Denise Napoli

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, according to a study published in Annals of the Rheumatic Diseases.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, "the standard method for detection and quantification of joint destruction in RA," cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d’Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d’Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d’Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617–23).

Patients were randomized to one of two groups. The first received HRT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 13 women had ineligible DXR-BMD readings at baseline because of prostheses, osteosynthetic materials, the position of the hands or insufficient x-ray, wrote the authors. Another 25 patients did not complete the second DXR-BMD 2 years later.

That left a total of 50 women (23 HRT patients, 27 controls) to be included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm²; HRT patients had a standard deviation of 0.096, vs. 0.081 in the control group.

Two years later, HT patients’ mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients’ mean DXR-BMD was 0.44, with a standard deviation of 0.084.

The minute difference was insignificant for the HT group (–0.0015 ± 0.0078), but significant for controls, both in terms of change from baseline and difference from the HT group (–0.18 ± 0.038, P less than .05 for both comparisons).

Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

"DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage," concluded the authors. "So far, there is limited knowledge of DXR-BMD used as an outcome measure in randomized controlled trials in long-term RA."

Based on the current data, however, "we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA," they wrote.

"Further studies on disease-modifying drugs are needed to assess its usability."

Dr. Forsblad-d’Elia and Dr. Carlsten said that this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, according to a study published in Annals of the Rheumatic Diseases.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, "the standard method for detection and quantification of joint destruction in RA," cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d’Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d’Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d’Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617–23).

Patients were randomized to one of two groups. The first received HRT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 13 women had ineligible DXR-BMD readings at baseline because of prostheses, osteosynthetic materials, the position of the hands or insufficient x-ray, wrote the authors. Another 25 patients did not complete the second DXR-BMD 2 years later.

That left a total of 50 women (23 HRT patients, 27 controls) to be included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm²; HRT patients had a standard deviation of 0.096, vs. 0.081 in the control group.

Two years later, HT patients’ mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients’ mean DXR-BMD was 0.44, with a standard deviation of 0.084.

The minute difference was insignificant for the HT group (–0.0015 ± 0.0078), but significant for controls, both in terms of change from baseline and difference from the HT group (–0.18 ± 0.038, P less than .05 for both comparisons).

Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

"DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage," concluded the authors. "So far, there is limited knowledge of DXR-BMD used as an outcome measure in randomized controlled trials in long-term RA."

Based on the current data, however, "we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA," they wrote.

"Further studies on disease-modifying drugs are needed to assess its usability."

Dr. Forsblad-d’Elia and Dr. Carlsten said that this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, according to a study published in Annals of the Rheumatic Diseases.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, "the standard method for detection and quantification of joint destruction in RA," cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d’Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d’Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d’Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617–23).

Patients were randomized to one of two groups. The first received HRT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 13 women had ineligible DXR-BMD readings at baseline because of prostheses, osteosynthetic materials, the position of the hands or insufficient x-ray, wrote the authors. Another 25 patients did not complete the second DXR-BMD 2 years later.

That left a total of 50 women (23 HRT patients, 27 controls) to be included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm²; HRT patients had a standard deviation of 0.096, vs. 0.081 in the control group.

Two years later, HT patients’ mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients’ mean DXR-BMD was 0.44, with a standard deviation of 0.084.

The minute difference was insignificant for the HT group (–0.0015 ± 0.0078), but significant for controls, both in terms of change from baseline and difference from the HT group (–0.18 ± 0.038, P less than .05 for both comparisons).

Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

"DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage," concluded the authors. "So far, there is limited knowledge of DXR-BMD used as an outcome measure in randomized controlled trials in long-term RA."

Based on the current data, however, "we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA," they wrote.

"Further studies on disease-modifying drugs are needed to assess its usability."

Dr. Forsblad-d’Elia and Dr. Carlsten said that this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient websites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, 'Let’s get started.'?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, 'You’re doing something that puts your information at risk,'?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient websites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, 'Let’s get started.'?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, 'You’re doing something that puts your information at risk,'?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient websites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians' groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, 'Let’s get started.'?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

Now, many physicians and physician groups want to see the concept of downloadable personal health records extended to all of their patients.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, 'You’re doing something that puts your information at risk,'?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it's never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Since the launch of the new "blue button" on the Medicare and Veterans Affairs patient Web sites this summer, tens of thousands of patients have downloaded their personal health records to computers, flash drives, and disks – including claims data, test results, and more.

Now, physicians’ groups and patients are calling for this practice to be commonplace for all.

Photo ©crystal kirk/Fotolia.com.

"If the patient has access to his or her [personal health] information, they become part of the decision-making process, they are more engaged in their care, and they’re empowered to make better decisions," said Dr. Steven Waldren, director of the American Academy of Family Physicians’ Center for Health Information Technology. "The blue button initiative is saying, ‘Let’s get started.’?"

