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BEST PRACTICES IN: Management of Patients With T2DM: The Risk and Role of Chronic Kidney Disease
A supplement to Internal Medicine News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With T2DM
- Early Identification and Screening
- CKD Strongly Effects CV Outcomes in Patients With DM
- Awareness of the Importance of CKD/RI Is Lacking
- CKD/RI Increases the Risk for Hypoglycemia in DM Treatment
- Multifactorial Therapy May Benefit Outcomes in Patients With T2DM and CKD
Faculty/Faculty Disclosure Mark Stolar, MD
Associate Professor of Clinical Medicine
Northwestern University Medical School
Chicago, IL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Mark Stolar, MD, has served on the Speakers Bureau of Takeda Pharmaceutical Company Limited and has developed educational programs for the TCL Institute and NACE. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
A supplement to Internal Medicine News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With T2DM
- Early Identification and Screening
- CKD Strongly Effects CV Outcomes in Patients With DM
- Awareness of the Importance of CKD/RI Is Lacking
- CKD/RI Increases the Risk for Hypoglycemia in DM Treatment
- Multifactorial Therapy May Benefit Outcomes in Patients With T2DM and CKD
Faculty/Faculty Disclosure Mark Stolar, MD
Associate Professor of Clinical Medicine
Northwestern University Medical School
Chicago, IL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Mark Stolar, MD, has served on the Speakers Bureau of Takeda Pharmaceutical Company Limited and has developed educational programs for the TCL Institute and NACE. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
A supplement to Internal Medicine News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With T2DM
- Early Identification and Screening
- CKD Strongly Effects CV Outcomes in Patients With DM
- Awareness of the Importance of CKD/RI Is Lacking
- CKD/RI Increases the Risk for Hypoglycemia in DM Treatment
- Multifactorial Therapy May Benefit Outcomes in Patients With T2DM and CKD
Faculty/Faculty Disclosure Mark Stolar, MD
Associate Professor of Clinical Medicine
Northwestern University Medical School
Chicago, IL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Mark Stolar, MD, has served on the Speakers Bureau of Takeda Pharmaceutical Company Limited and has developed educational programs for the TCL Institute and NACE. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
Pomalidomide in lenalidomide-refractory multiple myeloma and carfilzomib in refractory and newly diagnosed multiple myeloma
--Jame Abraham, MD, Editor
1. Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM). Leukemia 2010;24:1934−1939.
2. Siegel DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label, single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
3. Jakubowiak AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma: initial results of phase I/II MMRC trial. Blood 2010;116:862.
4. Singhal SB, Siegel DSD, Martin T, et al. Pooled safety analysis from phase 1 and 2 studies of carfilzomib (CFZ) in patients with relapsed and/or refractory multiple myeloma (MM). Blood 2010;116:1954.
Noopur Raje, MD, Massachusetts General Hospital Cancer Center; Division of Hematology and Oncology, Massachusetts General Hospital; and Harvard Medical School, Boston, MA
Although multiple myeloma (MM) remains an incurable bone marrow
cancer, survival rates have improved markedly over the past decade. An
understanding of MM pathobiology (Figure 1) and improvement in stem cell
transplantation, better supportive care, and novel therapies with
higher efficacy and lower toxicity are all responsible for this
improvement. The availability of a rich pipeline of novel agents
undergoing early-phase clinical trials in MM is an exciting and active
area of research.1
Current treatment
Over the past several years, five therapeutic strategies have
received US Food and Drug Administration (FDA) approval either as
monotherapy or in combination for treating MM, with thalidomide
(Thalomid), lenalidomide (Revlimid), and bortezomib (Velcade) as
important backbone drugs in these approaches. In the upfront setting,
thalidomide with dexamethasone2 and bortezomib in combination with melphalan and prednisone3
increased the overall response rate and significantly prolonged time to
disease progression and are FDA approved. For treatment of relapsed MM,
bortezomib alone4 and in combination with pegylated liposomal doxorubicin (Doxil),5 as well as lenalidomide/dexamethasone,6
have been approved. Results of a recent phase III randomized clinical
trial suggest that lower doses of dexamethasone provide a survival
advantage, at least in the upfront setting, mainly due to the increased
toxicity of high doses of dexamethasone.7
The availability of these novel agents has not only provided us
with several treatment options but has had an important impact on the
overall survival of our patients. To improve upon current outcomes,
optimal combinations of bortezomib, thalidomide, and lenalidomide are
currently under evaluation in phase II/III clinical trials.
Novel approaches
The preceding review refers to recent data on pomalidomide, the
newest immunomodulatory drug (IMiD) analog, which has shown single-agent
activity in phase I studies and was subsequently tested in a phase II
trial in combination with low-dose dexamethasone in patients with
relapsed or refractory MM. Pomalidomide/dexamethasone was found to be
highly active and well tolerated, providing a clinical benefit in 47% of
patients and no grade 3 neuropathy. These findings have led to a large
phase II study, which has completed accrual and is awaiting analysis.
Another promising agent discussed here is the novel proteasome
inhibitor carfilzomib. Although bortezomib is an effective agent in MM,
about 20% of newly diagnosed patients are resistant to bortezomib, and,
ultimately, all patients relapse and develop resistance to the drug.
Carfilzomib irreversibly blocks chymotrypsin-like activity and in phase I
studies achieved more than 80% proteasome inhibition. Encouraging data
presented at the 2010 annual meeting of the American Society of
Hematology demonstrated that it was well tolerated and had an overall
clinical benefit rate of 36% in relapsed/refractory MM.8 In the upfront setting, carfilzomib combined with lenalidomide led to a 100% response rate.9
This combination with low-dose dexamethasone is currently
undergoing testing in a phase III registration trial. These data,
therefore, provide important therapeutic options among the armamentarium
of current and future antimyeloma therapies, helping transform MM into
an even more chronic disease than it is today and ultimately leading to a
cure.
References
1. Cirstea D, Vallet S, Raje N. Future novel single agent and combination therapies. Cancer J 2009;15:511-518.
2. Rajkumar
SV, Rosinol L, Hussein M, et al. Multicenter, randomized, double-blind,
placebo-controlled study of thalidomide plus dexamethasone compared
with dexamethasone as initial therapy for newly diagnosed multiple
myeloma. J Clin Oncol 2008;26:2171-2177.
3. San
Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and
prednisone for initial treatment of multiple myeloma. N Engl J Med
2008;359:906-917.
4. Richardson
PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose
dexamethasone for relapsed multiple myeloma. N Engl J Med
2005;352:2487-2498.
5. Orlowski
RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of
pegylated liposomal doxorubicin plus bortezomib compared with bortezomib
alone in relapsed or refractory multiple myeloma: combination therapy
improves time to progression. J Clin Oncol 2007;25:3892-3901.
6. Dimopoulos
MA, Chen C, Spencer A, et al. Long-term follow-up on overall survival
from the MM-009 and MM-010 phase III trials of lenalidomide plus
dexamethasone in patients with relapsed or refractory multiple myeloma.
Leukemia 2009;23:2147-2152.
7. Rajkumar
SV, Jacobus S, Callander NS, et al. Lenalidomide plus high-dose
dexamethasone versus lenalidomide plus low-dose dexamethasone as initial
therapy for newly diagnosed multiple myeloma: an open-label randomised
controlled trial. Lancet Oncol 2010;11:29-37.
