Widower denies suicidal thoughts in hospital, but acts on them at home

DuPage County (IL) Circuit Court

A 77-year-old man was hospitalized after complaining of chest pain. He reported attempting suicide the night before by taking pills. His wife had died 5 months previously.

When the psychiatrist evaluated the patient the next day, the patient assured him that he was no longer suicidal, refused inpatient admission, but agreed to enter outpatient therapy. The patient repeated this intent to the hospital social worker.

The psychiatrist arranged visits by a home health care nurse. The patient was discharged after a 2-day stay, and the nurse visited the following day. The patient assured the nurse that he was not suicidal and called the psychiatrist to make an appointment for the next week. Two days later, the patient stabbed himself to death at home.

The estate claimed the psychiatrist should have kept the patient hospitalized. The psychiatrist claimed that involuntary admission was not possible because the patient was not dangerous to himself or others. The patient’s toxicology screen was negative except for his prescription drugs.

• The jury decided for the defense
  

Alcoholic promises to attend AA, but takes his life on Christmas Day

Davidson County (TN) Circuit Court

A 44-year-old man with a long history of alcohol abuse and failed rehabilitation was involuntarily admitted to a hospital after threatening suicide. His blood alcohol level was 0.393, and he had threatened suicide at the same facility 8 months before. A court order gave the hospital authority to involuntarily detain him until a hearing the following week.

The next day, the patient was transferred from the detoxification center to the psychiatric unit and evaluated by the psychiatrist. The patient disavowed suicidal thoughts, and the psychiatrist discharged the patient the following day (Christmas Eve, 48 hours after admission). The psychiatrist based this decision partially on the patient’s promise to enter inpatient alcohol treatment and attend an Alcoholics Anonymous meeting within 2 days.

On Christmas Day, the patient shot himself and died. His blood alcohol content at the time of death was 0.303.

The patient’s estate charged that the final discharge was negligent, the discharge instructions were inadequate, and the psychiatrist and hospital’s assessments were inaccurate.

The hospital argued that it deferred to the psychiatrist in the discharge decision. The psychiatrist argued that state law defined holding an individual without “immediate risk of substantial harm” as a felony.

• The jury decided in favor of the defendant psychiatrist. A directed verdict was granted for the hospital.
  

Plaintiff: Discharge led to hemiplegia

Broward County (FL) Circuit Court

Police took into custody a 27-year-old woman who had been wandering a public road, apparently under the influence of illegal substances. The officers transported her to a hospital, where the emergency room staff admitted her for psychiatric evaluation.

The psychiatrist determined that involuntary admission was not appropriate. When the patient refused the psychiatrist’s recommendation for voluntary admission, she was discharged.

The patient then went to her mother’s house, began drinking, and became combative. She started brandishing a rifle. The next day, the weapon discharged and a bullet lodged in her spine at the L2 vertebra. The patient is now hemiplegic and has no bladder or bowel control. She alleged that the hospital and psychiatrist were negligent in not admitting her.

• The hospital reached a $50,000 settlement before trial; the jury returned a $190,007 award, with 90% of fault apportioned to the plaintiff and 10% to the psychiatrist. After setoffs, the plaintiff’s net award was $80.
  

Dr. Grant’s observations

These cases illustrate suicide risk factors psychiatrists must consider even when a patient denies suicidal thoughts or intent. Suicide risk factors these patients showed include:

• recent discharge from psychiatric facilities¹
  
• recent suicide attempt with fairly high lethality potential (overdosing on pills)
  
• depressive turmoil and psychological isolation (recent loss of spouse)
  
• older widowed male^2-3
  
• history of dangerous behavior when intoxicated⁴
  
• possible “holiday effect.”⁵
  

These cases reflect one of psychiatry’s more troubling job requirements: assessing whether a patient is safe to discharge or should be admitted involuntarily. Such situations force us to balance the civil liberties of the mentally ill with our responsibility to care for those who lack insight into their illnesses. This tension often weighs heavily on psychiatrists⁶ and is, unfortunately, rather common. A study at one hospital found that approximately 8.5% of emergency department visits resulted in involuntary admission.⁷

As the verdicts in these cases suggest, the legal system recognizes that psychiatrists cannot predict suicide.⁸ Mistakes in clinical judgment are not the same as negligence, however, and failure to assess suicide risk or intervene appropriately for the level of risk may result in successful negligence claims.

 

Standards for emergency short-term hospitalization vary from state to state, so familiarize yourself with your state’s standards. Although one standard for involuntary admission is often imminent threat of harm to self, do not base the threat of danger only on a patient’s self-report. One study of patients who committed suicide while hospitalized found that 78% denied suicidal thoughts at their last communication.⁹ However, “locking up” suicidal patients to prevent a malpractice suit is equally inappropriate.

Assess suicide risk during a thoroughly documented psychiatric examination with particular attention to the patient’s history of suicidal behavior. Record details of the assessment in the patient’s chart (Table) at the time of evaluation, and document how these clinical factors influence your final decision.

Involuntary hospitalization provides the immediate benefit of supervision in a safe environment, and patients can gain short-term therapeutic benefits from inpatient treatment whether or not the admission was voluntary.¹⁰ Patients may eventually recognize admission was helpful, but their attitudes about the process often do not become more positive. To ease the stress of involuntary admission:

• acknowledge the patient’s disapproval
  
• tell the patient why he’s being hospitalized
  
• inform the patient about his or her legal rights.
  

Carry out this discussion with respect for the patient’s dignity and wishes.

