Identification of fibromyalgia patients who may not be appropriate candidates for duloxetine or pregabalin therapy – Source: American Pain Society Annual Meeting, May 2009

[Note: Duloxetine (trade name Cymbalta) and pregabalin (trade name Lyrica) are both FDA approved as therapies for symptoms of Fibromyalgia.]

This study assessed the prevalence of comorbidities and/or use of selected medications that may contraindicate the use of duloxetine (DLX and/or pregabalin (PGB) among patients with fibromyalgia (FM).

Using the Pharmetrics Patient-Centric Database, we identified all patients, aged 18 years or older, with 1 or more medical claims with an ICD-9-CM diagnosis code of FM (729.1) between 7/1/2004 and ending 6/30/2005, and at least one such claim in each of the 2 preceding 12-month periods.

We then assessed the prevalence of comorbidities and medication use that could contraindicate DLX and/or PGB.

• Comorbidities (DLX: narrow angle glaucoma, hepatic insufficiency, pregnancy, severe renal impairment, hypertension; PGB: severe renal impairment, hemodialysis, angioedema),

• And medications (DLX: monoamine oxidase inhibitors, serotonergic drugs, inhibitors of CYP1A2 or 2D6, drugs metabolized by CYP2D6, phenothiazines, linezolid; PGB: ACE inhibitors, thiazolidinediones)
… were designated of concern based on product labeling and summary reviews.

A comorbidity of interest was established for 2 or more outpatient claims on different days or any inpatient claims with a relevant ICD-9-CM diagnosis code; medication use was established by any pharmacy claims for the medication.

A total of 33,176 patients with FM were identified in the study database; mean (plus/minus SD) age was 45.5 plus/minus 10.2 years, and 74.5% were women.

In patients taking DLX, 32% had comorbidities and/or used medications that might render DLX use inappropriate – predominantly hypertension (17.2%), prescriptions for CYP1A2 or CYP2D6 inhibitors (13.6%), or for serotonergic drugs (11.5%).

The corresponding figure for PGB was 8% – predominantly ACE inhibitor use (5.9%) or pregnancy (1.6%).

FM patients were four times as likely to have comorbidities and/or to have used other medications that might render them potentially inappropriate candidates for DLX in comparison with PGB. (Supported by Pfizer Inc.)

Source: American Pain Society Annual Scientific Meeting, May 7-9, 2009, Poster #274. Sadosky A, Berger A, Zlateva G, Oster G. Pfizer Global Outcomes Research, New York.

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One thought on “Identification of fibromyalgia patients who may not be appropriate candidates for duloxetine or pregabalin therapy – Source: American Pain Society Annual Meeting, May 2009”

  1. anjel77 says:

    This is a very detailed and interesting find.Somewhat confusing with some of the symbols however found to be an easy read. I am or was a RN.
    I was diagnosed with Fibromyalgia after a work injury. I was healthy.No one doctor knew what was wrong.I ended up with the help of google diagnosing myself first.
    Doctors need MORE awareness on the contraindications with the use of SSRI and Lyrica together with ultram.The pharmacy says it can cause serotonin syndrome.
    Cymbalta made me sweat profusely. Lyrica made me to tired all the time.Over all this was a great study. We the medical community needs to do more research on this devastating disorder.

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