Adalimumab Linked to Sizeable Rates of RA Remission

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Adalimumab Linked to Sizeable Rates of RA Remission

WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

 

 

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

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WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

 

 

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

 

 

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

ELSEVIER GLOBAL MEDICAL NEWS

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Chondroitin Reduced Joint Space Narrowing in OA : The dietary supplement also reduced pain scores and lessened the use of NSAIDs.

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Chondroitin Reduced Joint Space Narrowing in OA : The dietary supplement also reduced pain scores and lessened the use of NSAIDs.

WASHINGTON — The dietary supplement chondroitin sulfate significantly reduced the progression of joint space narrowing among patients with knee osteoarthritis in a multicenter, prospective, double-blind study presented in a late-breaking abstract session at the annual meeting of the American College of Rheumatology.

This radiologic finding represents a structure-modifying effect in the clinical progression of the disease, according to Dr. Jean-Yves Reginster, who has an unspecified interest in the Institut Biochimique SA (Pambio-Noranco, Switzerland), the manufacturer of Chondrosulf, the chondroitin formulation used in the study.

The 2-year Study on Osteoarthritis Progression Prevention (STOPP) included 622 patients with mild to moderate osteoarthritis from 40 centers in Europe and the United States, randomizing them to receive oral chondroitin sulfate, 800 mg/day or placebo.

Rescue acetaminophen and nonsteroidal anti-inflammatory drugs were permitted.

All had tibiofemoral knee osteoarthritis evaluated for pain on a visual analog scale and radiologically on digital x-rays utilizing a high-performance Lyon schuss slightly modified semiflexed view. The minimal level of pain for inclusion was 33 mm for the past 3 months, and the minimum joint space was greater than 1 mm at the narrowest point.

Patients ranged in age from 45 to 80 years, and with a mean body mass index of 29 kg/m

If both knees were affected, the more severely affected knee was chosen as the index joint.

There were 206 completers in both groups. In an intention-to-treat analysis of the primary outcome measure—joint space narrowing at the medial compartment of the knee over 24 months—a significantly greater mean joint space narrowing of 0.24 mm was seen among patients receiving placebo, compared with 0.10 mm among those receiving chondroitin, reported Dr. Reginster of the University of Liège (Belgium).

The change in joint space was linear among patients receiving placebo, around 0.1 mm/year, which was prevented completely in patients receiving chondroitin sulfate, he said.

“The final difference was 55% prevention in joint space narrowing, which was statistically significant at the end of the second year,” he added.

Significant differences also were seen in pain scores on VAS and on the Western Ontario and McMaster Universities osteoarthritis index scores (WOMAC). The chondroitin group also used 20% fewer NSAIDs, compared with the placebo group, he said.

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WASHINGTON — The dietary supplement chondroitin sulfate significantly reduced the progression of joint space narrowing among patients with knee osteoarthritis in a multicenter, prospective, double-blind study presented in a late-breaking abstract session at the annual meeting of the American College of Rheumatology.

This radiologic finding represents a structure-modifying effect in the clinical progression of the disease, according to Dr. Jean-Yves Reginster, who has an unspecified interest in the Institut Biochimique SA (Pambio-Noranco, Switzerland), the manufacturer of Chondrosulf, the chondroitin formulation used in the study.

The 2-year Study on Osteoarthritis Progression Prevention (STOPP) included 622 patients with mild to moderate osteoarthritis from 40 centers in Europe and the United States, randomizing them to receive oral chondroitin sulfate, 800 mg/day or placebo.

Rescue acetaminophen and nonsteroidal anti-inflammatory drugs were permitted.

All had tibiofemoral knee osteoarthritis evaluated for pain on a visual analog scale and radiologically on digital x-rays utilizing a high-performance Lyon schuss slightly modified semiflexed view. The minimal level of pain for inclusion was 33 mm for the past 3 months, and the minimum joint space was greater than 1 mm at the narrowest point.

Patients ranged in age from 45 to 80 years, and with a mean body mass index of 29 kg/m

If both knees were affected, the more severely affected knee was chosen as the index joint.

There were 206 completers in both groups. In an intention-to-treat analysis of the primary outcome measure—joint space narrowing at the medial compartment of the knee over 24 months—a significantly greater mean joint space narrowing of 0.24 mm was seen among patients receiving placebo, compared with 0.10 mm among those receiving chondroitin, reported Dr. Reginster of the University of Liège (Belgium).

The change in joint space was linear among patients receiving placebo, around 0.1 mm/year, which was prevented completely in patients receiving chondroitin sulfate, he said.

“The final difference was 55% prevention in joint space narrowing, which was statistically significant at the end of the second year,” he added.

Significant differences also were seen in pain scores on VAS and on the Western Ontario and McMaster Universities osteoarthritis index scores (WOMAC). The chondroitin group also used 20% fewer NSAIDs, compared with the placebo group, he said.

WASHINGTON — The dietary supplement chondroitin sulfate significantly reduced the progression of joint space narrowing among patients with knee osteoarthritis in a multicenter, prospective, double-blind study presented in a late-breaking abstract session at the annual meeting of the American College of Rheumatology.

This radiologic finding represents a structure-modifying effect in the clinical progression of the disease, according to Dr. Jean-Yves Reginster, who has an unspecified interest in the Institut Biochimique SA (Pambio-Noranco, Switzerland), the manufacturer of Chondrosulf, the chondroitin formulation used in the study.

The 2-year Study on Osteoarthritis Progression Prevention (STOPP) included 622 patients with mild to moderate osteoarthritis from 40 centers in Europe and the United States, randomizing them to receive oral chondroitin sulfate, 800 mg/day or placebo.

Rescue acetaminophen and nonsteroidal anti-inflammatory drugs were permitted.

All had tibiofemoral knee osteoarthritis evaluated for pain on a visual analog scale and radiologically on digital x-rays utilizing a high-performance Lyon schuss slightly modified semiflexed view. The minimal level of pain for inclusion was 33 mm for the past 3 months, and the minimum joint space was greater than 1 mm at the narrowest point.

Patients ranged in age from 45 to 80 years, and with a mean body mass index of 29 kg/m

If both knees were affected, the more severely affected knee was chosen as the index joint.

There were 206 completers in both groups. In an intention-to-treat analysis of the primary outcome measure—joint space narrowing at the medial compartment of the knee over 24 months—a significantly greater mean joint space narrowing of 0.24 mm was seen among patients receiving placebo, compared with 0.10 mm among those receiving chondroitin, reported Dr. Reginster of the University of Liège (Belgium).

The change in joint space was linear among patients receiving placebo, around 0.1 mm/year, which was prevented completely in patients receiving chondroitin sulfate, he said.

“The final difference was 55% prevention in joint space narrowing, which was statistically significant at the end of the second year,” he added.

Significant differences also were seen in pain scores on VAS and on the Western Ontario and McMaster Universities osteoarthritis index scores (WOMAC). The chondroitin group also used 20% fewer NSAIDs, compared with the placebo group, he said.

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Evidence-Based Hand Arthritis Guidelines Issued

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The first evidence-based recommendations on the management of hand osteoarthritis have been developed by a multidisciplinary group commissioned by the European League Against Rheumatism.

Previous European League Against Rheumatism (EULAR) task forces have issued guidelines on the management of knee and hip osteoarthritis (OA), but many of the clinical consequences of small-joint OA, such as interference with grip and fine precision pinch, differ from those associated with large-joint OA, making distinct recommendations necessary.

Interventions therefore have been developed in a site-specific fashion, with 11 key recommendations regarding various types of treatments having emerged from an examination of research-based evidence and expert consensus. (See box.)

Among general considerations addressed are the principle that treatment must be individualized according to the patient's symptoms, severity of disease, and expectations. The patient also should be educated regarding joint protection and exercise.

Nonpharmacologic measures that can be useful include splints and topical analgesics. Such local treatments are preferred over systemic treatments, particularly in limited, mild disease.

First-line pharmacologic therapy is oral paracetamol (acetaminophen), which can be given in doses up to 4 g/day. Other options include nonsteroidal anti-inflammatory drugs and slow-acting agents such as glucosamine and chondroitin sulfate.