Table

Documenting suicide risk assessment

Include in patient’s chart…	Examples…
Short-term factors	Current suicidal ideation/plan, lethality potential, current stressors (bereavement, illness, loss of job), recent discharge from a psychiatric facility, time of year (holiday effect, anniversaries)
Long-term factors	History of suicidal behavior/attempts, personality factors (agitation, hopelessness), gender, age, marital status, substance abuse history, psychiatric illness (depression, bipolar disorder, schizophrenia)
Appropriate psychiatric interventions based on the assessed degree of risk	Involuntary admission, intensive monitoring, outpatient visits, home healthcare nursing, residential placement, substance abuse treatment
Sources of information used	Medical records, patient self-report, family report, observation

Widower denies suicidal thoughts in hospital, but acts on them at home

DuPage County (IL) Circuit Court

A 77-year-old man was hospitalized after complaining of chest pain. He reported attempting suicide the night before by taking pills. His wife had died 5 months previously.

When the psychiatrist evaluated the patient the next day, the patient assured him that he was no longer suicidal, refused inpatient admission, but agreed to enter outpatient therapy. The patient repeated this intent to the hospital social worker.

The psychiatrist arranged visits by a home health care nurse. The patient was discharged after a 2-day stay, and the nurse visited the following day. The patient assured the nurse that he was not suicidal and called the psychiatrist to make an appointment for the next week. Two days later, the patient stabbed himself to death at home.

The estate claimed the psychiatrist should have kept the patient hospitalized. The psychiatrist claimed that involuntary admission was not possible because the patient was not dangerous to himself or others. The patient’s toxicology screen was negative except for his prescription drugs.

• The jury decided for the defense
  

Alcoholic promises to attend AA, but takes his life on Christmas Day

Davidson County (TN) Circuit Court

A 44-year-old man with a long history of alcohol abuse and failed rehabilitation was involuntarily admitted to a hospital after threatening suicide. His blood alcohol level was 0.393, and he had threatened suicide at the same facility 8 months before. A court order gave the hospital authority to involuntarily detain him until a hearing the following week.

The next day, the patient was transferred from the detoxification center to the psychiatric unit and evaluated by the psychiatrist. The patient disavowed suicidal thoughts, and the psychiatrist discharged the patient the following day (Christmas Eve, 48 hours after admission). The psychiatrist based this decision partially on the patient’s promise to enter inpatient alcohol treatment and attend an Alcoholics Anonymous meeting within 2 days.

On Christmas Day, the patient shot himself and died. His blood alcohol content at the time of death was 0.303.

The patient’s estate charged that the final discharge was negligent, the discharge instructions were inadequate, and the psychiatrist and hospital’s assessments were inaccurate.

The hospital argued that it deferred to the psychiatrist in the discharge decision. The psychiatrist argued that state law defined holding an individual without “immediate risk of substantial harm” as a felony.

• The jury decided in favor of the defendant psychiatrist. A directed verdict was granted for the hospital.
  

Plaintiff: Discharge led to hemiplegia

Broward County (FL) Circuit Court

Police took into custody a 27-year-old woman who had been wandering a public road, apparently under the influence of illegal substances. The officers transported her to a hospital, where the emergency room staff admitted her for psychiatric evaluation.

The psychiatrist determined that involuntary admission was not appropriate. When the patient refused the psychiatrist’s recommendation for voluntary admission, she was discharged.

The patient then went to her mother’s house, began drinking, and became combative. She started brandishing a rifle. The next day, the weapon discharged and a bullet lodged in her spine at the L2 vertebra. The patient is now hemiplegic and has no bladder or bowel control. She alleged that the hospital and psychiatrist were negligent in not admitting her.

• The hospital reached a $50,000 settlement before trial; the jury returned a $190,007 award, with 90% of fault apportioned to the plaintiff and 10% to the psychiatrist. After setoffs, the plaintiff’s net award was $80.
  

Dr. Grant’s observations

These cases illustrate suicide risk factors psychiatrists must consider even when a patient denies suicidal thoughts or intent. Suicide risk factors these patients showed include:

• recent discharge from psychiatric facilities¹
  
• recent suicide attempt with fairly high lethality potential (overdosing on pills)
  
• depressive turmoil and psychological isolation (recent loss of spouse)
  
• older widowed male^2-3
  
• history of dangerous behavior when intoxicated⁴
  
• possible “holiday effect.”⁵
  

These cases reflect one of psychiatry’s more troubling job requirements: assessing whether a patient is safe to discharge or should be admitted involuntarily. Such situations force us to balance the civil liberties of the mentally ill with our responsibility to care for those who lack insight into their illnesses. This tension often weighs heavily on psychiatrists⁶ and is, unfortunately, rather common. A study at one hospital found that approximately 8.5% of emergency department visits resulted in involuntary admission.⁷

As the verdicts in these cases suggest, the legal system recognizes that psychiatrists cannot predict suicide.⁸ Mistakes in clinical judgment are not the same as negligence, however, and failure to assess suicide risk or intervene appropriately for the level of risk may result in successful negligence claims.

 

Standards for emergency short-term hospitalization vary from state to state, so familiarize yourself with your state’s standards. Although one standard for involuntary admission is often imminent threat of harm to self, do not base the threat of danger only on a patient’s self-report. One study of patients who committed suicide while hospitalized found that 78% denied suicidal thoughts at their last communication.⁹ However, “locking up” suicidal patients to prevent a malpractice suit is equally inappropriate.

Assess suicide risk during a thoroughly documented psychiatric examination with particular attention to the patient’s history of suicidal behavior. Record details of the assessment in the patient’s chart (Table) at the time of evaluation, and document how these clinical factors influence your final decision.

Involuntary hospitalization provides the immediate benefit of supervision in a safe environment, and patients can gain short-term therapeutic benefits from inpatient treatment whether or not the admission was voluntary.¹⁰ Patients may eventually recognize admission was helpful, but their attitudes about the process often do not become more positive. To ease the stress of involuntary admission:

• acknowledge the patient’s disapproval
  
• tell the patient why he’s being hospitalized
  
• inform the patient about his or her legal rights.
  

