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07 Декабрь,2002 | FED/ Researchers uncover possible cause of seasonal disorder

Judy Skatssoon, National Medical Writer 12/06/2002 SYDNEY, Dec 6 AAP - Melbourne researchers have found the first strong evidence of a possible cause for seasonal mood disorder, where people regularly become depressed during winter but recover in summer. AAP News via NewsEdge Corporation : Judy Skatssoon, National Medical Writer 12/06/2002 SYDNEY, Dec 6 AAP - Melbourne researchers have found the first strong evidence of a possible cause for seasonal mood disorder, where people regularly become depressed during winter but recover in summer. According to a research letter in The Lancet medical journal today, a lack of sunlight inhibits production of the "feel-good"neurotransmitter serotonin. Seasonal mood disorder was first documented in the mid 1980s but Hippocrates alluded to it as far back as 400BC. Dr Gavin Lambert, of Melbourne's Baker Institute, concluded lack of light affects key mood-controlling neurotransmitters in the brain. He said he measured levels of brain serotonin and other neurotransmitters by inserting a catheter high into internal jugular veins to obtain blood samples. Analysis of the samples showed that serotonin levels were much lower in winter than in spring and summer, and this was directly related to the amount of bright sunlight. "Up until this stage there's really only been indirect evidence that brain serotonin may be involved in this disease, or that other neurotransmitters may be involved," Dr Lambert told AAP. "What our research has done is provide strong evidence of a link between a seasonal variation in brain serotonin and a strong link between the amount of sunlight and brain serotonin." Previous postmortem studies also found serotonin levels lower in the brains of suicide victims. Meanwhile, shining a bright light into rats eyes had been shown to activate neurones in the hypothalamus, one of the mood-controlling centres of the brain. Seasonal mood disorder, which can be severe enough to put people at risk of suicide, is believed to have a genetic element, however it becomes more prevalent with increasing distance from the equator. Light therapy, or shining bright white light into a patients' eyes, has been shown to be effective in treating the disorder. But summer also posed a mental health hazard for certain people, Dr Lambert said. According to separate research, to be published next year, more people kill themselves in summer and spring than in winter. Dr Lambert admitted the figures posed a conundrum given the earlier study. "You could speculate that the rate of change from low level serotonin that occurred between winter and summer could result in an acute activation of serotonergic neurones in the brain, causing pronounced anxiety in susceptible individuals," he said. It could also account for people with bipolar depression having pronounced symptoms in spring and summer, Dr Lambert said. AAP jjs/csd/de Copyright 2002. All Rights Reserved. Financial Times Information Limited - Asia Africa Intelligence Wire <> << Copyright ©2002 Financial Times Limited, All Rights Reserved >>

05 Декабрь,2002 | Новости зарубежной психиатрии

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05 Декабрь,2002 | NeoTherapeutics Presents Data on Two Novel Antipsychotic Drugs

