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FDA Committee Considers Gardasil for Anal Cancer Prevention
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
FROM A MEETING OF THE FOOD AND DRUG ADMINISTRATION’S VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
FDA Committee Considers Gardasil for Anal Cancer Prevention
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
SILVER SPRING, Md. – The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
FROM A MEETING OF THE FOOD AND DRUG ADMINISTRATION’S VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
FDA Committee Considers Gardasil for Anal Cancer Prevention
SILVER SPRING, Md. - The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
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SILVER SPRING, Md. - The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
SILVER SPRING, Md. - The human papillomavirus vaccine Gardasil moved closer to an indication for anal cancer prevention after a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Nov. 17.
The vaccine, manufactured by Merck & Co. Inc., is approved for the prevention of cervical, vulvar, and vaginal cancers and precancerous lesions in females aged 9-26 years, and for the prevention of genital warts in males and females aged 9-26 years. The company is seeking an indication for the prevention of anal cancer in males and females aged 9-26 years.
Previous studies have shown that anal cancer and cervical cancer are biologically similar, and both are associated with HPV infections, Dr. Joel Palefsky, professor of medicine at the University of California, San Francisco, said at the meeting.
The primary data supporting an anal cancer indication for Gardasil came from a randomized, controlled trial of 602 men who have sex with men (MSM), who were part of the larger study that led to the indication for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo.
The vaccine showed 78% effectiveness, compared with placebo in preventing anal intraepithelial neoplasms related to human papillomavirus types 6, 11, 16, and 18. These lesions are considered precursors to anal cancer, Dr. Palefsky said.
Although MSM are at increased risk for HPV-associated anal cancer, they are not the only population at risk. Data from the National Cancer Institute presented at the meeting showed that anal cancer incidence in the United States is increasing by a rate of approximately 2% per year, and that approximately 60% of cases and deaths occur in women.
A majority of the committee members expressed opinions in favor of the indication, but no formal vote was taken. The FDA will consider the committee’s recommendations. If the indication is approved before the February 2011 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, the ACIP might revisit its previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. ACIP has given a permissive recommendation for HPV vaccination for boys and men aged 9-26 years at the discretion of the physician.
Dr. Palefsky has served as a consultant and clinical investigator for Merck & Co. Inc.
FROM A MEETING OF THE FOOD AND DRUG ADMINISTRATION’S VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
One-Third of Medicare Patients With Cancer Die in Hospitals
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
One-Third of Medicare Patients With Cancer Die in Hospitals
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
Approximately 29% of Medicare patients with cancer died in a hospital, and hospice care was inconsistent among medical centers in the United States, according to a report published Nov. 16 by the Dartmouth Institute for Health Policy & Clinical Practice.
The rate of hospital deaths varied widely by region, ranging from 47% in Manhattan (New York City) to 7% in Mason City, Iowa.
"The bottom line is that the care patients receive has less to do with what they want and more to do with the hospital they seek care from," Dr. David Goodman of Dartmouth University, Hanover, N.H., said in a press briefing. "We as physicians often make assumptions about what patients and families want for their lives. What patients really want is for a physician to be honest with them and to share the full range of options with them."
The report, "Quality of End-of-Life Cancer Care for Medicare Beneficiaries: Regional and Hospital-Specific Analyses," is the first to focus on cancer care at the end of life for the Medicare population in particular. The report was produced by the Dartmouth Atlas Project, which has been documenting the use of medical resources in the United States for more than 2 decades.
Researchers reviewed data from 235,821 Medicare patients (aged 65 years and older) with metastatic or aggressive cancer who died in 2003-2007. They identified regional trends as well as information about specific academic medical centers.
Nationwide, approximately 61% of cancer patients were hospitalized at least once during their last month of life. Hospital admissions varied from approximately 70% of cancer patients in Detroit to 46% of cancer patients in San Angelo, Tex.
The researchers identified the highest rates of hospitalization during the last month of life (more than 75%) among cancer patients at two hospitals in Detroit: St. John Hospital and Medical Center and Sinai-Grace Hospital. The lowest rate of hospitalization during the last month of life was 45% of cancer patients at the University of Washington Medical Center in Seattle.
Chemotherapy was part of care during the last 2 weeks of life in approximately 6% of patients nationwide, but the rate exceeded 10% in eight areas, including Olympia, Wash. (12%), and San Antonio (11%).
The researchers also found that fewer than 50% of cancer patients with a poor prognosis received hospice care, and some centers provided hospice care only in the last few days of life.
The degree of variation in the findings is too great to be explained by racial or ethnic preferences for aggressive end-of-life care, and adjustment for socioeconomic status does not change the results, said Dr. Goodman said.
But the data show that investment in beds, ICU facilities, and palliative care services is quite different from one health care system to another, he said.
The report highlights the need for doctors and health systems "to take a look at themselves and examine where they need to make their investments," said Dr. Goodman, who added that clinicians "need to look at ourselves in terms of how we communicate with patients" about cancer care options.
