Kate Johnson

MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

This preliminary safety and persistence information "justifies daily dosing," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

"These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed," she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, "the most important and interesting data" showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL. "The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration."

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

"There was no difference between groups in terms of concentration of microorganisms at every time point, or proinflammatory cytokines—and most importantly in the treatment group, there was no shift in these concentrations," she said. A total of 18 patients had new colposcopic findings on follow-up, but all were considered superficial.

MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

This preliminary safety and persistence information "justifies daily dosing," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

"These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed," she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, "the most important and interesting data" showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL. "The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration."

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

"There was no difference between groups in terms of concentration of microorganisms at every time point, or proinflammatory cytokines—and most importantly in the treatment group, there was no shift in these concentrations," she said. A total of 18 patients had new colposcopic findings on follow-up, but all were considered superficial.

MONTREAL — A single application of a vaginal microbicide gel resulted in persistently protective levels 24 hours later, with no significant side effects, reported Dr. Katherine Bunge of Magee-Womens Hospital in Pittsburgh.

This preliminary safety and persistence information "justifies daily dosing," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The phase I, single-center trial of the nonnucleoside reverse transcription inhibitor UC-781 randomized 60 healthy women at a ratio of 2:1 to either treatment or placebo, explained Dr. Bunge, who had no disclosures to declare.

The women (mean age 26 years) also were randomized to product exposure durations of either 2, 4, or 8 hours. They received a physician-administered dose of vaginal gel and were then required to stay in the research facility for their assigned time period, after which specimens were collected by cervicovaginal lavage (CVL) and vaginal swabs. The subjects then returned 1 day, 1 week, and 1 month later for follow-up.

Urogenital irritation was assessed by pelvic exam and symptoms, microscopic genital changes were assessed by colposcopy, systemic safety was assessed by history and laboratory parameters, vaginal flora was quantified, and cervical cytokines were measured.

"These are fairly typical safety measures in any phase I trial of a microbicide, but what we attempted to do that hadn't really been looked at before was to figure out a way to determine the persistence of this vaginally applied drug that we didn't really expect to be absorbed," she said.

To that end, plasma drug levels were measured both immediately after the patients' timed exposure and then again a day later; drug levels were measured in CVL and vaginal swab specimens, which also were collected at those two time points, Dr. Bunge explained.

At 24 hours post exposure, two patients had detectable levels of UC-781 in their plasma, but in both cases the levels were considered below the limits of quantification, she said.

In contrast, "the most important and interesting data" showed persistence of the drug in the vagina, she said. Eight hours after treatment, 100% of the women had detectable drug levels in CVL specimens and 90% had detectable levels in vaginal swab specimens. At 24 hours post exposure, 93% had detectable levels after a second CVL, and 42% showed detectable levels after a second vaginal swab.

Dr. Bunge pointed out that even after 24 hours, the median concentration of UC-781 in CVL specimens was 4,965 pmol/mL. "The inhibitory concentration of UC-781 is 2 pmol/mL, so in fact at 24 hours after washout, the median concentration of detectable drug in CVL samples was a thousand times the inhibitory concentration."

Among the 197 adverse events (121 in the treatment group and 76 in the placebo group), 85% were classified as mild. There were four severe events but all were deemed not related or probably not related to treatment, said Dr. Bunge.

"There was no difference between groups in terms of concentration of microorganisms at every time point, or proinflammatory cytokines—and most importantly in the treatment group, there was no shift in these concentrations," she said. A total of 18 patients had new colposcopic findings on follow-up, but all were considered superficial.

MONTREAL — Increased vitamin D intake is not protective against melanoma, according to the results of the largest prospective cohort study presented by Dr. Maryam M. Asgari of Kaiser Permanente in Oakland, Calif.

Her study, presented at the annual meeting of the Society for Investigative Dermatology, suggests a trend toward a greater risk of melanoma with high dietary intake of vitamin D.

“When we looked at diet alone there was a slightly increased risk, but when we combined diet and supplement use, the risk washed out,” she said in an interview.

The cohort comprised 68,611 participants in the Vitamins and Cohort Lifestyle study. The average age was 62 years; 52% were female.

The researchers studied dietary intake of vitamin D and other nutrients in the preceding year, and supplement use over the past 10 years.

There was no evidence of an association between supplement use and an increased or decreased risk of melanoma, reported Dr. Asgari.

However, there was a nonsignificant trend toward a protective effect at the higher supplement doses.

When supplement use was examined in combination with dietary intake, there was no association with melanoma risk. However, high dietary intake alone was significantly associated with a slightly increased risk of melanoma.

MONTREAL — Increased vitamin D intake is not protective against melanoma, according to the results of the largest prospective cohort study presented by Dr. Maryam M. Asgari of Kaiser Permanente in Oakland, Calif.

Her study, presented at the annual meeting of the Society for Investigative Dermatology, suggests a trend toward a greater risk of melanoma with high dietary intake of vitamin D.

“When we looked at diet alone there was a slightly increased risk, but when we combined diet and supplement use, the risk washed out,” she said in an interview.

The cohort comprised 68,611 participants in the Vitamins and Cohort Lifestyle study. The average age was 62 years; 52% were female.

The researchers studied dietary intake of vitamin D and other nutrients in the preceding year, and supplement use over the past 10 years.

There was no evidence of an association between supplement use and an increased or decreased risk of melanoma, reported Dr. Asgari.

However, there was a nonsignificant trend toward a protective effect at the higher supplement doses.

When supplement use was examined in combination with dietary intake, there was no association with melanoma risk. However, high dietary intake alone was significantly associated with a slightly increased risk of melanoma.

MONTREAL — Increased vitamin D intake is not protective against melanoma, according to the results of the largest prospective cohort study presented by Dr. Maryam M. Asgari of Kaiser Permanente in Oakland, Calif.

