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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by Brutus1 on February 26, 2007, at 18:49:19
FDA Approves Cymbaltaź for Treatment of Generalized Anxiety Disorder
February 26, 2007INDIANAPOLIS, Feb 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbaltaź (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD), a condition that affects more than 6.5 million American adults in a given year.(1) Because GAD presents with a variety of symptoms, it can be difficult to diagnose(2) and may have a negative impact on a person's ability to function properly in work, family and social situations.(3)
The safety and efficacy of Cymbalta in the treatment of GAD was established in three randomized, double-blind, placebo-controlled studies in more than 800 non-depressed adults with GAD. In all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), compared with placebo. In addition, Cymbalta patients reported greater improvement in functional impairment associated with the illness, including improved ability to perform everyday activities at work, home, and in social situations.
"If left untreated, symptoms of generalized anxiety disorder may worsen, potentially impacting many aspects of a person's life, including their job and social relationships," said Susan Kornstein, M.D., professor of psychiatry at Virginia Commonwealth University. "With this approval, physicians and patients will be happy to know that there is another medication now available to treat this debilitating condition."
Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitor (SNRI),(4) has been studied in more than 25,000 patients worldwide and is already approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain, both in adults.
"More than 4.5 million adults in the United States have been prescribed Cymbalta for major depressive disorder or diabetic peripheral neuropathic pain," said Mike Detke, M.D., Ph.D, Cymbalta medical director for Eli Lilly and Company. "We are excited to offer a new, approved treatment option for generalized anxiety disorder patients and are eager to continue our research with this medication."
In clinical trials, on average, patients treated with Cymbalta for generalized anxiety disorder experienced a 46 percent improvement in anxiety symptoms compared to 32 percent for those who took placebo, as measured by the Hamilton Anxiety Scale. In addition, patients in these studies experienced a 46 percent improvement in function compared to 26 percent for those who took placebo as measured by the Sheehan Disability Scale. The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction. In clinical trials, Cymbalta was studied in a dose range of 60-120 mg per day. While a 120mg/day dose was shown to be effective, there is no evidence that doses greater than 60mg/day confer additional benefit. Cymbalta comes in a capsule, and the target daily dose is 60 mg.
About Generalized Anxiety Disorder
Approximately 6.5 million Americans are diagnosed with generalized anxiety disorder each year.(5) Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety, irritability, poor concentration, sleep disturbance and fatigue.(6,7) Generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.(8)
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of duloxetine is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and now the treatment of generalized anxiety disorder, all in adults. Cymbalta is not approved for use in pediatric patients.
Important Safety Information
Cymbalta is approved to treat major depressive disorder, diabetic peripheral neuropathic pain and generalized anxiety disorder. In children and teens, antidepressants can increase the risk of suicidal thoughts or actions. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behavior or thoughts of suicide, especially at the beginning of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellarilź (thioridazine) or have uncontrolled glaucoma. Patients should speak with their doctor about all medicines they are taking, including those for migraine to avoid a potentially life- threatening condition. Patients should tell their doctor about their alcohol consumption, if they have liver disease, and about all of their medical conditions.
Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include:
-- For MDD: nausea, dry mouth and constipation
-- For DPNP: nausea, sleepiness and dizziness
-- For GAD: nausea, fatigue and dry mouth
This is not a complete list of side effects.For full Patient Information, visit www.cymbalta.com.
For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com
Posted by Phillipa on February 26, 2007, at 21:35:30
In reply to FDA Approves Cymbaltaź GAD, posted by Brutus1 on February 26, 2007, at 18:49:19
Only thing it did for me was get rid of back pain horrible anxiety with it. Love Phillipa
Posted by UgottaHaveHope on February 27, 2007, at 16:05:10
In reply to Re: FDA Approves Cymbaltaź GAD » Brutus1, posted by Phillipa on February 26, 2007, at 21:35:30
I have been diagnosed with generalized anxiety disorder. Has anyone taken Cymbalta and had it dramatically reduce anxiety? Please share your story. Michael
Posted by Brutus1 on February 27, 2007, at 18:36:44
In reply to Has anyone had Cymbaltaź help GAD?, posted by UgottaHaveHope on February 27, 2007, at 16:05:10
Jay (yxibow) is our resident expert on Cymbalta. Hopefully he will post:) I take 30 mgs and it helps. After the first few days no real side effects. Then again I couldn't tell if the SE's were Zoloft withdrawl or cymbalta. Some descreased sex drive now.
