Endo 2011

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.

BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.

Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.

According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.

The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.

Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).

Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).

"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.

Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.