Intra-articular injections of corticosteroids also can be beneficial for painful flares, and surgical procedures such as interposition arthroplasty are recommended for patients who do not respond to more conservative measures (Ann. Rheum. Dis. 2006 Oct. 17 [Epub doi:10.1136/ard.2006.062091]).

The EULAR task force noted that there is “a real paucity of clinical trials to guide recommendations for hand OA,” and that many of their recommendations are based on expert committee reports and/or clinical experience, rather than randomized trials. Aside from their clinical recommendations, therefore, the task force also highlighted the need for well-conducted clinical trials that would provide a more definitive evidence base.

The EULAR Recommendations

The guidelines for the management of hand OA are as follows:

Optimal management of hand OA requires a combination of nonpharmacologic and pharmacologic treatment, individualized to the patient's needs.

Individualize therapy according to site, risk factors, type of OA, presence of inflammation, severity of structural change, and level of pain and disability.

Educate patients on how to protect their joints and give them an exercise regimen involving both range of motion and strengthening exercises.

Application of heat, especially before exercise, and ultrasound are helpful.

Splints for thumb base OA and orthoses to correct lateral angulation and flexion deformity are recommended.

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) and capsaicin are useful, especially for mild to moderate pain involving only a few joints.

Acetaminophen is the oral analgesic of choice in dosages of up to 4 g/day.

For patients who respond inadequately to acetaminophen, oral NSAIDs can be used in the lowest effective dose and for the shortest duration needed. Patients at risk for GI adverse effects should receive a gastroprotective agent or a selective COX-2 inhibitor, but for those at cardiovascular risk, coxibs are contraindicated and nonselective NSAIDs should be used with caution.

Symptomatic slow-acting drugs for osteoarthritis—including glucosamine, chondroitin sulfate, avocado soybean unsaponifiables, diacerhein, and intra-articular hyaluronan—may provide some benefit with low toxicity, but suitable patients have not been defined.

Intra-articular injections of long-acting corticosteroids are effective for symptomatic flares of OA, particularly at the trapeziometacarpal joint.

Surgical procedures such as interposition arthroplasty can be beneficial for severe thumb base OA and may be considered when conservative measures have failed.

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The first evidence-based recommendations on the management of hand osteoarthritis have been developed by a multidisciplinary group commissioned by the European League Against Rheumatism.

Previous European League Against Rheumatism (EULAR) task forces have issued guidelines on the management of knee and hip osteoarthritis (OA), but many of the clinical consequences of small-joint OA, such as interference with grip and fine precision pinch, differ from those associated with large-joint OA, making distinct recommendations necessary.

Interventions therefore have been developed in a site-specific fashion, with 11 key recommendations regarding various types of treatments having emerged from an examination of research-based evidence and expert consensus. (See box.)

Among general considerations addressed are the principle that treatment must be individualized according to the patient's symptoms, severity of disease, and expectations. The patient also should be educated regarding joint protection and exercise.

Nonpharmacologic measures that can be useful include splints and topical analgesics. Such local treatments are preferred over systemic treatments, particularly in limited, mild disease.

First-line pharmacologic therapy is oral paracetamol (acetaminophen), which can be given in doses up to 4 g/day. Other options include nonsteroidal anti-inflammatory drugs and slow-acting agents such as glucosamine and chondroitin sulfate.

Intra-articular injections of corticosteroids also can be beneficial for painful flares, and surgical procedures such as interposition arthroplasty are recommended for patients who do not respond to more conservative measures (Ann. Rheum. Dis. 2006 Oct. 17 [Epub doi:10.1136/ard.2006.062091]).

The EULAR task force noted that there is “a real paucity of clinical trials to guide recommendations for hand OA,” and that many of their recommendations are based on expert committee reports and/or clinical experience, rather than randomized trials. Aside from their clinical recommendations, therefore, the task force also highlighted the need for well-conducted clinical trials that would provide a more definitive evidence base.

The EULAR Recommendations

The guidelines for the management of hand OA are as follows:

Optimal management of hand OA requires a combination of nonpharmacologic and pharmacologic treatment, individualized to the patient's needs.

Individualize therapy according to site, risk factors, type of OA, presence of inflammation, severity of structural change, and level of pain and disability.

Educate patients on how to protect their joints and give them an exercise regimen involving both range of motion and strengthening exercises.

Application of heat, especially before exercise, and ultrasound are helpful.

Splints for thumb base OA and orthoses to correct lateral angulation and flexion deformity are recommended.

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) and capsaicin are useful, especially for mild to moderate pain involving only a few joints.

Acetaminophen is the oral analgesic of choice in dosages of up to 4 g/day.

For patients who respond inadequately to acetaminophen, oral NSAIDs can be used in the lowest effective dose and for the shortest duration needed. Patients at risk for GI adverse effects should receive a gastroprotective agent or a selective COX-2 inhibitor, but for those at cardiovascular risk, coxibs are contraindicated and nonselective NSAIDs should be used with caution.

Symptomatic slow-acting drugs for osteoarthritis—including glucosamine, chondroitin sulfate, avocado soybean unsaponifiables, diacerhein, and intra-articular hyaluronan—may provide some benefit with low toxicity, but suitable patients have not been defined.

Intra-articular injections of long-acting corticosteroids are effective for symptomatic flares of OA, particularly at the trapeziometacarpal joint.

Surgical procedures such as interposition arthroplasty can be beneficial for severe thumb base OA and may be considered when conservative measures have failed.

The first evidence-based recommendations on the management of hand osteoarthritis have been developed by a multidisciplinary group commissioned by the European League Against Rheumatism.

Previous European League Against Rheumatism (EULAR) task forces have issued guidelines on the management of knee and hip osteoarthritis (OA), but many of the clinical consequences of small-joint OA, such as interference with grip and fine precision pinch, differ from those associated with large-joint OA, making distinct recommendations necessary.

Interventions therefore have been developed in a site-specific fashion, with 11 key recommendations regarding various types of treatments having emerged from an examination of research-based evidence and expert consensus. (See box.)

Among general considerations addressed are the principle that treatment must be individualized according to the patient's symptoms, severity of disease, and expectations. The patient also should be educated regarding joint protection and exercise.

Nonpharmacologic measures that can be useful include splints and topical analgesics. Such local treatments are preferred over systemic treatments, particularly in limited, mild disease.

First-line pharmacologic therapy is oral paracetamol (acetaminophen), which can be given in doses up to 4 g/day. Other options include nonsteroidal anti-inflammatory drugs and slow-acting agents such as glucosamine and chondroitin sulfate.

Intra-articular injections of corticosteroids also can be beneficial for painful flares, and surgical procedures such as interposition arthroplasty are recommended for patients who do not respond to more conservative measures (Ann. Rheum. Dis. 2006 Oct. 17 [Epub doi:10.1136/ard.2006.062091]).

The EULAR task force noted that there is “a real paucity of clinical trials to guide recommendations for hand OA,” and that many of their recommendations are based on expert committee reports and/or clinical experience, rather than randomized trials. Aside from their clinical recommendations, therefore, the task force also highlighted the need for well-conducted clinical trials that would provide a more definitive evidence base.

The EULAR Recommendations

The guidelines for the management of hand OA are as follows:

Optimal management of hand OA requires a combination of nonpharmacologic and pharmacologic treatment, individualized to the patient's needs.

Individualize therapy according to site, risk factors, type of OA, presence of inflammation, severity of structural change, and level of pain and disability.

Educate patients on how to protect their joints and give them an exercise regimen involving both range of motion and strengthening exercises.

Application of heat, especially before exercise, and ultrasound are helpful.

Splints for thumb base OA and orthoses to correct lateral angulation and flexion deformity are recommended.

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) and capsaicin are useful, especially for mild to moderate pain involving only a few joints.

Acetaminophen is the oral analgesic of choice in dosages of up to 4 g/day.