In a commentary accompanying the report, Dr. Joan Teno of Brown University in Providence, R.I., emphasized the need for health care providers to educate patients about their prognoses and to provide hospice options.
"If opportunities to improve are identified, hospitals should work with the local hospice or existing palliative care consult service, and/or start a palliative care consult service," to ensure that the institution is delivering high-quality care, Dr. Teno wrote.
Conversations about end-of-life care need to be started early in the course of treatment, Dr. Goodman said. "Our preferences can certainly change, but opening up the conversation early allows the conversation to evolve over time. The tragedy is when those conversations start near the end."
In a statement, Dr. George W. Sledge Jr., president of the American Society of Clinical Oncology said, "While saving lives is the oncologist’s goal, helping individuals live their final days in comfort and dignity is one of the most valuable and important responsibilities of our profession.
"Options to enhance a patient’s quality of life should be discussed throughout the course of their treatment. It is critical that we increase medical training in end-of-life patient communication and planning, and that Medicare and other insurers cover the costs of these essential conversations," Dr. Sledge noted.
The study was supported in part by the Robert Wood Johnson Foundation.
Major Finding: For patients with aggressive or metastatic cancer, hospital admission in the last month varied from about 70% of those in the Detroit area to 46% of those in San Angelo, Tex.
Data Source: Medicare data sets including the Medicare Denominator file, the 20% Carrier file, the MedPAR file, the Outpatient file, and the Hospital file.
Disclosures: Supported in part by the Robert Wood Johnson Foundation.
Program Improves Medical Training in Uganda
After receiving medical training at the University of Wisconsin, Madison, and the University of Pennsylvania, Philadelphia, Dr. Asghar Rastegar returned to his native Iran, taught medical school, and collaborated with several American institutions, including Yale University in New Haven, Conn. During that time, he says that he developed a sense of what strategies are the most effective at improving physician training.
Since his return to the United States 25 years ago, Dr. Rastegar, who is currently professor of medicine in nephrology and director of global health in the department of medicine at Yale, has devoted himself to improving medical training globally.
In 1995, he and his colleagues developed a collaborative program with Kazan (Russian Federation) State Medical University, aimed at boosting that institution's capacity to train their own physicians. Fifteen years later, Dr. Rastegar and his colleagues are still working with the Russian medical school to help them define their needs and improve medical training.
In an interview, Dr. Rastegar discussed a similar program in Uganda.
How did you get started with the physician-training program in Uganda?
After the success of the collaborative model in Russia, Dr. Majid Sadigh, also of the department of medicine at Yale and a close colleague who had worked extensively on this model, became interested in creating a similar program in Africa.
For decades, Yale's department of internal medicine has sent residents to work overseas for 4- to 6-week periods at as many as 16 different sites.
Four years ago, the International Health Program in the department of medicine, which has been funded by Johnson & Johnson as well as our own institution, decided to develop more in-depth collaborative programs with five sites. We applied the Russian model to Makerere University in Kampala, Uganda, with a capacity-building focus. As in Russia, the plan was to help enhance physician training with the goal of improving patient care. Makerere is one of the oldest medical schools in Africa, and probably the best known medical school outside of South Africa.
Mulago Hospital, which is affiliated with Makerere, is the main referral hospital for patients from all parts of Uganda. It has about 2,000 beds, and it handles up to 5,000 patients. It is a very underresourced hospital, and unfortunately about half the patients have HIV disease. Our goal has been to train their physicians so they can train their own specialists and subspecialists within 10 years.
What are the main elements of the physician-training program at Makerere?
Under Dr. Sadigh's leadership, we have an exchange program with Makerere that involves students and faculty. At any one time, we have two to four faculty members from Makerere who spend anywhere from 4 to 12 months at Yale. These faculty members come to receive specialized training in areas such as cardiology, kidney disease, and emergency medicine.
In addition, faculty from Yale and from other medical schools go to Makerere; we have medical residents there at all times, funded through the Yale/Stanford Johnson & Johnson Global Health Scholars Program. The idea is to help the Makerere faculty define what they need, and then find the resources to respond to that need.
What are the challenges of developing a training program in another country?
The key is to find the right partner and develop a relationship based on mutual respect. We didn't go to Mulago to do research; we went to improve patient care through education. There are other medical schools from the United States and Europe doing work with Makerere, but we were surprised that very few had become directly involved in providing the hands-on training to improve patient care. Research is critical to improving patient care, but often the fruit of such discoveries is not translated to improvement in patient care locally.
The people we have worked with at Makerere are as committed and intelligent as anyone I have worked with anywhere in the world. They know what to do to improve care, but they don't have the capacity to train specialists, so they are missing individuals with badly needed knowledge and skills in specific areas. That's the part we are playing.
How can other physicians in the United States get involved to volunteer on a short-term basis?
They can get involved through the Yale/Stanford Johnson & Johnson Global Health Scholars Program, which we at Yale codirect with Dr. Michele Barry, professor and senior associate dean for Global Health at Stanford (Calif.) University. The program is funded by Johnson & Johnson, and it selects residents and career physicians through a competitive application process. The funded scholars receive a travel award on completion of their 6-week assignments. More information is available on our Web site (http://medicine.yale.edu/intmed/globalhealthscholars
Ugandan students and faculty visit Yale University as part of the exchange program.