Some posters like it, Some didn't as Phillpa posted.
B
> I have been diagnosed with generalized anxiety disorder. Has anyone taken Cymbalta and had it dramatically reduce anxiety? Please share your story. Michael
Posted by johnnyj on February 27, 2007, at 22:10:15
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow), posted by Brutus1 on February 27, 2007, at 18:36:44
Can I ask what your dx is? Did it help you sleep at all? I have anxiety/ocd and gad is really becoming a problem right now. Thank you
johnnyj
Posted by yxibow on February 28, 2007, at 1:50:27
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow), posted by Brutus1 on February 27, 2007, at 18:36:44
> Jay (yxibow) is our resident expert on Cymbalta. Hopefully he will post:) I take 30 mgs and it helps. After the first few days no real side effects. Then again I couldn't tell if the SE's were Zoloft withdrawl or cymbalta. Some descreased sex drive now.
>
> Some posters like it, Some didn't as Phillpa posted.
>
> B
>
>
>
> > I have been diagnosed with generalized anxiety disorder. Has anyone taken Cymbalta and had it dramatically reduce anxiety? Please share your story. Michael
I didn't know I was crowned with the title :) Though Lilly probably enjoys my copays. I take it for MDD at 120mg and my unnamed insurance likes to double the copay because Lilly can't say officially that it has more effectiveness beyond 60mg. However, I experienced something different when I hit 80mg.
It's a very subtle agent and takes quite a long time to take effect which is probably why a number of people discontinue it (we're talking several months at least for a good effect). I don't know its effect on GAD though I do suffer from a fairly rare visual Somatiform disorder which you could say is in the OCD/anxiety spectrum though it does not resemble any form of OCD nor does it entail psychosis.
It is an agent that if you wish to push the windows of it and go up to 60 or beyond, it should be done conservatively. I know some doctors start it at 60, which can be harsh on some individuals. It should be started more conservatively, with 20s, if people have difficulties.
Some people become very sleepy on Cymbalta, opposite to what you think, but it is a label usually stamped on your jar of it. Some find it like I found Effexor -- impossible to take, very nerve wracking. I can't completely say whether or not it effects me in that regard because I also take a fair amount of Valium for my disorder which could cover up any side effects. Of course, even if it is an SSNRI, its effects are still more at serotonin than noradrenergic. A little dose of Klonopin or Valium while adjusting to it might help people who have troubles with it.
Absolutely do not chew, mangle, or otherwise destroy a capsule -- I know people who have difficulties open them, but it is printed directly on the website "Delayed Release Capsules." You run the risk of chewing, having the individual pulsules instantly give a noradrenergic and serotonergic rush which would be like Effexor Plus.
If you have no side effects at 30mg, you probably (but I'm not a psychic) won't have issues at 60mg. Still, give it time to percolate, so to speak. Generally dose adjustments may give slight nausea (ginger is usually good for that). Some people take it all at one dose, if you do, I would suggest in the morning if it is stimulating. But at 60 mg or above, I would take it in split doses. Still, some people get by with 60mg, and sometimes at night because ironically it can make some people sleepy (some people are sedated by stimulants though Cymbalta is not officially a real stimulant.)
I take a polypharmacy of medications that is like an iron chain dragging behind me -- wouldn't wish the disorder or the medication on anyone, so I can't conclusively point anything about anxiolytic effects. However, I started taking it when my doctor switched over from Luvox because he felt it could be better for my comorbid MDD. And it is, less feelings of suicide and such unpleasantries. There's always breakthrough depression, no agent is going to stop everything, that's where therapy and hard work comes in.
So that's my take on Cymbalta, I'm sure others have different views because it will affect people differently, depending on what sort of biological illness they have.