8. Siegel
DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label,
single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with
relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
9. Jakubowiak
AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and
dexamethasone in newly diagnosed multiple myeloma: initial results of
phase I/II MMRC trial. Blood 2010;116:862.
Dr. Raje can be reached at nraje@partners.org.
Noopur Raje, MD, Massachusetts General Hospital Cancer Center; Division of Hematology and Oncology, Massachusetts General Hospital; and Harvard Medical School, Boston, MA
Although multiple myeloma (MM) remains an incurable bone marrow
cancer, survival rates have improved markedly over the past decade. An
understanding of MM pathobiology (Figure 1) and improvement in stem cell
transplantation, better supportive care, and novel therapies with
higher efficacy and lower toxicity are all responsible for this
improvement. The availability of a rich pipeline of novel agents
undergoing early-phase clinical trials in MM is an exciting and active
area of research.1
Current treatment
Over the past several years, five therapeutic strategies have
received US Food and Drug Administration (FDA) approval either as
monotherapy or in combination for treating MM, with thalidomide
(Thalomid), lenalidomide (Revlimid), and bortezomib (Velcade) as
important backbone drugs in these approaches. In the upfront setting,
thalidomide with dexamethasone2 and bortezomib in combination with melphalan and prednisone3
increased the overall response rate and significantly prolonged time to
disease progression and are FDA approved. For treatment of relapsed MM,
bortezomib alone4 and in combination with pegylated liposomal doxorubicin (Doxil),5 as well as lenalidomide/dexamethasone,6
have been approved. Results of a recent phase III randomized clinical
trial suggest that lower doses of dexamethasone provide a survival
advantage, at least in the upfront setting, mainly due to the increased
toxicity of high doses of dexamethasone.7
The availability of these novel agents has not only provided us
with several treatment options but has had an important impact on the
overall survival of our patients. To improve upon current outcomes,
optimal combinations of bortezomib, thalidomide, and lenalidomide are
currently under evaluation in phase II/III clinical trials.
Novel approaches
The preceding review refers to recent data on pomalidomide, the
newest immunomodulatory drug (IMiD) analog, which has shown single-agent
activity in phase I studies and was subsequently tested in a phase II
trial in combination with low-dose dexamethasone in patients with
relapsed or refractory MM. Pomalidomide/dexamethasone was found to be
highly active and well tolerated, providing a clinical benefit in 47% of
patients and no grade 3 neuropathy. These findings have led to a large
phase II study, which has completed accrual and is awaiting analysis.
Another promising agent discussed here is the novel proteasome
inhibitor carfilzomib. Although bortezomib is an effective agent in MM,
about 20% of newly diagnosed patients are resistant to bortezomib, and,
ultimately, all patients relapse and develop resistance to the drug.
Carfilzomib irreversibly blocks chymotrypsin-like activity and in phase I
studies achieved more than 80% proteasome inhibition. Encouraging data
presented at the 2010 annual meeting of the American Society of
Hematology demonstrated that it was well tolerated and had an overall
clinical benefit rate of 36% in relapsed/refractory MM.8 In the upfront setting, carfilzomib combined with lenalidomide led to a 100% response rate.9
This combination with low-dose dexamethasone is currently
undergoing testing in a phase III registration trial. These data,
therefore, provide important therapeutic options among the armamentarium
of current and future antimyeloma therapies, helping transform MM into
an even more chronic disease than it is today and ultimately leading to a
cure.
References
1. Cirstea D, Vallet S, Raje N. Future novel single agent and combination therapies. Cancer J 2009;15:511-518.
2. Rajkumar
SV, Rosinol L, Hussein M, et al. Multicenter, randomized, double-blind,
placebo-controlled study of thalidomide plus dexamethasone compared
with dexamethasone as initial therapy for newly diagnosed multiple
myeloma. J Clin Oncol 2008;26:2171-2177.
3. San
Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and
prednisone for initial treatment of multiple myeloma. N Engl J Med
2008;359:906-917.
4. Richardson
PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose
dexamethasone for relapsed multiple myeloma. N Engl J Med
2005;352:2487-2498.
5. Orlowski
RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of
pegylated liposomal doxorubicin plus bortezomib compared with bortezomib
alone in relapsed or refractory multiple myeloma: combination therapy
improves time to progression. J Clin Oncol 2007;25:3892-3901.
6. Dimopoulos
MA, Chen C, Spencer A, et al. Long-term follow-up on overall survival
from the MM-009 and MM-010 phase III trials of lenalidomide plus
dexamethasone in patients with relapsed or refractory multiple myeloma.
Leukemia 2009;23:2147-2152.
7. Rajkumar
SV, Jacobus S, Callander NS, et al. Lenalidomide plus high-dose
dexamethasone versus lenalidomide plus low-dose dexamethasone as initial
therapy for newly diagnosed multiple myeloma: an open-label randomised
controlled trial. Lancet Oncol 2010;11:29-37.
8. Siegel
DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label,
single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with
relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
9. Jakubowiak
AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and
dexamethasone in newly diagnosed multiple myeloma: initial results of
phase I/II MMRC trial. Blood 2010;116:862.
Dr. Raje can be reached at nraje@partners.org.
Noopur Raje, MD, Massachusetts General Hospital Cancer Center; Division of Hematology and Oncology, Massachusetts General Hospital; and Harvard Medical School, Boston, MA
Although multiple myeloma (MM) remains an incurable bone marrow
cancer, survival rates have improved markedly over the past decade. An
understanding of MM pathobiology (Figure 1) and improvement in stem cell
transplantation, better supportive care, and novel therapies with
higher efficacy and lower toxicity are all responsible for this
improvement. The availability of a rich pipeline of novel agents
undergoing early-phase clinical trials in MM is an exciting and active
area of research.1
Current treatment
Over the past several years, five therapeutic strategies have
received US Food and Drug Administration (FDA) approval either as
monotherapy or in combination for treating MM, with thalidomide
(Thalomid), lenalidomide (Revlimid), and bortezomib (Velcade) as
important backbone drugs in these approaches. In the upfront setting,
thalidomide with dexamethasone2 and bortezomib in combination with melphalan and prednisone3
increased the overall response rate and significantly prolonged time to
disease progression and are FDA approved. For treatment of relapsed MM,
bortezomib alone4 and in combination with pegylated liposomal doxorubicin (Doxil),5 as well as lenalidomide/dexamethasone,6
have been approved. Results of a recent phase III randomized clinical
trial suggest that lower doses of dexamethasone provide a survival
advantage, at least in the upfront setting, mainly due to the increased
toxicity of high doses of dexamethasone.7
The availability of these novel agents has not only provided us
with several treatment options but has had an important impact on the
overall survival of our patients. To improve upon current outcomes,
optimal combinations of bortezomib, thalidomide, and lenalidomide are
currently under evaluation in phase II/III clinical trials.
Novel approaches
The preceding review refers to recent data on pomalidomide, the
newest immunomodulatory drug (IMiD) analog, which has shown single-agent
activity in phase I studies and was subsequently tested in a phase II
trial in combination with low-dose dexamethasone in patients with
relapsed or refractory MM. Pomalidomide/dexamethasone was found to be
highly active and well tolerated, providing a clinical benefit in 47% of
patients and no grade 3 neuropathy. These findings have led to a large
phase II study, which has completed accrual and is awaiting analysis.