Source Courtesy Dr. Asghar Rastegar
After receiving medical training at the University of Wisconsin, Madison, and the University of Pennsylvania, Philadelphia, Dr. Asghar Rastegar returned to his native Iran, taught medical school, and collaborated with several American institutions, including Yale University in New Haven, Conn. During that time, he says that he developed a sense of what strategies are the most effective at improving physician training.
Since his return to the United States 25 years ago, Dr. Rastegar, who is currently professor of medicine in nephrology and director of global health in the department of medicine at Yale, has devoted himself to improving medical training globally.
In 1995, he and his colleagues developed a collaborative program with Kazan (Russian Federation) State Medical University, aimed at boosting that institution's capacity to train their own physicians. Fifteen years later, Dr. Rastegar and his colleagues are still working with the Russian medical school to help them define their needs and improve medical training.
In an interview, Dr. Rastegar discussed a similar program in Uganda.
How did you get started with the physician-training program in Uganda?
After the success of the collaborative model in Russia, Dr. Majid Sadigh, also of the department of medicine at Yale and a close colleague who had worked extensively on this model, became interested in creating a similar program in Africa.
For decades, Yale's department of internal medicine has sent residents to work overseas for 4- to 6-week periods at as many as 16 different sites.
Four years ago, the International Health Program in the department of medicine, which has been funded by Johnson & Johnson as well as our own institution, decided to develop more in-depth collaborative programs with five sites. We applied the Russian model to Makerere University in Kampala, Uganda, with a capacity-building focus. As in Russia, the plan was to help enhance physician training with the goal of improving patient care. Makerere is one of the oldest medical schools in Africa, and probably the best known medical school outside of South Africa.
Mulago Hospital, which is affiliated with Makerere, is the main referral hospital for patients from all parts of Uganda. It has about 2,000 beds, and it handles up to 5,000 patients. It is a very underresourced hospital, and unfortunately about half the patients have HIV disease. Our goal has been to train their physicians so they can train their own specialists and subspecialists within 10 years.
What are the main elements of the physician-training program at Makerere?
Under Dr. Sadigh's leadership, we have an exchange program with Makerere that involves students and faculty. At any one time, we have two to four faculty members from Makerere who spend anywhere from 4 to 12 months at Yale. These faculty members come to receive specialized training in areas such as cardiology, kidney disease, and emergency medicine.
In addition, faculty from Yale and from other medical schools go to Makerere; we have medical residents there at all times, funded through the Yale/Stanford Johnson & Johnson Global Health Scholars Program. The idea is to help the Makerere faculty define what they need, and then find the resources to respond to that need.
What are the challenges of developing a training program in another country?
The key is to find the right partner and develop a relationship based on mutual respect. We didn't go to Mulago to do research; we went to improve patient care through education. There are other medical schools from the United States and Europe doing work with Makerere, but we were surprised that very few had become directly involved in providing the hands-on training to improve patient care. Research is critical to improving patient care, but often the fruit of such discoveries is not translated to improvement in patient care locally.
The people we have worked with at Makerere are as committed and intelligent as anyone I have worked with anywhere in the world. They know what to do to improve care, but they don't have the capacity to train specialists, so they are missing individuals with badly needed knowledge and skills in specific areas. That's the part we are playing.
How can other physicians in the United States get involved to volunteer on a short-term basis?
They can get involved through the Yale/Stanford Johnson & Johnson Global Health Scholars Program, which we at Yale codirect with Dr. Michele Barry, professor and senior associate dean for Global Health at Stanford (Calif.) University. The program is funded by Johnson & Johnson, and it selects residents and career physicians through a competitive application process. The funded scholars receive a travel award on completion of their 6-week assignments. More information is available on our Web site (http://medicine.yale.edu/intmed/globalhealthscholars
Ugandan students and faculty visit Yale University as part of the exchange program.
Source Courtesy Dr. Asghar Rastegar
After receiving medical training at the University of Wisconsin, Madison, and the University of Pennsylvania, Philadelphia, Dr. Asghar Rastegar returned to his native Iran, taught medical school, and collaborated with several American institutions, including Yale University in New Haven, Conn. During that time, he says that he developed a sense of what strategies are the most effective at improving physician training.
Since his return to the United States 25 years ago, Dr. Rastegar, who is currently professor of medicine in nephrology and director of global health in the department of medicine at Yale, has devoted himself to improving medical training globally.
In 1995, he and his colleagues developed a collaborative program with Kazan (Russian Federation) State Medical University, aimed at boosting that institution's capacity to train their own physicians. Fifteen years later, Dr. Rastegar and his colleagues are still working with the Russian medical school to help them define their needs and improve medical training.
In an interview, Dr. Rastegar discussed a similar program in Uganda.
How did you get started with the physician-training program in Uganda?
After the success of the collaborative model in Russia, Dr. Majid Sadigh, also of the department of medicine at Yale and a close colleague who had worked extensively on this model, became interested in creating a similar program in Africa.