I wish you well--- tidings
Jay
Posted by johnnyj on February 28, 2007, at 8:32:58
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow) » Brutus1, posted by yxibow on February 28, 2007, at 1:50:27
Hi Jay:
I see you have taken luvox. I started a trial about 5 days ago and have had a lot of anxiety with it. What side effects did you have with it? I heard it was supposed to be more sedating but I haven't found that to be the case. Without some klonopin(which I really don't want to take) I wouldn't be sleeping much if at all. I am about ready to chuck it. The internal nervousness is horrible. I have no idea if this will settle down or not. What to do next? Lexapro or paxil I guess. Sleep problems are my biggest problem. Thanksjohnnyj
Posted by Brutus1 on February 28, 2007, at 18:12:33
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow) » Brutus1, posted by johnnyj on February 27, 2007, at 22:10:15
Sure,
My DX is GAD, some ADD traits, and MDD. Too many D's :) I take Klonopin at night, have been for about 6 years. Prior to meds I was nervous insommniac. I plan on weaning off Klonopin over the next year. I think it's time.
Some people find Cymbalta enhances sleep others find it activating.
As for SSRI's I could sleep like a baby on Celexa. Sorry wish I could be more help.
B1
> Can I ask what your dx is? Did it help you sleep at all? I have anxiety/ocd and gad is really becoming a problem right now. Thank you
>
> johnnyj
Posted by Brutus1 on February 28, 2007, at 18:17:45
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow) » Brutus1, posted by yxibow on February 28, 2007, at 1:50:27
Sorry Jay, I didn't mean to put you on the spot. Going back thru previous posts you have the most experience and knowledge on Cymbalta.
I must say that was a very informative post.
B1
> I didn't know I was crowned with the title :) Though Lilly probably enjoys my copays. I take it for MDD at 120mg and my unnamed insurance likes to double the copay because Lilly can't say officially that it has more effectiveness beyond 60mg. However, I experienced something different when I hit 80mg.
>
>
> It's a very subtle agent and takes quite a long time to take effect which is probably why a number of people discontinue it (we're talking several months at least for a good effect). I don't know its effect on GAD though I do suffer from a fairly rare visual Somatiform disorder which you could say is in the OCD/anxiety spectrum though it does not resemble any form of OCD nor does it entail psychosis.
>
>
> It is an agent that if you wish to push the windows of it and go up to 60 or beyond, it should be done conservatively. I know some doctors start it at 60, which can be harsh on some individuals. It should be started more conservatively, with 20s, if people have difficulties.
>
>
> Some people become very sleepy on Cymbalta, opposite to what you think, but it is a label usually stamped on your jar of it. Some find it like I found Effexor -- impossible to take, very nerve wracking. I can't completely say whether or not it effects me in that regard because I also take a fair amount of Valium for my disorder which could cover up any side effects. Of course, even if it is an SSNRI, its effects are still more at serotonin than noradrenergic. A little dose of Klonopin or Valium while adjusting to it might help people who have troubles with it.
>
>
> Absolutely do not chew, mangle, or otherwise destroy a capsule -- I know people who have difficulties open them, but it is printed directly on the website "Delayed Release Capsules." You run the risk of chewing, having the individual pulsules instantly give a noradrenergic and serotonergic rush which would be like Effexor Plus.
>
>
> If you have no side effects at 30mg, you probably (but I'm not a psychic) won't have issues at 60mg. Still, give it time to percolate, so to speak. Generally dose adjustments may give slight nausea (ginger is usually good for that). Some people take it all at one dose, if you do, I would suggest in the morning if it is stimulating. But at 60 mg or above, I would take it in split doses. Still, some people get by with 60mg, and sometimes at night because ironically it can make some people sleepy (some people are sedated by stimulants though Cymbalta is not officially a real stimulant.)
>
>
> I take a polypharmacy of medications that is like an iron chain dragging behind me -- wouldn't wish the disorder or the medication on anyone, so I can't conclusively point anything about anxiolytic effects. However, I started taking it when my doctor switched over from Luvox because he felt it could be better for my comorbid MDD. And it is, less feelings of suicide and such unpleasantries. There's always breakthrough depression, no agent is going to stop everything, that's where therapy and hard work comes in.