Another promising agent discussed here is the novel proteasome
inhibitor carfilzomib. Although bortezomib is an effective agent in MM,
about 20% of newly diagnosed patients are resistant to bortezomib, and,
ultimately, all patients relapse and develop resistance to the drug.
Carfilzomib irreversibly blocks chymotrypsin-like activity and in phase I
studies achieved more than 80% proteasome inhibition. Encouraging data
presented at the 2010 annual meeting of the American Society of
Hematology demonstrated that it was well tolerated and had an overall
clinical benefit rate of 36% in relapsed/refractory MM.8 In the upfront setting, carfilzomib combined with lenalidomide led to a 100% response rate.9
This combination with low-dose dexamethasone is currently
undergoing testing in a phase III registration trial. These data,
therefore, provide important therapeutic options among the armamentarium
of current and future antimyeloma therapies, helping transform MM into
an even more chronic disease than it is today and ultimately leading to a
cure.
References
1. Cirstea D, Vallet S, Raje N. Future novel single agent and combination therapies. Cancer J 2009;15:511-518.
2. Rajkumar
SV, Rosinol L, Hussein M, et al. Multicenter, randomized, double-blind,
placebo-controlled study of thalidomide plus dexamethasone compared
with dexamethasone as initial therapy for newly diagnosed multiple
myeloma. J Clin Oncol 2008;26:2171-2177.
3. San
Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and
prednisone for initial treatment of multiple myeloma. N Engl J Med
2008;359:906-917.
4. Richardson
PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose
dexamethasone for relapsed multiple myeloma. N Engl J Med
2005;352:2487-2498.
5. Orlowski
RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of
pegylated liposomal doxorubicin plus bortezomib compared with bortezomib
alone in relapsed or refractory multiple myeloma: combination therapy
improves time to progression. J Clin Oncol 2007;25:3892-3901.
6. Dimopoulos
MA, Chen C, Spencer A, et al. Long-term follow-up on overall survival
from the MM-009 and MM-010 phase III trials of lenalidomide plus
dexamethasone in patients with relapsed or refractory multiple myeloma.
Leukemia 2009;23:2147-2152.
7. Rajkumar
SV, Jacobus S, Callander NS, et al. Lenalidomide plus high-dose
dexamethasone versus lenalidomide plus low-dose dexamethasone as initial
therapy for newly diagnosed multiple myeloma: an open-label randomised
controlled trial. Lancet Oncol 2010;11:29-37.
8. Siegel
DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label,
single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with
relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
9. Jakubowiak
AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and
dexamethasone in newly diagnosed multiple myeloma: initial results of
phase I/II MMRC trial. Blood 2010;116:862.
Dr. Raje can be reached at nraje@partners.org.
--Jame Abraham, MD, Editor
1. Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM). Leukemia 2010;24:1934−1939.
2. Siegel DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label, single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
3. Jakubowiak AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma: initial results of phase I/II MMRC trial. Blood 2010;116:862.
4. Singhal SB, Siegel DSD, Martin T, et al. Pooled safety analysis from phase 1 and 2 studies of carfilzomib (CFZ) in patients with relapsed and/or refractory multiple myeloma (MM). Blood 2010;116:1954.
--Jame Abraham, MD, Editor
1. Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM). Leukemia 2010;24:1934−1939.
2. Siegel DSD, Martin T, Wang M, et al. Results of PX-171-003-A1, an open-label, single-arm, phase 2 study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (MM). Blood 2010;116:985.
3. Jakubowiak AJ, Dytfeld D, Jagannath S, et al. Carfilzomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma: initial results of phase I/II MMRC trial. Blood 2010;116:862.
4. Singhal SB, Siegel DSD, Martin T, et al. Pooled safety analysis from phase 1 and 2 studies of carfilzomib (CFZ) in patients with relapsed and/or refractory multiple myeloma (MM). Blood 2010;116:1954.
BEST PRACTICES IN: The Treatment of Heavy Menstrual Bleeding
A supplement to Internal Medicine News®. This supplement was sponsored by Ferring Pharmaceuticals.
To view the supplement, click the image above.
Topics
- Introduction
- Definition & Diagnosis
- Tranexamic Acid for the Treatment of HMB
- Conclusion
Faculty/Faculty Disclosure
Lee Shulman, MD, FACOG, FACMG
The Anna Ross Lapham Professor in Obstetrics and Gynecology
Feinberg School of Medicine of Northwestern University
Chicago, Illinois
Dr Shulman is a consultant to Ferring Pharmaceuticals, Inc.
Matt T. Rosenberg, MD
Family Physician
Mid-Michigan Health Centers
Jackson, Michigan
Dr Rosenberg
Copyright © 2011 Elsevier Inc.
A supplement to Internal Medicine News®. This supplement was sponsored by Ferring Pharmaceuticals.
To view the supplement, click the image above.
Topics
- Introduction
- Definition & Diagnosis
- Tranexamic Acid for the Treatment of HMB
- Conclusion
Faculty/Faculty Disclosure
Lee Shulman, MD, FACOG, FACMG
The Anna Ross Lapham Professor in Obstetrics and Gynecology
Feinberg School of Medicine of Northwestern University
Chicago, Illinois
Dr Shulman is a consultant to Ferring Pharmaceuticals, Inc.
Matt T. Rosenberg, MD
Family Physician
Mid-Michigan Health Centers
Jackson, Michigan
Dr Rosenberg
Copyright © 2011 Elsevier Inc.
A supplement to Internal Medicine News®. This supplement was sponsored by Ferring Pharmaceuticals.
To view the supplement, click the image above.
Topics
- Introduction
- Definition & Diagnosis
- Tranexamic Acid for the Treatment of HMB
- Conclusion
Faculty/Faculty Disclosure
Lee Shulman, MD, FACOG, FACMG
The Anna Ross Lapham Professor in Obstetrics and Gynecology
Feinberg School of Medicine of Northwestern University
Chicago, Illinois
Dr Shulman is a consultant to Ferring Pharmaceuticals, Inc.
Matt T. Rosenberg, MD
Family Physician
Mid-Michigan Health Centers
Jackson, Michigan
Dr Rosenberg
Copyright © 2011 Elsevier Inc.
BEST PRACTICES IN: Renal Impairment in Patients With Type 2 Diabetes: an Important Determinant of Treatment Selection
A supplement to Family Practice News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Complications Associated With T2DM
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With DM
- Early Identification and Screening
- Healthcare Providers Are Unaware of the Negative Effects of CKD on Cardiovascular Outcomes in Patients With T2DM
- Awareness of CKD/RI: Clinicians
- Awareness of CKD/RI: Patients
- Awareness of CKD/RI: Glycemic Control
- Prevention and Management
Faculty/Faculty Disclosure
Fernando Ovalle, MD
Associate Professor, Medicine
Director, Fellowship Training Program,
Diabetes & Endocrine Research Unit and Comprehensive Diabetes Clinic
UAB School of Medicine
Birmingham, AL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Fernando Ovalle, MD, has disclosed no potential conflicts of interest. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
A supplement to Family Practice News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Complications Associated With T2DM
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With DM
- Early Identification and Screening
- Healthcare Providers Are Unaware of the Negative Effects of CKD on Cardiovascular Outcomes in Patients With T2DM
- Awareness of CKD/RI: Clinicians
- Awareness of CKD/RI: Patients
- Awareness of CKD/RI: Glycemic Control
- Prevention and Management
Faculty/Faculty Disclosure
Fernando Ovalle, MD
Associate Professor, Medicine
Director, Fellowship Training Program,
Diabetes & Endocrine Research Unit and Comprehensive Diabetes Clinic
UAB School of Medicine
Birmingham, AL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Fernando Ovalle, MD, has disclosed no potential conflicts of interest. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
A supplement to Family Practice News®. This supplement was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
To view the supplement, click the image above.
