Posted by jrbecker on June 5, 2003, at 10:11:54
Higher Rates Of Remission, Lower Incidence Of Sexual Dysfunction Demonstrated In Patients Taking Cymbalta (Duloxetine)
TORONTO, ON -- June 5, 2003 -- Two new sets of data on duloxetine (proposed brand name Cymbalta®), a serotonin norepinephrine reuptake inhibitor (SNRI) being studied for the treatment of depression, were released at the 156th American Psychiatric Association Annual Meeting. Cymbalta is a new investigational therapy developed by Eli Lilly and Company that has been submitted to Health Canada.
The first data set showed a significantly lower incidence of sexual dysfunction compared to patients taking paroxetine (marketed as Paxil®), a commonly prescribed selective serotonin reuptake inhibitor (SSRI). In the second data set, depressed patients treated with duloxetine had significantly greater reductions in painful physical symptoms and higher rates of remission compared to patients taking a placebo.
"Sexual dysfunction is a major and very real concern for patients on anti-depressant treatment," said Sidney Kennedy, MD, Psychiatrist-in-Chief, University Health Network, Toronto, Ontario. "Even at the highest studied duloxetine dose of 120 mg/day, the incidence of sexual dysfunction was significantly lower than paroxetine at 20 mg/day. This support previous reports that combination norepinephrine and serotonin-acting antidepressants produce less sexual dysfunction than straight serotonin-acting agents. Furthermore, when we see the high remission rates for patients relieved of their pain symptoms, we can see the potential significance of duloxetine. The combination of a lower incidence of sexual dysfunction and higher remission rates is very powerful."
Data Analysis: Sexual Dysfunction
Retrospective data analysis from four clinical trials shows that patients taking duloxetine experienced a significantly lower incidence of sexual dysfunction compared to patients taking paroxetine.
Higher Rates of Remission and Lower Incidence of Sexual Dysfunction
Nearly half of all people with depression experience sexual dysfunction as a part of their illness.1 Furthermore, up to 73 per cent of patients taking SSRIs may report sexual dysfunction.2
Study Highlights
At the highest studied duloxetine dose (120 mg/day), the incidence of acute-phase, treatment emergent sexual dysfunction was significantly lower than that of the active comparator, paroxetine. (20 mg/day; p=.027).Female patients receiving duloxetine had a significantly lower incidence of acute-phase, treatment emergent sexual dysfunction compared to those receiving paroxetine (p=.032). In male patients, the incidence of acute-phase, treatment emergent sexual dysfunction for duloxetine did not differ significantly from placebo, while the incidence among paroxetine-treated male patients was significantly higher than placebo (p=.012).
Method
Acute and long-term data on sexual functioning were evaluated using the Arizona Sexual Experience Scale (ASEX), a five-item questionnaire that assesses functioning in a number of areas including sex drive, arousal and ability to reach orgasm. Acute-phase data were obtained from four eight-week, randomized, double-blind studies with patients receiving 20-60 mg of duloxetine twice per day (n=736), 20 mg of paroxetine once-daily (n =359) or placebo (n=371). Long-term data were obtained from 26-week extension phases in two of the studies in which acute treatment responders received duloxetine (40 or 60 mg twice per day; n=297), paroxetine (20 mg once-daily; n=140) or placebo (n=129).New Clinical Study: Treating Physical Symptoms
In a new clinical study, remission rates for patients relieved of their painful physical symptoms was twice the rate of pain non-responders (p<.001), and early and robust overall relief (starting after Week 1) offered a good indication of whether a patient would reach remission (p=.005).Seventy-six per cent of patients with depression experience painful physical symptoms such as vague aches and pains, backache, headache or shoulder pain - a problem that impacts the treatment, as well as proper diagnosis, of depression.3
Higher Rates of Remission and Lower Incidence of Sexual Dysfunction
Study Highlights
Patients treated with duloxetine demonstrated a greater than 3-fold improvement in overall pain among remitters. Remission was defined as a total score of < 7 on the 17-item Hamilton Depression Rating Scale (HAMD17).Current medical literature suggests that medications affecting both serotonin and norepinephrine may reduce the painful physical symptoms and the emotional symptoms of depression.4
Method
In two identical but independent, nine-week, randomized, double-blind studies, patients who met the criteria for Major Depressive Disorder (MDD) were given either 60mg once daily of duloxetine (n=244) or placebo (n=251). Patients were not pre-screened for painful physical symptoms. Emotional symptoms were assessed by the HAMD17. Painful physical symptoms were measured using 100-mm Visual Analog Scales (VAS).References:
1. Kennedy SH, Dickens S, Elsfeld, et al. Sexual dysfunction before antidepressant therapy in major depression. J Affect Disord 1999;56;197-204.
2. Ferguson JM. The effects of antidepressants on sexual functioning in depressed patients: a review. J. Clin Psychiatry 2001;62(Suppl 3)22-34.
3. Kirmayer LJ et al. Am J Psychiatry. 1993;150:734-741.
4. Nemeroff, CB et al. Psychopharm Bull 2002;36:106-132.
SOURCE: Praxis Public Relations
poster:jrbecker
thread:231608
URL: http://www.dr-bob.org/babble/20030604/msgs/231608.html