>
>
> So that's my take on Cymbalta, I'm sure others have different views because it will affect people differently, depending on what sort of biological illness they have.
>
>
> I wish you well
>
> --- tidings
>
> Jay
Posted by yxibow on February 28, 2007, at 18:44:44
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow) » yxibow, posted by johnnyj on February 28, 2007, at 8:32:58
> Hi Jay:
> I see you have taken luvox. I started a trial about 5 days ago and have had a lot of anxiety with it. What side effects did you have with it? I heard it was supposed to be more sedating but I haven't found that to be the case. Without some klonopin(which I really don't want to take) I wouldn't be sleeping much if at all. I am about ready to chuck it. The internal nervousness is horrible. I have no idea if this will settle down or not. What to do next? Lexapro or paxil I guess. Sleep problems are my biggest problem. Thanks
It is theoretically the most sedating SSRI, though some say Paxil is. You may not be reacting to it in the same manner I did. Indeed it was slightly sedating, the main problems I had between dose adjustments was nausea, which I dealt with ginger. They subsided within a week or less.
Taking Klonopin (or Valium) for interdosal adjustments of an SSRI/SSNRI is not a bad thing; a small quantity shouldn't develop much tolerance and you can slowly shed it when you reach a higher dose that seems tolerable. Its a perfectly normal way of managing these things.
I got up to 450mg, though 400mg was eventually settled on. I was taking it for both dopamine deregulation (its complicated, but SSRIs do downregulate dopamine), and also OCD rumination about my complex (visual) Somatiform Disorder.
Like all serotonergic agents for me, I would and still get momentary electric shocks if I excercise hard or turn my head while doing so. But that's my personal experience, not everyone does so and I tend to be at higher levels than most. The same went for Remeron and now for Cymbalta.
How much Luvox did you start out with? If you start out with too large a dose of an SSRI you will definately experience some reaction. I believe the most conservative starting dose could be 25 or 50mg, I forget. If you started with a much larger dose, you might want to think about asking your doctor to start with a lower dose.
If Luvox is still untolerable, I would go to Paxil probably as a trial for an agent for people who tend to get anxiety with SSRIs. Just remember to take your Paxil on time as it has a shorter half life than the other agents. Luvox doesn't have a particularly long half life too, I believe it was twice daily.
I don't know much about how Lexapro affects people, I think it tends to be in the neutral side of things.
If you generally get nervousness with all SSRIs, all I can say is that 5 days is a little too soon to judge something unless we're talking wall crawling anxiety. It will slowly dissipate if it is to ever dissipate with any SSRI. Definately don't take Prozac, it won't get out of your system for a month (long half life) if you don't like it and I would predict you would definately not.
So I would give it a little more time, maybe another week or so at least -- if it is unbearable, yes, I think you're on track to try Paxil and then maybe Lexapro.-- tidings
Posted by johnnyj on February 28, 2007, at 19:29:49
In reply to Re: Has anyone had Cymbaltaź help GAD? ( yxibow) » johnnyj, posted by yxibow on February 28, 2007, at 18:44:44
thank you for the detailed post, it helps me a lot. Today I actually felt a little better even thought even though I didn't sleep particularly well. I started at 12.5 and then went to 25 after a few days. I am med sensitive and low doses are the only way for me. If I had started at 50 I would have been crawling the ceiling.
I do not find luvox to be very sedating, but I do have some high chest anxiety that I didn't have before I started it. I woke up early this morning and felt "off" too. It is definately luvox related. I agree it is too early to tell. With GAD/ocd I just want something to take the edge off so I can get decent rest. I have had some panic attacks in the past and this is the closet I have felt to having one in a long time.
This is my first ssri so I don't know what to expect really. We all have such paradoxial reactions it is hard too judge. I definately don't want a supposed stimulating ssri. I would have to be sedated to survive it.
I have been on remeron too and loved the sleep but it really numbed me and gave me sponge brain so I got off of it with lots of withdrawal.
I really don't know if any one ssri is better for gad or not. I personally think that my ocd is because of the the anxiety and not the other way around. I am sure my pdoc would not agree.
Thanks again
johnnyj
This is the end of the thread.
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