Topics
- Complications Associated With T2DM
- Epidemiology of CKD/RI With DM
- Risk Factors for CKD/RI in Patients With DM
- Early Identification and Screening
- Healthcare Providers Are Unaware of the Negative Effects of CKD on Cardiovascular Outcomes in Patients With T2DM
- Awareness of CKD/RI: Clinicians
- Awareness of CKD/RI: Patients
- Awareness of CKD/RI: Glycemic Control
- Prevention and Management
Faculty/Faculty Disclosure
Fernando Ovalle, MD
Associate Professor, Medicine
Director, Fellowship Training Program,
Diabetes & Endocrine Research Unit and Comprehensive Diabetes Clinic
UAB School of Medicine
Birmingham, AL
Michael Kodack, PharmD
Vice President, Medical
BlueSpark Healthcare Communications LLC
Basking Ridge, NJ
Fernando Ovalle, MD, has disclosed no potential conflicts of interest. Michael Kodack, PharmD, is an employee of BlueSpark Healthcare Communications LLC.
Copyright © 2011 Elsevier Inc.
CT Trial Results Change Lung Cancer Screening Landscape
LAS VEGAS – The results from the National Lung Screening Trial constitute a "game changer" for lung cancer screening, Dr. James R. Jett said at the annual meeting of the National Association for Medical Direction of Respiratory Care.
The study results, reported in a press release by the National Cancer Institute last November, "changed the landscape" for screening by showing that lung imaging by low-dose helical CT done annually for 3 years in people with a smoking history of least 30 pack-years cut their mortality rate from lung cancer during follow-up by 20%, compared with people who underwent three annual chest x-rays. "This is the biggest advance in lung cancer in my career, an absolutely stunning result," said Dr. Jett, a pulmonologist and lung cancer specialist at National Jewish Health in Denver.
The researchers who ran the National Lung Screening Trial will likely publish their full results this spring, after which annual screening of people who match the profile of those in the study should become the standard of care, Dr. Jett predicted.
The screening trial enrolled 53,454 current or former cigarette smokers aged 55-74 years, who had each accumulated at least 30 pack-years of smoking history but had quit within the previous 15 years. The more than 75,000 total screening events by CT and more than 73,000 total screens by chest x-ray yielded 24% positive CT images and 7% positive x-ray images. During roughly 144,000 person-years of follow-up in each arm, the mortality due to lung cancer reached 246 deaths per 100,000 person-years in the CT group and 308 deaths per 100,000 person-years in the x-ray group, a 20% absolute mortality reduction with CT screening that was statistically significant, and which led the trial’s Data and Safety Monitoring Board to stop the study and release the results.
The people screened by CT also had a 7% reduction in all-cause mortality, compared with those screened by x-ray, also a statistically significant difference.
As about 160,000 Americans die from lung cancer annually, a 20% cut in mortality from low-dose helical CT screening could potentially save about 32,000 lives a year in the United States alone. "That’s almost like eliminating all 40,000 breast cancer deaths each year," Dr. Jett said.
The results did not directly address the question of how long annual screening should continue. In the trial, screening stopped after three annual examinations because of limited financial resources, although despite that the study cost about $200 million, he said. But his review of the results identified no suggestion that in routine practice screening should stop after 3 years. "There was no drop in the number of cancers" during each sequential year of screening. "I don’t see anything that tells me you can stop [screening] after 3 years," he said.
"The biggest question is, can we afford" to do annual CT screening on the scale needed to include all people who fit the profile included in the trial.
A second issue is the safety of annual CT imaging, but Dr. Jett presented a brief analysis suggesting that it is safe. A low-dose CT scan involves a radiation exposure of about 0.65 mSv, less than 10% of the dose of a conventional chest CT, Dr. Jett said. With that level of exposure, annual low-dose CT imaging of currently smoking women aged 50 might cause an excess of 5 cancer deaths for every 10,000 people screened, compared with a background lung cancer mortality of 100 for every 10,000 people with no screening. Because screening could prevent 20% of these 100 deaths, it would avert more deaths that it might cause. For men, the risk: benefit ratio runs even higher because currently smoking men undergoing annual CT screening would have about 2 extra lung cancer deaths per 10,000 people due to the radiation exposure, compared with 110 per 10,000 without screening. Women face a higher risk from the radiation of screening than men because of the impact of chest radiation on breast cancer, Dr. Jett said.
Dr. Jett said that he has been an adviser to Genentech, Pfizer, and Bristol-Myers Squibb, and that he has a research grant pending from Oncimmune.
LAS VEGAS – The results from the National Lung Screening Trial constitute a "game changer" for lung cancer screening, Dr. James R. Jett said at the annual meeting of the National Association for Medical Direction of Respiratory Care.
The study results, reported in a press release by the National Cancer Institute last November, "changed the landscape" for screening by showing that lung imaging by low-dose helical CT done annually for 3 years in people with a smoking history of least 30 pack-years cut their mortality rate from lung cancer during follow-up by 20%, compared with people who underwent three annual chest x-rays. "This is the biggest advance in lung cancer in my career, an absolutely stunning result," said Dr. Jett, a pulmonologist and lung cancer specialist at National Jewish Health in Denver.
The researchers who ran the National Lung Screening Trial will likely publish their full results this spring, after which annual screening of people who match the profile of those in the study should become the standard of care, Dr. Jett predicted.
The screening trial enrolled 53,454 current or former cigarette smokers aged 55-74 years, who had each accumulated at least 30 pack-years of smoking history but had quit within the previous 15 years. The more than 75,000 total screening events by CT and more than 73,000 total screens by chest x-ray yielded 24% positive CT images and 7% positive x-ray images. During roughly 144,000 person-years of follow-up in each arm, the mortality due to lung cancer reached 246 deaths per 100,000 person-years in the CT group and 308 deaths per 100,000 person-years in the x-ray group, a 20% absolute mortality reduction with CT screening that was statistically significant, and which led the trial’s Data and Safety Monitoring Board to stop the study and release the results.
The people screened by CT also had a 7% reduction in all-cause mortality, compared with those screened by x-ray, also a statistically significant difference.
As about 160,000 Americans die from lung cancer annually, a 20% cut in mortality from low-dose helical CT screening could potentially save about 32,000 lives a year in the United States alone. "That’s almost like eliminating all 40,000 breast cancer deaths each year," Dr. Jett said.
The results did not directly address the question of how long annual screening should continue. In the trial, screening stopped after three annual examinations because of limited financial resources, although despite that the study cost about $200 million, he said. But his review of the results identified no suggestion that in routine practice screening should stop after 3 years. "There was no drop in the number of cancers" during each sequential year of screening. "I don’t see anything that tells me you can stop [screening] after 3 years," he said.
"The biggest question is, can we afford" to do annual CT screening on the scale needed to include all people who fit the profile included in the trial.