Her study, presented at the annual meeting of the Society for Investigative Dermatology, suggests a trend toward a greater risk of melanoma with high dietary intake of vitamin D.

“When we looked at diet alone there was a slightly increased risk, but when we combined diet and supplement use, the risk washed out,” she said in an interview.

The cohort comprised 68,611 participants in the Vitamins and Cohort Lifestyle study. The average age was 62 years; 52% were female.

The researchers studied dietary intake of vitamin D and other nutrients in the preceding year, and supplement use over the past 10 years.

There was no evidence of an association between supplement use and an increased or decreased risk of melanoma, reported Dr. Asgari.

However, there was a nonsignificant trend toward a protective effect at the higher supplement doses.

When supplement use was examined in combination with dietary intake, there was no association with melanoma risk. However, high dietary intake alone was significantly associated with a slightly increased risk of melanoma.

AMSTERDAM — A new genetic screen of zygotes performed a few hours after in vitro fertilization has advantages over conventional preimplantation genetic screening, particularly in patients with a very poor prognosis, based on results of the first clinical application of the procedure.

Although preimplantation genetic screening (PGS) allows examination of only about half of the chromosomes in a 3-day embryo, the new technique, known as comparative genomic hybridization (CGH), can evaluate all chromosomes in newly fertilized oocytes (zygotes), Elpida Fragouli, Ph.D., reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Her study of CGH in 82 women with a very poor prognosis shows an ongoing pregnancy rate of 20%, including three deliveries.

“This is exceptional considering the extremely poor prognosis of the women involved,” said Dr. Fragouli of the University of Oxford (England). “This represents a doubling of the usual pregnancy rate for people who fall into this category, which is otherwise, at best, under 10%, and at worst, 0.”

The women were an average of 41 years old, with histories of implantation failures and multiple unexplained spontaneous abortions, she said.

Using CGH, Dr. Fragouli and her associates found chromosomal abnormalities in 64% of 473 screened zygotes, including abnormalities in chromosomes that are not examined in conventional PGS. “With standard screening, 39% of these abnormalities would not have been detected, and 16% of abnormalities would have been incorrectly diagnosed as normal.”

Only healthy zygotes were allowed to mature, resulting in 73 embryos, which were transferred to 35 patients.

The CGH technique is considered less invasive than regular PGS, because it does not require a day 3 biopsy of embryonic cells, which some experts consider damaging to the embryo. Instead, CGH involves the removal and examination of polar bodies, which are by-products of fertilization and not necessary for embryo development.

Dr. Fragouli did not declare any conflicts of interest.

AMSTERDAM — A new genetic screen of zygotes performed a few hours after in vitro fertilization has advantages over conventional preimplantation genetic screening, particularly in patients with a very poor prognosis, based on results of the first clinical application of the procedure.

Although preimplantation genetic screening (PGS) allows examination of only about half of the chromosomes in a 3-day embryo, the new technique, known as comparative genomic hybridization (CGH), can evaluate all chromosomes in newly fertilized oocytes (zygotes), Elpida Fragouli, Ph.D., reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Her study of CGH in 82 women with a very poor prognosis shows an ongoing pregnancy rate of 20%, including three deliveries.

“This is exceptional considering the extremely poor prognosis of the women involved,” said Dr. Fragouli of the University of Oxford (England). “This represents a doubling of the usual pregnancy rate for people who fall into this category, which is otherwise, at best, under 10%, and at worst, 0.”

The women were an average of 41 years old, with histories of implantation failures and multiple unexplained spontaneous abortions, she said.

Using CGH, Dr. Fragouli and her associates found chromosomal abnormalities in 64% of 473 screened zygotes, including abnormalities in chromosomes that are not examined in conventional PGS. “With standard screening, 39% of these abnormalities would not have been detected, and 16% of abnormalities would have been incorrectly diagnosed as normal.”

Only healthy zygotes were allowed to mature, resulting in 73 embryos, which were transferred to 35 patients.

The CGH technique is considered less invasive than regular PGS, because it does not require a day 3 biopsy of embryonic cells, which some experts consider damaging to the embryo. Instead, CGH involves the removal and examination of polar bodies, which are by-products of fertilization and not necessary for embryo development.

Dr. Fragouli did not declare any conflicts of interest.

AMSTERDAM — A new genetic screen of zygotes performed a few hours after in vitro fertilization has advantages over conventional preimplantation genetic screening, particularly in patients with a very poor prognosis, based on results of the first clinical application of the procedure.

Although preimplantation genetic screening (PGS) allows examination of only about half of the chromosomes in a 3-day embryo, the new technique, known as comparative genomic hybridization (CGH), can evaluate all chromosomes in newly fertilized oocytes (zygotes), Elpida Fragouli, Ph.D., reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Her study of CGH in 82 women with a very poor prognosis shows an ongoing pregnancy rate of 20%, including three deliveries.

“This is exceptional considering the extremely poor prognosis of the women involved,” said Dr. Fragouli of the University of Oxford (England). “This represents a doubling of the usual pregnancy rate for people who fall into this category, which is otherwise, at best, under 10%, and at worst, 0.”

The women were an average of 41 years old, with histories of implantation failures and multiple unexplained spontaneous abortions, she said.

Using CGH, Dr. Fragouli and her associates found chromosomal abnormalities in 64% of 473 screened zygotes, including abnormalities in chromosomes that are not examined in conventional PGS. “With standard screening, 39% of these abnormalities would not have been detected, and 16% of abnormalities would have been incorrectly diagnosed as normal.”

Only healthy zygotes were allowed to mature, resulting in 73 embryos, which were transferred to 35 patients.