Carry out this discussion with respect for the patient’s dignity and wishes.

Table

Documenting suicide risk assessment

Include in patient’s chart…	Examples…
Short-term factors	Current suicidal ideation/plan, lethality potential, current stressors (bereavement, illness, loss of job), recent discharge from a psychiatric facility, time of year (holiday effect, anniversaries)
Long-term factors	History of suicidal behavior/attempts, personality factors (agitation, hopelessness), gender, age, marital status, substance abuse history, psychiatric illness (depression, bipolar disorder, schizophrenia)
Appropriate psychiatric interventions based on the assessed degree of risk	Involuntary admission, intensive monitoring, outpatient visits, home healthcare nursing, residential placement, substance abuse treatment
Sources of information used	Medical records, patient self-report, family report, observation

Widower denies suicidal thoughts in hospital, but acts on them at home

DuPage County (IL) Circuit Court

A 77-year-old man was hospitalized after complaining of chest pain. He reported attempting suicide the night before by taking pills. His wife had died 5 months previously.

When the psychiatrist evaluated the patient the next day, the patient assured him that he was no longer suicidal, refused inpatient admission, but agreed to enter outpatient therapy. The patient repeated this intent to the hospital social worker.

The psychiatrist arranged visits by a home health care nurse. The patient was discharged after a 2-day stay, and the nurse visited the following day. The patient assured the nurse that he was not suicidal and called the psychiatrist to make an appointment for the next week. Two days later, the patient stabbed himself to death at home.

The estate claimed the psychiatrist should have kept the patient hospitalized. The psychiatrist claimed that involuntary admission was not possible because the patient was not dangerous to himself or others. The patient’s toxicology screen was negative except for his prescription drugs.

• The jury decided for the defense
  

Alcoholic promises to attend AA, but takes his life on Christmas Day

Davidson County (TN) Circuit Court

A 44-year-old man with a long history of alcohol abuse and failed rehabilitation was involuntarily admitted to a hospital after threatening suicide. His blood alcohol level was 0.393, and he had threatened suicide at the same facility 8 months before. A court order gave the hospital authority to involuntarily detain him until a hearing the following week.

The next day, the patient was transferred from the detoxification center to the psychiatric unit and evaluated by the psychiatrist. The patient disavowed suicidal thoughts, and the psychiatrist discharged the patient the following day (Christmas Eve, 48 hours after admission). The psychiatrist based this decision partially on the patient’s promise to enter inpatient alcohol treatment and attend an Alcoholics Anonymous meeting within 2 days.

On Christmas Day, the patient shot himself and died. His blood alcohol content at the time of death was 0.303.

The patient’s estate charged that the final discharge was negligent, the discharge instructions were inadequate, and the psychiatrist and hospital’s assessments were inaccurate.

The hospital argued that it deferred to the psychiatrist in the discharge decision. The psychiatrist argued that state law defined holding an individual without “immediate risk of substantial harm” as a felony.

• The jury decided in favor of the defendant psychiatrist. A directed verdict was granted for the hospital.
  

Plaintiff: Discharge led to hemiplegia

Broward County (FL) Circuit Court

Police took into custody a 27-year-old woman who had been wandering a public road, apparently under the influence of illegal substances. The officers transported her to a hospital, where the emergency room staff admitted her for psychiatric evaluation.

The psychiatrist determined that involuntary admission was not appropriate. When the patient refused the psychiatrist’s recommendation for voluntary admission, she was discharged.

The patient then went to her mother’s house, began drinking, and became combative. She started brandishing a rifle. The next day, the weapon discharged and a bullet lodged in her spine at the L2 vertebra. The patient is now hemiplegic and has no bladder or bowel control. She alleged that the hospital and psychiatrist were negligent in not admitting her.

• The hospital reached a $50,000 settlement before trial; the jury returned a $190,007 award, with 90% of fault apportioned to the plaintiff and 10% to the psychiatrist. After setoffs, the plaintiff’s net award was $80.
  

Dr. Grant’s observations

These cases illustrate suicide risk factors psychiatrists must consider even when a patient denies suicidal thoughts or intent. Suicide risk factors these patients showed include:

• recent discharge from psychiatric facilities¹
  
• recent suicide attempt with fairly high lethality potential (overdosing on pills)
  
• depressive turmoil and psychological isolation (recent loss of spouse)
  
• older widowed male^2-3
  
• history of dangerous behavior when intoxicated⁴
  
• possible “holiday effect.”⁵
  

These cases reflect one of psychiatry’s more troubling job requirements: assessing whether a patient is safe to discharge or should be admitted involuntarily. Such situations force us to balance the civil liberties of the mentally ill with our responsibility to care for those who lack insight into their illnesses. This tension often weighs heavily on psychiatrists⁶ and is, unfortunately, rather common. A study at one hospital found that approximately 8.5% of emergency department visits resulted in involuntary admission.⁷

As the verdicts in these cases suggest, the legal system recognizes that psychiatrists cannot predict suicide.⁸ Mistakes in clinical judgment are not the same as negligence, however, and failure to assess suicide risk or intervene appropriately for the level of risk may result in successful negligence claims.

 

Standards for emergency short-term hospitalization vary from state to state, so familiarize yourself with your state’s standards. Although one standard for involuntary admission is often imminent threat of harm to self, do not base the threat of danger only on a patient’s self-report. One study of patients who committed suicide while hospitalized found that 78% denied suicidal thoughts at their last communication.⁹ However, “locking up” suicidal patients to prevent a malpractice suit is equally inappropriate.

Assess suicide risk during a thoroughly documented psychiatric examination with particular attention to the patient’s history of suicidal behavior. Record details of the assessment in the patient’s chart (Table) at the time of evaluation, and document how these clinical factors influence your final decision.