A second issue is the safety of annual CT imaging, but Dr. Jett presented a brief analysis suggesting that it is safe. A low-dose CT scan involves a radiation exposure of about 0.65 mSv, less than 10% of the dose of a conventional chest CT, Dr. Jett said. With that level of exposure, annual low-dose CT imaging of currently smoking women aged 50 might cause an excess of 5 cancer deaths for every 10,000 people screened, compared with a background lung cancer mortality of 100 for every 10,000 people with no screening. Because screening could prevent 20% of these 100 deaths, it would avert more deaths that it might cause. For men, the risk: benefit ratio runs even higher because currently smoking men undergoing annual CT screening would have about 2 extra lung cancer deaths per 10,000 people due to the radiation exposure, compared with 110 per 10,000 without screening. Women face a higher risk from the radiation of screening than men because of the impact of chest radiation on breast cancer, Dr. Jett said.
Dr. Jett said that he has been an adviser to Genentech, Pfizer, and Bristol-Myers Squibb, and that he has a research grant pending from Oncimmune.
LAS VEGAS – The results from the National Lung Screening Trial constitute a "game changer" for lung cancer screening, Dr. James R. Jett said at the annual meeting of the National Association for Medical Direction of Respiratory Care.
The study results, reported in a press release by the National Cancer Institute last November, "changed the landscape" for screening by showing that lung imaging by low-dose helical CT done annually for 3 years in people with a smoking history of least 30 pack-years cut their mortality rate from lung cancer during follow-up by 20%, compared with people who underwent three annual chest x-rays. "This is the biggest advance in lung cancer in my career, an absolutely stunning result," said Dr. Jett, a pulmonologist and lung cancer specialist at National Jewish Health in Denver.
The researchers who ran the National Lung Screening Trial will likely publish their full results this spring, after which annual screening of people who match the profile of those in the study should become the standard of care, Dr. Jett predicted.
The screening trial enrolled 53,454 current or former cigarette smokers aged 55-74 years, who had each accumulated at least 30 pack-years of smoking history but had quit within the previous 15 years. The more than 75,000 total screening events by CT and more than 73,000 total screens by chest x-ray yielded 24% positive CT images and 7% positive x-ray images. During roughly 144,000 person-years of follow-up in each arm, the mortality due to lung cancer reached 246 deaths per 100,000 person-years in the CT group and 308 deaths per 100,000 person-years in the x-ray group, a 20% absolute mortality reduction with CT screening that was statistically significant, and which led the trial’s Data and Safety Monitoring Board to stop the study and release the results.
The people screened by CT also had a 7% reduction in all-cause mortality, compared with those screened by x-ray, also a statistically significant difference.
As about 160,000 Americans die from lung cancer annually, a 20% cut in mortality from low-dose helical CT screening could potentially save about 32,000 lives a year in the United States alone. "That’s almost like eliminating all 40,000 breast cancer deaths each year," Dr. Jett said.
The results did not directly address the question of how long annual screening should continue. In the trial, screening stopped after three annual examinations because of limited financial resources, although despite that the study cost about $200 million, he said. But his review of the results identified no suggestion that in routine practice screening should stop after 3 years. "There was no drop in the number of cancers" during each sequential year of screening. "I don’t see anything that tells me you can stop [screening] after 3 years," he said.
"The biggest question is, can we afford" to do annual CT screening on the scale needed to include all people who fit the profile included in the trial.
A second issue is the safety of annual CT imaging, but Dr. Jett presented a brief analysis suggesting that it is safe. A low-dose CT scan involves a radiation exposure of about 0.65 mSv, less than 10% of the dose of a conventional chest CT, Dr. Jett said. With that level of exposure, annual low-dose CT imaging of currently smoking women aged 50 might cause an excess of 5 cancer deaths for every 10,000 people screened, compared with a background lung cancer mortality of 100 for every 10,000 people with no screening. Because screening could prevent 20% of these 100 deaths, it would avert more deaths that it might cause. For men, the risk: benefit ratio runs even higher because currently smoking men undergoing annual CT screening would have about 2 extra lung cancer deaths per 10,000 people due to the radiation exposure, compared with 110 per 10,000 without screening. Women face a higher risk from the radiation of screening than men because of the impact of chest radiation on breast cancer, Dr. Jett said.
Dr. Jett said that he has been an adviser to Genentech, Pfizer, and Bristol-Myers Squibb, and that he has a research grant pending from Oncimmune.
EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE NATIONAL ASSOCIATION FOR MEDICAL DIRECTION OF RESPIRATORY CARE
SHM Honors Four Hospitalists
SHM will induct its second class of Masters in Hospital Medicine (MHM) at HM11 in May, and while each of the four honorees says the title is a personal honor, they all emphasize that it is a professional point of pride to see just how far HM has come in the past 15 years.
"For the specialty, it brings identity and awareness of all that we do," Erin Stucky, MD, MHM, a pediatric hospitalist at Rady Children's Hospital in San Diego, wrote in an email. "We are QI in mortal form, acting and pressing on to deliver excellence in healthcare within our systems. Each of us, members of the society, those with FHM, SFHM, and MHM—we each deliver on this promise every day."
The other MHMs, each of whom spoke to The Hospitalist via email, are:
Ron Greeno, MD, MHM, chief medical officer for Cogent Healthcare and a member of SHM's Public Policy Committee. "I've had the privilege of working in hospital medicine for 18 years and, along with my colleagues at Cogent, have helped shape the field," Dr. Greeno says. "To be one of a handful of hospitalists to be named a Master in Hospital Medicine is truly exciting, but equally exciting is to see the growing leadership capabilities of a number of our younger colleagues who will become the future leaders of our specialty."
Russell L. Holman, MD, MHM, Cogent's COO and past president of SHM. "Our specialty is constantly evolving; there is no paved road before us," Dr. Holman says. "We are cutting the path, and are part of an historical transformation of the way care is provided in this country. Twenty years from now we will reflect on an enduring legacy of dramatically improving the quality, safety, and sustainability of care for hospitalized patients. The privilege of being part of this movement is rewarding and inspirational for me."
Mary Jo Gorman, MD, MBA, MHM, former SHM president and CEO of St. Louis-based Advanced ICU Care. "It is a terrific honor to be recognized by SHM in this way," Dr. Gorman says. "The group that is included has accomplished many things and it's gratifying to be recognized with them. It’s hard to believe that SHM has come so far that we have fellows and masters in the society! Those early days seem a long way away!"
SHM has now recognized seven MHMs. Last year's class consisted of Winthrop F. Whitcomb, MD, MHM, Robert Wachter, MD, MHM, and John Nelson, MD, MHM. Each is recognized for what SHM says is the "utmost demonstration of dedication to the field of hospital medicine through significant contributions to the development and maturation of the profession."
SHM will induct its second class of Masters in Hospital Medicine (MHM) at HM11 in May, and while each of the four honorees says the title is a personal honor, they all emphasize that it is a professional point of pride to see just how far HM has come in the past 15 years.
"For the specialty, it brings identity and awareness of all that we do," Erin Stucky, MD, MHM, a pediatric hospitalist at Rady Children's Hospital in San Diego, wrote in an email. "We are QI in mortal form, acting and pressing on to deliver excellence in healthcare within our systems. Each of us, members of the society, those with FHM, SFHM, and MHM—we each deliver on this promise every day."
