AstraZeneca announced new SEROQUEL
XR™ (extended release quetiapine fumarate) clinical study data in
patients with Generalised Anxiety Disorder (GAD), presented at the 21st
European College of Neuropsychopharmacology (ECNP) Congress in
Barcelona. In this study, extended release quetiapine fumarate
significantly improved symptoms of anxiety
at Week 8 compared with placebo and this was observed as early as day
4. The active comparator arm, escitalopram 10mg/day, was also effective
at improving symptoms of GAD at week 8 compared with placebo although
improvement was not observed at day 4.
During their lifetimes, it is estimated between 2.7% and 5.4% of people in Europe will suffer from GAD.1 Characteristic symptoms include chronic anxiety, exaggerated worry and tension - it is often accompanied by depression or other anxiety disorders2,3 - and it has a substantial negative impact on Health-Related Quality of Life (HRQoL), productivity at work (including absenteeism) and healthcare costs1.
Antidepressants (SSRIs (selective-serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors)) are standard treatments that are generally effective but approximately 30 percent of patients treated with SSRIs or SNRIs will have an inadequate response4. Additionally, they may have a relatively slow onset of action, sometimes requiring combination with a short course of benzodiazepines (BZDs) to achieve initial symptom control - however, BZDs may have the potential for dependence and withdrawal symptoms5.
The data presented today in Barcelona are the results of Study 10 - conducted across 64 centres in the U.S. and part of the clinical development programme for extended release quetiapine fumarate for the treatment of GAD6. A total of 854 patients aged 18-65 with a DSM-IV3 diagnosis of GAD were randomized to receive either extended release quetiapine fumarate 150mg/day (n=219), 300mg/day (n=207), escitalopram 10mg/day (n=213) or placebo (n=215). At week 8, extended release quetiapine fumarate 150mg/day, 300mg/day and escitalopram 10mg/day, significantly reduced mean Hamilton Anxiety Rating Scale (HAM-A) total scores from randomization compared with placebo (-13.9 [p<0.001], -12.3 [p<0.05], -12.3 [p<0.05] versus - 10.7). At day 4, mean HAM-A total scores were significantly reduced from randomization with extended release quetiapine fumarate 150mg/day, 300mg/day (-6.7, -6.3, p<0.001) but not with escitalopram 10mg/day (-4.6, p=0.889), compared with placebo (-4.5) 6.
Both extended release quetiapine fumarate and escitalopram were generally well tolerated. Among extended release quetiapine fumarate treated patients, adverse events with incidence greater than 10% and twice that of placebo were dry mouth, somnolence, sedation and constipation; among escitalopram-treated patients they were sedation and nausea.
The incidence of AEs associated with EPS among patients treated with extended release quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo were 4.2%, 6.0%, 6.8% and 5.7% respectively; the incidence of AEs associated with sexual dysfunction were were 4.1%, 3.9%, 8.1% and 3.7% respectively. The proportions of patients who experienced a clinically important shift in fasting blood glucose (from normal to >126mg/dL) were 3.7%, 1.6%, 1.1% and 3.2% in the quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo groups, respectively; the proportions of patients experiencing >7% increase in weight were 3.8%, 3.9%, 0.5% and 0.9% respectively6.
About Generalized Anxiety Disorder (GAD)
GAD is characterized by chronic anxiety, exaggerated worry, and tension, even when there is little or nothing to provoke it. People with GAD anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work.2,3
People with GAD can't seem to get rid of their concerns, even though they usually realize that their anxiety is more intense than the situation warrants. They can't relax, startle easily, and have difficulty concentrating. Often they have trouble falling asleep or staying asleep. Physical symptoms that often accompany the anxiety include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, twitching, irritability, sweating, nausea, lightheadedness, having to go to the bathroom frequently, feeling out of breath, and hot flushes. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least 6 months2,3.
About SEROQUEL and SEROQUEL XR
In May 2008, SEROQUEL XR™ (extended release quetiapine fumarate) became the first ever antipsychotic to complete a clinical development programme and be filed with the FDA in the U.S. for approval in the treatment of GAD7 - today it is not approved in any country for the treatment of GAD but remains under review with the FDA. SEROQUEL XR™ is approved in the US and 28 further countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of manic episodes associated with bipolar disorder, and the treatment of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder in the US was also announced in February. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide*. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. It was also recently approved by the FDA in the USA for the for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or valproate - a similar submission has been made in Europe.
* Based on assumptions: (1) estimated number of prescriptions per patient based upon IMS APLD data; and (2) IMS Prescription data for SEROQUEL covering 13 major markets in which this data is available since the time of launch.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
http://www.astrazeneca.com
During their lifetimes, it is estimated between 2.7% and 5.4% of people in Europe will suffer from GAD.1 Characteristic symptoms include chronic anxiety, exaggerated worry and tension - it is often accompanied by depression or other anxiety disorders2,3 - and it has a substantial negative impact on Health-Related Quality of Life (HRQoL), productivity at work (including absenteeism) and healthcare costs1.
Antidepressants (SSRIs (selective-serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors)) are standard treatments that are generally effective but approximately 30 percent of patients treated with SSRIs or SNRIs will have an inadequate response4. Additionally, they may have a relatively slow onset of action, sometimes requiring combination with a short course of benzodiazepines (BZDs) to achieve initial symptom control - however, BZDs may have the potential for dependence and withdrawal symptoms5.
