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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 13 of 13. This is the beginning of the thread.
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
Posted by johnj on June 5, 2003, at 13:07:58
In reply to Duloxetine v. Paxil study released, posted by jrbecker on June 5, 2003, at 10:11:54
Thanks for the quality updates as they are really appreciated. I just wish they would get the manufacturing problems solved and get this drug out there!
johnj
Posted by siobhan on June 5, 2003, at 16:21:12
In reply to Re: Duloxetine v. Paxil study released » jrbecker, posted by johnj on June 5, 2003, at 13:07:58
Have called Lilly every other week for several months now. Had I known about this board I could have saved myself the upset. And why did I think I was the only one waiting for this med?! It is frustrating to wait. Have been the Parnate route and it was good (many yrs ago) but now I consume a diet that would make an MAO a nightmare and take stims for my ADD issue. The patch (Selegiline) is who-knows-where and everything else has been tried to no avail. We can only hope that this med is worth the wait! Is Canada going to get it before we do? Yrs ago my pdoc got Moclobemide for me via Canada (unfortunately it was a useless med). I have visions of a bus ride over the border and hoping I don't get SARS there too!
Posted by dave40252 on June 5, 2003, at 16:42:46
In reply to Duloxetine v. Paxil study released, posted by jrbecker on June 5, 2003, at 10:11:54
Isn't Effexor also an SNRI? I had worse sexual side effects from that than I have with zoloft or prozac.
Posted by Larry Hoover on June 5, 2003, at 16:48:09
In reply to Re: Duloxetine v. Paxil study released » johnj, posted by siobhan on June 5, 2003, at 16:21:12
> I have visions of a bus ride over the border and hoping I don't get SARS there too!
Just for the record, the reason SARS got a foothold in Toronto is that it arrived here from Asia 20 or more days before anybody every heard of SARS. The first announcement was March 17 or 18. It was in Toronto at least as early as February 27.
It is now, and has always been, restricted to health-care settings, or those family members coming in contact with the afflicted. Unless you have a strong desire to be in the hospital in Toronto, you can't catch it. And you couldn't get past the security, even if you had a death wish.
Lar
Posted by siobhan on June 5, 2003, at 17:36:29
In reply to Re: SARS » siobhan, posted by Larry Hoover on June 5, 2003, at 16:48:09
I stand corrected, thank you!
Posted by Larry Hoover on June 5, 2003, at 18:24:12
In reply to Re: SARS » Larry Hoover, posted by siobhan on June 5, 2003, at 17:36:29
> I stand corrected, thank you!
I wouldn't want to say "corrected". I prefer, more fully informed.
Lar
Posted by cybercafe on June 6, 2003, at 1:34:31
In reply to Re: SARS » siobhan, posted by Larry Hoover on June 5, 2003, at 16:48:09
>
> Just for the record, the reason SARS got a foothold in Toronto is that it arrived here from Asia 20 or more days before anybody every heard of SARS. The first announcement was March 17 or 18. It was in Toronto at least as early as February 27.our gov't wanted to do a good job and get the word out about SARS, be cautious, etc, but people got the wrong idea and think everyone's catching it
(having said that, i was quarantined last week)
> It is now, and has always been, restricted to health-care settings, or those family members coming in contact with the afflicted. Unless you have a strong desire to be in the hospital in Toronto, you can't catch it. And you couldn't get past the security, even if you had a death wish.yeah... i'm hoping to find some hard hit dim sum places i can get a deal on food
are you in toronto to larry?
.. to keep this on topic... i hate SNRIs! effexor gave me tremors and high blood pressure ... celexa now relieves that, plus, my libido is back.. yay!
Posted by jemma on June 6, 2003, at 8:03:48
In reply to Re: SARS, posted by cybercafe on June 6, 2003, at 1:34:31
> yeah... i'm hoping to find some hard hit dim sum places i can get a deal on food
The whole city's been hit by the lack of tourism, but boy there are great deals everywhere. I saw a $2 ballgame last week, and the best seats to the best plays are available for next to nothing as rush seats. And for the record, I live right downtown and neither I nor anybody I've seen has ever worn a mask.
Sorry, Dr. Bob - couldn't resist the impulse to give my town a boost. It's sort of medical - this disease has depressed us all.