The blue button, developed jointly by Veterans Affairs, the Centers for Medicare and Medicaid Services, and the Defense Department, is a "a Web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust," according to Todd Park, chief technology officer at the Health and Human Services department, writing in a post on the White House Office of Science and Technology blog.

The blue button went live in August on www.mymedicare.gov and www.myhealth.va.gov. Since then, more than 60,000 vets and more than 5,000 Medicare beneficiaries have made use of the feature, according to Mr. Park.

"This new option will help veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy," Mr. Park wrote. "Having ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and partner more effectively with providers."

The American College of Physicians, however, is wary of the initiative. “There are a lot of great ideas out there. How do we know that this idea is better than the others? So far, attempts to link patients with [their health care records] have been less than stellar” because they have yet to merge data from multiple sources to provide a tool that’s clinically useful for patients and physicians. Blue button also faces this limitation, said Thomson Kuhn, who as senior systems architect at ACP, plays a role in the college’s health IT policy.

“We’re not saying ‘no’,” to blue button, “but it’s too early to mandate something that doesn’t have real-world implementation information,” he added. It’s been proposed that participation in blue button be included in the next set of meaningful use criteria issued for health providers’ use of EHR systems, according to Mr. Kuhn. But at this point, not enough is known about its benefits to justify the time and effort physicians would spend to participate, he said.

A policy paper on the topic, "The Download Capability," published by the nonprofit Markle Foundation aims to promote the use of the blue button by calling on "organizations that display personal health information electronically to individuals in Web browsers to include an option for individuals to download the information."

Additionally, the paper recommended making the download capability a "core procurement requirement for federal- and state-sponsored health [information technology] grants and projects" that come about as a result of the American Recovery and Reinvestment Act of 2009, which allocated billions of dollars for the development of health care technology.

Dr. Waldren was a member of the work group that reviewed the foundation’s paper; he and more than a dozen physicians and other stakeholders endorsed it, including Dr. Jack Lewin, CEO of the American College of Cardiology, Dr. Brian F. Keaton, past president of the American College of Emergency Physicians, and Dr. Allan Korn, chief medical officer for the Blue Cross and Blue Shield Association.

Patients, too, seem to embrace the concept of downloadable personal health records. In an online survey commissioned by Markle, 70% of almost 1,600 adult respondents agreed that they should be able to download and keep copies of their personal health information.

The real benefit, however, lies in the potential of Internet and mobile phone–based "apps," or applications, which can access the data and increase its usefulness for patients and physicians alike.

For example, said Dr. Waldren, imagine a tool that parses through all of a patient’s downloaded health data, highlighting all potential and actual medical problems, making lists of all prescribed medications and doses, assessing them for drug-drug interactions and communicating that information to the physician at every visit.

He went on to say that such a smart app also could scan resource Web sites to find new scientific data and government findings that affect patient care. "Those are the things that can start to happen," with blue button technology, Dr. Waldren said.

Despite the myriad possible benefits of downloadable records, however, privacy remains a concern, for patients and physicians alike.

According to the Markle Foundation paper, "Any online download capability for personal health information must be provided via secure access. That means the identity of each individual given credentials to access their own data must be proofed to an acceptable level of accuracy, and the individual must present those credentials or some acceptable token of those credentials upon login in order to get access to the data for download."

Dr. Waldren agreed. "There’s no question that privacy and security are real issues," he said. And that means not only keeping the site secure, but educating patients, too.

"Every time the patient clicks on that blue button, they need to be reminded, ‘You’re doing something that puts your information at risk,’?" he said.

But he added that privacy concerns should not be something that keeps technology like the blue button moving forward.

"I personally view privacy as a balance between benefit and risk. We could put your records in an encrypted format or in a safety deposit box that no one could get to. It would be highly secure and I would bet it would never be released inappropriately," Dr. Waldren said. "But it’s never available to actually help make sure you get good care. And missing data can cause a lot of morbidity and mortality."

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

Azathioprine was more effective than was mycophenolate mofetil for the prevention of relapse in antineutrophil cytoplasmic antibody–associated vasculitis.

"Although mycophenolate mofetil may be considered in refractory cases, it should not be considered the first-line remission maintenance therapy in AAV," wrote Dr. Thomas F. Hiemstra and colleagues in an article published online Nov. 8 in JAMA (doi:10.1001/jama.2010.1658).

Dr. Hiemstra of the University of Cambridge, England, looked at 156 patients in an open-label, multicenter, randomized controlled trial known as IMPROVE (International Mycophenolate Mofetil Protocol to Reduce Outbreaks of Vasculitides).