The other MHMs, each of whom spoke to The Hospitalist via email, are:
Ron Greeno, MD, MHM, chief medical officer for Cogent Healthcare and a member of SHM's Public Policy Committee. "I've had the privilege of working in hospital medicine for 18 years and, along with my colleagues at Cogent, have helped shape the field," Dr. Greeno says. "To be one of a handful of hospitalists to be named a Master in Hospital Medicine is truly exciting, but equally exciting is to see the growing leadership capabilities of a number of our younger colleagues who will become the future leaders of our specialty."
Russell L. Holman, MD, MHM, Cogent's COO and past president of SHM. "Our specialty is constantly evolving; there is no paved road before us," Dr. Holman says. "We are cutting the path, and are part of an historical transformation of the way care is provided in this country. Twenty years from now we will reflect on an enduring legacy of dramatically improving the quality, safety, and sustainability of care for hospitalized patients. The privilege of being part of this movement is rewarding and inspirational for me."
Mary Jo Gorman, MD, MBA, MHM, former SHM president and CEO of St. Louis-based Advanced ICU Care. "It is a terrific honor to be recognized by SHM in this way," Dr. Gorman says. "The group that is included has accomplished many things and it's gratifying to be recognized with them. It’s hard to believe that SHM has come so far that we have fellows and masters in the society! Those early days seem a long way away!"
SHM has now recognized seven MHMs. Last year's class consisted of Winthrop F. Whitcomb, MD, MHM, Robert Wachter, MD, MHM, and John Nelson, MD, MHM. Each is recognized for what SHM says is the "utmost demonstration of dedication to the field of hospital medicine through significant contributions to the development and maturation of the profession."
SHM will induct its second class of Masters in Hospital Medicine (MHM) at HM11 in May, and while each of the four honorees says the title is a personal honor, they all emphasize that it is a professional point of pride to see just how far HM has come in the past 15 years.
"For the specialty, it brings identity and awareness of all that we do," Erin Stucky, MD, MHM, a pediatric hospitalist at Rady Children's Hospital in San Diego, wrote in an email. "We are QI in mortal form, acting and pressing on to deliver excellence in healthcare within our systems. Each of us, members of the society, those with FHM, SFHM, and MHM—we each deliver on this promise every day."
The other MHMs, each of whom spoke to The Hospitalist via email, are:
Ron Greeno, MD, MHM, chief medical officer for Cogent Healthcare and a member of SHM's Public Policy Committee. "I've had the privilege of working in hospital medicine for 18 years and, along with my colleagues at Cogent, have helped shape the field," Dr. Greeno says. "To be one of a handful of hospitalists to be named a Master in Hospital Medicine is truly exciting, but equally exciting is to see the growing leadership capabilities of a number of our younger colleagues who will become the future leaders of our specialty."
Russell L. Holman, MD, MHM, Cogent's COO and past president of SHM. "Our specialty is constantly evolving; there is no paved road before us," Dr. Holman says. "We are cutting the path, and are part of an historical transformation of the way care is provided in this country. Twenty years from now we will reflect on an enduring legacy of dramatically improving the quality, safety, and sustainability of care for hospitalized patients. The privilege of being part of this movement is rewarding and inspirational for me."
Mary Jo Gorman, MD, MBA, MHM, former SHM president and CEO of St. Louis-based Advanced ICU Care. "It is a terrific honor to be recognized by SHM in this way," Dr. Gorman says. "The group that is included has accomplished many things and it's gratifying to be recognized with them. It’s hard to believe that SHM has come so far that we have fellows and masters in the society! Those early days seem a long way away!"
SHM has now recognized seven MHMs. Last year's class consisted of Winthrop F. Whitcomb, MD, MHM, Robert Wachter, MD, MHM, and John Nelson, MD, MHM. Each is recognized for what SHM says is the "utmost demonstration of dedication to the field of hospital medicine through significant contributions to the development and maturation of the profession."
In the Literature: Research You Need to Know
Clinical question: Are such alternatives as tiotropium bromide, a long-acting anticholinergic agent, effective in improving symptoms and lung function in those patients who are inadequately controlled on a low-dose inhaled glucocorticoid?
Background: Many asthmatics remain uncontrolled on low doses of inhaled glucocorticoid therapy. Treatment options include increasing the dose or adding a long-acting beta-agonist (LABA). Safety concerns, however, have emerged recently regarding LABA use. It is unclear whether the use of alternatives, such as anticholinergics, is beneficial in managing symptoms.
Study design: Double-blind, three-way crossover trial.
Setting: Multicenter study.
Synopsis: Researchers studied a total of 210 patients with uncontrolled asthma. Three treatments were used with low-dose inhaled glucocorticoids (beclomethasone) as a baseline: adding tiotropium, doubling the dose of inhaled glucocorticoids, or adding an LABA (salmeterol). Patients were treated in all three groups, each lasting 14 weeks with a two-week washout period between treatments (when only the baseline medication was used). The primary outcome measure was the morning peak expiratory flow (PEF).
When compared to doubling the inhaled glucocorticoid dose, patients receiving tiotropium had a higher morning PEF (25.8 liters, 95% CI 14.4-37.1, P<0.001). Tiotropium use also showed statistically significant improvement in the evening PEF, pre-bronchodilator FEV1, proportion of asthma control days, and scores for daily symptoms.
Tiotropium was found to be noninferior to salmeterol, including no difference in morning PEF. Other measurements were similar, except that pre-bronchodilator FEV1 favored tiotropium (0.11 liter increase, 95% CI 0.04-0.18, P=0.003). Because treatments did not last for more than 14 weeks, long-term safety issues and exacerbation rates could not be determined.
Bottom line: When added to a low-dose inhaled glucocorticoid, tiotropium improves asthma symptoms and lung function compared with doubling the corticosteroid dose and is noninferior when compared to a LABA.
Citation: Peters SP, Kunselman SJ, Icitovic N, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med. 2010;363(18):1715-1726.
Reviewed for TH eWire by Elizabeth Schulwolf, MD, MA, Sean Greenhalgh, MD, Aziz Ansari, DO, FHM, Nathan Derhammer, MD, FAAP, Paula Marfia, MD, Elizabeth Wantuch, MD, MS, Division of Hospital Medicine, Loyola University, Chicago.
For more physician reviews of HM-related research, visit our website.
Clinical question: Are such alternatives as tiotropium bromide, a long-acting anticholinergic agent, effective in improving symptoms and lung function in those patients who are inadequately controlled on a low-dose inhaled glucocorticoid?
Background: Many asthmatics remain uncontrolled on low doses of inhaled glucocorticoid therapy. Treatment options include increasing the dose or adding a long-acting beta-agonist (LABA). Safety concerns, however, have emerged recently regarding LABA use. It is unclear whether the use of alternatives, such as anticholinergics, is beneficial in managing symptoms.
Study design: Double-blind, three-way crossover trial.
Setting: Multicenter study.
Synopsis: Researchers studied a total of 210 patients with uncontrolled asthma. Three treatments were used with low-dose inhaled glucocorticoids (beclomethasone) as a baseline: adding tiotropium, doubling the dose of inhaled glucocorticoids, or adding an LABA (salmeterol). Patients were treated in all three groups, each lasting 14 weeks with a two-week washout period between treatments (when only the baseline medication was used). The primary outcome measure was the morning peak expiratory flow (PEF).
