Kate Johnson

The Food and Drug Administration in January approved Taclonex, a new topical therapy for psoriasis.

The combined steroid and vitamin D₃ analogue ointment adds both choice and convenience to the currently available first-line treatments for the disease, Dr. Alan Menter said in an interview. “It's a nice additional drug that will be well received in the marketplace,” he said.

The product, a combination of betamethasone dipropionate 0.064% and calcipotriene 0.005%, has been available in Europe as Daivobet since 2001 and in Canada as Dovobet since 2002, and will be marketed in the United States by Warner Chilcott and LEO Pharma.

“This drug is a significant advance in topical therapy for the U.S. market, although it is old hat for the European market,” said Dr. Menter, chief of dermatology at Baylor University Medical Center in Dallas. He said that he had no conflict of interest involving this drug or its manufacturer. “It is certainly the most interesting and exciting new topical drug for the United States,” he added, predicting Taclonex will renew interest in topical therapy and most likely improve compliance.

“This agent is approved for once-a-day use, which I think is very important, because most patients will not use a topical agent twice a day on a long-term basis,” he said. The combination of both a steroid and a vitamin D analogue in one ointment also should help compliance, he predicted.

There have been no clinical trials of the product in the United States, said Dr. Menter, but a European-industry-sponsored trial comparing continuous and intermittent therapy with the combined drug vs. calcipotriol monotherapy showed greater improvement in psoriasis area and severity index scores (73%) in the continuous therapy group, compared with 68% in the intermittent group and 64% in the monotherapy group. Overall treatment success rates were 66%, 57%, and 51% for the continuous, intermittent, and monotherapy groups, respectively.

'This drug is a significant advance in topical therapy for the U.S. market.' DR. MENTER

The Food and Drug Administration in January approved Taclonex, a new topical therapy for psoriasis.

The combined steroid and vitamin D₃ analogue ointment adds both choice and convenience to the currently available first-line treatments for the disease, Dr. Alan Menter said in an interview. “It's a nice additional drug that will be well received in the marketplace,” he said.

The product, a combination of betamethasone dipropionate 0.064% and calcipotriene 0.005%, has been available in Europe as Daivobet since 2001 and in Canada as Dovobet since 2002, and will be marketed in the United States by Warner Chilcott and LEO Pharma.

“This drug is a significant advance in topical therapy for the U.S. market, although it is old hat for the European market,” said Dr. Menter, chief of dermatology at Baylor University Medical Center in Dallas. He said that he had no conflict of interest involving this drug or its manufacturer. “It is certainly the most interesting and exciting new topical drug for the United States,” he added, predicting Taclonex will renew interest in topical therapy and most likely improve compliance.

“This agent is approved for once-a-day use, which I think is very important, because most patients will not use a topical agent twice a day on a long-term basis,” he said. The combination of both a steroid and a vitamin D analogue in one ointment also should help compliance, he predicted.

There have been no clinical trials of the product in the United States, said Dr. Menter, but a European-industry-sponsored trial comparing continuous and intermittent therapy with the combined drug vs. calcipotriol monotherapy showed greater improvement in psoriasis area and severity index scores (73%) in the continuous therapy group, compared with 68% in the intermittent group and 64% in the monotherapy group. Overall treatment success rates were 66%, 57%, and 51% for the continuous, intermittent, and monotherapy groups, respectively.

'This drug is a significant advance in topical therapy for the U.S. market.' DR. MENTER

The Food and Drug Administration in January approved Taclonex, a new topical therapy for psoriasis.

The combined steroid and vitamin D₃ analogue ointment adds both choice and convenience to the currently available first-line treatments for the disease, Dr. Alan Menter said in an interview. “It's a nice additional drug that will be well received in the marketplace,” he said.

The product, a combination of betamethasone dipropionate 0.064% and calcipotriene 0.005%, has been available in Europe as Daivobet since 2001 and in Canada as Dovobet since 2002, and will be marketed in the United States by Warner Chilcott and LEO Pharma.

“This drug is a significant advance in topical therapy for the U.S. market, although it is old hat for the European market,” said Dr. Menter, chief of dermatology at Baylor University Medical Center in Dallas. He said that he had no conflict of interest involving this drug or its manufacturer. “It is certainly the most interesting and exciting new topical drug for the United States,” he added, predicting Taclonex will renew interest in topical therapy and most likely improve compliance.

“This agent is approved for once-a-day use, which I think is very important, because most patients will not use a topical agent twice a day on a long-term basis,” he said. The combination of both a steroid and a vitamin D analogue in one ointment also should help compliance, he predicted.

There have been no clinical trials of the product in the United States, said Dr. Menter, but a European-industry-sponsored trial comparing continuous and intermittent therapy with the combined drug vs. calcipotriol monotherapy showed greater improvement in psoriasis area and severity index scores (73%) in the continuous therapy group, compared with 68% in the intermittent group and 64% in the monotherapy group. Overall treatment success rates were 66%, 57%, and 51% for the continuous, intermittent, and monotherapy groups, respectively.

'This drug is a significant advance in topical therapy for the U.S. market.' DR. MENTER

SAN DIEGO — A pregnant patient's suspicious or changing skin lesion should be investigated as promptly and as thoroughly as the same lesion in a nonpregnant patient, Dr. Dina Massry said at a melanoma update sponsored by the Scripps Clinic.

Studies pointing to delayed diagnosis of melanoma among pregnant patients “clearly illustrate that physicians should treat changing nevi in pregnant women exactly the same as in their nonpregnant patients, and biopsy promptly,” said Dr. Massry, head of the division of dermatology at the clinic's Green Hospital in La Jolla, Calif.

Although pregnancy itself does not increase a woman's risk of melanoma, the evidence consistently shows that pregnant women present with later-stage disease and more frequent nodal metastasis. This often occurs because suspicious lesions are dismissed as normal changes of pregnancy, she said in an interview.

“If you or your patient notes a changing mole, don't delay what you would normally do because she is pregnant, and don't ascribe the change as a normal phenomenon of pregnancy,” she said.

As with nonpregnant patients, the prognosis for melanoma depends on the thickness of the lesion and evidence of ulceration. Surgical excision remains the best management. Late-stage melanoma can be lethal, however, and even though metastatic disease rarely has an impact on the fetus, treatment considerations in such cases must weigh the survival prognosis of both the mother and the fetus, she said.

“Consideration has to be given to whether the mother will even survive to delivery, as well as whether the cancer will metastasize to the placenta or the fetus,” she said, adding that, in such rare cases, it might be reasonable to broach the topic of pregnancy termination with the patient.

“Also, the pregnancy itself is going to change the woman's treatment options. She could theoretically have more aggressive treatment if she were not pregnant,” Dr. Massry noted.

Metastasis of melanoma to the fetus is extremely rare. Only 1 in 1,000 pregnancies is affected by cancer, and just 8% of these cancers are melanoma, she said. However, of all cancers, melanoma is the most likely to spread to the products of conception—with one-third metastasizing to either the placenta or the fetus.

In the most recent literature review of 87 cases of fetal or placental metastasis, 27 cases were attributed to melanoma. Six of those 27 cases actually affected the fetus, with the remaining 21 showing placental metastasis only (J. Clin. Oncol. 2003;21:2179–86).

Among the cases of fetal metastasis, five of the infants died within the first year of life; in the sixth infant, lung and soft tissue metastasis spontaneously regressed for at least 14 years, she said.

Among the cases of placental metastasis, three infants died within 2 days of birth from causes not directly related to metastatic melanoma. Follow-up of the other 18 cases showed no evidence of disease within a range of 47 days to 2 years.

The timing of pregnancy after treatment for melanoma has no impact on recurrence, Dr. Massry said.

Patients can be advised that disease recurrence is primarily related to tumor thickness. A study of 43 women who became pregnant within 5 years of a melanoma diagnosis found no difference in their survival, compared with age-matched controls who became pregnant more than 5 years after their diagnosis (Cancer 1985;55:340–4).

SAN DIEGO — A pregnant patient's suspicious or changing skin lesion should be investigated as promptly and as thoroughly as the same lesion in a nonpregnant patient, Dr. Dina Massry said at a melanoma update sponsored by the Scripps Clinic.