Patients were aged at least 18 years with a new diagnosis of either Wegener granulomatosis or microscopic polyangiitis, recruited between April, 2002 and January, 2009. All patients had a positive indirect immunofluorescence or enzyme-linked immunosorbent assay test result for antineutrophil cytoplasmic antibodies, or ANCAs.

Initially, all study participants received cyclophosphamide and glucocorticoids for induction of remission. Once remission was established, patients were divided into two groups, to receive either azathioprine or mycophenolate mofetil.

A total of 80 patients in the azathioprine group were given 2 mg/kg per day of azathioprine, up to 200 mg. The dose was titrated to 1.5 mg/kg per day after 12 months of treatment, down to 1 mg/kg per day after 18 months, and discontinued after 42 months.

The remaining 76 patients received mycophenolate mofetil at 2,000 mg/day. The dose was reduced to 1,500 mg/day after 12 months, to 1,000 mg/day after 18 months and withdrawn after 42 months.

The median follow-up for both groups was 39 months. All participants were counted in an intent-to-treat analysis.

Dr. Hiemstra recorded 42 relapses in the mycophenolate mofetil group, out of 76 patients (55%), compared with the azathioprine group, which had 30 relapses out of 80 patients (38%).

That amounted to an unadjusted hazard ratio for relapse of 1.69 among mycophenolate mofetil users (95% confidence interval, 1.06-2.70; P = .03).

"After adjustment for the prespecified factors of age, sex, diagnostic subtype, route of cyclophosphamide administration [during initial treatment], and baseline creatinine level, the HR for relapses associated with mycophenolate mofetil use was 1.80 (95% CI, 1.10-2.93; P = .02)," added the researchers.

There were no significant adverse event rate differences between the groups. According to Dr. Hiemstra, there were 22 severe adverse events in 13 patients in the azathioprine group, and 8 events in 8 patients in the mycophenolate mofetil group.

These included severe infection (8 in the azathioprine group and 3 in the mycophenolate mofetil group); leukopenia (11 episodes in the azathioprine group and 5 in the mycophenolate mofetil group); and malignancies (2 bladder cancers and 3 skin cancers in the azathioprine group, versus 1 skin malignancy among mycophenolate mofetil users).

Intolerance led to discontinuation of therapy among six azathioprine and two mycophenolate mofetil users.

"Although mycophenolate mofetil is frequently regarded as a potent alternative to azathioprine, we found no evidence to support its use as the initial remission maintenance therapy for patients with AAV," they investigators said.

Moreover, "we found no significant advantages to the use of mycophenolate mofetil in terms of safety or tolerability," they added.

Dr. Hiemstra reported receiving honoraria from Amgen, and several coinvestigators disclosed financial relationships with other drug makers. The study was partially funded by Hoffmann-La Roche Ltd., which markets mycophenolate mofetil as CellCept.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

The presence of large, serrated polyps was associated with a greater risk of colorectal cancer than any other factor, including age, sex, size of adenomas, and number of adenomas, reported Dr. Sakiko Hiraoka and colleagues in an article appearing in the November issue of Gastroenterology.

Moreover, the cancers in patients with large serrated polyps were more than twice as likely to be proximal as opposed to distal, the authors reported (Gastroenterology 2010 November [doi:10.1053/j.gastro.2010.07.011]).

Dr. Hiraoka of the department of gastroenterology and hepatology at Okayama University, Japan, and colleagues performed a database study including 10,199 patients who had their first colonoscopy at Dr. Hiraoka’s institution or at 1 of 14 affiliated hospitals between June 2005 and May 2008.

Patients had to have no prior history of resection, no prior diagnosis of inflammatory bowel disease, and no familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.

The mean age was 58.9 years, with 51.5% being male. Overall, 8.6% of the 10,199 patients were having a standard screening colonoscopy, while 41.5% underwent colonoscopy secondary to a positive fecal occult blood test. Another 20.6% had the colonoscopy because of abdominal symptoms, 13.2% due to rectal bleeding, and 2.4% because of anemia or another reason.

In the cohort, there were a total of 1,573 patients (15.4%) with advanced neoplasia, including 708 (6.9%) with colorectal cancer and 140 (1.4%) with large serrated polyps.

Dr. Hiraoka and colleagues found that out of several known risk factors for colorectal cancer, the presence of large serrated polyps carried the greatest risk, with an odds ratio of 3.34 (P less than .0001). The next-highest risk among the variables studied was age of 65 years or older (OR 2.63; P less than .0001).

Having four or more adenomas on colonoscopy carried an OR of 1.65 (P less than .01), and having an adenoma greater than 10 mm carried an OR of 1.56 (P less than .001).