For patients who respond inadequately to acetaminophen, oral NSAIDs can be used in the lowest effective dose and for the shortest duration needed. Patients at risk for GI adverse effects should receive a gastroprotective agent or a selective COX-2 inhibitor, but for those at cardiovascular risk, coxibs are contraindicated and nonselective NSAIDs should be used with caution.

Symptomatic slow-acting drugs for osteoarthritis—including glucosamine, chondroitin sulfate, avocado soybean unsaponifiables, diacerhein, and intra-articular hyaluronan—may provide some benefit with low toxicity, but suitable patients have not been defined.

Intra-articular injections of long-acting corticosteroids are effective for symptomatic flares of OA, particularly at the trapeziometacarpal joint.

Surgical procedures such as interposition arthroplasty can be beneficial for severe thumb base OA and may be considered when conservative measures have failed.

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Weight Loss in Prehypertension Cuts Risks, Helps Avoid Drugs

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Weight Loss in Prehypertension Cuts Risks, Helps Avoid Drugs

BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg. Over an average follow-up period of just under 3 years, these readings fell to a mean of 119/74 mm Hg, reported Linda Grant of Health Management Resources (HMR), Boston.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of them remained medication free throughout the study.

Patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5%, Ms. Grant wrote in a poster (see box).

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options offered by HMR include medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to 35 servings/week or more.

In another study undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in another poster session at the meeting.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors.

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes. “The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

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BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg. Over an average follow-up period of just under 3 years, these readings fell to a mean of 119/74 mm Hg, reported Linda Grant of Health Management Resources (HMR), Boston.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of them remained medication free throughout the study.

Patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5%, Ms. Grant wrote in a poster (see box).

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options offered by HMR include medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to 35 servings/week or more.

In another study undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in another poster session at the meeting.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors.

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes. “The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

ELSEVIER GLOBAL MEDICAL NEWS

BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg. Over an average follow-up period of just under 3 years, these readings fell to a mean of 119/74 mm Hg, reported Linda Grant of Health Management Resources (HMR), Boston.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of them remained medication free throughout the study.

Patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5%, Ms. Grant wrote in a poster (see box).

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options offered by HMR include medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to 35 servings/week or more.

In another study undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in another poster session at the meeting.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors.

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes. “The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

ELSEVIER GLOBAL MEDICAL NEWS

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Orlistat Helps Maintain Weight Loss Long Term

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BOSTON — Three years of orlistat following significant weight loss helped patients maintain the loss and reduced the incidence of new-onset type 2 diabetes, Dr. Bjorn Richelsen said at the annual meeting of NAASO, the Obesity Society.

“We know that we can induce initial weight loss, with maximal loss occurring after about 6–9 months, but thereafter, a strong regain occurs, so we need strategies for weight loss maintenance,” Dr. Richelsen said.

In a study that included 383 abdominally obese patients from Denmark, Norway, Sweden, and Finland, 309 were able to lose at least 5% of their body weight during a 2-month very low energy diet consisting of 600–800 kcal/day and were randomized to 3 years of lifestyle counseling plus orlistat, 120 mg three times daily, or placebo.

Mean body mass index at baseline was 37.5 kg/m

There was an initial mean weight loss of 14.4 kg in the patients who subsequently were randomized. During each of the 3 years of the study, a statistically significantly greater number of patients in the orlistat group maintained at least a 5% weight loss, compared with those in the placebo group.

Patients in the orlistat group regained a mean of 4.6 kg during the 3 years, whereas those in the placebo group regained a mean of 7 kg. The overall weight loss, therefore, was 8.3% of body weight in the orlistat group and 6.4% in the placebo group, said Dr. Richelsen of the department of endocrinology and metabolism, Århus University Hospital, Århus, Denmark.

Waist circumference also was significantly more reduced in the orlistat group, by 7.7 cm, than in the placebo group, by 5.4 cm.

In contrast to findings from other studies, there were no differences between the active treatment group and the placebo group after 3 years on risk factors including insulin, glucose, and lipids. Nonetheless, there was a significantly lower incidence of new-onset diabetes during the study, with 8 cases (5.2%) developing in the orlistat-treated patients, compared with 17 cases (10.9%) in the placebo-treated patients.

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BOSTON — Three years of orlistat following significant weight loss helped patients maintain the loss and reduced the incidence of new-onset type 2 diabetes, Dr. Bjorn Richelsen said at the annual meeting of NAASO, the Obesity Society.

“We know that we can induce initial weight loss, with maximal loss occurring after about 6–9 months, but thereafter, a strong regain occurs, so we need strategies for weight loss maintenance,” Dr. Richelsen said.

In a study that included 383 abdominally obese patients from Denmark, Norway, Sweden, and Finland, 309 were able to lose at least 5% of their body weight during a 2-month very low energy diet consisting of 600–800 kcal/day and were randomized to 3 years of lifestyle counseling plus orlistat, 120 mg three times daily, or placebo.

Mean body mass index at baseline was 37.5 kg/m

There was an initial mean weight loss of 14.4 kg in the patients who subsequently were randomized. During each of the 3 years of the study, a statistically significantly greater number of patients in the orlistat group maintained at least a 5% weight loss, compared with those in the placebo group.

Patients in the orlistat group regained a mean of 4.6 kg during the 3 years, whereas those in the placebo group regained a mean of 7 kg. The overall weight loss, therefore, was 8.3% of body weight in the orlistat group and 6.4% in the placebo group, said Dr. Richelsen of the department of endocrinology and metabolism, Århus University Hospital, Århus, Denmark.

Waist circumference also was significantly more reduced in the orlistat group, by 7.7 cm, than in the placebo group, by 5.4 cm.

In contrast to findings from other studies, there were no differences between the active treatment group and the placebo group after 3 years on risk factors including insulin, glucose, and lipids. Nonetheless, there was a significantly lower incidence of new-onset diabetes during the study, with 8 cases (5.2%) developing in the orlistat-treated patients, compared with 17 cases (10.9%) in the placebo-treated patients.

BOSTON — Three years of orlistat following significant weight loss helped patients maintain the loss and reduced the incidence of new-onset type 2 diabetes, Dr. Bjorn Richelsen said at the annual meeting of NAASO, the Obesity Society.

“We know that we can induce initial weight loss, with maximal loss occurring after about 6–9 months, but thereafter, a strong regain occurs, so we need strategies for weight loss maintenance,” Dr. Richelsen said.

In a study that included 383 abdominally obese patients from Denmark, Norway, Sweden, and Finland, 309 were able to lose at least 5% of their body weight during a 2-month very low energy diet consisting of 600–800 kcal/day and were randomized to 3 years of lifestyle counseling plus orlistat, 120 mg three times daily, or placebo.

Mean body mass index at baseline was 37.5 kg/m

There was an initial mean weight loss of 14.4 kg in the patients who subsequently were randomized. During each of the 3 years of the study, a statistically significantly greater number of patients in the orlistat group maintained at least a 5% weight loss, compared with those in the placebo group.

Patients in the orlistat group regained a mean of 4.6 kg during the 3 years, whereas those in the placebo group regained a mean of 7 kg. The overall weight loss, therefore, was 8.3% of body weight in the orlistat group and 6.4% in the placebo group, said Dr. Richelsen of the department of endocrinology and metabolism, Århus University Hospital, Århus, Denmark.

Waist circumference also was significantly more reduced in the orlistat group, by 7.7 cm, than in the placebo group, by 5.4 cm.

In contrast to findings from other studies, there were no differences between the active treatment group and the placebo group after 3 years on risk factors including insulin, glucose, and lipids. Nonetheless, there was a significantly lower incidence of new-onset diabetes during the study, with 8 cases (5.2%) developing in the orlistat-treated patients, compared with 17 cases (10.9%) in the placebo-treated patients.

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Supplemental Calcium Fails to Prevent Weight Gain

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BOSTON — Two years of treatment with supplemental calcium failed to significantly prevent weight gain in overweight, middle-aged adults, Dr. Jack Yanovski reported at the annual meeting of NAASO, the Obesity Society.

