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Controlled-Released Paroxetine Effective for Premenstrual Dysphoric Disorder: Presented at ACOG

By Bruce Sylvester

NEW ORLEANS, LA -- May 5, 2003 -- A pooled analysis of data from three placebo-controlled studies indicates that controlled-release paroxetine (Paxil CR) effectively relieves symptoms of premenstrual dysphoric disorder (PMDD).

The analysis was presented in a poster session here on April 30^th at the 51^st Annual Meeting of the American College of Obstetricians and Gynecologists.

PMDD is the acronym for the more severe form of PMS (Premenstrual Syndrome). Like PMS, PMDD occurs the week before the onset of menstruation and disappears a few days after. PMDD is characterised by severe monthly mood swings and physical symptoms that interfere with everyday life, especially a woman's relationships with her family and friends. PMDD symptoms go far beyond what are considered manageable or normal premenstrual symptoms.

"The studies were the same in their designs," said investigator and presenter Kimberly Yonkers, MD, associate professor of psychiatry, Yale University School of Medicine, in New Haven, Connecticut. "So we felt confident that a pooled analysis would help us see the efficacy and tolerability variables between the 25 mg dosage and the 12.5 mg dosage. And indeed, despite overall efficacy and tolerability for both, we did find that the lowest rate of adverse events and withdrawals was among the women who used the 12.5 mg for up to three cycles."

In all three studies (1,030 intent-to-treat subjects), the subjects recorded daily PMDD symptoms using visual analog scales (VAS) on 11 items, including irritability, tension, depressed mood, affective labiality, decreased interest, difficulty concentrating, lack of energy, change in appetite, change in sleep pattern, out-of-control feelings and physical symptoms.

Primary efficacy was change from baseline to end point in mean VAS-Mood score (the mean of four core items -- irritability, tension, affective labiality and depressed mood.) at treatment cycle 3. Secondary efficacy measures were total-VAS, physical symptoms (breast tenderness/swelling, headache, feelings of bloating) and measures of occupational and social functioning.

At end point, the investigators found a statistically significant superiority of both paroxetine-CR 12.5 mg and 25 mg in treating symptoms of PMDD as measured by the patient-charted VAS scales (P<0.001 for both doses and for placebo). The same was true for the physical symptoms of PMDD.

The secondary-measure Sheehan Disability Scale (SDS) yielded a composite score for measures of impairment in work, social and family-life. The mean differences among the cohorts showed statistically significant improvements with paroxetine CR compared to placebo (paroxetine CR 12.5 mg mean difference versus placebo of -2.5, 95% confidence interval P<0.001), paroxetine 25 mg mean difference versus placebo was -3.3 (95% confidence interval, P<0.001).

Nausea and asthenia charted over three menstrual cycles led to a higher rate of withdrawals for the 25 mg group versus 12.5 mg and placebo.

The study authors concluded, "Paroxetine CR is effective in treating the core psychiatric symptoms of PMDD along with associated physical symptoms and impairment in social functioning. Paroxetine CR is well tolerated with few withdrawals for adverse events, particularly for those taking 12.5 mg for up to three cycles.

GlaxoSmithKline supported the study.


[Study title: Paroxetine Controlled-Release (CR) Is Effective In The Treatment of PMDD).]

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