Studies pointing to delayed diagnosis of melanoma among pregnant patients “clearly illustrate that physicians should treat changing nevi in pregnant women exactly the same as in their nonpregnant patients, and biopsy promptly,” said Dr. Massry, head of the division of dermatology at the clinic's Green Hospital in La Jolla, Calif.

Although pregnancy itself does not increase a woman's risk of melanoma, the evidence consistently shows that pregnant women present with later-stage disease and more frequent nodal metastasis. This often occurs because suspicious lesions are dismissed as normal changes of pregnancy, she said in an interview.

“If you or your patient notes a changing mole, don't delay what you would normally do because she is pregnant, and don't ascribe the change as a normal phenomenon of pregnancy,” she said.

As with nonpregnant patients, the prognosis for melanoma depends on the thickness of the lesion and evidence of ulceration. Surgical excision remains the best management. Late-stage melanoma can be lethal, however, and even though metastatic disease rarely has an impact on the fetus, treatment considerations in such cases must weigh the survival prognosis of both the mother and the fetus, she said.

“Consideration has to be given to whether the mother will even survive to delivery, as well as whether the cancer will metastasize to the placenta or the fetus,” she said, adding that, in such rare cases, it might be reasonable to broach the topic of pregnancy termination with the patient.

“Also, the pregnancy itself is going to change the woman's treatment options. She could theoretically have more aggressive treatment if she were not pregnant,” Dr. Massry noted.

Metastasis of melanoma to the fetus is extremely rare. Only 1 in 1,000 pregnancies is affected by cancer, and just 8% of these cancers are melanoma, she said. However, of all cancers, melanoma is the most likely to spread to the products of conception—with one-third metastasizing to either the placenta or the fetus.

In the most recent literature review of 87 cases of fetal or placental metastasis, 27 cases were attributed to melanoma. Six of those 27 cases actually affected the fetus, with the remaining 21 showing placental metastasis only (J. Clin. Oncol. 2003;21:2179–86).

Among the cases of fetal metastasis, five of the infants died within the first year of life; in the sixth infant, lung and soft tissue metastasis spontaneously regressed for at least 14 years, she said.

Among the cases of placental metastasis, three infants died within 2 days of birth from causes not directly related to metastatic melanoma. Follow-up of the other 18 cases showed no evidence of disease within a range of 47 days to 2 years.

The timing of pregnancy after treatment for melanoma has no impact on recurrence, Dr. Massry said.

Patients can be advised that disease recurrence is primarily related to tumor thickness. A study of 43 women who became pregnant within 5 years of a melanoma diagnosis found no difference in their survival, compared with age-matched controls who became pregnant more than 5 years after their diagnosis (Cancer 1985;55:340–4).

SAN DIEGO — A pregnant patient's suspicious or changing skin lesion should be investigated as promptly and as thoroughly as the same lesion in a nonpregnant patient, Dr. Dina Massry said at a melanoma update sponsored by the Scripps Clinic.

Studies pointing to delayed diagnosis of melanoma among pregnant patients “clearly illustrate that physicians should treat changing nevi in pregnant women exactly the same as in their nonpregnant patients, and biopsy promptly,” said Dr. Massry, head of the division of dermatology at the clinic's Green Hospital in La Jolla, Calif.

Although pregnancy itself does not increase a woman's risk of melanoma, the evidence consistently shows that pregnant women present with later-stage disease and more frequent nodal metastasis. This often occurs because suspicious lesions are dismissed as normal changes of pregnancy, she said in an interview.

“If you or your patient notes a changing mole, don't delay what you would normally do because she is pregnant, and don't ascribe the change as a normal phenomenon of pregnancy,” she said.

As with nonpregnant patients, the prognosis for melanoma depends on the thickness of the lesion and evidence of ulceration. Surgical excision remains the best management. Late-stage melanoma can be lethal, however, and even though metastatic disease rarely has an impact on the fetus, treatment considerations in such cases must weigh the survival prognosis of both the mother and the fetus, she said.

“Consideration has to be given to whether the mother will even survive to delivery, as well as whether the cancer will metastasize to the placenta or the fetus,” she said, adding that, in such rare cases, it might be reasonable to broach the topic of pregnancy termination with the patient.

“Also, the pregnancy itself is going to change the woman's treatment options. She could theoretically have more aggressive treatment if she were not pregnant,” Dr. Massry noted.

Metastasis of melanoma to the fetus is extremely rare. Only 1 in 1,000 pregnancies is affected by cancer, and just 8% of these cancers are melanoma, she said. However, of all cancers, melanoma is the most likely to spread to the products of conception—with one-third metastasizing to either the placenta or the fetus.

In the most recent literature review of 87 cases of fetal or placental metastasis, 27 cases were attributed to melanoma. Six of those 27 cases actually affected the fetus, with the remaining 21 showing placental metastasis only (J. Clin. Oncol. 2003;21:2179–86).

Among the cases of fetal metastasis, five of the infants died within the first year of life; in the sixth infant, lung and soft tissue metastasis spontaneously regressed for at least 14 years, she said.

Among the cases of placental metastasis, three infants died within 2 days of birth from causes not directly related to metastatic melanoma. Follow-up of the other 18 cases showed no evidence of disease within a range of 47 days to 2 years.

The timing of pregnancy after treatment for melanoma has no impact on recurrence, Dr. Massry said.

Patients can be advised that disease recurrence is primarily related to tumor thickness. A study of 43 women who became pregnant within 5 years of a melanoma diagnosis found no difference in their survival, compared with age-matched controls who became pregnant more than 5 years after their diagnosis (Cancer 1985;55:340–4).

SAN DIEGO — A longitudinal pigmented streak beneath the nail could either be a benign melanonychia striata or a far-from-benign subungual melanoma, but despite the vast difference in prognosis, the two conditions are very difficult to tell apart clinically, Dr. Constance Nagi said at a melanoma update sponsored by the Scripps Clinic.

“When it's melanoma, patients often present with late-stage disease, because there is frequently a delay in the correct diagnosis,” she warned, adding that late-stage subungual melanoma carries a 5-year survival rate of 16%–61%. The delay often occurs because it is mistaken for infection or inflammation resulting from trauma.

To add to this confusion, both types of lesions can develop as a result of trauma, and thus both are more commonly seen on thumbs, index fingers, and great toes. Furthermore, melanonychia striata can sometimes be an early sign of melanoma, she noted.

Despite these similarities, there are some key clues that distinguish melanonychia striata from subungual melanoma, said Dr. Nagi, clinical professor of medicine/dermatology at the University of California, San Diego.

Hutchinson's sign, though not always present, is a valuable clue to melanoma diagnosis. This periungual spread of pigmentation to the proximal or lateral nail folds is usually a late sign of melanoma, though absence of it does not imply a benign lesion, she said.

Be suspicious of benign melanonychia striata—usually occurring as a black, brown, or tan longitudinal streak within the nail—if it suddenly darkens or widens, or if it has blurred lateral borders. Additionally, the presence of nail dystrophy, either partial or complete, is a suspicious sign, she pointed out.

The sudden appearance of a nail streak in a single digit in adult life also warrants careful examination; this is especially true for patients who are at increased risk for melanoma or have a history of it.

Dr. Nagi warned that subungual melanoma is often asymptomatic and that up to 25% of cases can be amelanotic, so it is easily mistaken for pyogenic granuloma, chronic granulation tissue, or mycobacterial infection with nail dystrophy.

“When in doubt, biopsy,” she advised, adding that complete excision of the lesion should be considered, if feasible. Patients should be informed preoperatively about the possibility that the biopsy could result in permanent nail dystrophy.

Nail streaks, both benign and malignant, are more common in dark-skinned people than in whites, Dr. Nagi said. Subungual melanoma makes up 15%–20% of all melanomas in African Americans and 2%–3% of all melanomas in whites.

Benign melanonychia striata is uncommon in whites but occurs in virtually 100% of African Americans by age 50 years.

Biopsy showed that this patient's lesion was benign melanonychia striata.

This melanotic melanoma presented as a pyogenic granuloma-like lesion. Photos courtesy Dr. Constance Nagi

SAN DIEGO — A longitudinal pigmented streak beneath the nail could either be a benign melanonychia striata or a far-from-benign subungual melanoma, but despite the vast difference in prognosis, the two conditions are very difficult to tell apart clinically, Dr. Constance Nagi said at a melanoma update sponsored by the Scripps Clinic.

