Late-Onset GAD More Common Than Thought

PARIS – Generalized anxiety disorder occurs as a late-onset condition more often than is recognized, according to investigators who presented the first large treatment trial in elderly patients during the annual congress of the European College of Neuropsychopharmacology.

Dr. Francesca Baldinetti reported that the average age of onset was 56 years in 273 outpatients with generalized anxiety disorder (GAD) who were aged at least 65 years and who enrolled in the placebo-controlled trial. The study found pregabalin (Lyrica) to be at least as effective in the elderly as in previous trials with younger patients.

“In reality, there is a late onset of generalized anxiety disorder in the later stage of life,” said Dr. Baldinetti, medical director of worldwide neuroscience at Pfizer Inc., in a presentation of the new data at a session on psychiatric disorders in older people.

“That is not in the literature,” added the lead author, Dr. Stuart A. Montgomery, a professor emeritus of psychiatry at the Imperial College London.

Commenting from the audience at Dr. Montgomery's invitation, an investigator of pregabalin in adult patients described the characterization of GAD as an early-onset disorder as a misconception. Most patients develop the full syndrome after the age of 30, according to Dr. Hans-Ulrich Wittchen, professor of clinical psychology and epidemiology at the Technische Universität Dresden (Germany).

He urged careful questioning of newly diagnosed older GAD patients who report they first had symptoms as children. “It may be that there are anxiety disorders preceding that [new] development … But if you probe the GAD symptomatology, this is another disorder,” he said. “This is not an early anxiety disorder.”

In her presentation, Dr. Baldinetti said that at least half of all newly diagnosed cases of GAD occur after age 30 years and a third after age 40. Five different studies from the United States and Europe have shown prevalence rates ranging from 1.9% to 7.2% in the elderly, she said.

All patients in the pregabalin study had Hamilton Rating Scale for Anxiety (HAM-A) scores of 20 or more, with a baseline average of 26.6 for 177 patients randomized to pregabalin and 26.1 for 96 patients on placebo. Patients with major depression and other anxiety or substance abuse disorders were excluded. The participants had three to four prior episodes of GAD on average, with the current episode lasting about 15 months. The average age was 72 years, as about a third of the population was 75 years of age or older. About three-fourths of those enrolled were female.

A flexible-dose regimen started the active drug group on 150 mg per day of pregabalin, which clinicians could titrate up to 600 mg by week 6 of the 8-week trial. The average dose used was 270 mg.

Dr. Baldinetti suggested that the flexible dosing probably was responsible for the main difference in outcomes relative to the earlier adult trials. Whereas younger patients on pregabalin had a significantly better response than did those on placebo during week 1, elderly patients on pregabalin began to show significant improvement compared with the control group during week 2.

By the elderly trial's end, 64.2% of the pregabalin cohort had responded versus 50% of the control group. Total HAM-A scores fell by more than 12 points in the pregabalin group, versus more than 10 points with placebo in a last-observation-carried-forward (LOCF) analysis.

The effect was seen in HAM-A psychic and HAM-A somatic scores. HAM-A psychic scores fell by 7.8 points with pregabalin versus 6.3 points with placebo. HAM-A somatic scores fell by 6.6 points with pregabalin versus 5.4 points with placebo.

Dr. Baldinetti noted that the drug's benefits were significant in subgroups of patients with severe anxiety and with subsyndromal depression.

About a quarter of the patients–28% of those on placebo and 25% of the pregabalin group–dropped out of the study. Only 7% on placebo and 4% on pregabalin did so for lack of efficacy. Adverse events caused discontinuation by 11% of the pregabalin group and 9% on placebo. The most common adverse events with pregabalin were dizziness (20.3%), somnolence (13%), headache (10.2%) nausea (9%), and infection (5.6%).

An anticonvulsant with anxiolytic and analgesic properties, pregabalin is approved in the United States for treatment of neuropathic pain and seizures. It is also under study for fibromyalgia.

