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Sertraline improved itching from liver disease in small study.

SAN FRANCISCO -- The SSRI sertraline improved pruritus from cholestatic liver disease in a small double-blind crossover study of 12 patients, Dr. Marlyn J. Mayo said at the annual meeting of the American Association for the Study of Liver Diseases.

The findings support the results of previous small, retrospective case series that also suggested that SSRIs may improve pruritus, which often is the most debilitating symptom of cholestatic liver disease, said Dr. Mayo of the University of Texas Southwestern Medical Center at Dallas and her associates.

Pfizer Inc., which makes sertraline, paid Dr. Mayo's travel expenses to the meeting. The drug is not approved for this indication.

To determine the best dose of sertraline for itching, the investigators first performed an open-label dose-escalation study in 21 patients with chronic pruritus due to primary biliary cirrhosis, primary sclerosing cholangitis, chronic hepatitis-C cirrhosis, or postnecrotic cirrhosis. Patients took no other medications that might alter itching and rating their pruritus using a visual analog scale.

Doses of 25-50 mg/day sertraline (Zoloft) for 4 weeks had little effect on itching.

The greatest improvement overall came from 4 weeks of treatment with 75 mg/day, though some patients who didn't respond to these doses improved on 100 mg/day of sertraline for 4 weeks. The optimal dose seems to be 75-100 mg/day, Dr. Mayo said.

After a 2-week washout period, patients were randomized in a double-blind fashion to 6 weeks of sertraline 75 mg/day or placebo. A subsequent 2-week washout followed, and then patients were crossed over to the other treatment group for 6 more weeks. They were asked to rate their pruritus in a daily diary using the visual analog scale, and clinicians assessed the pruritus and depressive symptoms in visits after each study phase.

Twelve patients completed the study. Itching improved significantly more with sertraline than with placebo independent of the presence of depression, and was well tolerated even in patients with severe cholestatic liver disease, Dr. Mayo said.

The greatest improvements were seen in patients with the most severe pruritus, but itching resolved completely only in some patients with mild itching.

On a 10-point severity scale, itching scores decreased 2 points on sertraline but increased half a point on placebo.

Of the nine patients who did not complete both the open-label and randomized portions of the study, two died of causes unrelated to the study, and two underwent transplants.

Three said they found the clinic visits too cumbersome, one developed severe dizziness on sertraline during the dose-escalation study, and one was unwilling to stop sertraline after the open-label dose-escalation phase.

All 12 patients who completed the randomized study had excoriations at baseline. On sertraline, lesions improved in 10 patients and were unchanged in 2. On placebo, lesions worsened in eight patients and were unchanged in four.

Eight of the 12 patients had red-crusted nodules at baseline. These lesions improved in seven patients on sertraline and were unchanged in one. On placebo, the red-crusted nodules worsened in four patients, were unchanged in three, and improved in one patient.

The duration of itching decreased from 12-18 hours per day in many patients on placebo to less than 6 hours/day in all but one patient who itched 6-12 hours/day.

The distribution of pruritus improved on sertraline. A median of 13 itchy body areas at baseline did not change significantly on placebo but decreased to 8 areas on sertraline.

Most patients in the study were not depressed, and mild depressive symptoms did not change significantly, Dr. Mayo said.

One patient with moderate depression improved on sertraline but not placebo, and one patient with severe depression improved on both sertraline and placebo.

"The successful treatment of depression is not required for the treatment of pruritus" in these patients, she said.


San Francisco Bureau
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Title Annotation:Across Specialties
Author:Boschert, Sherry
Publication:Clinical Psychiatry News
Geographic Code:1USA
Date:Mar 1, 2006
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