For decades, Yale's department of internal medicine has sent residents to work overseas for 4- to 6-week periods at as many as 16 different sites.
Four years ago, the International Health Program in the department of medicine, which has been funded by Johnson & Johnson as well as our own institution, decided to develop more in-depth collaborative programs with five sites. We applied the Russian model to Makerere University in Kampala, Uganda, with a capacity-building focus. As in Russia, the plan was to help enhance physician training with the goal of improving patient care. Makerere is one of the oldest medical schools in Africa, and probably the best known medical school outside of South Africa.
Mulago Hospital, which is affiliated with Makerere, is the main referral hospital for patients from all parts of Uganda. It has about 2,000 beds, and it handles up to 5,000 patients. It is a very underresourced hospital, and unfortunately about half the patients have HIV disease. Our goal has been to train their physicians so they can train their own specialists and subspecialists within 10 years.
What are the main elements of the physician-training program at Makerere?
Under Dr. Sadigh's leadership, we have an exchange program with Makerere that involves students and faculty. At any one time, we have two to four faculty members from Makerere who spend anywhere from 4 to 12 months at Yale. These faculty members come to receive specialized training in areas such as cardiology, kidney disease, and emergency medicine.
In addition, faculty from Yale and from other medical schools go to Makerere; we have medical residents there at all times, funded through the Yale/Stanford Johnson & Johnson Global Health Scholars Program. The idea is to help the Makerere faculty define what they need, and then find the resources to respond to that need.
What are the challenges of developing a training program in another country?
The key is to find the right partner and develop a relationship based on mutual respect. We didn't go to Mulago to do research; we went to improve patient care through education. There are other medical schools from the United States and Europe doing work with Makerere, but we were surprised that very few had become directly involved in providing the hands-on training to improve patient care. Research is critical to improving patient care, but often the fruit of such discoveries is not translated to improvement in patient care locally.
The people we have worked with at Makerere are as committed and intelligent as anyone I have worked with anywhere in the world. They know what to do to improve care, but they don't have the capacity to train specialists, so they are missing individuals with badly needed knowledge and skills in specific areas. That's the part we are playing.
How can other physicians in the United States get involved to volunteer on a short-term basis?
They can get involved through the Yale/Stanford Johnson & Johnson Global Health Scholars Program, which we at Yale codirect with Dr. Michele Barry, professor and senior associate dean for Global Health at Stanford (Calif.) University. The program is funded by Johnson & Johnson, and it selects residents and career physicians through a competitive application process. The funded scholars receive a travel award on completion of their 6-week assignments. More information is available on our Web site (http://medicine.yale.edu/intmed/globalhealthscholars
Ugandan students and faculty visit Yale University as part of the exchange program.
Source Courtesy Dr. Asghar Rastegar
Type 2 Diabetes Linked to Risk for Colorectal Adenomas
SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.
“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” Dr. Nisheet Waghray of MetroHealth Medical Center, Cleveland, and colleagues wrote in a poster at the meeting.
Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.
The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.
All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.
The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.
The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.
The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.
The researchers said that they had no financial conflicts to disclose.
SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.
“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” Dr. Nisheet Waghray of MetroHealth Medical Center, Cleveland, and colleagues wrote in a poster at the meeting.
Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.
The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.
All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.
The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.
The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.
The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.
The researchers said that they had no financial conflicts to disclose.
SAN ANTONIO – Colorectal adenomas were significantly more common in adults with type 2 diabetes, compared with the general adult population, based on a study of 860 patients who underwent screening colonoscopy.
“Colonic adenomas and advanced adenomas were independently predicted by diabetes,” Dr. Nisheet Waghray of MetroHealth Medical Center, Cleveland, and colleagues wrote in a poster at the meeting.
Previous studies have shown a 30%-40% increase in colorectal cancer risk in adults with type 2 diabetes, but the association between type 2 diabetes and the risk of colorectal adenomas has not been well studied, the investigators said.
The researchers reviewed colonoscopy data from 269 adults with type 2 diabetes and 591 adults without diabetes who were screened at a single medical center between January 2007 and January 2010.
All of the following findings – three or more adenomas, adenomas larger than 1 cm, a proximal location of advanced adenomas, and a higher mean number of polyps – were significantly more common in the diabetes patients than in the nondiabetics.
The percentage of patients with three or more adenomas was 14% in those with diabetes vs. 10% in the general population, and the rate of adenomas larger than 1 cm was 9.7% and 4.7%, respectively. The average number of polyps in patients with diabetes vs. those without diabetes was 4.9 vs. 2.5. In addition, 68% of advanced adenomas in the diabetes patients were proximal, compared with 31% of those in the general population.
The average age of the patients with diabetes was 57 years, vs. 61 years in the general population, but this difference was not significant. There were no significant differences between the two groups in terms of body mass index, family history of colorectal cancer, or patient use of alcohol, tobacco, or nonsteroidal anti-inflammatory drugs. Approximately 60% of the patients in both groups were black.