The CGH technique is considered less invasive than regular PGS, because it does not require a day 3 biopsy of embryonic cells, which some experts consider damaging to the embryo. Instead, CGH involves the removal and examination of polar bodies, which are by-products of fertilization and not necessary for embryo development.

Dr. Fragouli did not declare any conflicts of interest.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those without, or in remission from, depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial that tested the effect of a motivational interviewing on medication adherence. It involved hypertensive African Americans (mean age 54; 87% women) who were followed in primary care practice.

Depressive symptomatology was assessed at baseline and at 6 and 12 months with the Center for Epidemiologic Studies-Depression Scale. Forty-four percent were classified as nondepressed, and 19% were considered depressed. Thirty-seven percent were classified as remittent, having progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months with the self-reported Morisky scale. At baseline, 64% reported nonadherence. This dropped to 48% by study's end.

A multivariate analysis showed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher said. Among the depressed patients, 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of symptoms can result in improved adherence suggests a benefit to addressing patient depression in this context, Ms. Gallagher said.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those without, or in remission from, depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial that tested the effect of a motivational interviewing on medication adherence. It involved hypertensive African Americans (mean age 54; 87% women) who were followed in primary care practice.

Depressive symptomatology was assessed at baseline and at 6 and 12 months with the Center for Epidemiologic Studies-Depression Scale. Forty-four percent were classified as nondepressed, and 19% were considered depressed. Thirty-seven percent were classified as remittent, having progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months with the self-reported Morisky scale. At baseline, 64% reported nonadherence. This dropped to 48% by study's end.

A multivariate analysis showed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher said. Among the depressed patients, 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of symptoms can result in improved adherence suggests a benefit to addressing patient depression in this context, Ms. Gallagher said.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those without, or in remission from, depression, according to a study of 161 patients.

“This suggests that any change in depressive symptomatology over time can affect medication adherence and may be clinically important,” Sara Gallagher said at the annual meeting of the Society of Behavioral Medicine.

Her study was embedded in a randomized, controlled trial that tested the effect of a motivational interviewing on medication adherence. It involved hypertensive African Americans (mean age 54; 87% women) who were followed in primary care practice.

Depressive symptomatology was assessed at baseline and at 6 and 12 months with the Center for Epidemiologic Studies-Depression Scale. Forty-four percent were classified as nondepressed, and 19% were considered depressed. Thirty-seven percent were classified as remittent, having progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher of New York (N.Y.) University.

Medication adherence was assessed at baseline and at 12 months with the self-reported Morisky scale. At baseline, 64% reported nonadherence. This dropped to 48% by study's end.

A multivariate analysis showed that depressive symptoms were associated with medication nonadherence, Ms. Gallagher said. Among the depressed patients, 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of symptoms can result in improved adherence suggests a benefit to addressing patient depression in this context, Ms. Gallagher said.

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on an 11-month study of the natural course of the lesions in people with extensive actinic damage.

“At any one time, less than half of the lesions are evident clinically,” said Dr. Craig Elmets, who reported his findings on at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

“If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AK are present,” he said. “In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions.”

Dr. Elmets did not disclose any conflictst in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage. At baseline, the subjects had 10-40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and at 3, 6, 9, and 11 months. The lesions also were biopsied at baseline and the end of the study. “If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied,” Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. “A total of 51 of the lesions regressed twice.”

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features.

AKs have been thought to be precursors to squamous cell carcinomas in some cases. The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas.

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on an 11-month study of the natural course of the lesions in people with extensive actinic damage.

“At any one time, less than half of the lesions are evident clinically,” said Dr. Craig Elmets, who reported his findings on at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

“If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AK are present,” he said. “In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions.”

Dr. Elmets did not disclose any conflictst in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage. At baseline, the subjects had 10-40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and at 3, 6, 9, and 11 months. The lesions also were biopsied at baseline and the end of the study. “If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied,” Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. “A total of 51 of the lesions regressed twice.”

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features.

AKs have been thought to be precursors to squamous cell carcinomas in some cases. The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas.

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on an 11-month study of the natural course of the lesions in people with extensive actinic damage.

“At any one time, less than half of the lesions are evident clinically,” said Dr. Craig Elmets, who reported his findings on at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

“If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AK are present,” he said. “In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions.”

Dr. Elmets did not disclose any conflictst in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage. At baseline, the subjects had 10-40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and at 3, 6, 9, and 11 months. The lesions also were biopsied at baseline and the end of the study. “If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied,” Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. “A total of 51 of the lesions regressed twice.”

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features.

AKs have been thought to be precursors to squamous cell carcinomas in some cases. The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study presented at the annual meeting of the Society of Behavioral Medicine.

Sara Gallagher of New York (N.Y.) University, studied 161 hypertensive African Americans who were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed using the Center for Epidemiologic Studies-Depression (CES-D) scale.

A total of 44% of patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. A total of 37% of patients were classified as remittent, meaning that they progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were tied to drug nonadherence, Ms. Gallagher reported. Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of depressive symptoms can result in improved adherence suggests a benefit to addressing patient depression, she said.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study presented at the annual meeting of the Society of Behavioral Medicine.

Sara Gallagher of New York (N.Y.) University, studied 161 hypertensive African Americans who were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed using the Center for Epidemiologic Studies-Depression (CES-D) scale.

A total of 44% of patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. A total of 37% of patients were classified as remittent, meaning that they progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were tied to drug nonadherence, Ms. Gallagher reported. Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of depressive symptoms can result in improved adherence suggests a benefit to addressing patient depression, she said.

MONTREAL — Hypertensive patients who have depression are less likely to stick to their therapy regimen than are those who are not depressed or are in remission from depression, according to a study presented at the annual meeting of the Society of Behavioral Medicine.