Involuntary hospitalization provides the immediate benefit of supervision in a safe environment, and patients can gain short-term therapeutic benefits from inpatient treatment whether or not the admission was voluntary.¹⁰ Patients may eventually recognize admission was helpful, but their attitudes about the process often do not become more positive. To ease the stress of involuntary admission:

• acknowledge the patient’s disapproval
  
• tell the patient why he’s being hospitalized
  
• inform the patient about his or her legal rights.
  

Carry out this discussion with respect for the patient’s dignity and wishes.

Table

Documenting suicide risk assessment

Include in patient’s chart…	Examples…
Short-term factors	Current suicidal ideation/plan, lethality potential, current stressors (bereavement, illness, loss of job), recent discharge from a psychiatric facility, time of year (holiday effect, anniversaries)
Long-term factors	History of suicidal behavior/attempts, personality factors (agitation, hopelessness), gender, age, marital status, substance abuse history, psychiatric illness (depression, bipolar disorder, schizophrenia)
Appropriate psychiatric interventions based on the assessed degree of risk	Involuntary admission, intensive monitoring, outpatient visits, home healthcare nursing, residential placement, substance abuse treatment
Sources of information used	Medical records, patient self-report, family report, observation

VIENNA — Pimecrolimus 1% cream proved safe and effective for the treatment of discoid lupus erythematosus in a small, uncontrolled patient series, Alberto Tlacuilo-Parra, M.D., reported at the annual European congress of rheumatology.

He reported on 10 patients with discoid LE of an average 3-year duration who were placed on 1% pimecrolimus cream twice daily for 8 weeks.

The mean age of the study population was 34 years. Four patients had previously received potent topical and/or systemic corticosteroids without therapeutic response.

The patients' mean clinical disease severity score fell significantly from a baseline of 6.1 to 2.9. Their score on a quality-of-life index improved by a mean of 46%, said Dr. Tlacuilo-Parra of the Mexican Institute of Social Security, Guadalajara.

Five patients rated themselves as having experienced marked improvement, four patients categorized their status as moderately improved, and one rated it as slightly improved, Dr. Tlacuilo-Parra added at the meeting, which was sponsored by the European League Against Rheumatism.

Adverse effects of the topical therapy were confined to several minutes of mild itching at treated sites.

VIENNA — Pimecrolimus 1% cream proved safe and effective for the treatment of discoid lupus erythematosus in a small, uncontrolled patient series, Alberto Tlacuilo-Parra, M.D., reported at the annual European congress of rheumatology.

He reported on 10 patients with discoid LE of an average 3-year duration who were placed on 1% pimecrolimus cream twice daily for 8 weeks.

The mean age of the study population was 34 years. Four patients had previously received potent topical and/or systemic corticosteroids without therapeutic response.

The patients' mean clinical disease severity score fell significantly from a baseline of 6.1 to 2.9. Their score on a quality-of-life index improved by a mean of 46%, said Dr. Tlacuilo-Parra of the Mexican Institute of Social Security, Guadalajara.

Five patients rated themselves as having experienced marked improvement, four patients categorized their status as moderately improved, and one rated it as slightly improved, Dr. Tlacuilo-Parra added at the meeting, which was sponsored by the European League Against Rheumatism.

Adverse effects of the topical therapy were confined to several minutes of mild itching at treated sites.

VIENNA — Pimecrolimus 1% cream proved safe and effective for the treatment of discoid lupus erythematosus in a small, uncontrolled patient series, Alberto Tlacuilo-Parra, M.D., reported at the annual European congress of rheumatology.

He reported on 10 patients with discoid LE of an average 3-year duration who were placed on 1% pimecrolimus cream twice daily for 8 weeks.

The mean age of the study population was 34 years. Four patients had previously received potent topical and/or systemic corticosteroids without therapeutic response.

The patients' mean clinical disease severity score fell significantly from a baseline of 6.1 to 2.9. Their score on a quality-of-life index improved by a mean of 46%, said Dr. Tlacuilo-Parra of the Mexican Institute of Social Security, Guadalajara.

Five patients rated themselves as having experienced marked improvement, four patients categorized their status as moderately improved, and one rated it as slightly improved, Dr. Tlacuilo-Parra added at the meeting, which was sponsored by the European League Against Rheumatism.

Adverse effects of the topical therapy were confined to several minutes of mild itching at treated sites.

VIENNA — Preliminary reports of safety and efficacy of the selective endothelin receptor antagonist sitaxsentan for pulmonary arterial hypertension associated with connective tissue disease have been confirmed in a double-blind study, Reda E. Girgis, M.D., reported in a poster session at the annual European congress of rheumatology.

Pulmonary arterial hypertension (PAH) related to connective tissue disease (CTD) is progressive and can be particularly problematic to manage. Prostacyclin regimens are complex and are generally reserved for critically ill patients.

One nonselective endothelin receptor antagonist, bosentan (Tracleer) is currently available but is not effective in all patients and has been associated with liver function abnormalities.

The Sitaxsentan to Relieve Impaired Exercise (STRIDE-1) study randomized 178 patients to 12 weeks of treatment with 100-mg or 300-mg sitaxsentan or placebo.

The patients had either primary pulmonary hypertension or PAH related to congenital heart disease or CTD.

A post-hoc analysis of the subgroup of 42 patients with CTD-related PAH found improvements in the results of the 6-minute walk test, New York Heart Association (NYHA) functional class, and hemodynamics.

Pooling of the 100-mg and 300-mg sitaxsentan groups found a treatment effect of 58 m on the 6-minute walk test; this was an increase of 20 m from baseline in the active treatment groups and a decrease of 38 m in the placebo group, according to Dr. Girgis of the department of medicine, Johns Hopkins University, Baltimore.

At baseline all patients were NYHA functional class II or III. By week 12, 8 of the 33 patients receiving the active treatment (24%) had improved by one NYHA functional class; none of the patients deteriorated.