At the Annual Meeting of Society for Neuroscience NEO-376 and NEO-392 May Represent a New Generation of Antipsychotics PR Newswire Leased Line via NewsEdge Corporation : At the Annual Meeting of Society for Neuroscience NEO-376 and NEO-392 May Represent a New Generation of Antipsychotics With a Unique Mechanism of Action IRVINE, Calif., Dec. 5 /PRNewswire-FirstCall/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT) announced results of research recently presented at the 32nd Annual Meeting of the Society for Neuroscience. This work helped identify two lead compounds from the Company's antipsychotic drug program. NEO-376 and NEO-392 showed similar efficacy to clozapine in reversal of PCP-induced disruption of pre-pulse inhibition, a commonly used model for evaluating antipsychotic treatments. In preliminary studies, both compounds had improved safety profiles compared to clozapine and risperidone. Particularly, the data showed that NEO-376 does not impair conditioned-avoidance responding, a measure of cognitive function. This suggests that NEO-376 may have reduced impact on cognition compared to currently marketed antipsychotics. The annual sales of antipsychotics are in multi-billion dollar range. Beginning in 2000, NeoTherapeutics began developing a series of novel compounds for the treatment of schizophrenia and mood disorders. Studies have shown that these compounds have an affinity for the D(4) and 5-HT(1A) receptors and functional studies have suggest that the compounds are D(4) antagonists and 5-HT(1A) agonists. Additional studies have shown that these compounds modulate dopaminergic and serotonergic neurotransmitter and metabolite levels in the prefrontal cortex or striatum. Such modulation is thought to be essential for alleviating the positive and negative symptoms of psychosis. "We have selected NEO-376 and NEO-392 as lead compounds from our anti-psychotic program. The data suggest that these drugs have a novel mechanism of action, efficacy in animal models of psychosis, and promising safety profiles. Further development of these drugs may produce a new class of drugs for treating psychosis," stated Rajesh Shrotriya, M.D., Chairman, President and Chief Executive Officer of NeoTherapeutics. "We are actively seeking a partner to help us bring NEO-376 and NEO-392 to Investigational New Drug (IND) filings and begin clinical studies in humans." NeoTherapeutics seeks to create value for shareholders through the development of in-licensed drugs for the treatment and supportive care of cancer patients. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. Neoquin(tm) is being studied in the treatment of superficial bladder cancer, and may have applications as a radiation sensitizer. The Company also has a pipeline of pre-clinical neurological drug candidates for disorders such as attention-deficit hyperactivity disorder, schizophrenia, mild cognitive impairment and pain, which it is actively seeking to out-license or co-develop. For additional information visit the Company's web site at www.neot.com . This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission. For further information please contact John McManus of NeoTherapeutics, Inc., +1-949-788-6700, ext. 247. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X75566852 SOURCE NeoTherapeutics, Inc. .TABLE -0- 12/05/2002 /CONTACT: John McManus of NeoTherapeutics, Inc., +1-949-788-6700, ext. 247/ /Web site: http://www.neot.com / (NEOT) CO: NeoTherapeutics, Inc. ST: California IN: MTC BIO OTC SU: TDS PDT SVY KK -- LATH062 -- 0783 12/05/2002 14:38 EST http://www.prnewswire.com <> << Copyright ©2002 PR Newswire >>

05 Декабрь,2002 | U. Pittsburgh researchers find link between gene, depression

U-WIRE-2002 U-Wire - http://www.uwire.com U-WIRE-12/04/2002-U. Pittsburgh: U. Pittsburgh researchers find link between gene, depression 2002 The Pitt News Via U-WIRE U-WIRE via NewsEdge Corporation : U-WIRE-(C)2002 U-Wire - http://www.uwire.com U-WIRE-12/04/2002-U. Pittsburgh: U. Pittsburgh researchers find link between gene, depression (C) 2002 The Pitt News Via U-WIRE By Michelle Scott, The Pitt News (U. Pittsburgh) PITTSBURGH -- According to Dr. George Zubenko, major depression will affect 5 to 15 percent of Americans and is a leading cause of disabling disorders worldwide. Moreover, 10 to 15 percent of those hospitalized for major depression commit suicide. Though doctors have developed some treatments for this disorder, the recent discovery of a gene that may influence major depression may help produce even more effective diagnosis methods and treatments, particularly for women, who are twice as likely to suffer from depression as men. Researchers at the Molecular Neurobiology and Genetics Lab at the University of Pittsburgh Medical Center have uncovered a great deal of evidence linking the susceptibility gene known as CREB1, to unipolar mood disorders in women. This 15-year-long study, led by Zubenko, professor of psychiatry at Pitt's medical school, and an adjunct professor of biological sciences at Carnegie Mellon University, was sponsored by the National Institute of Mental Health. The team's study suggests that CREB1 contributes to the high risk of women in families that exhibit recurrent, early onset major depression disorder. Men with the same genetic background do not have an elevated risk for such disorders. In order to isolate the basis for major depression, the research team used multiple approaches, including varied methods of psychiatric analysis and classification for 400 participants from 81 families affected by recurrent, early onset depression disorder. The team also studied the phenotypes, or genetic makeups, for the 400 study participants with the help of the Center for Inherited Disease Research. The team's examinations encompassed 19 regions of the genome that are related to major depression and turned up significant results on a narrow region of eight genes on chromosome 2, where the gene CREB1 is located. Examinations of the brains of those who died with major depression disorder, those of animals who experienced animal models of major depression and those treated with anti-depressants all revealed alterations in CREB 1 behavior. According to Zubenko, CREB1 acts as a regulatory gene that influences what other genes in the brain do and how they behave through their effects on DNA transcription. "It helps to modulate the brain's reward systems, which influence people's enjoyment of certain activities," he said. "It also can cause abnormalities in neuronal plasticity, which effects cognition, emotional responses, sensory experiences, and long-term memory, which are common symptoms of those suffering major depression disorder, or may cause the onset or recurrence of the disease." The CREB1 gene may also help explain the high depression rate for females, since it only affects women. Zubenko and his team published a study in March, which revealed that of the 19 regions linked to recurrent early onset depression disorder, 16 were specific to either men or women only. He explained CREB1's sex specificity by saying that sex in human beings is primarily hormone-based, and CREB1 has an influence on estrogen receptors. "Studies such as this one are providing us with a better understanding of the biology of complicated disorders such as major depression, which is unlikely to represent a single disease with a unitary cause," Zubenko said. "Instead, clinical depression is probably more like anemia. Both of these disorders are defined by a collection of clinical features that result from different causes in different people." The team's study also revealed a trend of accelerated mortality rate among family members of those affected by recurrent early onset depression disorder, though these individuals were affected by the same disorders that cause death in most Americans, like heart disease and cancer. "[The depression-related genes] probably don't just put the brain at risk. They probably affect other organ systems as well as the brain," Zubenko said. ##30## ((Distributed via M2 Communications Ltd - http://www.m2.com )) <> << Copyright ©2002 M2 Communications Ltd >>