“When it's melanoma, patients often present with late-stage disease, because there is frequently a delay in the correct diagnosis,” she warned, adding that late-stage subungual melanoma carries a 5-year survival rate of 16%–61%. The delay often occurs because it is mistaken for infection or inflammation resulting from trauma.

To add to this confusion, both types of lesions can develop as a result of trauma, and thus both are more commonly seen on thumbs, index fingers, and great toes. Furthermore, melanonychia striata can sometimes be an early sign of melanoma, she noted.

Despite these similarities, there are some key clues that distinguish melanonychia striata from subungual melanoma, said Dr. Nagi, clinical professor of medicine/dermatology at the University of California, San Diego.

Hutchinson's sign, though not always present, is a valuable clue to melanoma diagnosis. This periungual spread of pigmentation to the proximal or lateral nail folds is usually a late sign of melanoma, though absence of it does not imply a benign lesion, she said.

Be suspicious of benign melanonychia striata—usually occurring as a black, brown, or tan longitudinal streak within the nail—if it suddenly darkens or widens, or if it has blurred lateral borders. Additionally, the presence of nail dystrophy, either partial or complete, is a suspicious sign, she pointed out.

The sudden appearance of a nail streak in a single digit in adult life also warrants careful examination; this is especially true for patients who are at increased risk for melanoma or have a history of it.

Dr. Nagi warned that subungual melanoma is often asymptomatic and that up to 25% of cases can be amelanotic, so it is easily mistaken for pyogenic granuloma, chronic granulation tissue, or mycobacterial infection with nail dystrophy.

“When in doubt, biopsy,” she advised, adding that complete excision of the lesion should be considered, if feasible. Patients should be informed preoperatively about the possibility that the biopsy could result in permanent nail dystrophy.

Nail streaks, both benign and malignant, are more common in dark-skinned people than in whites, Dr. Nagi said. Subungual melanoma makes up 15%–20% of all melanomas in African Americans and 2%–3% of all melanomas in whites.

Benign melanonychia striata is uncommon in whites but occurs in virtually 100% of African Americans by age 50 years.

Biopsy showed that this patient's lesion was benign melanonychia striata.

This melanotic melanoma presented as a pyogenic granuloma-like lesion. Photos courtesy Dr. Constance Nagi

SAN DIEGO — A longitudinal pigmented streak beneath the nail could either be a benign melanonychia striata or a far-from-benign subungual melanoma, but despite the vast difference in prognosis, the two conditions are very difficult to tell apart clinically, Dr. Constance Nagi said at a melanoma update sponsored by the Scripps Clinic.

“When it's melanoma, patients often present with late-stage disease, because there is frequently a delay in the correct diagnosis,” she warned, adding that late-stage subungual melanoma carries a 5-year survival rate of 16%–61%. The delay often occurs because it is mistaken for infection or inflammation resulting from trauma.

To add to this confusion, both types of lesions can develop as a result of trauma, and thus both are more commonly seen on thumbs, index fingers, and great toes. Furthermore, melanonychia striata can sometimes be an early sign of melanoma, she noted.

Despite these similarities, there are some key clues that distinguish melanonychia striata from subungual melanoma, said Dr. Nagi, clinical professor of medicine/dermatology at the University of California, San Diego.

Hutchinson's sign, though not always present, is a valuable clue to melanoma diagnosis. This periungual spread of pigmentation to the proximal or lateral nail folds is usually a late sign of melanoma, though absence of it does not imply a benign lesion, she said.

Be suspicious of benign melanonychia striata—usually occurring as a black, brown, or tan longitudinal streak within the nail—if it suddenly darkens or widens, or if it has blurred lateral borders. Additionally, the presence of nail dystrophy, either partial or complete, is a suspicious sign, she pointed out.

The sudden appearance of a nail streak in a single digit in adult life also warrants careful examination; this is especially true for patients who are at increased risk for melanoma or have a history of it.

Dr. Nagi warned that subungual melanoma is often asymptomatic and that up to 25% of cases can be amelanotic, so it is easily mistaken for pyogenic granuloma, chronic granulation tissue, or mycobacterial infection with nail dystrophy.

“When in doubt, biopsy,” she advised, adding that complete excision of the lesion should be considered, if feasible. Patients should be informed preoperatively about the possibility that the biopsy could result in permanent nail dystrophy.

Nail streaks, both benign and malignant, are more common in dark-skinned people than in whites, Dr. Nagi said. Subungual melanoma makes up 15%–20% of all melanomas in African Americans and 2%–3% of all melanomas in whites.

Benign melanonychia striata is uncommon in whites but occurs in virtually 100% of African Americans by age 50 years.

Biopsy showed that this patient's lesion was benign melanonychia striata.

This melanotic melanoma presented as a pyogenic granuloma-like lesion. Photos courtesy Dr. Constance Nagi

ORLANDO – Cognitive-behavioral therapy can significantly reduce seniors' fear of falling and the avoidance of activity that accompanies it, according to the preliminary results of a Dutch study.

CBT may also improve depression and quality of life; however, this data remains to be analyzed, reported Rixt Zijlstra, a Ph.D. candidate at the University of Maastricht, the Netherlands.

Previous work by her group has shown that up to 52% of Dutch adults aged 70 years and older have a fear of falling, regardless of whether they have actually fallen in the past, she said at the annual meeting of the Gerontological Society of America.

Her study randomized 540 community-living adults aged 70 years or older to CBT or no therapy (control group). All participants felt at least some fear of falling and avoided certain activities as a result of that fear. The CBT was designed to challenge the fear through the exploration and management of concerns about falling, the recognition of risks, and instruction in physical exercises and assertiveness designed to optimize fall prevention.

CBT was delivered in 8 weekly sessions of 2 hours each, followed by one booster session at 6 months. Groups included about 10 participants each and were run by nurses trained in geriatric medicine.

One year after the start of the CBT, fear of falling was reported by 25% of the intervention group, compared with 43% of the control group, a significant difference. Avoidance of activities was reported by 25% of the intervention group and by 35% of the control group, she said. The intervention group also reported better perceived control and more daily activity than did the control group.

About 88% of the intervention group said they behaved more safely as a result of the CBT, 80% said they had more confidence, and 75% reported an increase in their physical activity. Secondary outcomes of general health, life satisfaction, physical functioning, anxiety, depression, social support, feelings of loneliness, and falls–and their clinical significance–have not yet been analyzed.

ORLANDO – Cognitive-behavioral therapy can significantly reduce seniors' fear of falling and the avoidance of activity that accompanies it, according to the preliminary results of a Dutch study.

CBT may also improve depression and quality of life; however, this data remains to be analyzed, reported Rixt Zijlstra, a Ph.D. candidate at the University of Maastricht, the Netherlands.

Previous work by her group has shown that up to 52% of Dutch adults aged 70 years and older have a fear of falling, regardless of whether they have actually fallen in the past, she said at the annual meeting of the Gerontological Society of America.

Her study randomized 540 community-living adults aged 70 years or older to CBT or no therapy (control group). All participants felt at least some fear of falling and avoided certain activities as a result of that fear. The CBT was designed to challenge the fear through the exploration and management of concerns about falling, the recognition of risks, and instruction in physical exercises and assertiveness designed to optimize fall prevention.

CBT was delivered in 8 weekly sessions of 2 hours each, followed by one booster session at 6 months. Groups included about 10 participants each and were run by nurses trained in geriatric medicine.

One year after the start of the CBT, fear of falling was reported by 25% of the intervention group, compared with 43% of the control group, a significant difference. Avoidance of activities was reported by 25% of the intervention group and by 35% of the control group, she said. The intervention group also reported better perceived control and more daily activity than did the control group.

About 88% of the intervention group said they behaved more safely as a result of the CBT, 80% said they had more confidence, and 75% reported an increase in their physical activity. Secondary outcomes of general health, life satisfaction, physical functioning, anxiety, depression, social support, feelings of loneliness, and falls–and their clinical significance–have not yet been analyzed.

