Heidi Splete

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

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Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

View on the News

Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Memantine might improve behavioral symptoms and reduce brain deterioration in patients with mild to moderate Lewy body dementia, but not Parkinson's disease dementia, data from a randomized, placebo-controlled trial show.

The higher amount of Alzheimer's disease–like amyloid pathology that is normally observed in patients with dementia with Lewy bodies (DLB) might explain why the drug appears to provide symptomatic relief to that group but not to patients with Parkinson's disease dementia (PDD), in whom amyloid pathology is encountered less often, Dr. Murat Emre of Istanbul (Turkey) University and his colleagues reported online.

Dr. Emre and his coauthors conducted the study of memantine, which is approved in the United States for treating moderate to severe Alzheimer's disease, because previous studies had suggested that the drug might yield similar benefits in patients with Lewy body–related dementias such as PDD or DLB, which have some overlap in pathology.

The researchers randomized 78 patients with DLB and 121 patients with PDD to a 20-mg dose of memantine once daily or a placebo. Concomitant use of cholinesterase inhibitors was not allowed (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70194-0]).

Patients were assessed when they were screened, at baseline, and at weeks 4, 12, 16, and 24. The study included patients from 30 sites in Austria, France, Germany, Greece, Italy, Spain, Turkey, and the United Kingdom.

In DLB patients, memantine significantly improved scores on the ADCS-CGIC (Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change) scale from baseline to 24 weeks, compared with placebo (mean change from baseline, 3.3 vs. 3.9, respectively). In addition, NPI (Neuropsychiatry Inventory) scores improved significantly more from baseline to 24 weeks in memantine-treated patients than in placebo-treated patients.

Among PDD patients, memantine did not significantly change scores with either measurement, compared with placebo. “Memantine might exert stronger beneficial effects in patients with more prominent Alzheimer's disease–type pathology,” the investigators wrote. The differences in effects between DLB and PDD patients also could be accounted for by the range in symptoms and in concomitant drug use between these two patient populations, they added.

Disclosures: The study was funded by Lundbeck, a maker and distributor of memantine. Dr. Emre and some of his coauthors disclosed financial relationships with Lundbeck and other pharmaceutical companies. One author is an employee of Lundbeck.

View on the News

Hopeful Results

The study by Dr. Emre raises the possibility that memantine could improve global function by improving mood symptoms.

More research is needed, but memantine could be part of a plan to manage DLB and PDD symptoms until definitive cognitive therapies are developed.

LAURA MARSH, M.D., is from Baylor College of Medicine in Houston. Her comments are paraphrased from an editorial (Lancet Neurology 2010 Aug. 23 [doi:10.1016/S1474-4422(10)70208-8]). Dr. Marsh has received funding from Forest Research Institute to study the effects of memantine on the treatment of dementia in Parkinson's ddisease.

Vitals

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

Only one in four women diagnosed with breast cancer in the 1940s was alive 10 years later, compared with three of four women diagnosed in recent years, based on data gathered over a 6-decade period at a single institution.

Overall, the 10-year survival rate for all types of breast cancer improved significantly over 60 years, from 25% between 1944 and 1954, to 77% between 1995 and 2004. This improvement is because of earlier disease detection and a multimodal approach to managing and treating patients with different stages of breast cancer, Dr. Aman Buzdar, the study’s lead author, reported Sept. 29.

The goal of the study was to quantify the steady improvements in breast cancer survival rates over the past 6 decades in patients seen at the MD Anderson Cancer Center in Houston. Dr. Buzdar said he believes that the survival rates seen at MD Anderson are generalizable to survival rates at smaller regional hospitals and community cancer centers, given the rapid adoption of the multimodal treatment model and new therapies.

“If patients are appropriately managed, they have a much better chance of surviving breast cancer today than they would have had 30 or 20 or even 10 years ago, because the therapies are constantly evolving and improving,” Dr. Buzdar, professor of medicine and breast medical oncology at the center, said in a written statement. Therefore, if the approaches used at MD Anderson are applied in the community, similar outcomes can be achieved, he said during a press briefing sponsored by the American Society of Clinical Oncology.