Sara Gallagher of New York (N.Y.) University, studied 161 hypertensive African Americans who were followed in primary care practice. The patients had a mean age of 54 years, and 87% of them were women. Depressive symptomatology was assessed using the Center for Epidemiologic Studies-Depression (CES-D) scale.

A total of 44% of patients were classified as nondepressed, with a CES-D score of less than 16 at all time points, while 19% were considered depressed, with a score of 16 or above at all time points. A total of 37% of patients were classified as remittent, meaning that they progressed from depressed to nondepressed over the course of the study, said Ms. Gallagher.

Medication adherence was assessed at baseline and at 12 months using the self-reported Morisky scale. At baseline, 64% of the study population reported nonadherence to their medication, and this dropped to 48% at the end of the study.

A multivariate analysis revealed that depressive symptoms were tied to drug nonadherence, Ms. Gallagher reported. Among the depressed patients, only 34% reported adherence at 12 months, compared with 66% in the nondepressed group and 47% in the remittent group.

The finding that a remittence of depressive symptoms can result in improved adherence suggests a benefit to addressing patient depression, she said.

MONTREAL — Despite postmarketing concerns about the psychiatric side effects of varenicline for smoking cessation, the medication appears to be safe in patients who are depressed or at risk for depression, Jennifer B. McClure, Ph.D., reported at the annual meeting of the Society of Behavioral Medicine.

In a subanalysis of the Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial, 661 smokers with a baseline history of depression, or a risk of depression, were monitored for mood changes and compared with 516 nondepressed smokers during their 12-week course of varenicline (Chantix) combined with behavioral smoking-cessation counseling (J. Gen. Intern. Med. 2009;24:563-9).

“We think that physicians should continue to closely monitor patients who are using varenicline, particularly if they have a psychiatric history,” she said.

Although people with a history of depression were more likely than nondepressed people to report side effects with the medication, “we didn't find an overall difference in their qualitative symptom experience or treatment outcomes,” said Dr. McClure, who is affiliated with Group Health Center for Health Studies, Seattle.

The study, funded by the National Cancer Institute, was a collaborative effort between Group Health; Free & Clear Inc., Seattle; and SRI International, an independent, nonprofit, research and development organization in Menlo Park, Calif. Medication was provided by Pfizer Inc., manufacturer of varenicline.

Varenicline was approved by the Food and Drug Administration about 3 years ago. It works by blocking nicotinic receptors and thus the rewarding effects of nicotine, while stimulating some dopamine release in order to provide relief from craving and withdrawal, Dr. McClure said.

Shortly after its release to market, the FDA raised concerns that varenicline might be associated with increased neuropsychiatric symptoms, including depressed mood, agitation, suicidal ideation, and behavior—particularly in people with a psychiatric history, she said.

“Unfortunately, due to the nature of the reports to the FDA, we are not able to determine if varenicline itself was the cause of the symptoms reported—it's possible they were due to nicotine withdrawal, substance use, the psychiatric conditions themselves, or some other factors. Unfortunately, subjects with a psychiatric history were excluded from the original efficacy trials.”

Research shows that between one- and two-thirds of smokers have a history of depression, and that smokers with a history of depression report more symptoms of nicotine withdrawal, have more negative affect after they quit, and have higher relapse rates, compared with nondepressed smokers, she added.

“But because varenicline does stimulate some release of dopamine, it's possible that it might ameliorate some of this negative effect and other side effects, and so prevent relapse.”

At baseline, the subjects in the study were screened briefly for symptoms of depression. “We didn't do an in-depth clinical interview. We just looked for the hallmark symptoms by asking: 'Have you ever, for a 2-week period or more, felt down, depressed, or hopeless, or had little interest or pleasure in doing things?'” she said.

Depressed and nondepressed subjects had similar nonsmoking rates at 21 days (49% vs. 47%, respectively) and 3 months (45% vs. 43%, respectively). However, depressed patients were more likely to report depression, anxiety, tension, agitation, difficulty concentrating and sleeping, and confusion. Depressed patients also were more likely to report other known side effects of the medication. However, despite this, negative affect actually declined in both groups, Dr. McClure said. One case of suicidal ideation was reported in a subject with undisclosed, untreated bipolar disorder.

Additional research is necessary in order to more fully tease out the safety and effectiveness of varenicline among psychologically vulnerable populations, she concluded.

Dr. McClure said she had no conflicts to disclose in connection with this study.

MONTREAL — Despite postmarketing concerns about the psychiatric side effects of varenicline for smoking cessation, the medication appears to be safe in patients who are depressed or at risk for depression, Jennifer B. McClure, Ph.D., reported at the annual meeting of the Society of Behavioral Medicine.

In a subanalysis of the Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial, 661 smokers with a baseline history of depression, or a risk of depression, were monitored for mood changes and compared with 516 nondepressed smokers during their 12-week course of varenicline (Chantix) combined with behavioral smoking-cessation counseling (J. Gen. Intern. Med. 2009;24:563-9).

“We think that physicians should continue to closely monitor patients who are using varenicline, particularly if they have a psychiatric history,” she said.

Although people with a history of depression were more likely than nondepressed people to report side effects with the medication, “we didn't find an overall difference in their qualitative symptom experience or treatment outcomes,” said Dr. McClure, who is affiliated with Group Health Center for Health Studies, Seattle.

The study, funded by the National Cancer Institute, was a collaborative effort between Group Health; Free & Clear Inc., Seattle; and SRI International, an independent, nonprofit, research and development organization in Menlo Park, Calif. Medication was provided by Pfizer Inc., manufacturer of varenicline.

Varenicline was approved by the Food and Drug Administration about 3 years ago. It works by blocking nicotinic receptors and thus the rewarding effects of nicotine, while stimulating some dopamine release in order to provide relief from craving and withdrawal, Dr. McClure said.