- Jemma
Posted by Larry Hoover on June 6, 2003, at 8:17:43
In reply to Re: SARS, posted by cybercafe on June 6, 2003, at 1:34:31
> >
> > Just for the record, the reason SARS got a foothold in Toronto is that it arrived here from Asia 20 or more days before anybody every heard of SARS. The first announcement was March 17 or 18. It was in Toronto at least as early as February 27.
>
> our gov't wanted to do a good job and get the word out about SARS, be cautious, etc, but people got the wrong idea and think everyone's catching it
> (having said that, i was quarantined last week)Exactly. Even the way they were calculating the number of cases was deceiving people into thinking it was worse than it was. They were giving the "total cases since it began", an ever-increasing number, rather than the "active cases now in hospital", a number generally in decline.
There have been no cases of community transmission, i.e. random transmission between strangers outside a hospital setting. There were a couple of suspected transmissions at funeral homes, but I think those were ruled out after the fact.
> > It is now, and has always been, restricted to health-care settings, or those family members coming in contact with the afflicted. Unless you have a strong desire to be in the hospital in Toronto, you can't catch it. And you couldn't get past the security, even if you had a death wish.
>
> yeah... i'm hoping to find some hard hit dim sum places i can get a deal on foodThat might be a strong possibility. With the tourism slump, and the connection to anything Asian, I hear business is seriously affected in many areas, especially the three "chinatowns".
> are you in toronto to larry?Close. About one hour drive to the NE. When I had to go to the hospital with pneumonia eight weeks ago, it was right in the midst of the SARS hoopla. They had all the regular entrances to the hospital locked and guarded. You couldn't get directly into emerg. I had to "run the gauntlet" of security and screening staff, but one mention of "chest pain" and I was whisked away. Only later, after I was stabilized, did they complete the SARS checklist.
Even yesterday, when I attended the psych outpatient department, which is in a separate building altogether, I had to go through a SARS screening and hand-dissinfection process. They're not taking any chances. Thousands of people get quarantined, but very few people have taken ill.
> .. to keep this on topic... i hate SNRIs! effexor gave me tremors and high blood pressure ... celexa now relieves that, plus, my libido is back.. yay!
>Whoa! No sexual side-effects on an SSRI? Way cool.
Lar
Posted by Larry Hoover on June 6, 2003, at 8:43:12
In reply to Re: SARS, posted by jemma on June 6, 2003, at 8:03:48
> > yeah... i'm hoping to find some hard hit dim sum places i can get a deal on food
>
> The whole city's been hit by the lack of tourism, but boy there are great deals everywhere. I saw a $2 ballgame last week, and the best seats to the best plays are available for next to nothing as rush seats. And for the record, I live right downtown and neither I nor anybody I've seen has ever worn a mask.Ya, I'll say there's some great deals around. I scored some free passes to the CN Tower. I've never been up it, despite virtually living in its shadow for years. Taking the kids this weekend.
Although it's not my cup of tea, there's a $69 special on in a couple weeks.... a ticket to WWE Raw, a ticket to Molson Indy, and a ticket to a Jay's game....all for $69.
> Sorry, Dr. Bob - couldn't resist the impulse to give my town a boost. It's sort of medical - this disease has depressed us all.
>
> - JemmaI think you're right, Jemma. They're starting to diagnose PTSD in some of the front-line healthcare workers. This isn't a trivial occurrence.
Lar
Posted by Caleb462 on June 7, 2003, at 1:13:33
In reply to Re: Duloxetine v. Paxil study released, posted by dave40252 on June 5, 2003, at 16:42:46
> Isn't Effexor also an SNRI? I had worse sexual side effects from that than I have with zoloft or prozac.
Yes, effexor is also an SNRI. However, effexor's affinity for the serotonin transporter is much higher than effexor's affinity for the norepinephrine transporter. This may be signifigant as far as sexual dysfunction goes.
Posted by jemma on June 7, 2003, at 15:24:47
In reply to Re: SARS » jemma, posted by Larry Hoover on June 6, 2003, at 8:43:12
The Jays, the Indy, and the WWE Raw - now there's a weekend! (lol)
- Jemma
This is the end of the thread.
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