ORLANDO – Cognitive-behavioral therapy can significantly reduce seniors' fear of falling and the avoidance of activity that accompanies it, according to the preliminary results of a Dutch study.

CBT may also improve depression and quality of life; however, this data remains to be analyzed, reported Rixt Zijlstra, a Ph.D. candidate at the University of Maastricht, the Netherlands.

Previous work by her group has shown that up to 52% of Dutch adults aged 70 years and older have a fear of falling, regardless of whether they have actually fallen in the past, she said at the annual meeting of the Gerontological Society of America.

Her study randomized 540 community-living adults aged 70 years or older to CBT or no therapy (control group). All participants felt at least some fear of falling and avoided certain activities as a result of that fear. The CBT was designed to challenge the fear through the exploration and management of concerns about falling, the recognition of risks, and instruction in physical exercises and assertiveness designed to optimize fall prevention.

CBT was delivered in 8 weekly sessions of 2 hours each, followed by one booster session at 6 months. Groups included about 10 participants each and were run by nurses trained in geriatric medicine.

One year after the start of the CBT, fear of falling was reported by 25% of the intervention group, compared with 43% of the control group, a significant difference. Avoidance of activities was reported by 25% of the intervention group and by 35% of the control group, she said. The intervention group also reported better perceived control and more daily activity than did the control group.

About 88% of the intervention group said they behaved more safely as a result of the CBT, 80% said they had more confidence, and 75% reported an increase in their physical activity. Secondary outcomes of general health, life satisfaction, physical functioning, anxiety, depression, social support, feelings of loneliness, and falls–and their clinical significance–have not yet been analyzed.

ORLANDO – Elderly people tend to quit drinking alcohol as their health declines, but their medications play little role in this decision, according to a new study.

“We found no increased likelihood of drinking cessation among people taking alcohol-interactive medications, as opposed to those taking nonalcohol-interactive medications,” said Kristine E. Pringle, Ph.D., who presented that study in a poster at the annual meeting of the Gerontological Society of America.

“Our study really underscores the importance of physicians warning patients about alcohol-interactive drugs and the fact that they can produce serious, even fatal, reactions when mixed with alcohol,” she said in an interview.

The retrospective study included 8,883 subjects in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) program who reported using alcohol in a 2000 survey. Survey data were then linked to prescription drug claims to examine which medications and health factors were associated with drinking cessation over the next 2 years.

Overall, 3.9% (347) of study subjects quit drinking during the study period. The most common reason was entry into a nursing home (odds ratio 4.5), followed by the addition of antipsychotic medications (OR 2.9) and antineoplastic agents (OR 2.67).

A decline in self-reported health increased the likelihood of quitting (OR 1.55), as did a fall in the previous year (OR 1.28).

But the addition of alcohol-interactive medications was not significantly more likely than the addition of nonalcohol-interactive medications to result in alcohol cessation (OR 1.8 vs. 1.78, respectively), said Dr. Pringle, a research specialist at First Health Services Corporation in Harrisburg, Pa.

“There were many medication classes where 100% of the drugs interacted with alcohol, such as some of the cardiovascular classes or the central nervous system agents. And people who initiated those classes between baseline and follow-up were no more likely to quit drinking,” she said.

“It's not clear if maybe the physician did warn them, but they disregarded the warning, or possibly they did not receive the warning. The prescription bottle itself would have the warning, but sometimes it's printed so small that they might have trouble reading it or they don't understand it. So, especially with older patients, verbal warnings are of paramount importance.”

Dr. Pringle said there were certain classes of drugs that were the least predictive of alcohol cessation, possibly because of the underlying conditions they were treating. These classes included anxiolytics and narcotic analgesics.

Several previous cross-sectional studies have linked poorer health in the elderly to former drinking, rather than current drinking, suggesting that the decision to quit was motivated by declining health. But this is the first longitudinal study to examine the associations with alcohol cessation, Dr. Pringle said.

ORLANDO – Elderly people tend to quit drinking alcohol as their health declines, but their medications play little role in this decision, according to a new study.

“We found no increased likelihood of drinking cessation among people taking alcohol-interactive medications, as opposed to those taking nonalcohol-interactive medications,” said Kristine E. Pringle, Ph.D., who presented that study in a poster at the annual meeting of the Gerontological Society of America.

“Our study really underscores the importance of physicians warning patients about alcohol-interactive drugs and the fact that they can produce serious, even fatal, reactions when mixed with alcohol,” she said in an interview.

The retrospective study included 8,883 subjects in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) program who reported using alcohol in a 2000 survey. Survey data were then linked to prescription drug claims to examine which medications and health factors were associated with drinking cessation over the next 2 years.

Overall, 3.9% (347) of study subjects quit drinking during the study period. The most common reason was entry into a nursing home (odds ratio 4.5), followed by the addition of antipsychotic medications (OR 2.9) and antineoplastic agents (OR 2.67).

A decline in self-reported health increased the likelihood of quitting (OR 1.55), as did a fall in the previous year (OR 1.28).

But the addition of alcohol-interactive medications was not significantly more likely than the addition of nonalcohol-interactive medications to result in alcohol cessation (OR 1.8 vs. 1.78, respectively), said Dr. Pringle, a research specialist at First Health Services Corporation in Harrisburg, Pa.

“There were many medication classes where 100% of the drugs interacted with alcohol, such as some of the cardiovascular classes or the central nervous system agents. And people who initiated those classes between baseline and follow-up were no more likely to quit drinking,” she said.

“It's not clear if maybe the physician did warn them, but they disregarded the warning, or possibly they did not receive the warning. The prescription bottle itself would have the warning, but sometimes it's printed so small that they might have trouble reading it or they don't understand it. So, especially with older patients, verbal warnings are of paramount importance.”

Dr. Pringle said there were certain classes of drugs that were the least predictive of alcohol cessation, possibly because of the underlying conditions they were treating. These classes included anxiolytics and narcotic analgesics.

Several previous cross-sectional studies have linked poorer health in the elderly to former drinking, rather than current drinking, suggesting that the decision to quit was motivated by declining health. But this is the first longitudinal study to examine the associations with alcohol cessation, Dr. Pringle said.

ORLANDO – Elderly people tend to quit drinking alcohol as their health declines, but their medications play little role in this decision, according to a new study.

“We found no increased likelihood of drinking cessation among people taking alcohol-interactive medications, as opposed to those taking nonalcohol-interactive medications,” said Kristine E. Pringle, Ph.D., who presented that study in a poster at the annual meeting of the Gerontological Society of America.

“Our study really underscores the importance of physicians warning patients about alcohol-interactive drugs and the fact that they can produce serious, even fatal, reactions when mixed with alcohol,” she said in an interview.

The retrospective study included 8,883 subjects in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) program who reported using alcohol in a 2000 survey. Survey data were then linked to prescription drug claims to examine which medications and health factors were associated with drinking cessation over the next 2 years.

Overall, 3.9% (347) of study subjects quit drinking during the study period. The most common reason was entry into a nursing home (odds ratio 4.5), followed by the addition of antipsychotic medications (OR 2.9) and antineoplastic agents (OR 2.67).

A decline in self-reported health increased the likelihood of quitting (OR 1.55), as did a fall in the previous year (OR 1.28).

But the addition of alcohol-interactive medications was not significantly more likely than the addition of nonalcohol-interactive medications to result in alcohol cessation (OR 1.8 vs. 1.78, respectively), said Dr. Pringle, a research specialist at First Health Services Corporation in Harrisburg, Pa.

“There were many medication classes where 100% of the drugs interacted with alcohol, such as some of the cardiovascular classes or the central nervous system agents. And people who initiated those classes between baseline and follow-up were no more likely to quit drinking,” she said.

“It's not clear if maybe the physician did warn them, but they disregarded the warning, or possibly they did not receive the warning. The prescription bottle itself would have the warning, but sometimes it's printed so small that they might have trouble reading it or they don't understand it. So, especially with older patients, verbal warnings are of paramount importance.”

Dr. Pringle said there were certain classes of drugs that were the least predictive of alcohol cessation, possibly because of the underlying conditions they were treating. These classes included anxiolytics and narcotic analgesics.

Several previous cross-sectional studies have linked poorer health in the elderly to former drinking, rather than current drinking, suggesting that the decision to quit was motivated by declining health. But this is the first longitudinal study to examine the associations with alcohol cessation, Dr. Pringle said.