Multiple epidemiologic and observational studies have suggested that greater calcium intake is associated with less adiposity and reduced weight gain, but there have been no large clinical trials directly assessing the effects of calcium supplementation on body weight and composition.

To address the hypothesis of whether calcium can help prevent weight gain, a 2-year, double-blind trial randomized 340 healthy subjects to 1,500 mg calcium carbonate per day or placebo, said Dr. Yanovski, who heads the unit on growth and obesity in the Developmental Endocrinology Branch of the National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

Participants were informed that the study's purpose was to examine the health effects of calcium supplementation. They completed questionnaires every 3 months regarding their health and activities, and they were evaluated yearly for body weight and composition.

Mean age of the participants was 38.8 years, mean body mass index (BMI) was 33.4 kg/m

There were no baseline differences between the calcium and placebo groups in terms of age, BMI, sex, race, or reported dietary calcium intake, which was a mean of 882 mg/day. Roughly 23% of patients reported calcium intake that was extremely low, less than 600 mg/day, he said.

A total of 77% of patients in the calcium group completed the 2-year study, as did 71% of those in the placebo group, Dr. Yanovski said. Most of the noncompleters were lost to follow-up, and there were very few adverse effects.

“To assess blinding, we asked them if they thought they were receiving calcium or placebo, and somewhat to our surprise, almost two-thirds of both groups thought they were receiving placebo,” he said.

At the conclusion of the investigation, body weight had increased by a mean of 0.26 kg in the calcium group and by 0.96 kg in the placebo group, BMI had increased by 0.09 kg/m

None of these differences was statistically significant, he said.

Secondary analyses also found no differences in changes between males and females, among those with low baseline calcium intake, or between those classified as overweight or obese, he said.

“In summary, currently available data do not support the hypothesis that calcium supplementation is effective for avoiding weight gain or assisting in weight reduction,” Dr. Yanovski said.

A key proponent of the concept that calcium plays a role in obesity is Michael Zemel, Ph.D., of the University of Tennessee's Nutrition Institute, Knoxville. According to Dr. Zemel, the primary effect of dietary calcium on weight gain “appears to be inhibition of calcitrophic hormone effects on adipocyte energy storage and utilization,” (J. Am. Coll. Nutr. 2005;24[6 suppl.]:537S-46S).

Dr. Zemel also has emphasized the importance of dietary foods rather than supplements, explaining that dairy products contain bioactive compounds that may act synergistically with calcium to affect adipocyte metabolism.

The fact that Dr. Yanovski's study looked at calcium supplements instead of dietary calcium may have been a factor in its negative findings, an audience member suggested. Dr. Yanovski added that designing a randomized trial to look at dairy product consumption would be “very difficult to do in humans.”

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BOSTON — Two years of treatment with supplemental calcium failed to significantly prevent weight gain in overweight, middle-aged adults, Dr. Jack Yanovski reported at the annual meeting of NAASO, the Obesity Society.

Multiple epidemiologic and observational studies have suggested that greater calcium intake is associated with less adiposity and reduced weight gain, but there have been no large clinical trials directly assessing the effects of calcium supplementation on body weight and composition.

To address the hypothesis of whether calcium can help prevent weight gain, a 2-year, double-blind trial randomized 340 healthy subjects to 1,500 mg calcium carbonate per day or placebo, said Dr. Yanovski, who heads the unit on growth and obesity in the Developmental Endocrinology Branch of the National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

Participants were informed that the study's purpose was to examine the health effects of calcium supplementation. They completed questionnaires every 3 months regarding their health and activities, and they were evaluated yearly for body weight and composition.

Mean age of the participants was 38.8 years, mean body mass index (BMI) was 33.4 kg/m

There were no baseline differences between the calcium and placebo groups in terms of age, BMI, sex, race, or reported dietary calcium intake, which was a mean of 882 mg/day. Roughly 23% of patients reported calcium intake that was extremely low, less than 600 mg/day, he said.

A total of 77% of patients in the calcium group completed the 2-year study, as did 71% of those in the placebo group, Dr. Yanovski said. Most of the noncompleters were lost to follow-up, and there were very few adverse effects.

“To assess blinding, we asked them if they thought they were receiving calcium or placebo, and somewhat to our surprise, almost two-thirds of both groups thought they were receiving placebo,” he said.

At the conclusion of the investigation, body weight had increased by a mean of 0.26 kg in the calcium group and by 0.96 kg in the placebo group, BMI had increased by 0.09 kg/m

None of these differences was statistically significant, he said.

Secondary analyses also found no differences in changes between males and females, among those with low baseline calcium intake, or between those classified as overweight or obese, he said.

“In summary, currently available data do not support the hypothesis that calcium supplementation is effective for avoiding weight gain or assisting in weight reduction,” Dr. Yanovski said.

A key proponent of the concept that calcium plays a role in obesity is Michael Zemel, Ph.D., of the University of Tennessee's Nutrition Institute, Knoxville. According to Dr. Zemel, the primary effect of dietary calcium on weight gain “appears to be inhibition of calcitrophic hormone effects on adipocyte energy storage and utilization,” (J. Am. Coll. Nutr. 2005;24[6 suppl.]:537S-46S).

Dr. Zemel also has emphasized the importance of dietary foods rather than supplements, explaining that dairy products contain bioactive compounds that may act synergistically with calcium to affect adipocyte metabolism.

The fact that Dr. Yanovski's study looked at calcium supplements instead of dietary calcium may have been a factor in its negative findings, an audience member suggested. Dr. Yanovski added that designing a randomized trial to look at dairy product consumption would be “very difficult to do in humans.”

BOSTON — Two years of treatment with supplemental calcium failed to significantly prevent weight gain in overweight, middle-aged adults, Dr. Jack Yanovski reported at the annual meeting of NAASO, the Obesity Society.

Multiple epidemiologic and observational studies have suggested that greater calcium intake is associated with less adiposity and reduced weight gain, but there have been no large clinical trials directly assessing the effects of calcium supplementation on body weight and composition.

To address the hypothesis of whether calcium can help prevent weight gain, a 2-year, double-blind trial randomized 340 healthy subjects to 1,500 mg calcium carbonate per day or placebo, said Dr. Yanovski, who heads the unit on growth and obesity in the Developmental Endocrinology Branch of the National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

Participants were informed that the study's purpose was to examine the health effects of calcium supplementation. They completed questionnaires every 3 months regarding their health and activities, and they were evaluated yearly for body weight and composition.

Mean age of the participants was 38.8 years, mean body mass index (BMI) was 33.4 kg/m

There were no baseline differences between the calcium and placebo groups in terms of age, BMI, sex, race, or reported dietary calcium intake, which was a mean of 882 mg/day. Roughly 23% of patients reported calcium intake that was extremely low, less than 600 mg/day, he said.

A total of 77% of patients in the calcium group completed the 2-year study, as did 71% of those in the placebo group, Dr. Yanovski said. Most of the noncompleters were lost to follow-up, and there were very few adverse effects.

“To assess blinding, we asked them if they thought they were receiving calcium or placebo, and somewhat to our surprise, almost two-thirds of both groups thought they were receiving placebo,” he said.

At the conclusion of the investigation, body weight had increased by a mean of 0.26 kg in the calcium group and by 0.96 kg in the placebo group, BMI had increased by 0.09 kg/m

None of these differences was statistically significant, he said.

Secondary analyses also found no differences in changes between males and females, among those with low baseline calcium intake, or between those classified as overweight or obese, he said.

“In summary, currently available data do not support the hypothesis that calcium supplementation is effective for avoiding weight gain or assisting in weight reduction,” Dr. Yanovski said.

A key proponent of the concept that calcium plays a role in obesity is Michael Zemel, Ph.D., of the University of Tennessee's Nutrition Institute, Knoxville. According to Dr. Zemel, the primary effect of dietary calcium on weight gain “appears to be inhibition of calcitrophic hormone effects on adipocyte energy storage and utilization,” (J. Am. Coll. Nutr. 2005;24[6 suppl.]:537S-46S).

Dr. Zemel also has emphasized the importance of dietary foods rather than supplements, explaining that dairy products contain bioactive compounds that may act synergistically with calcium to affect adipocyte metabolism.