Dr. Buzdar and his colleagues reviewed the center’s detailed database on breast cancer patients dating back to the 1940s. The database included approximately 57,000 breast cancer patients seen between 1944 and 2004. The review included 12,809 patients who had their diagnoses established and treatments initiated at MD Anderson.

Ten-year survival rates improved significantly from the 1944-1954 period to the 1995-2004 period: For local breast cancer, the rates rose from 55% to 86% and for regional breast cancer they increased from 16% to 76%. The survival rate for metastatic disease improved from 3% to 22%.

Disclosures: Dr. Buzdar said he had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

A uterus-sparing therapy that combines delivery of progesterone via an intrauterine device with injections of gonadotropin-releasing hormone appears to have preserved fertility in a majority of women treated for early endometrial cancer in a small prospective study.

Data on 34 patients younger than 43 years were published online Sept. 28 in the Annals of Oncology.

Previous studies had examined oral progestins as fertility-preserving therapies for younger women with atypical endometrial hyperplasia (AEH) and endometrial cancer, but neither the dose nor the schedule were standardized, said Dr. Lucas Minig of Hospital Universitario Madrid Norte Sanchinarro in Madrid, Spain, and coauthors.

In this study, Dr. Minig and colleagues tested the combination of a levonorgestrel-release intrauterine device (Mirena) and a gonadotropin-releasing hormone (GnRH) analog as a fertility-preserving treatment for AEH and well-differentiated endometrial cancer (EC-G1). “The progesterone-releasing intrauterine device (IUD) is a newly available delivery system for treatment of estrogen-dependent endometrial cancer,” the researchers said.

A total of 43 patients were selected between January 1996 and June 2009. Three patients dropped out, and five remain under treatment, leaving 20 women with AEH and 14 with EC-G1 in the current analysis. They received 20 mcg of levonorgestrel released daily by the IUD for up to 5 years and monthly depot injections of 3.75 mg of the GnRH for 6 months. The IUDs were removed after 1 year.

After 1 year of treatment, the complete response rate was 95% in the AEH patients and 57% in the EC-G1 patients, with 19 of 20 patients and 8 of 14 patients, respectively, responding in each group. Disease progression was noted in one AEH patient (5%) and four EC-G1 patients (28%).

Recurrence of disease occurred in 4 AEH patients and 2 EC-GI patients after an average of 36 months. They were staged surgically and received adjuvant chemotherapy and/or radiation. With the exception of one patient lost to follow-up, all were alive and disease free at last follow-up.

The researchers noted no major side effects or complications caused by the IUD-delivered hormonal treatment.

Of the 27 patients who had a complete response, 9 achieved 11 spontaneous pregnancies after their IUDs were removed. Seven of these had reached full term at the time of the report, and two ended in miscarriages.

The average age of the women was 34 years, and the median follow-up time was 29 months. Prior to the study, five women (14%) were diagnosed with concomitant early-stage ovarian cancer, but none of these patients underwent adjuvant chemotherapy, and two of them had full-term pregnancies (Ann. Onc. 2010 Sept. 28 [doi:10.1093/annonc/mdq463]).

The study was limited by its small size, but the trial is the first known to test the combination of IUD and GnRH in women with endometrial cancer who want to preserve fertility, the researchers noted. Longer follow-up data are needed to reinforce the findings, but the results suggest that the treatment can be effective in some patients. However, “given the risks of disease progression or relapse, only those patients with significant expected benefit from uterine retention should be considered and then only following an adequate pretreatment evaluation,” the researchers said.

Disclosures: The researchers said they had no financial conflicts to disclose.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.