ORLANDO – The use of biofeedback to control heart rate variability could be useful in the treatment of older patients with depression, just as it has been beneficial for patients with asthma, chronic obstructive pulmonary disease, and various cancers.

“Heart rate variability is probably the best marker of health in general, such that if one has good heart rate variability, one is generally healthy. But should someone have any health problems, they can learn to improve their heart rate variability and do better,” said Leon Hyer, Ph.D., in a poster presentation given at the annual meeting of the Gerontological Society of America.

In a pilot study of two depressed women aged 55 and 56 years, Dr. Hyer, a professor of psychiatry at the Robert Wood Johnson Medical School, Piscataway, N.J., found that biofeedback training aimed at improving heart rate variability (HRV) resulted in a significant decrease in depressive symptoms.

“This has been shown in young, depressed patients but not in older patients,” said Dr. Hyer in an interview. The two subjects underwent 10 biofeedback sessions in which they were taught–using audio and video feedback from laptop computers–how to regulate their heart rates and breathe at their resonant frequency. They were encouraged to practice frequently.

At the end of the 10 sessions, both subjects experienced a significant decrease in depressive symptoms. Their baseline scores on the Beck Depression Inventory II (BDI-II) were 18 and 21, dropping to 0 for one patient by the end of the study. The second patient's score dropped from 21 to 3 by the end of the 4th session, but rose to 11 by the study's end.

“Since both medical disorders and mood state have a bidirectionality in their effects, there is a significant advantage in applying a treatment that can improve both,” he said.

Although pharmacologic therapy for depression typically has a 60% response rate, this response is not usually sustained in the long term.

By contrast, biofeedback, combined with cognitive-behavioral training, has been shown to produce sustained responses in other health conditions, Dr. Hyer said.

ORLANDO – The use of biofeedback to control heart rate variability could be useful in the treatment of older patients with depression, just as it has been beneficial for patients with asthma, chronic obstructive pulmonary disease, and various cancers.

“Heart rate variability is probably the best marker of health in general, such that if one has good heart rate variability, one is generally healthy. But should someone have any health problems, they can learn to improve their heart rate variability and do better,” said Leon Hyer, Ph.D., in a poster presentation given at the annual meeting of the Gerontological Society of America.

In a pilot study of two depressed women aged 55 and 56 years, Dr. Hyer, a professor of psychiatry at the Robert Wood Johnson Medical School, Piscataway, N.J., found that biofeedback training aimed at improving heart rate variability (HRV) resulted in a significant decrease in depressive symptoms.

“This has been shown in young, depressed patients but not in older patients,” said Dr. Hyer in an interview. The two subjects underwent 10 biofeedback sessions in which they were taught–using audio and video feedback from laptop computers–how to regulate their heart rates and breathe at their resonant frequency. They were encouraged to practice frequently.

At the end of the 10 sessions, both subjects experienced a significant decrease in depressive symptoms. Their baseline scores on the Beck Depression Inventory II (BDI-II) were 18 and 21, dropping to 0 for one patient by the end of the study. The second patient's score dropped from 21 to 3 by the end of the 4th session, but rose to 11 by the study's end.

“Since both medical disorders and mood state have a bidirectionality in their effects, there is a significant advantage in applying a treatment that can improve both,” he said.

Although pharmacologic therapy for depression typically has a 60% response rate, this response is not usually sustained in the long term.

By contrast, biofeedback, combined with cognitive-behavioral training, has been shown to produce sustained responses in other health conditions, Dr. Hyer said.

ORLANDO – The use of biofeedback to control heart rate variability could be useful in the treatment of older patients with depression, just as it has been beneficial for patients with asthma, chronic obstructive pulmonary disease, and various cancers.

“Heart rate variability is probably the best marker of health in general, such that if one has good heart rate variability, one is generally healthy. But should someone have any health problems, they can learn to improve their heart rate variability and do better,” said Leon Hyer, Ph.D., in a poster presentation given at the annual meeting of the Gerontological Society of America.

In a pilot study of two depressed women aged 55 and 56 years, Dr. Hyer, a professor of psychiatry at the Robert Wood Johnson Medical School, Piscataway, N.J., found that biofeedback training aimed at improving heart rate variability (HRV) resulted in a significant decrease in depressive symptoms.

“This has been shown in young, depressed patients but not in older patients,” said Dr. Hyer in an interview. The two subjects underwent 10 biofeedback sessions in which they were taught–using audio and video feedback from laptop computers–how to regulate their heart rates and breathe at their resonant frequency. They were encouraged to practice frequently.

At the end of the 10 sessions, both subjects experienced a significant decrease in depressive symptoms. Their baseline scores on the Beck Depression Inventory II (BDI-II) were 18 and 21, dropping to 0 for one patient by the end of the study. The second patient's score dropped from 21 to 3 by the end of the 4th session, but rose to 11 by the study's end.

“Since both medical disorders and mood state have a bidirectionality in their effects, there is a significant advantage in applying a treatment that can improve both,” he said.

Although pharmacologic therapy for depression typically has a 60% response rate, this response is not usually sustained in the long term.

By contrast, biofeedback, combined with cognitive-behavioral training, has been shown to produce sustained responses in other health conditions, Dr. Hyer said.

ORLANDO – Elderly patients who answer unenthusiastically when asked how long they would like to live may have a dramatically increased risk of dying within 2 years if this attitude is combined with even minor or subthreshold depression, according to some unexpected findings from the Philadelphia Quality of Life of Elders Study.

The findings highlight the importance of even subthreshold depression in this population, said Jana M. Mossey, Ph.D. “From a clinical perspective, when you ask a person how they are doing today you should be really paying attention to the answer,” she said in an interview.

The study, which she presented as a poster at the annual meeting of the Gerontological Society of America, analyzed self-rated health, depression, and years of desired life (YDL) among 600 community-living elderly people (mean age 77 years) and compared this with their mortality rates within the 2 years following the interviews.

Predictably, among the 12% of subjects who died during this period, both poor self-rated health and depressive symptoms were risk factors for mortality, said Dr. Mossey, professor at Drexel University's School of Public Health in Philadelphia.

Although below-average YDL was not a risk factor by itself, it was a factor in the highest mortality risk when combined with depressive symptoms.

“Once you identify someone who is at increased risk [based on depressive symptoms], it's important to delve a bit further and find out what they're thinking about in terms of how they see themselves in the future and how long they want to go on the way they are. This is all information that's going to tell the doctor that here is a person who has high mortality risk and needs to be looked at through a different lens,” she said.

After controlling for objective health status, poor self-rated health increased mortality risk by about 3.5 times, compared with excellent self-rated health. And presence of depressive symptoms (measured using the Centers for Epidemiological Studies Depression scale) doubled mortality, compared with absence of depressive symptoms.

YDL was measured by asking subjects the following question: “Thinking of yourself today–your health and how you manage things–if you were going to be just like you are now for the rest of your life, please tell me the longest time you'd want to live? How many more years or days?” Responses were categorized according to norms established for each age group.

Although 22% of subjects had below-average YDL, this characteristic in itself did not increase their mortality risk, compared with those that had above-average YDL, said Dr. Mossey. But the combination of below-average YDL with depressive symptoms dramatically increased mortality risk by more than eightfold.

“This tells us that depressive symptoms, even when they are minor or subthreshold, need to be taken more seriously than we had thought in the past,” she said.

In a recent paper on subthreshold depression, Dr. Mossey wrote that unlike major depression, which occurs in between 2% and 6% of the population, subthreshold depression is significantly more common, with a prevalence of up to 25%, and rates in excess of 50% among hospitalized patients (Advance for Nurses 2005;7:37–9).

With growing evidence that subthreshold depression compromises quality of life, physical and social functioning, and recovery from illness and injury, and is associated with a disproportionate use of health services, this form of depression represents “a disease state that warrants treatment,” she wrote.

ORLANDO – Elderly patients who answer unenthusiastically when asked how long they would like to live may have a dramatically increased risk of dying within 2 years if this attitude is combined with even minor or subthreshold depression, according to some unexpected findings from the Philadelphia Quality of Life of Elders Study.