The fact that Dr. Yanovski's study looked at calcium supplements instead of dietary calcium may have been a factor in its negative findings, an audience member suggested. Dr. Yanovski added that designing a randomized trial to look at dairy product consumption would be “very difficult to do in humans.”

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Staff Education Program Leads to Decrease in Use of Seclusion, Restraint

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Staff Education Program Leads to Decrease in Use of Seclusion, Restraint

NEW YORK – The use of seclusion and restraint among psychiatric inpatients was successfully reduced by a program involving staff education, changes in policy and practice, and improved communication with patients, Dr. David J. Hellerstein said in a poster presentation at the American Psychiatric Association's Institute on Psychiatric Services.

Although a standard of care has evolved that generally limits the use of the “last resort” measures of seclusion and restraint to instances of imminent harm to the patient or others, the actual use of these practices varies widely, he wrote.

The 58-bed New York State Psychiatric Institute (NYSPI) in upper Manhattan has a large research population as well as the typical state hospital population of patients with schizophrenia and other severe mental illnesses.

Before the program began in 2000, the rates of seclusion and restraint at NYSPI were the highest among the New York Office of Mental Health hospitals, according to Dr. Hellerstein, who is medical director of the psychiatry clinical trials program at Columbia University Medical Center, New York.

This high use was attributed to NYSPI's status as an acute-care hospital that is also a research facility where clinical trials are conducted and patients may be taken off medication at times.

The program includes several components:

▸ Decrease in time of initial restraint or seclusion order from 4 to 2 hours.

▸ Staff education and in-service training.

▸ Relaxation of no-smoking policy.

Some other studies have reported increased rates of injury with reductions in use of restraint and seclusion. In this study, emphasis was also placed on helping staff members manage patients' agitation, psychosis, and potential for violence.

After the program was implemented, there were statistically significant reductions in the mean number of patients secluded–3.18 to 1.13 patients per month–and in length of seclusion–1.28 to 0.09 hours per 1,000 patient-hours, he reported.

The reduction in restraint and seclusion has been maintained through 5 years of follow-up, suggesting that a “culture change” has occurred at NYSPI, he said. Culture change in this context has been described as emphasizing staff sensitivity and training in noncoercive methods of de-escalating possible violence (J. Psychiatr. Pract. 2003;9:7–15).

No increase has been seen in rates of injury to the staff, Dr. Hellerstein said.

Future steps to be taken include the implementation of patient involvement in coping plans and the eventual elimination of the use of restraint, he wrote.

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NEW YORK – The use of seclusion and restraint among psychiatric inpatients was successfully reduced by a program involving staff education, changes in policy and practice, and improved communication with patients, Dr. David J. Hellerstein said in a poster presentation at the American Psychiatric Association's Institute on Psychiatric Services.

Although a standard of care has evolved that generally limits the use of the “last resort” measures of seclusion and restraint to instances of imminent harm to the patient or others, the actual use of these practices varies widely, he wrote.

The 58-bed New York State Psychiatric Institute (NYSPI) in upper Manhattan has a large research population as well as the typical state hospital population of patients with schizophrenia and other severe mental illnesses.

Before the program began in 2000, the rates of seclusion and restraint at NYSPI were the highest among the New York Office of Mental Health hospitals, according to Dr. Hellerstein, who is medical director of the psychiatry clinical trials program at Columbia University Medical Center, New York.

This high use was attributed to NYSPI's status as an acute-care hospital that is also a research facility where clinical trials are conducted and patients may be taken off medication at times.

The program includes several components:

▸ Decrease in time of initial restraint or seclusion order from 4 to 2 hours.

▸ Staff education and in-service training.

▸ Relaxation of no-smoking policy.

Some other studies have reported increased rates of injury with reductions in use of restraint and seclusion. In this study, emphasis was also placed on helping staff members manage patients' agitation, psychosis, and potential for violence.

After the program was implemented, there were statistically significant reductions in the mean number of patients secluded–3.18 to 1.13 patients per month–and in length of seclusion–1.28 to 0.09 hours per 1,000 patient-hours, he reported.

The reduction in restraint and seclusion has been maintained through 5 years of follow-up, suggesting that a “culture change” has occurred at NYSPI, he said. Culture change in this context has been described as emphasizing staff sensitivity and training in noncoercive methods of de-escalating possible violence (J. Psychiatr. Pract. 2003;9:7–15).

No increase has been seen in rates of injury to the staff, Dr. Hellerstein said.

Future steps to be taken include the implementation of patient involvement in coping plans and the eventual elimination of the use of restraint, he wrote.

NEW YORK – The use of seclusion and restraint among psychiatric inpatients was successfully reduced by a program involving staff education, changes in policy and practice, and improved communication with patients, Dr. David J. Hellerstein said in a poster presentation at the American Psychiatric Association's Institute on Psychiatric Services.

Although a standard of care has evolved that generally limits the use of the “last resort” measures of seclusion and restraint to instances of imminent harm to the patient or others, the actual use of these practices varies widely, he wrote.

The 58-bed New York State Psychiatric Institute (NYSPI) in upper Manhattan has a large research population as well as the typical state hospital population of patients with schizophrenia and other severe mental illnesses.

Before the program began in 2000, the rates of seclusion and restraint at NYSPI were the highest among the New York Office of Mental Health hospitals, according to Dr. Hellerstein, who is medical director of the psychiatry clinical trials program at Columbia University Medical Center, New York.

This high use was attributed to NYSPI's status as an acute-care hospital that is also a research facility where clinical trials are conducted and patients may be taken off medication at times.

The program includes several components:

▸ Decrease in time of initial restraint or seclusion order from 4 to 2 hours.

▸ Staff education and in-service training.

▸ Relaxation of no-smoking policy.

Some other studies have reported increased rates of injury with reductions in use of restraint and seclusion. In this study, emphasis was also placed on helping staff members manage patients' agitation, psychosis, and potential for violence.

After the program was implemented, there were statistically significant reductions in the mean number of patients secluded–3.18 to 1.13 patients per month–and in length of seclusion–1.28 to 0.09 hours per 1,000 patient-hours, he reported.

The reduction in restraint and seclusion has been maintained through 5 years of follow-up, suggesting that a “culture change” has occurred at NYSPI, he said. Culture change in this context has been described as emphasizing staff sensitivity and training in noncoercive methods of de-escalating possible violence (J. Psychiatr. Pract. 2003;9:7–15).

No increase has been seen in rates of injury to the staff, Dr. Hellerstein said.

Future steps to be taken include the implementation of patient involvement in coping plans and the eventual elimination of the use of restraint, he wrote.

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Weight Loss Cuts Risks In Prehypertension

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Weight Loss Cuts Risks In Prehypertension

BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg, Linda Grant of Health Management Resources (HMR), Boston, wrote in a poster session.

Over an average follow-up period of just under 3 years, these blood pressure readings fell to a mean of 119/74 mm Hg, Ms. Grant reported.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of the patients remained medication-free throughout the study, Ms. Grant said.

The patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5% on average, she reported.

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options that were offered by HMR included medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to a total of 35 servings/week or more.

In another study that was also undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in cardiovascular risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in a poster presentation.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors. (See table at right.)

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes, he reported.

“The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

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BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg, Linda Grant of Health Management Resources (HMR), Boston, wrote in a poster session.

Over an average follow-up period of just under 3 years, these blood pressure readings fell to a mean of 119/74 mm Hg, Ms. Grant reported.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of the patients remained medication-free throughout the study, Ms. Grant said.

The patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5% on average, she reported.

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options that were offered by HMR included medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to a total of 35 servings/week or more.

In another study that was also undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in cardiovascular risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in a poster presentation.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors. (See table at right.)

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes, he reported.

“The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

ELSEVIER GLOBAL MEDICAL NEWS

BOSTON — Prehypertensive patients who participate in a structured weight-management program can significantly reduce their risk factors and may avoid the need for antihypertensive drug therapy, according to a study presented at the annual meeting of NAASO, the Obesity Society.