In contrast, 1 of 9 (11%) placebo patients improved by one NYHA functional class and 1 of 9 (11%) deteriorated.

Among hemodynamic findings were an average increase in the cardiac index of 0.55 L/min per square meter, an average decrease in the mean pulmonary arterial pressure of 7.66 mm Hg, and an average fall in pulmonary vascular resistance of 320 dynes.sec.cm

Sitaxsentan was well tolerated. No patients experienced liver abnormalities and no patients withdrew because of adverse events.

VIENNA — Preliminary reports of safety and efficacy of the selective endothelin receptor antagonist sitaxsentan for pulmonary arterial hypertension associated with connective tissue disease have been confirmed in a double-blind study, Reda E. Girgis, M.D., reported in a poster session at the annual European congress of rheumatology.

Pulmonary arterial hypertension (PAH) related to connective tissue disease (CTD) is progressive and can be particularly problematic to manage. Prostacyclin regimens are complex and are generally reserved for critically ill patients.

One nonselective endothelin receptor antagonist, bosentan (Tracleer) is currently available but is not effective in all patients and has been associated with liver function abnormalities.

The Sitaxsentan to Relieve Impaired Exercise (STRIDE-1) study randomized 178 patients to 12 weeks of treatment with 100-mg or 300-mg sitaxsentan or placebo.

The patients had either primary pulmonary hypertension or PAH related to congenital heart disease or CTD.

A post-hoc analysis of the subgroup of 42 patients with CTD-related PAH found improvements in the results of the 6-minute walk test, New York Heart Association (NYHA) functional class, and hemodynamics.

Pooling of the 100-mg and 300-mg sitaxsentan groups found a treatment effect of 58 m on the 6-minute walk test; this was an increase of 20 m from baseline in the active treatment groups and a decrease of 38 m in the placebo group, according to Dr. Girgis of the department of medicine, Johns Hopkins University, Baltimore.

At baseline all patients were NYHA functional class II or III. By week 12, 8 of the 33 patients receiving the active treatment (24%) had improved by one NYHA functional class; none of the patients deteriorated.

In contrast, 1 of 9 (11%) placebo patients improved by one NYHA functional class and 1 of 9 (11%) deteriorated.

Among hemodynamic findings were an average increase in the cardiac index of 0.55 L/min per square meter, an average decrease in the mean pulmonary arterial pressure of 7.66 mm Hg, and an average fall in pulmonary vascular resistance of 320 dynes.sec.cm

Sitaxsentan was well tolerated. No patients experienced liver abnormalities and no patients withdrew because of adverse events.

VIENNA — Preliminary reports of safety and efficacy of the selective endothelin receptor antagonist sitaxsentan for pulmonary arterial hypertension associated with connective tissue disease have been confirmed in a double-blind study, Reda E. Girgis, M.D., reported in a poster session at the annual European congress of rheumatology.

Pulmonary arterial hypertension (PAH) related to connective tissue disease (CTD) is progressive and can be particularly problematic to manage. Prostacyclin regimens are complex and are generally reserved for critically ill patients.

One nonselective endothelin receptor antagonist, bosentan (Tracleer) is currently available but is not effective in all patients and has been associated with liver function abnormalities.

The Sitaxsentan to Relieve Impaired Exercise (STRIDE-1) study randomized 178 patients to 12 weeks of treatment with 100-mg or 300-mg sitaxsentan or placebo.

The patients had either primary pulmonary hypertension or PAH related to congenital heart disease or CTD.

A post-hoc analysis of the subgroup of 42 patients with CTD-related PAH found improvements in the results of the 6-minute walk test, New York Heart Association (NYHA) functional class, and hemodynamics.

Pooling of the 100-mg and 300-mg sitaxsentan groups found a treatment effect of 58 m on the 6-minute walk test; this was an increase of 20 m from baseline in the active treatment groups and a decrease of 38 m in the placebo group, according to Dr. Girgis of the department of medicine, Johns Hopkins University, Baltimore.

At baseline all patients were NYHA functional class II or III. By week 12, 8 of the 33 patients receiving the active treatment (24%) had improved by one NYHA functional class; none of the patients deteriorated.

In contrast, 1 of 9 (11%) placebo patients improved by one NYHA functional class and 1 of 9 (11%) deteriorated.

Among hemodynamic findings were an average increase in the cardiac index of 0.55 L/min per square meter, an average decrease in the mean pulmonary arterial pressure of 7.66 mm Hg, and an average fall in pulmonary vascular resistance of 320 dynes.sec.cm

Sitaxsentan was well tolerated. No patients experienced liver abnormalities and no patients withdrew because of adverse events.

VIENNA — Patients with systemic lupus erythematosus experience an exceptionally high rate of major infections, Irene E.M. Bultink, M.D., reported at the annual European congress of rheumatology.

In her retrospective series of 103 unselected SLE patients, one-half experienced a collective total of 115 infections—not including lower urinary tract infections—during their mean 7-year disease duration.

Of these infections, 37% were classified as major in that they required hospitalization and intravenous antibiotics. The most common sites of major infections were the lower respiratory tract (33%), systemic infections (19%), and the gastrointestinal tract (12%), said Dr. Bultink, a rheumatologist at Slotervaart Hospital, Amsterdam.

Staphylococcus aureus was identified as the causal organism in 16% of major infections, making it the No. 1 culprit microorganism in severe episodes.

In a multivariate regression analysis, the significant independent risk factors for development of major infections were the presence of IgG anticardiolipin antibodies; leukopenia during the disease course; use of methotrexate at any time in treating SLE; and longer disease duration.

Turning to the 115 infections in the group as a whole, microorganisms were isolated in 50% of cases. The single most common type of infection was herpes zoster skin eruption at 16% of all infections.