The findings suggest that type 2 diabetes influences not only the number of adenomatous polyps, but also their location within the colon. More research is needed to confirm the results, but this study “adds plausibility that diabetes may play a role in the adenoma-carcinoma sequence,” Dr. Waghray and colleagues noted.
The researchers said that they had no financial conflicts to disclose.
Meta-Analysis: Statin Use Cut Colorectal Cancer Risk by 10%
SAN ANTONIO, TEX. – Statin use was associated with a moderate but significant 10% reduction in risk of colorectal cancer, based on a meta-analysis of 24 studies, investigators reported at the meeting.
Data from some previous studies have suggested that statin use helps protect against colon cancer, but epidemiologic studies have shown mixed results, said Dr. Ivo Ditah of Wayne State University in Detroit and his colleagues in their poster.
The researchers reviewed data from 24 studies published from 1996 to 2009. The results included a total of 1.7 million adults who participated in 12 case-control studies, 6 randomized controlled trials, and 6 cohort studies.
Overall, the pooled risk estimate was 0.90, for a significant 10% reduction in colorectal cancer risk among statin users. The average duration of statin use was 2.8 years.
When the types of studies were analyzed separately, statin use was associated with a significant 10% reduction in colorectal cancer risk in the case-control studies and a significant 11% reduction in the cohort studies. In the randomized controlled trials, statin use was linked to a 10% reduction in risk of colorectal cancer, but this decrease was not significant.
Although the data show a modest overall reduction in colorectal cancer risk associated with statin use, the results appear to be driven by less robust study designs, rather than by randomized, controlled trials, the investigators noted.
In addition, the study was limited by the lack of long-term trials, which are important given the latency period between the initial stages of cancer development and its detection, the researchers said.
The researchers had no financial conflicts to disclose.
SAN ANTONIO, TEX. – Statin use was associated with a moderate but significant 10% reduction in risk of colorectal cancer, based on a meta-analysis of 24 studies, investigators reported at the meeting.
Data from some previous studies have suggested that statin use helps protect against colon cancer, but epidemiologic studies have shown mixed results, said Dr. Ivo Ditah of Wayne State University in Detroit and his colleagues in their poster.
The researchers reviewed data from 24 studies published from 1996 to 2009. The results included a total of 1.7 million adults who participated in 12 case-control studies, 6 randomized controlled trials, and 6 cohort studies.
Overall, the pooled risk estimate was 0.90, for a significant 10% reduction in colorectal cancer risk among statin users. The average duration of statin use was 2.8 years.
When the types of studies were analyzed separately, statin use was associated with a significant 10% reduction in colorectal cancer risk in the case-control studies and a significant 11% reduction in the cohort studies. In the randomized controlled trials, statin use was linked to a 10% reduction in risk of colorectal cancer, but this decrease was not significant.
Although the data show a modest overall reduction in colorectal cancer risk associated with statin use, the results appear to be driven by less robust study designs, rather than by randomized, controlled trials, the investigators noted.
In addition, the study was limited by the lack of long-term trials, which are important given the latency period between the initial stages of cancer development and its detection, the researchers said.
The researchers had no financial conflicts to disclose.
SAN ANTONIO, TEX. – Statin use was associated with a moderate but significant 10% reduction in risk of colorectal cancer, based on a meta-analysis of 24 studies, investigators reported at the meeting.
Data from some previous studies have suggested that statin use helps protect against colon cancer, but epidemiologic studies have shown mixed results, said Dr. Ivo Ditah of Wayne State University in Detroit and his colleagues in their poster.
The researchers reviewed data from 24 studies published from 1996 to 2009. The results included a total of 1.7 million adults who participated in 12 case-control studies, 6 randomized controlled trials, and 6 cohort studies.
Overall, the pooled risk estimate was 0.90, for a significant 10% reduction in colorectal cancer risk among statin users. The average duration of statin use was 2.8 years.
When the types of studies were analyzed separately, statin use was associated with a significant 10% reduction in colorectal cancer risk in the case-control studies and a significant 11% reduction in the cohort studies. In the randomized controlled trials, statin use was linked to a 10% reduction in risk of colorectal cancer, but this decrease was not significant.
Although the data show a modest overall reduction in colorectal cancer risk associated with statin use, the results appear to be driven by less robust study designs, rather than by randomized, controlled trials, the investigators noted.
In addition, the study was limited by the lack of long-term trials, which are important given the latency period between the initial stages of cancer development and its detection, the researchers said.
The researchers had no financial conflicts to disclose.
Lupus Diagnosis Doubles Risk for Certain Cancers
ATLANTA – Lupus patients were more than 2.5 times as likely as the general population to develop blood cancers, based on data from 13,492 adults with lupus.
The risk for hematologic cancers was significantly elevated among patients with lupus. Specifically, lupus patients were more than three times as likely as the general population to develop any type of lymphoma, and more than three times as likely to develop non-Hodgkin’s lymphoma. In addition, lupus patients were 1.15 times more likely than the general population to develop any cancer, said Dr. Sasha R. Bernatsky of the divisions of clinical epidemiology and rheumatology at McGill University in Montreal.