Shortly after its release to market, the FDA raised concerns that varenicline might be associated with increased neuropsychiatric symptoms, including depressed mood, agitation, suicidal ideation, and behavior—particularly in people with a psychiatric history, she said.

“Unfortunately, due to the nature of the reports to the FDA, we are not able to determine if varenicline itself was the cause of the symptoms reported—it's possible they were due to nicotine withdrawal, substance use, the psychiatric conditions themselves, or some other factors. Unfortunately, subjects with a psychiatric history were excluded from the original efficacy trials.”

Research shows that between one- and two-thirds of smokers have a history of depression, and that smokers with a history of depression report more symptoms of nicotine withdrawal, have more negative affect after they quit, and have higher relapse rates, compared with nondepressed smokers, she added.

“But because varenicline does stimulate some release of dopamine, it's possible that it might ameliorate some of this negative effect and other side effects, and so prevent relapse.”

At baseline, the subjects in the study were screened briefly for symptoms of depression. “We didn't do an in-depth clinical interview. We just looked for the hallmark symptoms by asking: 'Have you ever, for a 2-week period or more, felt down, depressed, or hopeless, or had little interest or pleasure in doing things?'” she said.

Depressed and nondepressed subjects had similar nonsmoking rates at 21 days (49% vs. 47%, respectively) and 3 months (45% vs. 43%, respectively). However, depressed patients were more likely to report depression, anxiety, tension, agitation, difficulty concentrating and sleeping, and confusion. Depressed patients also were more likely to report other known side effects of the medication. However, despite this, negative affect actually declined in both groups, Dr. McClure said. One case of suicidal ideation was reported in a subject with undisclosed, untreated bipolar disorder.

Additional research is necessary in order to more fully tease out the safety and effectiveness of varenicline among psychologically vulnerable populations, she concluded.

Dr. McClure said she had no conflicts to disclose in connection with this study.

MONTREAL — Despite postmarketing concerns about the psychiatric side effects of varenicline for smoking cessation, the medication appears to be safe in patients who are depressed or at risk for depression, Jennifer B. McClure, Ph.D., reported at the annual meeting of the Society of Behavioral Medicine.

In a subanalysis of the Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial, 661 smokers with a baseline history of depression, or a risk of depression, were monitored for mood changes and compared with 516 nondepressed smokers during their 12-week course of varenicline (Chantix) combined with behavioral smoking-cessation counseling (J. Gen. Intern. Med. 2009;24:563-9).

“We think that physicians should continue to closely monitor patients who are using varenicline, particularly if they have a psychiatric history,” she said.

Although people with a history of depression were more likely than nondepressed people to report side effects with the medication, “we didn't find an overall difference in their qualitative symptom experience or treatment outcomes,” said Dr. McClure, who is affiliated with Group Health Center for Health Studies, Seattle.

The study, funded by the National Cancer Institute, was a collaborative effort between Group Health; Free & Clear Inc., Seattle; and SRI International, an independent, nonprofit, research and development organization in Menlo Park, Calif. Medication was provided by Pfizer Inc., manufacturer of varenicline.

Varenicline was approved by the Food and Drug Administration about 3 years ago. It works by blocking nicotinic receptors and thus the rewarding effects of nicotine, while stimulating some dopamine release in order to provide relief from craving and withdrawal, Dr. McClure said.

Shortly after its release to market, the FDA raised concerns that varenicline might be associated with increased neuropsychiatric symptoms, including depressed mood, agitation, suicidal ideation, and behavior—particularly in people with a psychiatric history, she said.

“Unfortunately, due to the nature of the reports to the FDA, we are not able to determine if varenicline itself was the cause of the symptoms reported—it's possible they were due to nicotine withdrawal, substance use, the psychiatric conditions themselves, or some other factors. Unfortunately, subjects with a psychiatric history were excluded from the original efficacy trials.”

Research shows that between one- and two-thirds of smokers have a history of depression, and that smokers with a history of depression report more symptoms of nicotine withdrawal, have more negative affect after they quit, and have higher relapse rates, compared with nondepressed smokers, she added.

“But because varenicline does stimulate some release of dopamine, it's possible that it might ameliorate some of this negative effect and other side effects, and so prevent relapse.”

At baseline, the subjects in the study were screened briefly for symptoms of depression. “We didn't do an in-depth clinical interview. We just looked for the hallmark symptoms by asking: 'Have you ever, for a 2-week period or more, felt down, depressed, or hopeless, or had little interest or pleasure in doing things?'” she said.

Depressed and nondepressed subjects had similar nonsmoking rates at 21 days (49% vs. 47%, respectively) and 3 months (45% vs. 43%, respectively). However, depressed patients were more likely to report depression, anxiety, tension, agitation, difficulty concentrating and sleeping, and confusion. Depressed patients also were more likely to report other known side effects of the medication. However, despite this, negative affect actually declined in both groups, Dr. McClure said. One case of suicidal ideation was reported in a subject with undisclosed, untreated bipolar disorder.

Additional research is necessary in order to more fully tease out the safety and effectiveness of varenicline among psychologically vulnerable populations, she concluded.

Dr. McClure said she had no conflicts to disclose in connection with this study.

MONTREAL — A twice-daily dose of celecoxib given over a period of 9 months was associated with a 60% reduction in the incidence of nonmelanoma skin cancer, according to the results of a new study.

“Inhibition of COX-2 is an effective means of limiting the development of cutaneous squamous and basal cell carcinomas in humans,” said Dr. Craig Elmets at the annual meeting of the Society for Investigative Dermatology.

The findings suggest that pharmaceutical agents such as celecoxib may offer greater protection against skin cancer than do sunscreens, which are only “modestly effective,” said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham. “There's only about a 35% reduction in squamous cell carcinomas when sunscreens are used on a regular basis over a 5-year period of time, and there's no reduction in basal cell carcinomas.”