Of infections in the SLE patients, 29% involved the skin and/or mucosa, 22% involved the lower respiratory tract, and 14% involved the upper respiratory tract, she said at the meeting sponsored by the European League Against Rheumatism.

Five patients developed opportunistic infections. There were two cases of Candida albicans esophagitis; one of sepsis from cytomegalovirus and C. albicans; one case of sinusitis caused by Aspergillus fumigatus; and a Klebsiella pneumoniae pneumonia.

VIENNA — Patients with systemic lupus erythematosus experience an exceptionally high rate of major infections, Irene E.M. Bultink, M.D., reported at the annual European congress of rheumatology.

In her retrospective series of 103 unselected SLE patients, one-half experienced a collective total of 115 infections—not including lower urinary tract infections—during their mean 7-year disease duration.

Of these infections, 37% were classified as major in that they required hospitalization and intravenous antibiotics. The most common sites of major infections were the lower respiratory tract (33%), systemic infections (19%), and the gastrointestinal tract (12%), said Dr. Bultink, a rheumatologist at Slotervaart Hospital, Amsterdam.

Staphylococcus aureus was identified as the causal organism in 16% of major infections, making it the No. 1 culprit microorganism in severe episodes.

In a multivariate regression analysis, the significant independent risk factors for development of major infections were the presence of IgG anticardiolipin antibodies; leukopenia during the disease course; use of methotrexate at any time in treating SLE; and longer disease duration.

Turning to the 115 infections in the group as a whole, microorganisms were isolated in 50% of cases. The single most common type of infection was herpes zoster skin eruption at 16% of all infections.

Of infections in the SLE patients, 29% involved the skin and/or mucosa, 22% involved the lower respiratory tract, and 14% involved the upper respiratory tract, she said at the meeting sponsored by the European League Against Rheumatism.

Five patients developed opportunistic infections. There were two cases of Candida albicans esophagitis; one of sepsis from cytomegalovirus and C. albicans; one case of sinusitis caused by Aspergillus fumigatus; and a Klebsiella pneumoniae pneumonia.

VIENNA — Patients with systemic lupus erythematosus experience an exceptionally high rate of major infections, Irene E.M. Bultink, M.D., reported at the annual European congress of rheumatology.

In her retrospective series of 103 unselected SLE patients, one-half experienced a collective total of 115 infections—not including lower urinary tract infections—during their mean 7-year disease duration.

Of these infections, 37% were classified as major in that they required hospitalization and intravenous antibiotics. The most common sites of major infections were the lower respiratory tract (33%), systemic infections (19%), and the gastrointestinal tract (12%), said Dr. Bultink, a rheumatologist at Slotervaart Hospital, Amsterdam.

Staphylococcus aureus was identified as the causal organism in 16% of major infections, making it the No. 1 culprit microorganism in severe episodes.

In a multivariate regression analysis, the significant independent risk factors for development of major infections were the presence of IgG anticardiolipin antibodies; leukopenia during the disease course; use of methotrexate at any time in treating SLE; and longer disease duration.

Turning to the 115 infections in the group as a whole, microorganisms were isolated in 50% of cases. The single most common type of infection was herpes zoster skin eruption at 16% of all infections.

Of infections in the SLE patients, 29% involved the skin and/or mucosa, 22% involved the lower respiratory tract, and 14% involved the upper respiratory tract, she said at the meeting sponsored by the European League Against Rheumatism.

Five patients developed opportunistic infections. There were two cases of Candida albicans esophagitis; one of sepsis from cytomegalovirus and C. albicans; one case of sinusitis caused by Aspergillus fumigatus; and a Klebsiella pneumoniae pneumonia.

VIENNA — Nearly two-thirds of a cohort of childhood-onset systemic lupus erythematosus patients had evidence of irreversible organ damage after a decade of disease, Vibke Lilleby, M.D., said at the annual European congress of rheumatology.

The most frequently affected organ systems were the neuropsychiatric, in 28% of cases; renal, in 13%; and musculoskeletal, in 13%, according to Dr. Lilleby of the University of Oslo.

Her 71-patient series with childhood-onset SLE had a mean age of 12.5 years at lupus symptom onset and a 10.8-year disease duration. Their mean Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)—a validated measure of nonreversible organ damage—was 1.3.

The independent predictors of a higher SDI were ever having taken cyclophosphamide, hypertension, and disease duration. In contrast, cumulative corticosteroid dose, the presence of renal disease at diagnosis, and erythrocyte sedimentation rate at diagnosis were among the examined factors that did not predict subsequent organ damage.

The high rate of irreversible organ damage in this cohort is a byproduct of the greatly improved long-term prognosis for childhood-onset SLE during the past 4 decades. Patients who in former years would have had a poor life expectancy are surviving much longer, with an associated increase in multiorgan morbidity due to the disease process itself or to its treatment, she explained at the congress, sponsored by the European League Against Rheumatism.

In a separate comparative study involving 70 of the same Norwegian patients with childhood-onset SLE and an equal number of matched controls, Dr. Lilleby found that osteopenia was much more frequent in the childhood-onset SLE group. For example, 41% of them had osteopenia at the lumbar spine and 40% at the femoral neck vs. 7% and 6% of the controls.

Cumulative dose of corticosteroids was a strong predictor of reduced bone mass at these sites. Reduced bone mineral density at the lumbar spine was also associated with male gender.

VIENNA — Nearly two-thirds of a cohort of childhood-onset systemic lupus erythematosus patients had evidence of irreversible organ damage after a decade of disease, Vibke Lilleby, M.D., said at the annual European congress of rheumatology.

The most frequently affected organ systems were the neuropsychiatric, in 28% of cases; renal, in 13%; and musculoskeletal, in 13%, according to Dr. Lilleby of the University of Oslo.