Previous studies have shown an association between systemic lupus erythematosus (SLE) and cancer, due largely to the increased risk for lymphoma. In this study, Dr. Bernatsky and her colleagues aimed for a more precise estimate of cancer rates in lupus patients, as well as stratification by age. This global effort included researchers from the Systemic Lupus International Collaborating Clinics, the Canadian Network for Improved Outcomes in SLE, and other sites around the world.
Dr. Bernatsky and her colleagues reviewed data on patients from 24 centers worldwide for an average follow-up period of 9 years, and a total of 118,359 patient-years. They identified 632 cancers during the study period.
The researchers also found a significantly increased risk of lung cancer, vulvovaginal cancer, and hepatic cancer in lupus patients, compared with the general population.
However, there was a significant decrease in the risk of hormone-sensitive cancers, including breast cancer, endometrial cancer, and ovarian cancer.
Altered clearance of viruses such as human papillomavirus might be behind the increased risk for cervical and vulvovaginal cancers in lupus patients, suggested Dr. Bernatsky. Changes in estrogen metabolism might be behind the decreased risk for hormone-sensitive cancers, although more research is needed to study these possible associations.
When the results were stratified by age, patients in the youngest age group (younger than 40 years) were significantly (1.7 times) more likely to develop any cancer, compared with the general population.
Despite the increased risk, blood cancers remain rare in lupus patients, Dr. Bernatsky noted. But the study results highlight the overall risk of cancer in lupus patients. The findings remind clinicians to counsel smoking cessation to reduce the risk of lung cancer, and to emphasize regular Pap testing for female patients to catch precancerous changes as soon as possible.
The decreased risk of certain cancers such as breast cancer is good news for women with SLE "and will be an area of keen research interest in the future," Dr. Bernatsky said at the annual meeting of the American College of Rheumatology.
She disclosed that she has received funding from the National Institutes of Health and research grants from the Arthritis Society of Canada.
ATLANTA – Lupus patients were more than 2.5 times as likely as the general population to develop blood cancers, based on data from 13,492 adults with lupus.
The risk for hematologic cancers was significantly elevated among patients with lupus. Specifically, lupus patients were more than three times as likely as the general population to develop any type of lymphoma, and more than three times as likely to develop non-Hodgkin’s lymphoma. In addition, lupus patients were 1.15 times more likely than the general population to develop any cancer, said Dr. Sasha R. Bernatsky of the divisions of clinical epidemiology and rheumatology at McGill University in Montreal.
Previous studies have shown an association between systemic lupus erythematosus (SLE) and cancer, due largely to the increased risk for lymphoma. In this study, Dr. Bernatsky and her colleagues aimed for a more precise estimate of cancer rates in lupus patients, as well as stratification by age. This global effort included researchers from the Systemic Lupus International Collaborating Clinics, the Canadian Network for Improved Outcomes in SLE, and other sites around the world.
Dr. Bernatsky and her colleagues reviewed data on patients from 24 centers worldwide for an average follow-up period of 9 years, and a total of 118,359 patient-years. They identified 632 cancers during the study period.
The researchers also found a significantly increased risk of lung cancer, vulvovaginal cancer, and hepatic cancer in lupus patients, compared with the general population.
However, there was a significant decrease in the risk of hormone-sensitive cancers, including breast cancer, endometrial cancer, and ovarian cancer.
Altered clearance of viruses such as human papillomavirus might be behind the increased risk for cervical and vulvovaginal cancers in lupus patients, suggested Dr. Bernatsky. Changes in estrogen metabolism might be behind the decreased risk for hormone-sensitive cancers, although more research is needed to study these possible associations.
When the results were stratified by age, patients in the youngest age group (younger than 40 years) were significantly (1.7 times) more likely to develop any cancer, compared with the general population.
Despite the increased risk, blood cancers remain rare in lupus patients, Dr. Bernatsky noted. But the study results highlight the overall risk of cancer in lupus patients. The findings remind clinicians to counsel smoking cessation to reduce the risk of lung cancer, and to emphasize regular Pap testing for female patients to catch precancerous changes as soon as possible.
The decreased risk of certain cancers such as breast cancer is good news for women with SLE "and will be an area of keen research interest in the future," Dr. Bernatsky said at the annual meeting of the American College of Rheumatology.
She disclosed that she has received funding from the National Institutes of Health and research grants from the Arthritis Society of Canada.
ATLANTA – Lupus patients were more than 2.5 times as likely as the general population to develop blood cancers, based on data from 13,492 adults with lupus.
The risk for hematologic cancers was significantly elevated among patients with lupus. Specifically, lupus patients were more than three times as likely as the general population to develop any type of lymphoma, and more than three times as likely to develop non-Hodgkin’s lymphoma. In addition, lupus patients were 1.15 times more likely than the general population to develop any cancer, said Dr. Sasha R. Bernatsky of the divisions of clinical epidemiology and rheumatology at McGill University in Montreal.