A group of 351 patients who enrolled in various weight-loss programs had a mean baseline blood pressure of 127/83 mm Hg, Linda Grant of Health Management Resources (HMR), Boston, wrote in a poster session.

Over an average follow-up period of just under 3 years, these blood pressure readings fell to a mean of 119/74 mm Hg, Ms. Grant reported.

The patients' mean weight at baseline was 231 pounds. During the follow-up period, this fell to 194 pounds, which represented an average of 16% of initial body weight lost.

None of the patients was taking antihypertensive medications at baseline, and about 94 of the patients remained medication-free throughout the study, Ms. Grant said.

The patients in this cohort also had significant decreases in all other measured risk factors. Total cholesterol levels fell by an average of 14%, triglycerides decreased by 30%, and fasting blood glucose was lowered by 5% on average, she reported.

“Lifestyle changes, including weight management, should be the first step in preventing or delaying the progression of prehypertension to hypertension and in reducing other comorbid risk factors,” Ms. Grant wrote.

The weight-management options that were offered by HMR included medically supervised low and very low calorie diets, moderately restricted diets, and telephone-based programs. All of the options focus on lifestyle changes such as increased physical activity to an expenditure of 2,000 kcal/week or more, the use of meal replacements, and increased fruit and vegetable intake to a total of 35 servings/week or more.

In another study that was also undertaken by HMR, Steve May, Ph.D., reported that program participants who lost 20% or more of their body weight had greater decreases in cardiovascular risk factors than did those who lost smaller amounts of weight.

“There is some controversy as to whether health professionals should encourage patients to lose more than the standard 5%–10% of their body weight,” Dr. May of HMR wrote in a poster presentation.

Among 2,564 patients who had participated in the HMR weight-management programs at 65 clinics across the country, those who lost the most weight—and kept it off for an average time of 123 weeks—also showed significant decreases in all other measured risk factors. (See table at right.)

Moreover, a significant percentage of patients were able to eliminate medications for cholesterol, blood pressure, and diabetes, he reported.

“The standard 5%–10% of initial weight should not be considered a limit,” Dr. May wrote.

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Shared Decision Making Is Best Approach to Obesity

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BOSTON — The decision to embark on a weight management program that incorporates pharmacotherapy is one that should be shared by patient and clinician, based on reasonable goals, and must take into account the patient's cardiovascular risk factors, according to Dr. David Arterburn.

“Selecting the right drug for the right patient in primary care is a process of shared decision making, which is a nonpaternalistic approach that is particularly useful when there are no clear best options for the patient,” Dr. Arterburn said at the annual meeting of NAASO, the Obesity Society.

“And arguably, in weight management it's safe to say we can't come to the table knowing that there is one clear best option today,” he said.

The role of the caregiver is to provide the patient with the best available information on benefits, risks, and likely outcomes, and to help set an achievable goal, which generally is a 5%–10% weight loss over 6 months. Many patients want to lose more than that, but they are more likely to succeed with a modest initial goal that can later be renegotiated, explained Dr. Arterburn, an internist at the Center for Health Studies, Seattle, Wash.

Also, even a relatively small 5% reduction in body weight is an amount that is associated with significantly reduced long-term health risks, he said.

Two agents, orlistat and sibutramine, have been approved for long-term use in obesity. Orlistat is a lipase inhibitor that blocks the absorption of approximately 30% of ingested fat, while sibutramine is a norepinephrine, serotonin, and dopamine reuptake inhibitor.

A third agent, phentermine, is a sympathomimetic amine similar to the amphetamines and is recommended only for short-term use of 12 weeks or less.

To be eligible for drug treatment, patients generally must have a body mass index of 30 kg/m

Both orlistat and sibutramine have been shown to be more effective than placebo in clinical trials with patients who were also dieting and exercising. Patients receiving orlistat averaged a 2.89-kg greater weight loss than did those receiving placebo, and in one study, patients on this drug plus diet and exercise were 15% more likely to achieve a 5% weight loss than were those on diet and exercise alone (Diabetes Care 2004;27:155–61).

The effect size has been larger in studies of sibutramine, with patients losing an average of 4.5 kg. “Adults taking sibutramine plus diet and exercise for 1 year were 19%–34% more likely to achieve a 5% weight loss than were those taking placebo,” Dr. Arterburn said.

While both drugs do aid in weight loss, they differ in impact on attendant obesity risk factors. Orlistat has an excellent cardiovascular safety profile, typically showing small improvements in blood pressure, lipids, and glycemic control, and therefore would be a suitable first-line therapy for obese patients with hypertension, cardiovascular disease, or dyslipidemia, he said.

Sibutramine is associated with small increases in both systolic and diastolic blood pressure and so would be more appropriate for the otherwise healthy patient without cardiovascular risk factors. Sibutramine also might be preferable for a patient who is unable or unwilling to tolerate the gastrointestinal side effects of orlistat, he said.

Phentermine is limited by a lack of long-term studies and potential for abuse. Nonetheless, it is still the most commonly prescribed weight-loss drug, largely because of its lower cost, said Dr. Arterburn, also of the department of internal medicine, University of Washington, Seattle.

And the cost of treatment can be a barrier for some patients, with a 30-day supply of 120-mg orlistat and 15-mg sibutramine costing $140 and $115, respectively.

An audience member asked how much weight loss would have to be demonstrated before insurers would be more willing to reimburse for treatment. Dr. Arterburn replied that most payers are not so much interested in the amount of weight lost as in a reduction in disease incidence, reduced hospitalizations, and overall lower costs. “Until we can get studies far enough along to demonstrate the harder outcomes that impact patient health care, we're not going to see widespread adoption of these medications by large organizations.”

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BOSTON — The decision to embark on a weight management program that incorporates pharmacotherapy is one that should be shared by patient and clinician, based on reasonable goals, and must take into account the patient's cardiovascular risk factors, according to Dr. David Arterburn.

“Selecting the right drug for the right patient in primary care is a process of shared decision making, which is a nonpaternalistic approach that is particularly useful when there are no clear best options for the patient,” Dr. Arterburn said at the annual meeting of NAASO, the Obesity Society.

“And arguably, in weight management it's safe to say we can't come to the table knowing that there is one clear best option today,” he said.

The role of the caregiver is to provide the patient with the best available information on benefits, risks, and likely outcomes, and to help set an achievable goal, which generally is a 5%–10% weight loss over 6 months. Many patients want to lose more than that, but they are more likely to succeed with a modest initial goal that can later be renegotiated, explained Dr. Arterburn, an internist at the Center for Health Studies, Seattle, Wash.

Also, even a relatively small 5% reduction in body weight is an amount that is associated with significantly reduced long-term health risks, he said.

Two agents, orlistat and sibutramine, have been approved for long-term use in obesity. Orlistat is a lipase inhibitor that blocks the absorption of approximately 30% of ingested fat, while sibutramine is a norepinephrine, serotonin, and dopamine reuptake inhibitor.

A third agent, phentermine, is a sympathomimetic amine similar to the amphetamines and is recommended only for short-term use of 12 weeks or less.

To be eligible for drug treatment, patients generally must have a body mass index of 30 kg/m

Both orlistat and sibutramine have been shown to be more effective than placebo in clinical trials with patients who were also dieting and exercising. Patients receiving orlistat averaged a 2.89-kg greater weight loss than did those receiving placebo, and in one study, patients on this drug plus diet and exercise were 15% more likely to achieve a 5% weight loss than were those on diet and exercise alone (Diabetes Care 2004;27:155–61).

The effect size has been larger in studies of sibutramine, with patients losing an average of 4.5 kg. “Adults taking sibutramine plus diet and exercise for 1 year were 19%–34% more likely to achieve a 5% weight loss than were those taking placebo,” Dr. Arterburn said.

While both drugs do aid in weight loss, they differ in impact on attendant obesity risk factors. Orlistat has an excellent cardiovascular safety profile, typically showing small improvements in blood pressure, lipids, and glycemic control, and therefore would be a suitable first-line therapy for obese patients with hypertension, cardiovascular disease, or dyslipidemia, he said.