Her 71-patient series with childhood-onset SLE had a mean age of 12.5 years at lupus symptom onset and a 10.8-year disease duration. Their mean Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)—a validated measure of nonreversible organ damage—was 1.3.

The independent predictors of a higher SDI were ever having taken cyclophosphamide, hypertension, and disease duration. In contrast, cumulative corticosteroid dose, the presence of renal disease at diagnosis, and erythrocyte sedimentation rate at diagnosis were among the examined factors that did not predict subsequent organ damage.

The high rate of irreversible organ damage in this cohort is a byproduct of the greatly improved long-term prognosis for childhood-onset SLE during the past 4 decades. Patients who in former years would have had a poor life expectancy are surviving much longer, with an associated increase in multiorgan morbidity due to the disease process itself or to its treatment, she explained at the congress, sponsored by the European League Against Rheumatism.

In a separate comparative study involving 70 of the same Norwegian patients with childhood-onset SLE and an equal number of matched controls, Dr. Lilleby found that osteopenia was much more frequent in the childhood-onset SLE group. For example, 41% of them had osteopenia at the lumbar spine and 40% at the femoral neck vs. 7% and 6% of the controls.

Cumulative dose of corticosteroids was a strong predictor of reduced bone mass at these sites. Reduced bone mineral density at the lumbar spine was also associated with male gender.

VIENNA — Nearly two-thirds of a cohort of childhood-onset systemic lupus erythematosus patients had evidence of irreversible organ damage after a decade of disease, Vibke Lilleby, M.D., said at the annual European congress of rheumatology.

The most frequently affected organ systems were the neuropsychiatric, in 28% of cases; renal, in 13%; and musculoskeletal, in 13%, according to Dr. Lilleby of the University of Oslo.

Her 71-patient series with childhood-onset SLE had a mean age of 12.5 years at lupus symptom onset and a 10.8-year disease duration. Their mean Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)—a validated measure of nonreversible organ damage—was 1.3.

The independent predictors of a higher SDI were ever having taken cyclophosphamide, hypertension, and disease duration. In contrast, cumulative corticosteroid dose, the presence of renal disease at diagnosis, and erythrocyte sedimentation rate at diagnosis were among the examined factors that did not predict subsequent organ damage.

The high rate of irreversible organ damage in this cohort is a byproduct of the greatly improved long-term prognosis for childhood-onset SLE during the past 4 decades. Patients who in former years would have had a poor life expectancy are surviving much longer, with an associated increase in multiorgan morbidity due to the disease process itself or to its treatment, she explained at the congress, sponsored by the European League Against Rheumatism.

In a separate comparative study involving 70 of the same Norwegian patients with childhood-onset SLE and an equal number of matched controls, Dr. Lilleby found that osteopenia was much more frequent in the childhood-onset SLE group. For example, 41% of them had osteopenia at the lumbar spine and 40% at the femoral neck vs. 7% and 6% of the controls.

Cumulative dose of corticosteroids was a strong predictor of reduced bone mass at these sites. Reduced bone mineral density at the lumbar spine was also associated with male gender.

VIENNA — The endothelin receptor antagonist bosentan, currently used for the treatment of pulmonary hypertension, also is showing long-term beneficial effects on digital ulceration and cutaneous fibrosis in patients with scleroderma.

Short-term improvements on digital ulcers associated with Raynaud's phenomenon in patients with systemic sclerosis have previously been reported, but a group of eight patients with ulcers that have not responded to other treatments—including intravenous iloprost—now have been treated with oral bosentan for up to 18 months with continued success, according to Juan J. Alegre-Sancho, M.D., and his colleagues in the department of rheumatology, Hospital Universitario Dr. Peset, Valencia, Spain.

Five of the patients in the study have diffuse cutaneous sclerosis, and three have a more limited form of the disease. All are women, with a mean age of 41 years and mean disease duration of 14 years.

At baseline, all patients had esophageal involvement, 63% had pulmonary fibrosis, 14% had pulmonary hypertension, 25% had cardiac involvement, and 63% had calcinosis and acro-osteolysis. Mean Rodnan skin score, which assesses skin thickening on a scale of 0 to 3 by clinical palpation at 17 body sites, was 21.

Previous treatments included calcium channel blockers, topical nitrates, losartan, aspirin, corticosteroids, and D-penicillamine. Hospitalizations for iloprost infusions had been required for four of the patients, Dr. Alegre-Sancho wrote in a poster at the meeting, which was sponsored by the European League Against Rheumatism.

Ischemic digital ulcers present at baseline have healed in all patients, and the number, frequency, and time to healing of new ulcers have diminished in 63% of patients. In three patients who have been followed for 18 months and in five patients followed for 12 months, no new ulcers have developed.

The drug was given in standard dosages and was monitored according to recommended guidelines. The usual dosage of bosentan (Tracleer) is 125 mg twice daily, and patients must be followed for elevations in liver enzymes and for pregnancy prevention.

Raynaud's phenomenon has improved in frequency and severity of episodes in all patients, and three patients have been able to stop vasodilators.

Adverse events have generally been mild and transient, occurring in the first month of therapy.

In two patients, slight elevations of liver enzymes were seen, but these resolved spontaneously without dosage adjustment.

Bosentan treatment also has led to improvements in skin fibrosis, Dr. Alegre-Sancho noted in another poster session.

In these eight patients who were given the drug for ischemic digital ulcers and in three others who were being treated for scleroderma-related pulmonary hypertension, changes in skin thickness were seen beginning in the first month of therapy and continuing up to 18 months.

The improvements are first seen on the face, neck, chest, abdomen, and back; then gradually progress distally to the upper arms, thighs, forearms, and legs; and finally extend to the hands and feet.

All patients have recovered normal pigmentation, and the appearance of hyperhidrosis and hypertrichosis on the legs and arms of approximately one-third of patients suggests a recovery of normal skin structures, according to Dr. Alegre-Sancho.