When compared to doubling the inhaled glucocorticoid dose, patients receiving tiotropium had a higher morning PEF (25.8 liters, 95% CI 14.4-37.1, P<0.001). Tiotropium use also showed statistically significant improvement in the evening PEF, pre-bronchodilator FEV1, proportion of asthma control days, and scores for daily symptoms.
Tiotropium was found to be noninferior to salmeterol, including no difference in morning PEF. Other measurements were similar, except that pre-bronchodilator FEV1 favored tiotropium (0.11 liter increase, 95% CI 0.04-0.18, P=0.003). Because treatments did not last for more than 14 weeks, long-term safety issues and exacerbation rates could not be determined.
Bottom line: When added to a low-dose inhaled glucocorticoid, tiotropium improves asthma symptoms and lung function compared with doubling the corticosteroid dose and is noninferior when compared to a LABA.
Citation: Peters SP, Kunselman SJ, Icitovic N, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med. 2010;363(18):1715-1726.
Reviewed for TH eWire by Elizabeth Schulwolf, MD, MA, Sean Greenhalgh, MD, Aziz Ansari, DO, FHM, Nathan Derhammer, MD, FAAP, Paula Marfia, MD, Elizabeth Wantuch, MD, MS, Division of Hospital Medicine, Loyola University, Chicago.
For more physician reviews of HM-related research, visit our website.
Clinical question: Are such alternatives as tiotropium bromide, a long-acting anticholinergic agent, effective in improving symptoms and lung function in those patients who are inadequately controlled on a low-dose inhaled glucocorticoid?
Background: Many asthmatics remain uncontrolled on low doses of inhaled glucocorticoid therapy. Treatment options include increasing the dose or adding a long-acting beta-agonist (LABA). Safety concerns, however, have emerged recently regarding LABA use. It is unclear whether the use of alternatives, such as anticholinergics, is beneficial in managing symptoms.
Study design: Double-blind, three-way crossover trial.
Setting: Multicenter study.
Synopsis: Researchers studied a total of 210 patients with uncontrolled asthma. Three treatments were used with low-dose inhaled glucocorticoids (beclomethasone) as a baseline: adding tiotropium, doubling the dose of inhaled glucocorticoids, or adding an LABA (salmeterol). Patients were treated in all three groups, each lasting 14 weeks with a two-week washout period between treatments (when only the baseline medication was used). The primary outcome measure was the morning peak expiratory flow (PEF).
When compared to doubling the inhaled glucocorticoid dose, patients receiving tiotropium had a higher morning PEF (25.8 liters, 95% CI 14.4-37.1, P<0.001). Tiotropium use also showed statistically significant improvement in the evening PEF, pre-bronchodilator FEV1, proportion of asthma control days, and scores for daily symptoms.
Tiotropium was found to be noninferior to salmeterol, including no difference in morning PEF. Other measurements were similar, except that pre-bronchodilator FEV1 favored tiotropium (0.11 liter increase, 95% CI 0.04-0.18, P=0.003). Because treatments did not last for more than 14 weeks, long-term safety issues and exacerbation rates could not be determined.
Bottom line: When added to a low-dose inhaled glucocorticoid, tiotropium improves asthma symptoms and lung function compared with doubling the corticosteroid dose and is noninferior when compared to a LABA.
Citation: Peters SP, Kunselman SJ, Icitovic N, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med. 2010;363(18):1715-1726.
Reviewed for TH eWire by Elizabeth Schulwolf, MD, MA, Sean Greenhalgh, MD, Aziz Ansari, DO, FHM, Nathan Derhammer, MD, FAAP, Paula Marfia, MD, Elizabeth Wantuch, MD, MS, Division of Hospital Medicine, Loyola University, Chicago.
For more physician reviews of HM-related research, visit our website.
NCCN Upgrades Rituximab Regimens for Follicular Lymphoma
HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.
Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.
At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:
Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.
The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).
"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.
Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.
Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.
The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).
"Unfortunately, neither study was associated with improvement in overall survival," he said.
PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).
In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.
Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.
The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.
NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."
Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.
positron emission tomography, posttransplant lymphoproliferative disorder, PTLD, Dr. Andrew D. Zelenetz, Memorial Sloan-Kettering Cancer Center, Rituximab, bendamustine, R-CHOP
HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.
Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.
At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:
Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.
The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).
"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.
Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.
Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.
The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).
"Unfortunately, neither study was associated with improvement in overall survival," he said.
PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).
In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.
Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.
The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.
NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."
Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.
HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.
Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.
At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:
Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.
The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).
"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.
Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.
Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.
The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).
"Unfortunately, neither study was associated with improvement in overall survival," he said.
PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).
In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.
Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.
The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.
NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."
Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.
positron emission tomography, posttransplant lymphoproliferative disorder, PTLD, Dr. Andrew D. Zelenetz, Memorial Sloan-Kettering Cancer Center, Rituximab, bendamustine, R-CHOP
positron emission tomography, posttransplant lymphoproliferative disorder, PTLD, Dr. Andrew D. Zelenetz, Memorial Sloan-Kettering Cancer Center, Rituximab, bendamustine, R-CHOP
FROM THE ANNUAL CONFERENCE OF THE NATIONAL COMPREHENSIVE CANCER NETWORK
Touchscreen Medicine
Mobile technology, such as tablet computers, Internet-enabled smartphones, and the applications both devices use, will change the face of HM and other physician specialties, one medical software executive says.
"Mobile technology will improve efficiency and reduce costs," Mark Cain, chief technology officer of MIM Software Inc., writes in an e-mail to The Hospitalist. "Compare the cost of an iPad to that of an exam room PC. If I was making the decision, I'd find a way to remove every exam room PC [with their keyboards, CPUs, mice, monitors, and network cables] and instead supply iPads to be carried by the staff. With a good Wi-Fi network and iPads, every room is digitally equipped as soon as the doctor walks in."
Cain has seen the paradigm shift of touchscreen technology firsthand: The FDA recently approved an application from Cleveland-based MIM to let doctors make medical diagnoses based on computed tomography (CT) and magnetic resonance imaging (MRI) via an application available for the iPhone and iPad. The application, the first with the FDA's imprimatur for diagnostic radiology, allows hospitalists and other physicians to access data via a secure network transfer.
The app for that is just the latest sign that the growing prevalence of touchscreen technology is changing the face of HM.
The evolution has its pitfalls, though. Patient privacy, wireless security, and the hesitancy of physicians to adopt change will likely slow the adoption of technology, but "the integration of interactive devices into a physician's daily workflow could become as commonplace in 10 years as the presence of hospitalists is today," Cain says.
Mobile technology, such as tablet computers, Internet-enabled smartphones, and the applications both devices use, will change the face of HM and other physician specialties, one medical software executive says.
"Mobile technology will improve efficiency and reduce costs," Mark Cain, chief technology officer of MIM Software Inc., writes in an e-mail to The Hospitalist. "Compare the cost of an iPad to that of an exam room PC. If I was making the decision, I'd find a way to remove every exam room PC [with their keyboards, CPUs, mice, monitors, and network cables] and instead supply iPads to be carried by the staff. With a good Wi-Fi network and iPads, every room is digitally equipped as soon as the doctor walks in."