Patients with systemic sclerosis have about a 55% chance of dying from their disease. Specifically, more than half of systemic sclerosis deaths are caused by pulmonary fibrosis, pulmonary arterial hypertension, and heart-related problems that are attributable to the disease, according to an analysis of data from an international registry.

The findings were published in the October issue of the Annals of the Rheumatic Diseases.

The overall mortality from systemic sclerosis (SSc) remains high, wrote Dr. Anthony J. Tyndall of the department of rheumatology at the University of Basel (Switzerland) and colleagues. To identify the causes and predictors of death in SSc patients, the researchers reviewed data from 5,860 adults who were enrolled in the EULAR Scleroderma Trial and Research Database (EUSTAR) database between 2004 and 2008. In all, 284 deaths were reported during the study period. Complete data were available for 234 deaths via questionnaires completed by the medical centers that reported a death in an SSc patient (Ann. Rheum. Dis. 2010;69:1809-15).

More than half (55%) of the deaths were directly attributable to SSc. Another 41% of deaths were not related to SSc, and the cause of death was not known in the remaining 4%.

Pulmonary fibrosis was the most common cause of death in SSc deaths (19%), followed by pulmonary arterial hypertension (14%) and myocardial causes (14%). Most myocardial causes were attributed to arrhythmia. Another 4% of SSc deaths were caused by renal crises.

These findings contrast with data from other autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis, in which clinically overt myocardial infarctions are more common causes of death, the researchers noted.

The main causes of death that were not related to SSc were infections (33%), malignancies (31%), and cardiovascular causes (29%). However, 25% of the patients who died of non-SSc causes had SSc-related comorbidities that likely contributed to their deaths, the researchers noted. These comorbidities included pneumonia, sepsis, and gastrointestinal hemorrhage. If these cases were added to the deaths directly caused by SSc, “the disease-related death toll would be as high as 65%,” the researchers said.

The average age of patients entering the study was 57 years, and 80% were women.

After control for multiple variables, the independent predictors of death in SSc patients included proteinuria, pulmonary arterial hypertension (PAH), forced vital capacity (FVC) less than 80% of normal, shortness of breath on exertion, reduced diffusing capacity of the lung for carbon monoxide (DLCO), and older age at onset of SSc (defined by the first signs of Raynaud’s phenomenon and modified Rodnan skin scores).

Sex was not an independent predictor of death in this study, but the researchers said that the effect of sex can be accounted for by the other variables.

The study was limited by possible biases in the coding of death certificates, but the findings support data from previous studies showing PAH and pulmonary restriction as independent risk factors for mortality in SSc patients, the researchers noted.

“The EUSTAR figures presented here are useful in estimating the number of patients that need to be included in clinical trials that investigate survival as an end point,” they said.

The researchers had no financial conflicts to disclose. EUSTAR exists under the auspices of the EULAR Standing Committee for Clinical Affairs and is funded by a research grant from EULAR.

Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.

"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."

The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.

Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.

It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.

Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.

One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.

The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.

Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.

Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.

Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.

"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."

The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.

Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.

It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.

Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.

One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.

The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.

Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.

Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.

Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.

"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."

The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.

Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.

It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.

Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.

One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.

The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.

Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.

Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.

Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.

The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.

Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.

The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.

The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.

“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).

Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.

The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.

These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.

Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.

When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.

Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.

Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.

“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.

The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.

The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.

The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.

“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.

The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.

The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.

Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.

Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).

Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).

“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.

The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.

Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.

Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.

Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.

Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.

Disclosures: The researchers had no financial conflicts to disclose.

Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.

Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.

Disclosures: The researchers had no financial conflicts to disclose.

Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.

Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.

Disclosures: The researchers had no financial conflicts to disclose.

Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.

Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.

Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.

CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.

Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.

In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m

The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.

The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.

Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.

Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.

Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.

Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.

Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.

CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.

Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.

In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m

The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.

The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.

Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.

Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.

Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.

Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.

Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.

CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.

Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.

In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m

The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.

The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.

Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.

Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.

Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.

Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.

Disclosures: The researchers said they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.

Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.

Disclosures: The researchers said they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.

Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.

Disclosures: The researchers said they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.