparative analysis."

They included any randomized clinical trial of any of the three pharmacotherapies that were of any duration and that reported on any cardiovascular events. Dr. Mills and his colleagues then considered two separate definitions of cardiovascular events: the first was any such event, including minor occurrences such as palpitations, and the second was only major adverse cardiovascular events as defined by the Food and Drug Administration, which is "considered to be a more stringent definition of important patient outcomes."

A total of 19 of the randomized clinical trials assessed nicotine replacement therapy against placebo, 27 assessed bupropion against placebo, 18 assessed varenicline against placebo, 1 assessed high-dose nicotine replacement therapy against placebo, 1 assessed combination nicotine replacement therapy against a control condition, 2 assessed bupropion against varenicline, 3 assessed bupropion against nicotine replacement therapy, and 1 assessed varenicline against nicotine replacement therapy.

Both a pairwise meta-analysis and the network meta-analysis demonstrated that none of the three pharmacotherapies raised the risk of major adverse cardiovascular events. Bupropion appeared to exert a protective effect against both minor and major events, while varenicline showed no harmful or beneficial effect at all concerning minor or major cardiovascular events.

"Nicotine replacement therapy, the most widely used pharmacotherapy for smoking cessation, was associated with an increase in cardiovascular events that was driven by lower-risk events" such as palpitations and tachycardia, which are "well known and largely benign" effects of nicotine replacement, Dr. Mills and his associates said (Circulation 2013 Dec. 9 [doi:10.1161/circulationaha.113.003961]).

"Concerns about adverse cardiovascular events need to be balanced with the consistent evidence for the benefit of smoking cessation, and patients should be counseled about what adverse events may be associated with smoking cessation therapies, the symptoms associated with the withdrawal period from cigarettes, and symptoms that may be due to existing cardiovascular diseases," the investigators added.

This study was supported by the Canadian Institutes of Health Research, the U.S. National Institutes of Health, and the California Tobacco-Related Disease Research Program. Dr. Mills reported ties to Merck; Pfizer, maker of Chantix (varenicline); Novartis; Takeda; and GlaxoSmithKline, maker of Zyban (bupropion); and his associates reported ties to Pfizer.