The findings highlight the importance of even subthreshold depression in this population, said Jana M. Mossey, Ph.D. “From a clinical perspective, when you ask a person how they are doing today you should be really paying attention to the answer,” she said in an interview.

The study, which she presented as a poster at the annual meeting of the Gerontological Society of America, analyzed self-rated health, depression, and years of desired life (YDL) among 600 community-living elderly people (mean age 77 years) and compared this with their mortality rates within the 2 years following the interviews.

Predictably, among the 12% of subjects who died during this period, both poor self-rated health and depressive symptoms were risk factors for mortality, said Dr. Mossey, professor at Drexel University's School of Public Health in Philadelphia.

Although below-average YDL was not a risk factor by itself, it was a factor in the highest mortality risk when combined with depressive symptoms.

“Once you identify someone who is at increased risk [based on depressive symptoms], it's important to delve a bit further and find out what they're thinking about in terms of how they see themselves in the future and how long they want to go on the way they are. This is all information that's going to tell the doctor that here is a person who has high mortality risk and needs to be looked at through a different lens,” she said.

After controlling for objective health status, poor self-rated health increased mortality risk by about 3.5 times, compared with excellent self-rated health. And presence of depressive symptoms (measured using the Centers for Epidemiological Studies Depression scale) doubled mortality, compared with absence of depressive symptoms.

YDL was measured by asking subjects the following question: “Thinking of yourself today–your health and how you manage things–if you were going to be just like you are now for the rest of your life, please tell me the longest time you'd want to live? How many more years or days?” Responses were categorized according to norms established for each age group.

Although 22% of subjects had below-average YDL, this characteristic in itself did not increase their mortality risk, compared with those that had above-average YDL, said Dr. Mossey. But the combination of below-average YDL with depressive symptoms dramatically increased mortality risk by more than eightfold.

“This tells us that depressive symptoms, even when they are minor or subthreshold, need to be taken more seriously than we had thought in the past,” she said.

In a recent paper on subthreshold depression, Dr. Mossey wrote that unlike major depression, which occurs in between 2% and 6% of the population, subthreshold depression is significantly more common, with a prevalence of up to 25%, and rates in excess of 50% among hospitalized patients (Advance for Nurses 2005;7:37–9).

With growing evidence that subthreshold depression compromises quality of life, physical and social functioning, and recovery from illness and injury, and is associated with a disproportionate use of health services, this form of depression represents “a disease state that warrants treatment,” she wrote.

ORLANDO – Elderly patients who answer unenthusiastically when asked how long they would like to live may have a dramatically increased risk of dying within 2 years if this attitude is combined with even minor or subthreshold depression, according to some unexpected findings from the Philadelphia Quality of Life of Elders Study.

The findings highlight the importance of even subthreshold depression in this population, said Jana M. Mossey, Ph.D. “From a clinical perspective, when you ask a person how they are doing today you should be really paying attention to the answer,” she said in an interview.

The study, which she presented as a poster at the annual meeting of the Gerontological Society of America, analyzed self-rated health, depression, and years of desired life (YDL) among 600 community-living elderly people (mean age 77 years) and compared this with their mortality rates within the 2 years following the interviews.

Predictably, among the 12% of subjects who died during this period, both poor self-rated health and depressive symptoms were risk factors for mortality, said Dr. Mossey, professor at Drexel University's School of Public Health in Philadelphia.

Although below-average YDL was not a risk factor by itself, it was a factor in the highest mortality risk when combined with depressive symptoms.

“Once you identify someone who is at increased risk [based on depressive symptoms], it's important to delve a bit further and find out what they're thinking about in terms of how they see themselves in the future and how long they want to go on the way they are. This is all information that's going to tell the doctor that here is a person who has high mortality risk and needs to be looked at through a different lens,” she said.

After controlling for objective health status, poor self-rated health increased mortality risk by about 3.5 times, compared with excellent self-rated health. And presence of depressive symptoms (measured using the Centers for Epidemiological Studies Depression scale) doubled mortality, compared with absence of depressive symptoms.

YDL was measured by asking subjects the following question: “Thinking of yourself today–your health and how you manage things–if you were going to be just like you are now for the rest of your life, please tell me the longest time you'd want to live? How many more years or days?” Responses were categorized according to norms established for each age group.

Although 22% of subjects had below-average YDL, this characteristic in itself did not increase their mortality risk, compared with those that had above-average YDL, said Dr. Mossey. But the combination of below-average YDL with depressive symptoms dramatically increased mortality risk by more than eightfold.

“This tells us that depressive symptoms, even when they are minor or subthreshold, need to be taken more seriously than we had thought in the past,” she said.

In a recent paper on subthreshold depression, Dr. Mossey wrote that unlike major depression, which occurs in between 2% and 6% of the population, subthreshold depression is significantly more common, with a prevalence of up to 25%, and rates in excess of 50% among hospitalized patients (Advance for Nurses 2005;7:37–9).

With growing evidence that subthreshold depression compromises quality of life, physical and social functioning, and recovery from illness and injury, and is associated with a disproportionate use of health services, this form of depression represents “a disease state that warrants treatment,” she wrote.

ORLANDO – The quality of life among caregivers of Alzheimer's patients can improve significantly when interventions are tailored to their needs, according to the first randomized trial of such interventions.

“Physicians are in a position to identify highly stressed caregivers and intervene,” said Richard Schulz, Ph.D., the principal investigator on the Resources for Enhancing Alzheimer's Caregiver Health (REACH) II trial.

Speaking at the annual meeting of the Gerontological Society of America, Dr. Schulz and several other of the trial's investigators noted that a goal of the REACH team is to develop a brief assessment for use by physicians to evaluate caregivers' depressive symptoms. “This would be something a caregiver could fill out in the waiting room and would give the doctor an indication that there may be problems,” he said in an interview.

The REACH II trial randomized 642 family member caregivers of Alzheimer's patients to either usual care (control group) or a tailored intervention aimed at improving their quality of life. The primary outcome, measured after 6 months, was a multivariate quality of life indicator that assessed caregiver burden (how extensively their lives were disrupted as a result of caregiving), depressive symptoms, self-care, social support, and patient problem behaviors, said Dr. Schulz, a professor of psychiatry at the University of Pittsburgh.

The group's racial and ethnic backgrounds were equally divided among whites, blacks, and Hispanics. Most caregivers were female, in their late 50s, and living with the Alzheimer's patient.

Prior to randomization, all caregivers underwent an extensive baseline evaluation, which assessed their risk for poor or decreasing quality of life. Those in the intervention arm then received a series of 12 intervention visits tailored specifically to their areas of concern.

When reassessed at the end of the study period, whites and Hispanics showed significant improvement after the intervention, whether the caregiver was a spouse or an adult child, while blacks showed improvement only when the caregiver was a spouse.

The study also measured clinical depression among caregivers as well as their intentions of placing the Alzheimer's patient in an institution. Caregivers who received the intervention were significantly less likely than the control group to consider institutionalization (4% vs. 7%) and to be clinically depressed (13% vs. 23%).

ORLANDO – The quality of life among caregivers of Alzheimer's patients can improve significantly when interventions are tailored to their needs, according to the first randomized trial of such interventions.

“Physicians are in a position to identify highly stressed caregivers and intervene,” said Richard Schulz, Ph.D., the principal investigator on the Resources for Enhancing Alzheimer's Caregiver Health (REACH) II trial.

Speaking at the annual meeting of the Gerontological Society of America, Dr. Schulz and several other of the trial's investigators noted that a goal of the REACH team is to develop a brief assessment for use by physicians to evaluate caregivers' depressive symptoms. “This would be something a caregiver could fill out in the waiting room and would give the doctor an indication that there may be problems,” he said in an interview.

The REACH II trial randomized 642 family member caregivers of Alzheimer's patients to either usual care (control group) or a tailored intervention aimed at improving their quality of life. The primary outcome, measured after 6 months, was a multivariate quality of life indicator that assessed caregiver burden (how extensively their lives were disrupted as a result of caregiving), depressive symptoms, self-care, social support, and patient problem behaviors, said Dr. Schulz, a professor of psychiatry at the University of Pittsburgh.

The group's racial and ethnic backgrounds were equally divided among whites, blacks, and Hispanics. Most caregivers were female, in their late 50s, and living with the Alzheimer's patient.