Elderly patients on pregabalin began to show significant improvement during week 2. DR. BALDINETTI

PARIS – Generalized anxiety disorder occurs as a late-onset condition more often than is recognized, according to investigators who presented the first large treatment trial in elderly patients during the annual congress of the European College of Neuropsychopharmacology.

Dr. Francesca Baldinetti reported that the average age of onset was 56 years in 273 outpatients with generalized anxiety disorder (GAD) who were aged at least 65 years and who enrolled in the placebo-controlled trial. The study found pregabalin (Lyrica) to be at least as effective in the elderly as in previous trials with younger patients.

“In reality, there is a late onset of generalized anxiety disorder in the later stage of life,” said Dr. Baldinetti, medical director of worldwide neuroscience at Pfizer Inc., in a presentation of the new data at a session on psychiatric disorders in older people.

“That is not in the literature,” added the lead author, Dr. Stuart A. Montgomery, a professor emeritus of psychiatry at the Imperial College London.

Commenting from the audience at Dr. Montgomery's invitation, an investigator of pregabalin in adult patients described the characterization of GAD as an early-onset disorder as a misconception. Most patients develop the full syndrome after the age of 30, according to Dr. Hans-Ulrich Wittchen, professor of clinical psychology and epidemiology at the Technische Universität Dresden (Germany).

He urged careful questioning of newly diagnosed older GAD patients who report they first had symptoms as children. “It may be that there are anxiety disorders preceding that [new] development … But if you probe the GAD symptomatology, this is another disorder,” he said. “This is not an early anxiety disorder.”

In her presentation, Dr. Baldinetti said that at least half of all newly diagnosed cases of GAD occur after age 30 years and a third after age 40. Five different studies from the United States and Europe have shown prevalence rates ranging from 1.9% to 7.2% in the elderly, she said.

All patients in the pregabalin study had Hamilton Rating Scale for Anxiety (HAM-A) scores of 20 or more, with a baseline average of 26.6 for 177 patients randomized to pregabalin and 26.1 for 96 patients on placebo. Patients with major depression and other anxiety or substance abuse disorders were excluded. The participants had three to four prior episodes of GAD on average, with the current episode lasting about 15 months. The average age was 72 years, as about a third of the population was 75 years of age or older. About three-fourths of those enrolled were female.

A flexible-dose regimen started the active drug group on 150 mg per day of pregabalin, which clinicians could titrate up to 600 mg by week 6 of the 8-week trial. The average dose used was 270 mg.

Dr. Baldinetti suggested that the flexible dosing probably was responsible for the main difference in outcomes relative to the earlier adult trials. Whereas younger patients on pregabalin had a significantly better response than did those on placebo during week 1, elderly patients on pregabalin began to show significant improvement compared with the control group during week 2.

By the elderly trial's end, 64.2% of the pregabalin cohort had responded versus 50% of the control group. Total HAM-A scores fell by more than 12 points in the pregabalin group, versus more than 10 points with placebo in a last-observation-carried-forward (LOCF) analysis.

The effect was seen in HAM-A psychic and HAM-A somatic scores. HAM-A psychic scores fell by 7.8 points with pregabalin versus 6.3 points with placebo. HAM-A somatic scores fell by 6.6 points with pregabalin versus 5.4 points with placebo.

Dr. Baldinetti noted that the drug's benefits were significant in subgroups of patients with severe anxiety and with subsyndromal depression.

About a quarter of the patients–28% of those on placebo and 25% of the pregabalin group–dropped out of the study. Only 7% on placebo and 4% on pregabalin did so for lack of efficacy. Adverse events caused discontinuation by 11% of the pregabalin group and 9% on placebo. The most common adverse events with pregabalin were dizziness (20.3%), somnolence (13%), headache (10.2%) nausea (9%), and infection (5.6%).

An anticonvulsant with anxiolytic and analgesic properties, pregabalin is approved in the United States for treatment of neuropathic pain and seizures. It is also under study for fibromyalgia.