Previous studies have shown an association between systemic lupus erythematosus (SLE) and cancer, due largely to the increased risk for lymphoma. In this study, Dr. Bernatsky and her colleagues aimed for a more precise estimate of cancer rates in lupus patients, as well as stratification by age. This global effort included researchers from the Systemic Lupus International Collaborating Clinics, the Canadian Network for Improved Outcomes in SLE, and other sites around the world.
Dr. Bernatsky and her colleagues reviewed data on patients from 24 centers worldwide for an average follow-up period of 9 years, and a total of 118,359 patient-years. They identified 632 cancers during the study period.
The researchers also found a significantly increased risk of lung cancer, vulvovaginal cancer, and hepatic cancer in lupus patients, compared with the general population.
However, there was a significant decrease in the risk of hormone-sensitive cancers, including breast cancer, endometrial cancer, and ovarian cancer.
Altered clearance of viruses such as human papillomavirus might be behind the increased risk for cervical and vulvovaginal cancers in lupus patients, suggested Dr. Bernatsky. Changes in estrogen metabolism might be behind the decreased risk for hormone-sensitive cancers, although more research is needed to study these possible associations.
When the results were stratified by age, patients in the youngest age group (younger than 40 years) were significantly (1.7 times) more likely to develop any cancer, compared with the general population.
Despite the increased risk, blood cancers remain rare in lupus patients, Dr. Bernatsky noted. But the study results highlight the overall risk of cancer in lupus patients. The findings remind clinicians to counsel smoking cessation to reduce the risk of lung cancer, and to emphasize regular Pap testing for female patients to catch precancerous changes as soon as possible.
The decreased risk of certain cancers such as breast cancer is good news for women with SLE "and will be an area of keen research interest in the future," Dr. Bernatsky said at the annual meeting of the American College of Rheumatology.
She disclosed that she has received funding from the National Institutes of Health and research grants from the Arthritis Society of Canada.
FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF RHEUMATOLOGY
Pentoxifylline Improved Nonalcoholic Steatohepatitis in Small Randomized Trial
SAN ANTONIO – Fifty percent of adults with nonalcoholic steatohepatitis improved their disease scores by at least two points with pentoxifylline therapy, compared with 15% of the placebo group, in a randomized, double-blind trial of 55 patients.
Pentoxifylline is known to increase the flexibility of red blood cells and reduce platelet aggregation. Preliminary work in mice and rats has prompted studies of pentoxifylline in patients with nonalcoholic steatohepatitis (NASH), but most of these studies have been small and lacking in control groups or histologic follow-up, said Dr. Claudia Zein, who presented the results at the annual scientific meeting of the American College of Gastroenterology.
Effective therapies are important because a significant number of patients with NASH will go on to develop cirrhosis, said Dr. Zein of the Cleveland Clinic. One recent study showed some benefits of vitamin E in some patients, but "there is still a great need for effective and safe therapies for NASH," Dr. Zein said.
In this study, 55 adults who were recruited from two medical centers in Cleveland were randomized to receive either 400-mg pentoxifylline three times daily (26 patients) or placebo (29 patients) for 1 year. The baseline histologic characteristics were similar between the two groups. The mean age of the patients was 50 years, and most were men.
Treatment success was defined as an improvement of 2 or more points in the NAS (NAFLD [Nonalcoholic Fatty Liver Disease] Activity Score), a validated scoring system that combines several histologic features, namely steatosis, lobular inflammation, and intracellular ballooning.
In the per protocol analysis of 49 patients, 50% of the pentoxifylline group improved their NAS scores by at least 2 points after 1 year, compared with 15% of the placebo group; this difference was statistically significant. Three patients in each group dropped out because of reasons unrelated to the study drug.
Patients in the pentoxifylline group were significantly more likely than the placebo patients to have improved steatosis (80% vs. 20%) and inflammation (55% vs. 23%). However, hepatocellular ballooning results did not differ significantly between the two groups.
In addition, no differences in progression of fibrosis were seen between the two groups. "But in future studies, we think we will see a lack of progression of fibrosis," Dr. Zein said.
In addition, 57% of the pentoxifylline patients met the secondary end point of an improvement of 30% or more in ALT (alanine aminotransferase) levels, compared with 25% of the placebo patients.
No serious adverse events were reported in either group, and the incidence of adverse events was similar between the two groups. Nausea and vomiting appeared to be more prominent in the pentoxifylline group, but the difference fell short of statistical significance.
"Pentoxifylline appeared to be safe and well tolerated in patients with NASH," said Dr. Zein. "We feel that further trials with larger numbers of patients are warranted."
This study was a 2010 Governor’s Award Recipient for Excellence in Clinical Research from the American College of Gastroenterology, which involved a monetary grant.
SAN ANTONIO – Fifty percent of adults with nonalcoholic steatohepatitis improved their disease scores by at least two points with pentoxifylline therapy, compared with 15% of the placebo group, in a randomized, double-blind trial of 55 patients.