The data presented today in Barcelona are the results of Study 10 - conducted across 64 centres in the U.S. and part of the clinical development programme for extended release quetiapine fumarate for the treatment of GAD6. A total of 854 patients aged 18-65 with a DSM-IV3 diagnosis of GAD were randomized to receive either extended release quetiapine fumarate 150mg/day (n=219), 300mg/day (n=207), escitalopram 10mg/day (n=213) or placebo (n=215). At week 8, extended release quetiapine fumarate 150mg/day, 300mg/day and escitalopram 10mg/day, significantly reduced mean Hamilton Anxiety Rating Scale (HAM-A) total scores from randomization compared with placebo (-13.9 [p<0.001], -12.3 [p<0.05], -12.3 [p<0.05] versus - 10.7). At day 4, mean HAM-A total scores were significantly reduced from randomization with extended release quetiapine fumarate 150mg/day, 300mg/day (-6.7, -6.3, p<0.001) but not with escitalopram 10mg/day (-4.6, p=0.889), compared with placebo (-4.5) 6.
Both extended release quetiapine fumarate and escitalopram were generally well tolerated. Among extended release quetiapine fumarate treated patients, adverse events with incidence greater than 10% and twice that of placebo were dry mouth, somnolence, sedation and constipation; among escitalopram-treated patients they were sedation and nausea.
The incidence of AEs associated with EPS among patients treated with extended release quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo were 4.2%, 6.0%, 6.8% and 5.7% respectively; the incidence of AEs associated with sexual dysfunction were were 4.1%, 3.9%, 8.1% and 3.7% respectively. The proportions of patients who experienced a clinically important shift in fasting blood glucose (from normal to >126mg/dL) were 3.7%, 1.6%, 1.1% and 3.2% in the quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo groups, respectively; the proportions of patients experiencing >7% increase in weight were 3.8%, 3.9%, 0.5% and 0.9% respectively6.
About Generalized Anxiety Disorder (GAD)
GAD is characterized by chronic anxiety, exaggerated worry, and tension, even when there is little or nothing to provoke it. People with GAD anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work.2,3
People with GAD can't seem to get rid of their concerns, even though they usually realize that their anxiety is more intense than the situation warrants. They can't relax, startle easily, and have difficulty concentrating. Often they have trouble falling asleep or staying asleep. Physical symptoms that often accompany the anxiety include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, twitching, irritability, sweating, nausea, lightheadedness, having to go to the bathroom frequently, feeling out of breath, and hot flushes. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least 6 months2,3.
About SEROQUEL and SEROQUEL XR
In May 2008, SEROQUEL XR™ (extended release quetiapine fumarate) became the first ever antipsychotic to complete a clinical development programme and be filed with the FDA in the U.S. for approval in the treatment of GAD7 - today it is not approved in any country for the treatment of GAD but remains under review with the FDA. SEROQUEL XR™ is approved in the US and 28 further countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of manic episodes associated with bipolar disorder, and the treatment of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder in the US was also announced in February. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide*. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. It was also recently approved by the FDA in the USA for the for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or valproate - a similar submission has been made in Europe.
* Based on assumptions: (1) estimated number of prescriptions per patient based upon IMS APLD data; and (2) IMS Prescription data for SEROQUEL covering 13 major markets in which this data is available since the time of launch.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
http://www.astrazeneca.com
6 comments:
Greеtings І am sо happy І fοund уour webpagе, I гeallу found you by eгror, whіlе I was reѕearching on Google foг sοmething else, Regаrdlesѕ I am here
now anԁ ωould just likе to sаy many thanks
fоr a mагvelous ρoѕt and a
аll гound intеrestіng blоg (I also loѵe the themе/design),
I don’t hаve tіmе to rеad through it
all at the moment but I have boоκmаrkеd іt and alѕо includeԁ yοuг RSS fеeds, so ωhеn I have
time I will bе bacκ to геad a lоt mοrе,
Ρlease do keeρ up the supеrb jo. Ripon Commonwealth Press\/Express
- http://rippln.blogspot.com - rippln reviews
my ѕite :: Rippln Mobile
What a matеrial of un-ambіguіty and preseгνeness
of valuable famіliaritу regаrding unpredіcted fеelingѕ.
junior boys banana ripple lyrics - ripples of battle hanson - rippln mobile
Feel frеe to surf to my webѕitе
... ripple mobile emulator
Ηello thегe! Would you mind іf I share youг blog wіth my zyngа grοup?
Theге's a lot of people that I think would really appreciate your content. Please let me know. Cheers auto insurance companies - auto insurance companies in ny - compare auto insurance
My web-site: auto Insurance Comparison
Ӏ ԁο not evеn κnow hοw I
еndeԁ up hеre, but I thought this
ρost was great. I do not know who you are but dеfіnitely уou're going to a famous blogger if you are not already ;) Cheers!
Here is my webpage - auto Transportation
Ηello all, here every peгson is sharing these κіnԁs
of еxpeгience, thuѕ it's good to read this weblog, and I used to pay a visit this website daily.
Visit my web blog home based business opportunities
This агticle will helρ the intеrnet
viewers fоr buіlding up new websіte oг even a blog
frοm start to end.
Alѕo visіt my homepage :: low cost health insurance
Post a Comment