Sibutramine is associated with small increases in both systolic and diastolic blood pressure and so would be more appropriate for the otherwise healthy patient without cardiovascular risk factors. Sibutramine also might be preferable for a patient who is unable or unwilling to tolerate the gastrointestinal side effects of orlistat, he said.

Phentermine is limited by a lack of long-term studies and potential for abuse. Nonetheless, it is still the most commonly prescribed weight-loss drug, largely because of its lower cost, said Dr. Arterburn, also of the department of internal medicine, University of Washington, Seattle.

And the cost of treatment can be a barrier for some patients, with a 30-day supply of 120-mg orlistat and 15-mg sibutramine costing $140 and $115, respectively.

An audience member asked how much weight loss would have to be demonstrated before insurers would be more willing to reimburse for treatment. Dr. Arterburn replied that most payers are not so much interested in the amount of weight lost as in a reduction in disease incidence, reduced hospitalizations, and overall lower costs. “Until we can get studies far enough along to demonstrate the harder outcomes that impact patient health care, we're not going to see widespread adoption of these medications by large organizations.”

BOSTON — The decision to embark on a weight management program that incorporates pharmacotherapy is one that should be shared by patient and clinician, based on reasonable goals, and must take into account the patient's cardiovascular risk factors, according to Dr. David Arterburn.

“Selecting the right drug for the right patient in primary care is a process of shared decision making, which is a nonpaternalistic approach that is particularly useful when there are no clear best options for the patient,” Dr. Arterburn said at the annual meeting of NAASO, the Obesity Society.

“And arguably, in weight management it's safe to say we can't come to the table knowing that there is one clear best option today,” he said.

The role of the caregiver is to provide the patient with the best available information on benefits, risks, and likely outcomes, and to help set an achievable goal, which generally is a 5%–10% weight loss over 6 months. Many patients want to lose more than that, but they are more likely to succeed with a modest initial goal that can later be renegotiated, explained Dr. Arterburn, an internist at the Center for Health Studies, Seattle, Wash.

Also, even a relatively small 5% reduction in body weight is an amount that is associated with significantly reduced long-term health risks, he said.

Two agents, orlistat and sibutramine, have been approved for long-term use in obesity. Orlistat is a lipase inhibitor that blocks the absorption of approximately 30% of ingested fat, while sibutramine is a norepinephrine, serotonin, and dopamine reuptake inhibitor.

A third agent, phentermine, is a sympathomimetic amine similar to the amphetamines and is recommended only for short-term use of 12 weeks or less.

To be eligible for drug treatment, patients generally must have a body mass index of 30 kg/m

Both orlistat and sibutramine have been shown to be more effective than placebo in clinical trials with patients who were also dieting and exercising. Patients receiving orlistat averaged a 2.89-kg greater weight loss than did those receiving placebo, and in one study, patients on this drug plus diet and exercise were 15% more likely to achieve a 5% weight loss than were those on diet and exercise alone (Diabetes Care 2004;27:155–61).

The effect size has been larger in studies of sibutramine, with patients losing an average of 4.5 kg. “Adults taking sibutramine plus diet and exercise for 1 year were 19%–34% more likely to achieve a 5% weight loss than were those taking placebo,” Dr. Arterburn said.

While both drugs do aid in weight loss, they differ in impact on attendant obesity risk factors. Orlistat has an excellent cardiovascular safety profile, typically showing small improvements in blood pressure, lipids, and glycemic control, and therefore would be a suitable first-line therapy for obese patients with hypertension, cardiovascular disease, or dyslipidemia, he said.

Sibutramine is associated with small increases in both systolic and diastolic blood pressure and so would be more appropriate for the otherwise healthy patient without cardiovascular risk factors. Sibutramine also might be preferable for a patient who is unable or unwilling to tolerate the gastrointestinal side effects of orlistat, he said.

Phentermine is limited by a lack of long-term studies and potential for abuse. Nonetheless, it is still the most commonly prescribed weight-loss drug, largely because of its lower cost, said Dr. Arterburn, also of the department of internal medicine, University of Washington, Seattle.

And the cost of treatment can be a barrier for some patients, with a 30-day supply of 120-mg orlistat and 15-mg sibutramine costing $140 and $115, respectively.

An audience member asked how much weight loss would have to be demonstrated before insurers would be more willing to reimburse for treatment. Dr. Arterburn replied that most payers are not so much interested in the amount of weight lost as in a reduction in disease incidence, reduced hospitalizations, and overall lower costs. “Until we can get studies far enough along to demonstrate the harder outcomes that impact patient health care, we're not going to see widespread adoption of these medications by large organizations.”

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Early Trauma Tied to Adult Mental, Physical Health

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NEW YORK — Traumatic stress in youth is the single most important contributor to later psychiatric morbidity and mortality, and the American Psychiatric Association should make violence and its sequelae a major organizational priority, according to a new report.

The report of the APA Task Force on the Biopsychosocial Consequences of Childhood Violence, which is being submitted by the association's joint reference committee for approval, also concluded that the prevention of trauma and violence is potentially the single most effective strategy for the prevention of mental illness.

Much of the epidemiologic data on exposure to violence during childhood has emerged from the Adverse Childhood Experiences (ACE) study, which is a collaboration of the Centers for Disease Control and Prevention and the Kaiser-Permanente Medical Care Program in San Diego. This ongoing study, which is investigating the impact of adverse childhood experiences on adult health, includes approximately 175,000 members of the Kaiser health plan, coprincipal investigator Vincent J. Felitti said at the American Psychiatric Association's Institute on Psychiatric Services. The subjects in the study are predominantly white and well educated.

The ACE study has identified several specific categories of adverse childhood experiences that are associated with numerous health risk factors later in life and has found these experiences to be far more common than was previously appreciated. (See box.)

Nonetheless, more than half of the subjects reported having experienced at least one of these early life adverse events (ACE score 1) and one-quarter reported having two or more, according to Dr. Felitti, who is an internist with Kaiser-Permanente and clinical professor of medicine, University of California, San Diego.

Serious physical and emotional abuse was reported by one in nine people, and sexual abuse was reported by 28% of women and 16% of men. “This is hard to believe unless you routinely ask people—in which case it becomes blatantly obvious,” he said.

Then the ACE researchers looked at the impact of these events on health risk factors in adulthood. Smoking and self-acknowledged alcohol abuse strongly correlated with childhood exposure to violence, as did intravenous drug use. For men who had an ACE score of 6 or higher, there was a 46-fold increase in likelihood of intravenous drug use. An ACE score of 6 or higher also was associated with a 30- to 51-fold increase in the likelihood of attempted suicide in later life, he said.

In addition, the report highlights the fact that traumatic stress is not only linked to psychological disorders such as depression and posttraumatic stress disorder (PTSD), but is also a major etiologic factor in medical morbidity and mortality. For example, regular smoking before the age of 14 years not only correlated with early life exposure to violence, but also with later development of chronic obstructive pulmonary disease.

“This was an important conceptual shift, the conversion of life experience into biomedical disease,” Dr. Felitti said. And this conversion extended to ischemic heart disease, cancer, fractures, and liver disease.

Nonetheless, although exposure to violence heightens the risk for the development of PTSD, other stress-related disorders, and medical morbidity, it is not necessarily predictive of psychopathology. Another task force member, Dr. Carl C. Bell, who is chief executive officer of Community Mental Health Council Inc. in Chicago, emphasized this point. “Risk factors are not predictive factors because of protective factors,” he said.

Only one-third of individuals exposed to violence develop PTSD. The rest are characterized by a variety of protective factors, such as intellectual ability, a feeling of connectedness, and having an internal locus of control and blame, according to Dr. Bell, who is also clinical professor of psychiatry and public health, University of Illinois in Chicago.

These protective factors together cultivate resilience and stress resistance in the individual, and psychiatrists have an important role in helping individuals cultivate resiliency by means of a community psychiatry model, the task force report states.