Male gender did not carry any significant increased risk in this analysis.

The authors then looked at the predictors of advanced neoplasia and cancer according to location, "since clinical and biological differences have been shown recently to exist between colorectal neoplasia in the proximal and distal colon," they wrote.

Dr. Hiraoka and colleagues found that large serrated polyps were more than twice as likely to develop into proximal colon cancer than into distal colorectal cancer (OR for proximal cancer, 4.79; P less than .0001; OR for distal colorectal cancer, 2.23; P less than .01).

The correlation between serrated polyps and proximal cancer may be a manifestation of common molecular backgrounds between them, including BRAF mutation, according to the authors.

However, it does not follow that large serrated polyps necessarily progress into colorectal cancers themselves. "In fact, CRCs which develop in [hyperplastic polyposis syndrome] patients are largely microsatellite stable rather than [microsatellite instability-high] MSI-H, suggesting that serrated polyps do not always progress into MSI-H cancer," they commented.

The authors noted that one advantage of their study was the "relatively large" proportion of patients with colorectal neoplasia.

However, they noted that their study did not involve correlating neoplasia with the specific type of serrated polyp (including hyperplastic, sessile serrated adenoma, traditional serrated adenoma, and mixed serrated polyp), which was a limitation.

Dr. Hiraoka and colleagues disclosed no conflicts of interest related to this study.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.

Having cirrhosis, diabetes, or substance use disorder increased the odds of treatment discontinuation in type 1 hepatitis C virus infection, whereas use of growth factor drugs correlated with treatment persistence, reported Dr. Lauren A. Beste and colleagues in the November issue of Clinical Gastroenterology and Hepatology.

The investigators looked at 11,019 patients in the VA health care system with hepatitis C genotype 1 who received at least two prescriptions for pegylated interferon and ribavirin between Jan. 1, 2002 and Dec. 31, 2007.

Patients who completed at least 80% (38.4 weeks) of the standard 48-week treatment regimen were considered to have completed treatment; overall, 5,795 patients (52.6%) reached this goal (Clin. Gastroenterol. Hepatol. 2010 November [doi:10.1016/j.cgh.2010.07.012]).

Although "no indications currently exist for discontinuing treatment [before 12 weeks] due to lack of response," a total of 1,184 patients (roughly 10% of the total cohort) did just that, the authors said. Patients who stopped therapy before 12 weeks were significantly more likely to have cirrhosis, compared with patients who persisted with therapy (adjusted odds ratio [AOR] 1.42; P less than .01), and also were more likely to have diabetes (AOR, 1.25; P = .02) and pretreatment substance use disorder, or SUD (AOR, 1.24; P = .01).

They were also half as likely to use growth factor as were their counterparts who continued with therapy (AOR, 0.56; P less than .01). The growth factors included erythropoietin, darbepoetin, granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor.

The authors also assessed patients who discontinued treatment between 12 and 24 weeks of therapy (including 317 patients with known early virologic response who discontinued despite their response). These patients were more likely to have pretreatment depression (AOR, 1.59; P less than .01), were slightly less likely to have other mental illnesses (AOR, 0.65; P = .02), and – once again – were nearly half as likely to use growth factor as were patients who persisted with the therapy (AOR, 0.64; P less than .01).

Finally, the authors looked at patients who discontinued therapy before 38.4 weeks. "No variables significantly predicted discontinuation in this time period in bivariate or multivariate analyses," wrote Dr. Beste, of the VA Puget Sound Healthcare System in Seattle, and her coauthors.

Regarding SUD as a predictor of discontinuation, the authors wrote that "patients with history of substance abuse may benefit from early support and intervention during treatment in order to continue antiviral therapy."

Of the pretreatment depression that emerged as a predictor in the 12-24 week discontinuation group, they wrote: "Prior studies report that the depressive side effects of interferon peak by week 25, which may explain the observed association between depression and discontinuation midtreatment."

And regarding the links between cirrhosis and diabetes and discontinuation, they pointed to other studies showing that these patients "may be more susceptible to treatment side-effects." However, they also speculated that blood glucose derangements in diabetic patients receiving treatment may lead to discontinuation.

Finally, Dr. Beste and her colleagues commented on the use of growth factor, which correlated with reduced risk of discontinuation both before 12 weeks and from weeks 12 to 24. They speculated that growth factor use "leads to improvement in low blood counts, allowing providers to continue treatment when otherwise it would be stopped."

Therefore, "appropriate use of growth factors should be prospectively evaluated as a modifiable means to prevent treatment discontinuation," they recommended.

Dr. Beste and her colleagues had no relevant financial disclosures. The study was supported by the Department of Veterans Affairs and the Northwest Hepatitis C Resource Center.