Elderly patients on pregabalin began to show significant improvement during week 2. DR. BALDINETTI

PARIS – Generalized anxiety disorder occurs as a late-onset condition more often than is recognized, according to investigators who presented the first large treatment trial in elderly patients during the annual congress of the European College of Neuropsychopharmacology.

Dr. Francesca Baldinetti reported that the average age of onset was 56 years in 273 outpatients with generalized anxiety disorder (GAD) who were aged at least 65 years and who enrolled in the placebo-controlled trial. The study found pregabalin (Lyrica) to be at least as effective in the elderly as in previous trials with younger patients.

“In reality, there is a late onset of generalized anxiety disorder in the later stage of life,” said Dr. Baldinetti, medical director of worldwide neuroscience at Pfizer Inc., in a presentation of the new data at a session on psychiatric disorders in older people.

“That is not in the literature,” added the lead author, Dr. Stuart A. Montgomery, a professor emeritus of psychiatry at the Imperial College London.

Commenting from the audience at Dr. Montgomery's invitation, an investigator of pregabalin in adult patients described the characterization of GAD as an early-onset disorder as a misconception. Most patients develop the full syndrome after the age of 30, according to Dr. Hans-Ulrich Wittchen, professor of clinical psychology and epidemiology at the Technische Universität Dresden (Germany).

He urged careful questioning of newly diagnosed older GAD patients who report they first had symptoms as children. “It may be that there are anxiety disorders preceding that [new] development … But if you probe the GAD symptomatology, this is another disorder,” he said. “This is not an early anxiety disorder.”

In her presentation, Dr. Baldinetti said that at least half of all newly diagnosed cases of GAD occur after age 30 years and a third after age 40. Five different studies from the United States and Europe have shown prevalence rates ranging from 1.9% to 7.2% in the elderly, she said.

All patients in the pregabalin study had Hamilton Rating Scale for Anxiety (HAM-A) scores of 20 or more, with a baseline average of 26.6 for 177 patients randomized to pregabalin and 26.1 for 96 patients on placebo. Patients with major depression and other anxiety or substance abuse disorders were excluded. The participants had three to four prior episodes of GAD on average, with the current episode lasting about 15 months. The average age was 72 years, as about a third of the population was 75 years of age or older. About three-fourths of those enrolled were female.

A flexible-dose regimen started the active drug group on 150 mg per day of pregabalin, which clinicians could titrate up to 600 mg by week 6 of the 8-week trial. The average dose used was 270 mg.

Dr. Baldinetti suggested that the flexible dosing probably was responsible for the main difference in outcomes relative to the earlier adult trials. Whereas younger patients on pregabalin had a significantly better response than did those on placebo during week 1, elderly patients on pregabalin began to show significant improvement compared with the control group during week 2.

By the elderly trial's end, 64.2% of the pregabalin cohort had responded versus 50% of the control group. Total HAM-A scores fell by more than 12 points in the pregabalin group, versus more than 10 points with placebo in a last-observation-carried-forward (LOCF) analysis.

The effect was seen in HAM-A psychic and HAM-A somatic scores. HAM-A psychic scores fell by 7.8 points with pregabalin versus 6.3 points with placebo. HAM-A somatic scores fell by 6.6 points with pregabalin versus 5.4 points with placebo.

Dr. Baldinetti noted that the drug's benefits were significant in subgroups of patients with severe anxiety and with subsyndromal depression.

About a quarter of the patients–28% of those on placebo and 25% of the pregabalin group–dropped out of the study. Only 7% on placebo and 4% on pregabalin did so for lack of efficacy. Adverse events caused discontinuation by 11% of the pregabalin group and 9% on placebo. The most common adverse events with pregabalin were dizziness (20.3%), somnolence (13%), headache (10.2%) nausea (9%), and infection (5.6%).

An anticonvulsant with anxiolytic and analgesic properties, pregabalin is approved in the United States for treatment of neuropathic pain and seizures. It is also under study for fibromyalgia.

Elderly patients on pregabalin began to show significant improvement during week 2. DR. BALDINETTI