The task force recommended that the APA make a long-term commitment to addressing issues of trauma, establishing a committee with a 5-year mandate to raise consciousness within psychiatry, and to address fiscal issues, training, research, prevention, and public education.

“The only way this is going to happen politically is to form many partnerships, both within the APA and other professional organizations, the police, Head Start, and early childhood care teachers, so that they begin to understand more about these kids,” said William W. Harris, Ph.D., another task force member and president of KidsPac, a political action committee dedicated to obtaining federal government assistance for disadvantaged children.

 

 

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NEW YORK — Traumatic stress in youth is the single most important contributor to later psychiatric morbidity and mortality, and the American Psychiatric Association should make violence and its sequelae a major organizational priority, according to a new report.

The report of the APA Task Force on the Biopsychosocial Consequences of Childhood Violence, which is being submitted by the association's joint reference committee for approval, also concluded that the prevention of trauma and violence is potentially the single most effective strategy for the prevention of mental illness.

Much of the epidemiologic data on exposure to violence during childhood has emerged from the Adverse Childhood Experiences (ACE) study, which is a collaboration of the Centers for Disease Control and Prevention and the Kaiser-Permanente Medical Care Program in San Diego. This ongoing study, which is investigating the impact of adverse childhood experiences on adult health, includes approximately 175,000 members of the Kaiser health plan, coprincipal investigator Vincent J. Felitti said at the American Psychiatric Association's Institute on Psychiatric Services. The subjects in the study are predominantly white and well educated.

The ACE study has identified several specific categories of adverse childhood experiences that are associated with numerous health risk factors later in life and has found these experiences to be far more common than was previously appreciated. (See box.)

Nonetheless, more than half of the subjects reported having experienced at least one of these early life adverse events (ACE score 1) and one-quarter reported having two or more, according to Dr. Felitti, who is an internist with Kaiser-Permanente and clinical professor of medicine, University of California, San Diego.

Serious physical and emotional abuse was reported by one in nine people, and sexual abuse was reported by 28% of women and 16% of men. “This is hard to believe unless you routinely ask people—in which case it becomes blatantly obvious,” he said.

Then the ACE researchers looked at the impact of these events on health risk factors in adulthood. Smoking and self-acknowledged alcohol abuse strongly correlated with childhood exposure to violence, as did intravenous drug use. For men who had an ACE score of 6 or higher, there was a 46-fold increase in likelihood of intravenous drug use. An ACE score of 6 or higher also was associated with a 30- to 51-fold increase in the likelihood of attempted suicide in later life, he said.

In addition, the report highlights the fact that traumatic stress is not only linked to psychological disorders such as depression and posttraumatic stress disorder (PTSD), but is also a major etiologic factor in medical morbidity and mortality. For example, regular smoking before the age of 14 years not only correlated with early life exposure to violence, but also with later development of chronic obstructive pulmonary disease.

“This was an important conceptual shift, the conversion of life experience into biomedical disease,” Dr. Felitti said. And this conversion extended to ischemic heart disease, cancer, fractures, and liver disease.

Nonetheless, although exposure to violence heightens the risk for the development of PTSD, other stress-related disorders, and medical morbidity, it is not necessarily predictive of psychopathology. Another task force member, Dr. Carl C. Bell, who is chief executive officer of Community Mental Health Council Inc. in Chicago, emphasized this point. “Risk factors are not predictive factors because of protective factors,” he said.

Only one-third of individuals exposed to violence develop PTSD. The rest are characterized by a variety of protective factors, such as intellectual ability, a feeling of connectedness, and having an internal locus of control and blame, according to Dr. Bell, who is also clinical professor of psychiatry and public health, University of Illinois in Chicago.

These protective factors together cultivate resilience and stress resistance in the individual, and psychiatrists have an important role in helping individuals cultivate resiliency by means of a community psychiatry model, the task force report states.

The task force recommended that the APA make a long-term commitment to addressing issues of trauma, establishing a committee with a 5-year mandate to raise consciousness within psychiatry, and to address fiscal issues, training, research, prevention, and public education.

“The only way this is going to happen politically is to form many partnerships, both within the APA and other professional organizations, the police, Head Start, and early childhood care teachers, so that they begin to understand more about these kids,” said William W. Harris, Ph.D., another task force member and president of KidsPac, a political action committee dedicated to obtaining federal government assistance for disadvantaged children.

 

 

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Traumatic stress in youth is the single most important contributor to later psychiatric morbidity and mortality, and the American Psychiatric Association should make violence and its sequelae a major organizational priority, according to a new report.

The report of the APA Task Force on the Biopsychosocial Consequences of Childhood Violence, which is being submitted by the association's joint reference committee for approval, also concluded that the prevention of trauma and violence is potentially the single most effective strategy for the prevention of mental illness.

Much of the epidemiologic data on exposure to violence during childhood has emerged from the Adverse Childhood Experiences (ACE) study, which is a collaboration of the Centers for Disease Control and Prevention and the Kaiser-Permanente Medical Care Program in San Diego. This ongoing study, which is investigating the impact of adverse childhood experiences on adult health, includes approximately 175,000 members of the Kaiser health plan, coprincipal investigator Vincent J. Felitti said at the American Psychiatric Association's Institute on Psychiatric Services. The subjects in the study are predominantly white and well educated.

The ACE study has identified several specific categories of adverse childhood experiences that are associated with numerous health risk factors later in life and has found these experiences to be far more common than was previously appreciated. (See box.)

Nonetheless, more than half of the subjects reported having experienced at least one of these early life adverse events (ACE score 1) and one-quarter reported having two or more, according to Dr. Felitti, who is an internist with Kaiser-Permanente and clinical professor of medicine, University of California, San Diego.

Serious physical and emotional abuse was reported by one in nine people, and sexual abuse was reported by 28% of women and 16% of men. “This is hard to believe unless you routinely ask people—in which case it becomes blatantly obvious,” he said.

Then the ACE researchers looked at the impact of these events on health risk factors in adulthood. Smoking and self-acknowledged alcohol abuse strongly correlated with childhood exposure to violence, as did intravenous drug use. For men who had an ACE score of 6 or higher, there was a 46-fold increase in likelihood of intravenous drug use. An ACE score of 6 or higher also was associated with a 30- to 51-fold increase in the likelihood of attempted suicide in later life, he said.

In addition, the report highlights the fact that traumatic stress is not only linked to psychological disorders such as depression and posttraumatic stress disorder (PTSD), but is also a major etiologic factor in medical morbidity and mortality. For example, regular smoking before the age of 14 years not only correlated with early life exposure to violence, but also with later development of chronic obstructive pulmonary disease.

“This was an important conceptual shift, the conversion of life experience into biomedical disease,” Dr. Felitti said. And this conversion extended to ischemic heart disease, cancer, fractures, and liver disease.

Nonetheless, although exposure to violence heightens the risk for the development of PTSD, other stress-related disorders, and medical morbidity, it is not necessarily predictive of psychopathology. Another task force member, Dr. Carl C. Bell, who is chief executive officer of Community Mental Health Council Inc. in Chicago, emphasized this point. “Risk factors are not predictive factors because of protective factors,” he said.

Only one-third of individuals exposed to violence develop PTSD. The rest are characterized by a variety of protective factors, such as intellectual ability, a feeling of connectedness, and having an internal locus of control and blame, according to Dr. Bell, who is also clinical professor of psychiatry and public health, University of Illinois in Chicago.

These protective factors together cultivate resilience and stress resistance in the individual, and psychiatrists have an important role in helping individuals cultivate resiliency by means of a community psychiatry model, the task force report states.

The task force recommended that the APA make a long-term commitment to addressing issues of trauma, establishing a committee with a 5-year mandate to raise consciousness within psychiatry, and to address fiscal issues, training, research, prevention, and public education.

“The only way this is going to happen politically is to form many partnerships, both within the APA and other professional organizations, the police, Head Start, and early childhood care teachers, so that they begin to understand more about these kids,” said William W. Harris, Ph.D., another task force member and president of KidsPac, a political action committee dedicated to obtaining federal government assistance for disadvantaged children.

 

 

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