Cain has seen the paradigm shift of touchscreen technology firsthand: The FDA recently approved an application from Cleveland-based MIM to let doctors make medical diagnoses based on computed tomography (CT) and magnetic resonance imaging (MRI) via an application available for the iPhone and iPad. The application, the first with the FDA's imprimatur for diagnostic radiology, allows hospitalists and other physicians to access data via a secure network transfer.
The app for that is just the latest sign that the growing prevalence of touchscreen technology is changing the face of HM.
The evolution has its pitfalls, though. Patient privacy, wireless security, and the hesitancy of physicians to adopt change will likely slow the adoption of technology, but "the integration of interactive devices into a physician's daily workflow could become as commonplace in 10 years as the presence of hospitalists is today," Cain says.
Mobile technology, such as tablet computers, Internet-enabled smartphones, and the applications both devices use, will change the face of HM and other physician specialties, one medical software executive says.
"Mobile technology will improve efficiency and reduce costs," Mark Cain, chief technology officer of MIM Software Inc., writes in an e-mail to The Hospitalist. "Compare the cost of an iPad to that of an exam room PC. If I was making the decision, I'd find a way to remove every exam room PC [with their keyboards, CPUs, mice, monitors, and network cables] and instead supply iPads to be carried by the staff. With a good Wi-Fi network and iPads, every room is digitally equipped as soon as the doctor walks in."
Cain has seen the paradigm shift of touchscreen technology firsthand: The FDA recently approved an application from Cleveland-based MIM to let doctors make medical diagnoses based on computed tomography (CT) and magnetic resonance imaging (MRI) via an application available for the iPhone and iPad. The application, the first with the FDA's imprimatur for diagnostic radiology, allows hospitalists and other physicians to access data via a secure network transfer.
The app for that is just the latest sign that the growing prevalence of touchscreen technology is changing the face of HM.
The evolution has its pitfalls, though. Patient privacy, wireless security, and the hesitancy of physicians to adopt change will likely slow the adoption of technology, but "the integration of interactive devices into a physician's daily workflow could become as commonplace in 10 years as the presence of hospitalists is today," Cain says.
C. Diff Rates Rise for Hospitalized Children
An article in the upcoming May issue of Archives of Pediatrics and Adolescent Medicine tracks the growing incidence of Clostridium difficile bacterial infections in hospitalized children.
Cade M. Nylund, MD, assistant professor of pediatrics at the Uniformed Services University of the Health Sciences in Bethesda, Md., and colleagues analyzed a national database of children discharged from hospitals in 1997, 2000, 2003, and 2006. Of 10.5 million total cases, only 0.2% had C. diff infections, but the number of cases increased by about 15% per year.
Incidence, severity, and deaths from C. diff in adults have also been increasing. Unlike adults, however, the authors did not observe an increase in severity of the disease for children over this time period. Infection, however, was associated with increased risk of death, higher colectomy rates, longer hospital stays, and higher costs.
Dr. Nylund says it is difficult to explain why is increasing in hospitalized children, but it might reflect antibiotic treatment practices, since prior antibiotic exposure is considered a risk factor. It also could be due to a more virulent strain of C. diff commonly found in hospitals, or the fact that healthcare providers are more aware of the need to test symptomatic patients for this infection.
According to Dr. Nylund, pediatric hospitalists should be aware of the significant impact of C. diff. "These children are more likely to stay in the hospital or die," he says. He suggests paying attention to such risk factors as antibiotic use, immune system suppression, and persistent diarrhea, as well as the need for a differential diagnosis. Appropriate and early isolation is important, as is hand-washing with soap and water, not using just alcohol-based hand gels, he adds.
"A lot of antibiotics are used to treat C. diff, some of them off-label," Dr. Nylund says. "I get phone consults, typically for difficult, recurring, and chronic cases. It seems like I'm receiving those calls more frequently."
For more information on treatment of C. diff, check out the Key Clinical Question in the March 2009 issue of The Hospitalist.
An article in the upcoming May issue of Archives of Pediatrics and Adolescent Medicine tracks the growing incidence of Clostridium difficile bacterial infections in hospitalized children.
Cade M. Nylund, MD, assistant professor of pediatrics at the Uniformed Services University of the Health Sciences in Bethesda, Md., and colleagues analyzed a national database of children discharged from hospitals in 1997, 2000, 2003, and 2006. Of 10.5 million total cases, only 0.2% had C. diff infections, but the number of cases increased by about 15% per year.
Incidence, severity, and deaths from C. diff in adults have also been increasing. Unlike adults, however, the authors did not observe an increase in severity of the disease for children over this time period. Infection, however, was associated with increased risk of death, higher colectomy rates, longer hospital stays, and higher costs.
Dr. Nylund says it is difficult to explain why is increasing in hospitalized children, but it might reflect antibiotic treatment practices, since prior antibiotic exposure is considered a risk factor. It also could be due to a more virulent strain of C. diff commonly found in hospitals, or the fact that healthcare providers are more aware of the need to test symptomatic patients for this infection.
According to Dr. Nylund, pediatric hospitalists should be aware of the significant impact of C. diff. "These children are more likely to stay in the hospital or die," he says. He suggests paying attention to such risk factors as antibiotic use, immune system suppression, and persistent diarrhea, as well as the need for a differential diagnosis. Appropriate and early isolation is important, as is hand-washing with soap and water, not using just alcohol-based hand gels, he adds.
"A lot of antibiotics are used to treat C. diff, some of them off-label," Dr. Nylund says. "I get phone consults, typically for difficult, recurring, and chronic cases. It seems like I'm receiving those calls more frequently."
For more information on treatment of C. diff, check out the Key Clinical Question in the March 2009 issue of The Hospitalist.
An article in the upcoming May issue of Archives of Pediatrics and Adolescent Medicine tracks the growing incidence of Clostridium difficile bacterial infections in hospitalized children.
Cade M. Nylund, MD, assistant professor of pediatrics at the Uniformed Services University of the Health Sciences in Bethesda, Md., and colleagues analyzed a national database of children discharged from hospitals in 1997, 2000, 2003, and 2006. Of 10.5 million total cases, only 0.2% had C. diff infections, but the number of cases increased by about 15% per year.
Incidence, severity, and deaths from C. diff in adults have also been increasing. Unlike adults, however, the authors did not observe an increase in severity of the disease for children over this time period. Infection, however, was associated with increased risk of death, higher colectomy rates, longer hospital stays, and higher costs.
Dr. Nylund says it is difficult to explain why is increasing in hospitalized children, but it might reflect antibiotic treatment practices, since prior antibiotic exposure is considered a risk factor. It also could be due to a more virulent strain of C. diff commonly found in hospitals, or the fact that healthcare providers are more aware of the need to test symptomatic patients for this infection.
According to Dr. Nylund, pediatric hospitalists should be aware of the significant impact of C. diff. "These children are more likely to stay in the hospital or die," he says. He suggests paying attention to such risk factors as antibiotic use, immune system suppression, and persistent diarrhea, as well as the need for a differential diagnosis. Appropriate and early isolation is important, as is hand-washing with soap and water, not using just alcohol-based hand gels, he adds.
"A lot of antibiotics are used to treat C. diff, some of them off-label," Dr. Nylund says. "I get phone consults, typically for difficult, recurring, and chronic cases. It seems like I'm receiving those calls more frequently."
For more information on treatment of C. diff, check out the Key Clinical Question in the March 2009 issue of The Hospitalist.