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October 2008

Two Drugs for Fibromyalgia
Pregabalin (Lyrica) and duloxetine (Cymbalta) are approved in the United States for the treatment of fibromyalgia.

Preventing Poststroke Depression
In a 2008 study by Robinson and colleagues, escitalopram (Lexapro) and problem-solving therapy decreased the likelihood of poststroke depression.

Duloxetine for Elderly Patients with GAD
Due to possible adverse events, duloxetine (Cymbalta) should be a second-line option for elderly patients with generalized anxiety disorder.

In Brief
Switch to Aripiprazole Reduces Cardiovascular Risk in Schizophrenia; SSRIs Are Effective for Treating PMS/PMDD; Statins May Protect Against Dementia

Antidepressants for Social Anxiety Disorder
Sertraline (Zoloft and others), paroxetine (Paxil and others), venlafaxine (Effexor and others), and fluvoxamine (Luvox and others) appear to be the most efficacious antidepressants for the treatment of social anxiety disorder, with escitalopram (Lexapro) a reasonable alternative.

Duloxetine for Elderly Patients with GAD

October 2008

Earlier this year, we reviewed treatment options for patients with generalized anxiety disorder (GAD) (BTP 2008;31:6-8). The newest medication to attain approval from the U.S. Food and Drug Administration for GAD is duloxetine (Cymbalta), a serotonin-norepinephrine reuptake inhibitor. Recently, Davidson and coauthors conducted a pooled analysis of four randomized, double-blind, placebo-controlled studies of duloxetine, focusing on participants who were at least 65 years old.1

In the studies analyzed, 73 patients fell within the authors' designated age range. Patients in two studies were started at 60 mg/day of duloxetine, which could be temporarily lowered to 30 mg/day if tolerability concerns arose. All patients were receiving 60 mg/day by week 2, and some were subsequently raised to 120 mg/day by weekly increments of 30 mg/day. In the two other studies, patients were started on 30 mg/day, followed by an increase to 60 mg/day after one week, and then flexible dosing up to 120 mg/day in weekly 30 mg/day increments.

The good news was that patients assigned to duloxetine treatment had statistically greater improvement compared with placebo-treated patients on the Hamilton Anxiety Scale. Most other anxiety ratings showed similar benefit of drug over placebo. More patients reached "response" criteria on active drug, but the difference was not statistically significant. Duloxetine did show statistical superiority in the number of patients achieving "remission" and "sustained improvement."

The bad news is that there were more adverse events among patients taking duloxetine. While no placebo-treated patient discontinued treatment due to an adverse event, over 20% of duloxetine-treated patients did (P = .011). Nausea occurred in 30.0% of patients taking duloxetine versus 7.1% among those taking placebo (P = .023). There were no significant differences between the treatment groups in mean baseline-to-endpoint changes in supine systolic or diastolic blood pressure or pulse.

Weight loss can be a clinical problem among older patients. There was no average weight loss in the placebo group, but patients taking duloxetine lost an average of 1.1 kg (2.4 lb) (P = .018) over approximately 12 weeks.

The bottom line? There are now a number of treatment options—both medication and psychotherapy—for patients with GAD. When an elderly patient is diagnosed with GAD, and the clinician and patient elect to try medication treatment, it might be prudent to try a better tolerated antidepressant first, probably a selective serotonin reuptake inhibitor. Duloxetine can serve as a second-line option, with attention to nausea, weight loss, and blood pressure.

1Davidson J, Allgulander C, Pollack MH, Hartford J, Erickson JS, Russell JM, Perahia D, Wohlreich MM, Carlson J, Raskin J: Efficacy and tolerability of duloxetine in elderly patients with generalized anxiety disorder: A pooled analysis of four randomized, double-blind, placebo-controlled studies. Hum Psychopharmacol 2008;23:519-526.