The multicenter, randomized, placebo-controlled study was funded by the National Cancer Institute and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, with additional funding from Pfizer through a contractual agreement with the National Institutes of Health, he said. Dr. Elmets did not disclose any personal conflicts of interest.

The study enrolled 238 patients with nonmelanoma skin cancers from eight U.S. centers. The mean age of the patients was 65 years, most were male, and virtually all were white.

“The study was terminated somewhat early because of concerns of cardiovascular effects due to another COX-2 inhibitor,” he noted.

Subjects in the study had Fitzpatrick skin types I-III, extensive actinic damage with 10-40 actinic keratoses (AKs), and a prior histologic diagnosis of either AK or nonmelanoma skin cancer. Subjects were excluded if they required treatment with NSAIDs, although cardioprotective doses of aspirin were allowed.

At entry, patients had a mean number of 22 AKs, and between 2.1 and 2.5 nonmelanoma skin cancers, he said.

Patients were randomized to either placebo or celecoxib 200 mg twice daily, which is the approved dosage for arthritis, Dr. Elmets said. “We were concerned about cardiovascular abnormalities and GI abnormalities, and if anything there was a bias towards patients in the celecoxib group having a prior history of that.”

A comparison of the number of AKs at baseline and completion showed a lack of effect of celecoxib, compared with placebo, he noted. However, the development of new cutaneous basal and squamous cell carcinomas was much reduced. “We were delighted to find that celecoxib was quite effective, with a 58% reduction compared to placebo-treated controls,” he said.

If the two types of lesions are considered separately, celecoxib treatment led to a 58% reduction in squamous cell carcinoma (SCC), and a 62% reduction in basal cell carcinoma (BCC).

“The difference between the [placebo and treated] groups started to become apparent quite rapidly, at 3 months, and persisted throughout the study. We were concerned that there might be one or two outliers that were skewing the results, so rather than looking at the total number of skin cancers, we also looked at the number of individuals who developed BCC or SCC or both. Again we found that patients with celecoxib had fewer BCCs and SCCs than the placebo group.”

There were no differences in adverse events including cardiovascular adverse events between the two groups, Dr. Elmets reported. During the question period, he acknowledged that there were higher blood pressures reported in the treatment group.

The data are “very compelling,” commented Dr. Maryam Asgari of Kaiser Permanente in Oakland, Calif., in an interview. But she suggested perhaps the study was too short to have such dramatic conclusions. “I know that typically for most cancers you would need a study to last 2-5 years before you would expect to measure an effect,” she said. Similarly, adverse events from COX-2 inhibitors would likely need longer to develop.

Dr. Asgari said her research in the same field has produced the opposite results. Her study found no protective effect for all NSAIDs—both selective and nonselective COX inhibitors—on the incidence of squamous cell carcinoma. A previous paper published by her group also found no protective effect of these drugs on melanomas (J. Natl. Cancer Inst. 2008;100:967-71).

Celecoxib's lack of effect on AKs is a puzzling result, she added. “You would think that if COX-2 inhibitors are working to prevent new cancers from arising that they would also have a pretty dramatic effect on actinic keratoses because they both share the same pathway.”

Finally, patients in the COX-2 study were allowed to take cardioprotective doses of aspirin—an important factor that the analysis did not adjust for, she pointed out. “Even low-dose aspirin inhibits COX, and it could just be that the people in the treatment arm were much more likely to be on aspirin as well.”

MONTREAL — A twice-daily dose of celecoxib given over a period of 9 months was associated with a 60% reduction in the incidence of nonmelanoma skin cancer, according to the results of a new study.

“Inhibition of COX-2 is an effective means of limiting the development of cutaneous squamous and basal cell carcinomas in humans,” said Dr. Craig Elmets at the annual meeting of the Society for Investigative Dermatology.

The findings suggest that pharmaceutical agents such as celecoxib may offer greater protection against skin cancer than do sunscreens, which are only “modestly effective,” said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham. “There's only about a 35% reduction in squamous cell carcinomas when sunscreens are used on a regular basis over a 5-year period of time, and there's no reduction in basal cell carcinomas.”

The multicenter, randomized, placebo-controlled study was funded by the National Cancer Institute and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, with additional funding from Pfizer through a contractual agreement with the National Institutes of Health, he said. Dr. Elmets did not disclose any personal conflicts of interest.

The study enrolled 238 patients with nonmelanoma skin cancers from eight U.S. centers. The mean age of the patients was 65 years, most were male, and virtually all were white.

“The study was terminated somewhat early because of concerns of cardiovascular effects due to another COX-2 inhibitor,” he noted.

Subjects in the study had Fitzpatrick skin types I-III, extensive actinic damage with 10-40 actinic keratoses (AKs), and a prior histologic diagnosis of either AK or nonmelanoma skin cancer. Subjects were excluded if they required treatment with NSAIDs, although cardioprotective doses of aspirin were allowed.

At entry, patients had a mean number of 22 AKs, and between 2.1 and 2.5 nonmelanoma skin cancers, he said.

Patients were randomized to either placebo or celecoxib 200 mg twice daily, which is the approved dosage for arthritis, Dr. Elmets said. “We were concerned about cardiovascular abnormalities and GI abnormalities, and if anything there was a bias towards patients in the celecoxib group having a prior history of that.”

A comparison of the number of AKs at baseline and completion showed a lack of effect of celecoxib, compared with placebo, he noted. However, the development of new cutaneous basal and squamous cell carcinomas was much reduced. “We were delighted to find that celecoxib was quite effective, with a 58% reduction compared to placebo-treated controls,” he said.

If the two types of lesions are considered separately, celecoxib treatment led to a 58% reduction in squamous cell carcinoma (SCC), and a 62% reduction in basal cell carcinoma (BCC).