Prior to randomization, all caregivers underwent an extensive baseline evaluation, which assessed their risk for poor or decreasing quality of life. Those in the intervention arm then received a series of 12 intervention visits tailored specifically to their areas of concern.

When reassessed at the end of the study period, whites and Hispanics showed significant improvement after the intervention, whether the caregiver was a spouse or an adult child, while blacks showed improvement only when the caregiver was a spouse.

The study also measured clinical depression among caregivers as well as their intentions of placing the Alzheimer's patient in an institution. Caregivers who received the intervention were significantly less likely than the control group to consider institutionalization (4% vs. 7%) and to be clinically depressed (13% vs. 23%).

ORLANDO – The quality of life among caregivers of Alzheimer's patients can improve significantly when interventions are tailored to their needs, according to the first randomized trial of such interventions.

“Physicians are in a position to identify highly stressed caregivers and intervene,” said Richard Schulz, Ph.D., the principal investigator on the Resources for Enhancing Alzheimer's Caregiver Health (REACH) II trial.

Speaking at the annual meeting of the Gerontological Society of America, Dr. Schulz and several other of the trial's investigators noted that a goal of the REACH team is to develop a brief assessment for use by physicians to evaluate caregivers' depressive symptoms. “This would be something a caregiver could fill out in the waiting room and would give the doctor an indication that there may be problems,” he said in an interview.

The REACH II trial randomized 642 family member caregivers of Alzheimer's patients to either usual care (control group) or a tailored intervention aimed at improving their quality of life. The primary outcome, measured after 6 months, was a multivariate quality of life indicator that assessed caregiver burden (how extensively their lives were disrupted as a result of caregiving), depressive symptoms, self-care, social support, and patient problem behaviors, said Dr. Schulz, a professor of psychiatry at the University of Pittsburgh.

The group's racial and ethnic backgrounds were equally divided among whites, blacks, and Hispanics. Most caregivers were female, in their late 50s, and living with the Alzheimer's patient.

Prior to randomization, all caregivers underwent an extensive baseline evaluation, which assessed their risk for poor or decreasing quality of life. Those in the intervention arm then received a series of 12 intervention visits tailored specifically to their areas of concern.

When reassessed at the end of the study period, whites and Hispanics showed significant improvement after the intervention, whether the caregiver was a spouse or an adult child, while blacks showed improvement only when the caregiver was a spouse.

The study also measured clinical depression among caregivers as well as their intentions of placing the Alzheimer's patient in an institution. Caregivers who received the intervention were significantly less likely than the control group to consider institutionalization (4% vs. 7%) and to be clinically depressed (13% vs. 23%).

MONTREAL — Pantoprazole safely reduces gastroesophageal reflux symptoms in children and adolescents at roughly half the adult dosage, according to two studies funded by Wyeth Pharmaceuticals, which manufactures the proton pump inhibitor.

The company does not yet have pediatric approval for the drug (Protonix), but the study fills “an unmet need for appropriate dosing information across the spectrum of pediatric patients,” said Elaine Soffer, director of clinical research and development for the company, which is based in Collegeville, Pa.

The studies, presented as posters at the 13th World Congress of Gastroenterology, compared once-daily treatment at 10, 20, or 40 mg in 53 children aged 5–11 years, and once-daily treatment at 20 or 40 mg in 136 adolescents aged 12–16 years.

The younger age group had endoscopically proven gastroesophageal reflux disease (GERD), while the older age group had a clinical diagnosis of GERD. All patients were randomized into one of the treatment groups for 8 weeks.

The GERD Assessment of Symptoms in Pediatrics Questionnaire (GASP-Q) was used at baseline and then weekly to measure the frequency and severity of abdominal pain, chest pain or heartburn, difficulty swallowing, nausea, vomiting or regurgitation, choking when eating, belching, and pain after eating.

After 1 week of treatment, there was a significant improvement in the mean symptom score for children in the 20-mg and 40-mg treatment groups, but this change was not seen until week 3 in the 10-mg treatment group. The difference between the 10-mg and 40-mg groups after 1 week was statistically significant (25 vs. 87 mean change in score from baseline); but scores improved significantly from baseline in all groups by week 8.

In the adolescents, the 40-mg dose was significantly more effective at week 1 and week 6 than was the 20-mg dose, but by week 8, a significant improvement in symptoms was evident in both groups, as measured by the Physicians Global Assessment and the GASP-Q scores.

Teens in the 40-mg group, but not the 20-mg group, significantly decreased their antacid use in the last week of the study, compared with the first week (1.3 tablets vs. 3.2 tablets per week).

Safety was comparable in both teen treatment groups, although there were more early exits and significantly more diarrhea in the high-dose group.

Among the children, one withdrew in the low-dose group because of lack of efficacy. No significant adverse events occurred in any of the treatment groups, and no patients dropped out because of adverse events.

“What these studies demonstrate is that at 8 weeks, there is a significant reduction in symptoms at all doses, and that even at 1 week, you can see a dose effect at the higher dose,” Ms. Soffer said in an interview. Treatment also resulted in healing of erosive esophagitis in all four patients with this diagnosis, she added.

“In children, one might want to be conservative and select the middle dose because it shows an effect at 1 week. … Then if the child doesn't respond fast enough, the higher dose is available,” Ms. Soffer said.

MONTREAL — Pantoprazole safely reduces gastroesophageal reflux symptoms in children and adolescents at roughly half the adult dosage, according to two studies funded by Wyeth Pharmaceuticals, which manufactures the proton pump inhibitor.

The company does not yet have pediatric approval for the drug (Protonix), but the study fills “an unmet need for appropriate dosing information across the spectrum of pediatric patients,” said Elaine Soffer, director of clinical research and development for the company, which is based in Collegeville, Pa.

The studies, presented as posters at the 13th World Congress of Gastroenterology, compared once-daily treatment at 10, 20, or 40 mg in 53 children aged 5–11 years, and once-daily treatment at 20 or 40 mg in 136 adolescents aged 12–16 years.

The younger age group had endoscopically proven gastroesophageal reflux disease (GERD), while the older age group had a clinical diagnosis of GERD. All patients were randomized into one of the treatment groups for 8 weeks.

The GERD Assessment of Symptoms in Pediatrics Questionnaire (GASP-Q) was used at baseline and then weekly to measure the frequency and severity of abdominal pain, chest pain or heartburn, difficulty swallowing, nausea, vomiting or regurgitation, choking when eating, belching, and pain after eating.

After 1 week of treatment, there was a significant improvement in the mean symptom score for children in the 20-mg and 40-mg treatment groups, but this change was not seen until week 3 in the 10-mg treatment group. The difference between the 10-mg and 40-mg groups after 1 week was statistically significant (25 vs. 87 mean change in score from baseline); but scores improved significantly from baseline in all groups by week 8.

In the adolescents, the 40-mg dose was significantly more effective at week 1 and week 6 than was the 20-mg dose, but by week 8, a significant improvement in symptoms was evident in both groups, as measured by the Physicians Global Assessment and the GASP-Q scores.

Teens in the 40-mg group, but not the 20-mg group, significantly decreased their antacid use in the last week of the study, compared with the first week (1.3 tablets vs. 3.2 tablets per week).

Safety was comparable in both teen treatment groups, although there were more early exits and significantly more diarrhea in the high-dose group.

Among the children, one withdrew in the low-dose group because of lack of efficacy. No significant adverse events occurred in any of the treatment groups, and no patients dropped out because of adverse events.

“What these studies demonstrate is that at 8 weeks, there is a significant reduction in symptoms at all doses, and that even at 1 week, you can see a dose effect at the higher dose,” Ms. Soffer said in an interview. Treatment also resulted in healing of erosive esophagitis in all four patients with this diagnosis, she added.

“In children, one might want to be conservative and select the middle dose because it shows an effect at 1 week. … Then if the child doesn't respond fast enough, the higher dose is available,” Ms. Soffer said.

MONTREAL — Pantoprazole safely reduces gastroesophageal reflux symptoms in children and adolescents at roughly half the adult dosage, according to two studies funded by Wyeth Pharmaceuticals, which manufactures the proton pump inhibitor.