VIENNA — The endothelin receptor antagonist bosentan, currently used for the treatment of pulmonary hypertension, also is showing long-term beneficial effects on digital ulceration and cutaneous fibrosis in patients with scleroderma.

Short-term improvements on digital ulcers associated with Raynaud's phenomenon in patients with systemic sclerosis have previously been reported, but a group of eight patients with ulcers that have not responded to other treatments—including intravenous iloprost—now have been treated with oral bosentan for up to 18 months with continued success, according to Juan J. Alegre-Sancho, M.D., and his colleagues in the department of rheumatology, Hospital Universitario Dr. Peset, Valencia, Spain.

Five of the patients in the study have diffuse cutaneous sclerosis, and three have a more limited form of the disease. All are women, with a mean age of 41 years and mean disease duration of 14 years.

At baseline, all patients had esophageal involvement, 63% had pulmonary fibrosis, 14% had pulmonary hypertension, 25% had cardiac involvement, and 63% had calcinosis and acro-osteolysis. Mean Rodnan skin score, which assesses skin thickening on a scale of 0 to 3 by clinical palpation at 17 body sites, was 21.

Previous treatments included calcium channel blockers, topical nitrates, losartan, aspirin, corticosteroids, and D-penicillamine. Hospitalizations for iloprost infusions had been required for four of the patients, Dr. Alegre-Sancho wrote in a poster at the meeting, which was sponsored by the European League Against Rheumatism.

Ischemic digital ulcers present at baseline have healed in all patients, and the number, frequency, and time to healing of new ulcers have diminished in 63% of patients. In three patients who have been followed for 18 months and in five patients followed for 12 months, no new ulcers have developed.

The drug was given in standard dosages and was monitored according to recommended guidelines. The usual dosage of bosentan (Tracleer) is 125 mg twice daily, and patients must be followed for elevations in liver enzymes and for pregnancy prevention.

Raynaud's phenomenon has improved in frequency and severity of episodes in all patients, and three patients have been able to stop vasodilators.

Adverse events have generally been mild and transient, occurring in the first month of therapy.

In two patients, slight elevations of liver enzymes were seen, but these resolved spontaneously without dosage adjustment.

Bosentan treatment also has led to improvements in skin fibrosis, Dr. Alegre-Sancho noted in another poster session.

In these eight patients who were given the drug for ischemic digital ulcers and in three others who were being treated for scleroderma-related pulmonary hypertension, changes in skin thickness were seen beginning in the first month of therapy and continuing up to 18 months.

The improvements are first seen on the face, neck, chest, abdomen, and back; then gradually progress distally to the upper arms, thighs, forearms, and legs; and finally extend to the hands and feet.

All patients have recovered normal pigmentation, and the appearance of hyperhidrosis and hypertrichosis on the legs and arms of approximately one-third of patients suggests a recovery of normal skin structures, according to Dr. Alegre-Sancho.

VIENNA — The endothelin receptor antagonist bosentan, currently used for the treatment of pulmonary hypertension, also is showing long-term beneficial effects on digital ulceration and cutaneous fibrosis in patients with scleroderma.

Short-term improvements on digital ulcers associated with Raynaud's phenomenon in patients with systemic sclerosis have previously been reported, but a group of eight patients with ulcers that have not responded to other treatments—including intravenous iloprost—now have been treated with oral bosentan for up to 18 months with continued success, according to Juan J. Alegre-Sancho, M.D., and his colleagues in the department of rheumatology, Hospital Universitario Dr. Peset, Valencia, Spain.

Five of the patients in the study have diffuse cutaneous sclerosis, and three have a more limited form of the disease. All are women, with a mean age of 41 years and mean disease duration of 14 years.

At baseline, all patients had esophageal involvement, 63% had pulmonary fibrosis, 14% had pulmonary hypertension, 25% had cardiac involvement, and 63% had calcinosis and acro-osteolysis. Mean Rodnan skin score, which assesses skin thickening on a scale of 0 to 3 by clinical palpation at 17 body sites, was 21.

Previous treatments included calcium channel blockers, topical nitrates, losartan, aspirin, corticosteroids, and D-penicillamine. Hospitalizations for iloprost infusions had been required for four of the patients, Dr. Alegre-Sancho wrote in a poster at the meeting, which was sponsored by the European League Against Rheumatism.

Ischemic digital ulcers present at baseline have healed in all patients, and the number, frequency, and time to healing of new ulcers have diminished in 63% of patients. In three patients who have been followed for 18 months and in five patients followed for 12 months, no new ulcers have developed.

The drug was given in standard dosages and was monitored according to recommended guidelines. The usual dosage of bosentan (Tracleer) is 125 mg twice daily, and patients must be followed for elevations in liver enzymes and for pregnancy prevention.

Raynaud's phenomenon has improved in frequency and severity of episodes in all patients, and three patients have been able to stop vasodilators.

Adverse events have generally been mild and transient, occurring in the first month of therapy.

In two patients, slight elevations of liver enzymes were seen, but these resolved spontaneously without dosage adjustment.

Bosentan treatment also has led to improvements in skin fibrosis, Dr. Alegre-Sancho noted in another poster session.

In these eight patients who were given the drug for ischemic digital ulcers and in three others who were being treated for scleroderma-related pulmonary hypertension, changes in skin thickness were seen beginning in the first month of therapy and continuing up to 18 months.

The improvements are first seen on the face, neck, chest, abdomen, and back; then gradually progress distally to the upper arms, thighs, forearms, and legs; and finally extend to the hands and feet.

All patients have recovered normal pigmentation, and the appearance of hyperhidrosis and hypertrichosis on the legs and arms of approximately one-third of patients suggests a recovery of normal skin structures, according to Dr. Alegre-Sancho.