“The difference between the [placebo and treated] groups started to become apparent quite rapidly, at 3 months, and persisted throughout the study. We were concerned that there might be one or two outliers that were skewing the results, so rather than looking at the total number of skin cancers, we also looked at the number of individuals who developed BCC or SCC or both. Again we found that patients with celecoxib had fewer BCCs and SCCs than the placebo group.”

There were no differences in adverse events including cardiovascular adverse events between the two groups, Dr. Elmets reported. During the question period, he acknowledged that there were higher blood pressures reported in the treatment group.

The data are “very compelling,” commented Dr. Maryam Asgari of Kaiser Permanente in Oakland, Calif., in an interview. But she suggested perhaps the study was too short to have such dramatic conclusions. “I know that typically for most cancers you would need a study to last 2-5 years before you would expect to measure an effect,” she said. Similarly, adverse events from COX-2 inhibitors would likely need longer to develop.

Dr. Asgari said her research in the same field has produced the opposite results. Her study found no protective effect for all NSAIDs—both selective and nonselective COX inhibitors—on the incidence of squamous cell carcinoma. A previous paper published by her group also found no protective effect of these drugs on melanomas (J. Natl. Cancer Inst. 2008;100:967-71).

Celecoxib's lack of effect on AKs is a puzzling result, she added. “You would think that if COX-2 inhibitors are working to prevent new cancers from arising that they would also have a pretty dramatic effect on actinic keratoses because they both share the same pathway.”

Finally, patients in the COX-2 study were allowed to take cardioprotective doses of aspirin—an important factor that the analysis did not adjust for, she pointed out. “Even low-dose aspirin inhibits COX, and it could just be that the people in the treatment arm were much more likely to be on aspirin as well.”

MONTREAL — A twice-daily dose of celecoxib given over a period of 9 months was associated with a 60% reduction in the incidence of nonmelanoma skin cancer, according to the results of a new study.

“Inhibition of COX-2 is an effective means of limiting the development of cutaneous squamous and basal cell carcinomas in humans,” said Dr. Craig Elmets at the annual meeting of the Society for Investigative Dermatology.

The findings suggest that pharmaceutical agents such as celecoxib may offer greater protection against skin cancer than do sunscreens, which are only “modestly effective,” said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham. “There's only about a 35% reduction in squamous cell carcinomas when sunscreens are used on a regular basis over a 5-year period of time, and there's no reduction in basal cell carcinomas.”

The multicenter, randomized, placebo-controlled study was funded by the National Cancer Institute and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, with additional funding from Pfizer through a contractual agreement with the National Institutes of Health, he said. Dr. Elmets did not disclose any personal conflicts of interest.

The study enrolled 238 patients with nonmelanoma skin cancers from eight U.S. centers. The mean age of the patients was 65 years, most were male, and virtually all were white.

“The study was terminated somewhat early because of concerns of cardiovascular effects due to another COX-2 inhibitor,” he noted.

Subjects in the study had Fitzpatrick skin types I-III, extensive actinic damage with 10-40 actinic keratoses (AKs), and a prior histologic diagnosis of either AK or nonmelanoma skin cancer. Subjects were excluded if they required treatment with NSAIDs, although cardioprotective doses of aspirin were allowed.

At entry, patients had a mean number of 22 AKs, and between 2.1 and 2.5 nonmelanoma skin cancers, he said.

Patients were randomized to either placebo or celecoxib 200 mg twice daily, which is the approved dosage for arthritis, Dr. Elmets said. “We were concerned about cardiovascular abnormalities and GI abnormalities, and if anything there was a bias towards patients in the celecoxib group having a prior history of that.”

A comparison of the number of AKs at baseline and completion showed a lack of effect of celecoxib, compared with placebo, he noted. However, the development of new cutaneous basal and squamous cell carcinomas was much reduced. “We were delighted to find that celecoxib was quite effective, with a 58% reduction compared to placebo-treated controls,” he said.

If the two types of lesions are considered separately, celecoxib treatment led to a 58% reduction in squamous cell carcinoma (SCC), and a 62% reduction in basal cell carcinoma (BCC).

“The difference between the [placebo and treated] groups started to become apparent quite rapidly, at 3 months, and persisted throughout the study. We were concerned that there might be one or two outliers that were skewing the results, so rather than looking at the total number of skin cancers, we also looked at the number of individuals who developed BCC or SCC or both. Again we found that patients with celecoxib had fewer BCCs and SCCs than the placebo group.”

There were no differences in adverse events including cardiovascular adverse events between the two groups, Dr. Elmets reported. During the question period, he acknowledged that there were higher blood pressures reported in the treatment group.

The data are “very compelling,” commented Dr. Maryam Asgari of Kaiser Permanente in Oakland, Calif., in an interview. But she suggested perhaps the study was too short to have such dramatic conclusions. “I know that typically for most cancers you would need a study to last 2-5 years before you would expect to measure an effect,” she said. Similarly, adverse events from COX-2 inhibitors would likely need longer to develop.

Dr. Asgari said her research in the same field has produced the opposite results. Her study found no protective effect for all NSAIDs—both selective and nonselective COX inhibitors—on the incidence of squamous cell carcinoma. A previous paper published by her group also found no protective effect of these drugs on melanomas (J. Natl. Cancer Inst. 2008;100:967-71).

Celecoxib's lack of effect on AKs is a puzzling result, she added. “You would think that if COX-2 inhibitors are working to prevent new cancers from arising that they would also have a pretty dramatic effect on actinic keratoses because they both share the same pathway.”

Finally, patients in the COX-2 study were allowed to take cardioprotective doses of aspirin—an important factor that the analysis did not adjust for, she pointed out. “Even low-dose aspirin inhibits COX, and it could just be that the people in the treatment arm were much more likely to be on aspirin as well.”