The company does not yet have pediatric approval for the drug (Protonix), but the study fills “an unmet need for appropriate dosing information across the spectrum of pediatric patients,” said Elaine Soffer, director of clinical research and development for the company, which is based in Collegeville, Pa.

The studies, presented as posters at the 13th World Congress of Gastroenterology, compared once-daily treatment at 10, 20, or 40 mg in 53 children aged 5–11 years, and once-daily treatment at 20 or 40 mg in 136 adolescents aged 12–16 years.

The younger age group had endoscopically proven gastroesophageal reflux disease (GERD), while the older age group had a clinical diagnosis of GERD. All patients were randomized into one of the treatment groups for 8 weeks.

The GERD Assessment of Symptoms in Pediatrics Questionnaire (GASP-Q) was used at baseline and then weekly to measure the frequency and severity of abdominal pain, chest pain or heartburn, difficulty swallowing, nausea, vomiting or regurgitation, choking when eating, belching, and pain after eating.

After 1 week of treatment, there was a significant improvement in the mean symptom score for children in the 20-mg and 40-mg treatment groups, but this change was not seen until week 3 in the 10-mg treatment group. The difference between the 10-mg and 40-mg groups after 1 week was statistically significant (25 vs. 87 mean change in score from baseline); but scores improved significantly from baseline in all groups by week 8.

In the adolescents, the 40-mg dose was significantly more effective at week 1 and week 6 than was the 20-mg dose, but by week 8, a significant improvement in symptoms was evident in both groups, as measured by the Physicians Global Assessment and the GASP-Q scores.

Teens in the 40-mg group, but not the 20-mg group, significantly decreased their antacid use in the last week of the study, compared with the first week (1.3 tablets vs. 3.2 tablets per week).

Safety was comparable in both teen treatment groups, although there were more early exits and significantly more diarrhea in the high-dose group.

Among the children, one withdrew in the low-dose group because of lack of efficacy. No significant adverse events occurred in any of the treatment groups, and no patients dropped out because of adverse events.

“What these studies demonstrate is that at 8 weeks, there is a significant reduction in symptoms at all doses, and that even at 1 week, you can see a dose effect at the higher dose,” Ms. Soffer said in an interview. Treatment also resulted in healing of erosive esophagitis in all four patients with this diagnosis, she added.

“In children, one might want to be conservative and select the middle dose because it shows an effect at 1 week. … Then if the child doesn't respond fast enough, the higher dose is available,” Ms. Soffer said.

ORLANDO — Up to 39% of geriatric patients are taking potentially inappropriate medications, and this trend is associated with increased drug-related problems and health care costs, according to a new study.

The findings should encourage physicians to be more critical in their prescribing decisions, said Diane M. Spokus, one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

The retrospective examination of medication use among 17,971 managed-care patients aged 65 or older found that 6,875 (39%) were using at least one potentially inappropriate medication (PIM), including 13% who were using two or more PIMs.

PIMs were defined by the revised Beers criteria (Arch. Intern. Med. 2003;163:2716–24) as either “medications or medication classes that should generally be avoided in persons 65 years or older because they are either ineffective, or they pose unnecessarily high risk for older persons, and a safer alternative is available.”

The finding of a 39% rate of PIM prescriptions is higher than what has been previously reported, “but we attributed that to the fact that we included oral estrogen as a PIM, and that accounted for almost 10%,” Ms. Spokus said in an interview.

After estrogen, the two most commonly prescribed PIMs were propoxyphene and combination products, as well as short-acting benzodiazepines (7% each), followed by digoxin (4.7%) and long-term, nonsteroidal anti-inflammatories (4.6%), according to the findings.

By using principal and secondary discharge diagnoses occurring within 30 days of the medication prescription, the study found a nearly threefold higher rate of drug-related problems among patients taking at least one PIM, compared with those not taking such medications (14% vs. 5%).

The most common drug-related problems were syncope (3.6%), malaise and fatigue (3.5%), dehydration (1.8%), sleep disturbances (1.5%), and any cognitive impairment (1.5%).

PIMs were associated with increased costs, including facility-paid, provider-paid, and prescription costs (about $2,250 per patient over 6 months), compared with patients who were not taking the medications (about $1,000), with patients taking more than one PIM accounting for the highest costs.

A larger, prospective study is needed to determine which drugs are associated with the most problems, Ms. Spokus said.

The researchers also noted that their measures were limited in their ability to infer causality.

ORLANDO — Up to 39% of geriatric patients are taking potentially inappropriate medications, and this trend is associated with increased drug-related problems and health care costs, according to a new study.

The findings should encourage physicians to be more critical in their prescribing decisions, said Diane M. Spokus, one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

The retrospective examination of medication use among 17,971 managed-care patients aged 65 or older found that 6,875 (39%) were using at least one potentially inappropriate medication (PIM), including 13% who were using two or more PIMs.

PIMs were defined by the revised Beers criteria (Arch. Intern. Med. 2003;163:2716–24) as either “medications or medication classes that should generally be avoided in persons 65 years or older because they are either ineffective, or they pose unnecessarily high risk for older persons, and a safer alternative is available.”

The finding of a 39% rate of PIM prescriptions is higher than what has been previously reported, “but we attributed that to the fact that we included oral estrogen as a PIM, and that accounted for almost 10%,” Ms. Spokus said in an interview.

After estrogen, the two most commonly prescribed PIMs were propoxyphene and combination products, as well as short-acting benzodiazepines (7% each), followed by digoxin (4.7%) and long-term, nonsteroidal anti-inflammatories (4.6%), according to the findings.

By using principal and secondary discharge diagnoses occurring within 30 days of the medication prescription, the study found a nearly threefold higher rate of drug-related problems among patients taking at least one PIM, compared with those not taking such medications (14% vs. 5%).

The most common drug-related problems were syncope (3.6%), malaise and fatigue (3.5%), dehydration (1.8%), sleep disturbances (1.5%), and any cognitive impairment (1.5%).

PIMs were associated with increased costs, including facility-paid, provider-paid, and prescription costs (about $2,250 per patient over 6 months), compared with patients who were not taking the medications (about $1,000), with patients taking more than one PIM accounting for the highest costs.

A larger, prospective study is needed to determine which drugs are associated with the most problems, Ms. Spokus said.

The researchers also noted that their measures were limited in their ability to infer causality.

ORLANDO — Up to 39% of geriatric patients are taking potentially inappropriate medications, and this trend is associated with increased drug-related problems and health care costs, according to a new study.

The findings should encourage physicians to be more critical in their prescribing decisions, said Diane M. Spokus, one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

The retrospective examination of medication use among 17,971 managed-care patients aged 65 or older found that 6,875 (39%) were using at least one potentially inappropriate medication (PIM), including 13% who were using two or more PIMs.

PIMs were defined by the revised Beers criteria (Arch. Intern. Med. 2003;163:2716–24) as either “medications or medication classes that should generally be avoided in persons 65 years or older because they are either ineffective, or they pose unnecessarily high risk for older persons, and a safer alternative is available.”

The finding of a 39% rate of PIM prescriptions is higher than what has been previously reported, “but we attributed that to the fact that we included oral estrogen as a PIM, and that accounted for almost 10%,” Ms. Spokus said in an interview.

After estrogen, the two most commonly prescribed PIMs were propoxyphene and combination products, as well as short-acting benzodiazepines (7% each), followed by digoxin (4.7%) and long-term, nonsteroidal anti-inflammatories (4.6%), according to the findings.

By using principal and secondary discharge diagnoses occurring within 30 days of the medication prescription, the study found a nearly threefold higher rate of drug-related problems among patients taking at least one PIM, compared with those not taking such medications (14% vs. 5%).

The most common drug-related problems were syncope (3.6%), malaise and fatigue (3.5%), dehydration (1.8%), sleep disturbances (1.5%), and any cognitive impairment (1.5%).

PIMs were associated with increased costs, including facility-paid, provider-paid, and prescription costs (about $2,250 per patient over 6 months), compared with patients who were not taking the medications (about $1,000), with patients taking more than one PIM accounting for the highest costs.

A larger, prospective study is needed to determine which drugs are associated with the most problems, Ms. Spokus said.

The researchers also noted that their measures were limited in their ability to infer causality.