Pentoxifylline is known to increase the flexibility of red blood cells and reduce platelet aggregation. Preliminary work in mice and rats has prompted studies of pentoxifylline in patients with nonalcoholic steatohepatitis (NASH), but most of these studies have been small and lacking in control groups or histologic follow-up, said Dr. Claudia Zein, who presented the results at the annual scientific meeting of the American College of Gastroenterology.
Effective therapies are important because a significant number of patients with NASH will go on to develop cirrhosis, said Dr. Zein of the Cleveland Clinic. One recent study showed some benefits of vitamin E in some patients, but "there is still a great need for effective and safe therapies for NASH," Dr. Zein said.
In this study, 55 adults who were recruited from two medical centers in Cleveland were randomized to receive either 400-mg pentoxifylline three times daily (26 patients) or placebo (29 patients) for 1 year. The baseline histologic characteristics were similar between the two groups. The mean age of the patients was 50 years, and most were men.
Treatment success was defined as an improvement of 2 or more points in the NAS (NAFLD [Nonalcoholic Fatty Liver Disease] Activity Score), a validated scoring system that combines several histologic features, namely steatosis, lobular inflammation, and intracellular ballooning.
In the per protocol analysis of 49 patients, 50% of the pentoxifylline group improved their NAS scores by at least 2 points after 1 year, compared with 15% of the placebo group; this difference was statistically significant. Three patients in each group dropped out because of reasons unrelated to the study drug.
Patients in the pentoxifylline group were significantly more likely than the placebo patients to have improved steatosis (80% vs. 20%) and inflammation (55% vs. 23%). However, hepatocellular ballooning results did not differ significantly between the two groups.
In addition, no differences in progression of fibrosis were seen between the two groups. "But in future studies, we think we will see a lack of progression of fibrosis," Dr. Zein said.
In addition, 57% of the pentoxifylline patients met the secondary end point of an improvement of 30% or more in ALT (alanine aminotransferase) levels, compared with 25% of the placebo patients.
No serious adverse events were reported in either group, and the incidence of adverse events was similar between the two groups. Nausea and vomiting appeared to be more prominent in the pentoxifylline group, but the difference fell short of statistical significance.
"Pentoxifylline appeared to be safe and well tolerated in patients with NASH," said Dr. Zein. "We feel that further trials with larger numbers of patients are warranted."
This study was a 2010 Governor’s Award Recipient for Excellence in Clinical Research from the American College of Gastroenterology, which involved a monetary grant.
SAN ANTONIO – Fifty percent of adults with nonalcoholic steatohepatitis improved their disease scores by at least two points with pentoxifylline therapy, compared with 15% of the placebo group, in a randomized, double-blind trial of 55 patients.
Pentoxifylline is known to increase the flexibility of red blood cells and reduce platelet aggregation. Preliminary work in mice and rats has prompted studies of pentoxifylline in patients with nonalcoholic steatohepatitis (NASH), but most of these studies have been small and lacking in control groups or histologic follow-up, said Dr. Claudia Zein, who presented the results at the annual scientific meeting of the American College of Gastroenterology.
Effective therapies are important because a significant number of patients with NASH will go on to develop cirrhosis, said Dr. Zein of the Cleveland Clinic. One recent study showed some benefits of vitamin E in some patients, but "there is still a great need for effective and safe therapies for NASH," Dr. Zein said.
In this study, 55 adults who were recruited from two medical centers in Cleveland were randomized to receive either 400-mg pentoxifylline three times daily (26 patients) or placebo (29 patients) for 1 year. The baseline histologic characteristics were similar between the two groups. The mean age of the patients was 50 years, and most were men.
Treatment success was defined as an improvement of 2 or more points in the NAS (NAFLD [Nonalcoholic Fatty Liver Disease] Activity Score), a validated scoring system that combines several histologic features, namely steatosis, lobular inflammation, and intracellular ballooning.
In the per protocol analysis of 49 patients, 50% of the pentoxifylline group improved their NAS scores by at least 2 points after 1 year, compared with 15% of the placebo group; this difference was statistically significant. Three patients in each group dropped out because of reasons unrelated to the study drug.
Patients in the pentoxifylline group were significantly more likely than the placebo patients to have improved steatosis (80% vs. 20%) and inflammation (55% vs. 23%). However, hepatocellular ballooning results did not differ significantly between the two groups.
In addition, no differences in progression of fibrosis were seen between the two groups. "But in future studies, we think we will see a lack of progression of fibrosis," Dr. Zein said.
In addition, 57% of the pentoxifylline patients met the secondary end point of an improvement of 30% or more in ALT (alanine aminotransferase) levels, compared with 25% of the placebo patients.
No serious adverse events were reported in either group, and the incidence of adverse events was similar between the two groups. Nausea and vomiting appeared to be more prominent in the pentoxifylline group, but the difference fell short of statistical significance.
"Pentoxifylline appeared to be safe and well tolerated in patients with NASH," said Dr. Zein. "We feel that further trials with larger numbers of patients are warranted."
This study was a 2010 Governor’s Award Recipient for Excellence in Clinical Research from the American College of Gastroenterology, which involved a monetary grant.
From the annual scientific meeting of the American College of Gastroenterology