MONTREAL — Although the prevalence of human papillomavirus is similar among females and males, physicians will need to be careful about promoting a vaccine that specifically targets men, according to a survey of male college students.

Efficacy trials suggest that the Gardasil HPV vaccine, which is currently approved for females only, is efficacious in males, and it could be approved for this population as early as the fall, said Mary Gerend, Ph.D., of Florida State University, Tallahassee.

However, her study of 221 young males suggests that their attitudes about the acceptability of the vaccine are only slightly positive, and depend partly on what it is called. On a scale of 1 (unlikely) to 6 (very likely) they indicated a 3.6 level of interest in receiving the vaccine, she reported.

"Marketing it as 'the cervical cancer' vaccine may not be the most effective strategy for this group," she said at the annual meeting of the Society of Behavioral Medicine.

The men in her group were aged 18–26 years, and 96% of them were heterosexual. Although only 47% had a current partner, 81% indicated that they had had sexual intercourse. The group reported a mean of 4.8 lifetime partners (range 0–34).

"Younger men were more interested, as were gay and bisexual men," Dr. Gerend said, adding that other predictors of interest were having already had sex, having a current partner, and ever being tested for a sexually transmitted infection.

Regarding a potential name for the vaccine, most of the group (76%) said they preferred "Gardasil" or "the HPV vaccine."

In a separate study of 356 heterosexual male college students, Dr. Gerend found that emphasizing the benefits of vaccination for a man's partner versus the personal benefits did not boost interest in vaccination (Sex. Transm. Dis. 2009;36:58-62).

Dr. Gerend did not disclose any conflicts of interest.

MONTREAL — Although the prevalence of human papillomavirus is similar among females and males, physicians will need to be careful about promoting a vaccine that specifically targets men, according to a survey of male college students.

Efficacy trials suggest that the Gardasil HPV vaccine, which is currently approved for females only, is efficacious in males, and it could be approved for this population as early as the fall, said Mary Gerend, Ph.D., of Florida State University, Tallahassee.

However, her study of 221 young males suggests that their attitudes about the acceptability of the vaccine are only slightly positive, and depend partly on what it is called. On a scale of 1 (unlikely) to 6 (very likely) they indicated a 3.6 level of interest in receiving the vaccine, she reported.

"Marketing it as 'the cervical cancer' vaccine may not be the most effective strategy for this group," she said at the annual meeting of the Society of Behavioral Medicine.

The men in her group were aged 18–26 years, and 96% of them were heterosexual. Although only 47% had a current partner, 81% indicated that they had had sexual intercourse. The group reported a mean of 4.8 lifetime partners (range 0–34).

"Younger men were more interested, as were gay and bisexual men," Dr. Gerend said, adding that other predictors of interest were having already had sex, having a current partner, and ever being tested for a sexually transmitted infection.

Regarding a potential name for the vaccine, most of the group (76%) said they preferred "Gardasil" or "the HPV vaccine."

In a separate study of 356 heterosexual male college students, Dr. Gerend found that emphasizing the benefits of vaccination for a man's partner versus the personal benefits did not boost interest in vaccination (Sex. Transm. Dis. 2009;36:58-62).

Dr. Gerend did not disclose any conflicts of interest.

MONTREAL — Although the prevalence of human papillomavirus is similar among females and males, physicians will need to be careful about promoting a vaccine that specifically targets men, according to a survey of male college students.

Efficacy trials suggest that the Gardasil HPV vaccine, which is currently approved for females only, is efficacious in males, and it could be approved for this population as early as the fall, said Mary Gerend, Ph.D., of Florida State University, Tallahassee.

However, her study of 221 young males suggests that their attitudes about the acceptability of the vaccine are only slightly positive, and depend partly on what it is called. On a scale of 1 (unlikely) to 6 (very likely) they indicated a 3.6 level of interest in receiving the vaccine, she reported.

"Marketing it as 'the cervical cancer' vaccine may not be the most effective strategy for this group," she said at the annual meeting of the Society of Behavioral Medicine.

The men in her group were aged 18–26 years, and 96% of them were heterosexual. Although only 47% had a current partner, 81% indicated that they had had sexual intercourse. The group reported a mean of 4.8 lifetime partners (range 0–34).

"Younger men were more interested, as were gay and bisexual men," Dr. Gerend said, adding that other predictors of interest were having already had sex, having a current partner, and ever being tested for a sexually transmitted infection.

Regarding a potential name for the vaccine, most of the group (76%) said they preferred "Gardasil" or "the HPV vaccine."

In a separate study of 356 heterosexual male college students, Dr. Gerend found that emphasizing the benefits of vaccination for a man's partner versus the personal benefits did not boost interest in vaccination (Sex. Transm. Dis. 2009;36:58-62).

Dr. Gerend did not disclose any conflicts of interest.

A new report from the National Survey on Drug Use and Health provides data on the prevalence of past-year depression among veterans aged 21–39.

An estimated 25%-30% of veterans of the wars in Iraq and Afghanistan have reported symptoms of a mental disorder or cognitive condition. The report is at www.oas.samhsa.gov/2k8/veteransDepressed/veteransDepressed.htm

A new report from the National Survey on Drug Use and Health provides data on the prevalence of past-year depression among veterans aged 21–39.

An estimated 25%-30% of veterans of the wars in Iraq and Afghanistan have reported symptoms of a mental disorder or cognitive condition. The report is at www.oas.samhsa.gov/2k8/veteransDepressed/veteransDepressed.htm

A new report from the National Survey on Drug Use and Health provides data on the prevalence of past-year depression among veterans aged 21–39.

An estimated 25%-30% of veterans of the wars in Iraq and Afghanistan have reported symptoms of a mental disorder or cognitive condition. The report is at www.oas.samhsa.gov/2k8/veteransDepressed/veteransDepressed.htm