05 Декабрь,2002 | The Herald (United Kingdom)/ A new cross to bear;The new wonder drug to combat depression wa s lauded as a breakthrough. But one woman's painful s...

AYOUNG woman suffering from depression is prescribed the latest wonder drug: it comes from a new generation of so-called non-addictive medicines, supposedly a world away from the Valium-based tablets that a previous generation of women battled to give up. Europe Intelligence Wire via NewsEdge Corporation : AYOUNG woman suffering from depression is prescribed the latest wonder drug: it comes from a new generation of so-called non-addictive medicines, supposedly a world away from the Valium-based tablets that a previous generation of women battled to give up. But, years later, Fiona Reid finds herself struggling along the same road as countless numbers before her - that of fighting addiction to a prescription drug. The drug is Seroxat. It is one of a group called Selective Serotonin Reuptake Inhibitors, or SSRIs. It has replaced Prozac, which replaced Valium as the GPs' answer to depression, anxiety, and panic attacks. But, like them, Seroxat now appears to have serious drawbacks. Originally described by its makers, GlaxoSmithkline, as non-addictive, it has caused such severe withdrawal symptoms that 4000 people in Britain are pursuing a lawsuit. Reid, from Edinburgh, is one of them, prompted into action because, at 23, she is angry about the effect it has had on her young life. She is determined that other people will not take the drug without knowing more about its likely effects. ''They are saying it is non-addictive, but GlaxoSmithKline uses a medical definition of addiction, which says that it is addictive if you need an ever-increasing dose to gain the same effect, but a layperson assumes that non-addictive means you can stop without withdrawal symptoms,'' she says. As a first-year student at Edinburgh University, Reid went to the doctor because she was depressed. Five years later, and with the benefit of hindsight, she says that although she was depressed at the time, she doesn't think she was suffering from depression. It's a significant difference because there were good reasons for her to be depressed. Not only was she adjusting to university life and under some financial pressure, but her mother had MS, her grandparents had moved into the family home, and her brother, with whom she was sharing a flat, had developed schizophrenia. She was prescribed Seroxat and told she would need to stay on it for six months. It solved her immediate problems, and she found it easy to come off. So when, a year later, she experienced depression again, she went back on Seroxat without any serious qualms. By that time, her state of health had become more complicated. She had developed ovarian cysts and a damaged liver. Concerned that these could be the side- effects of Seroxat, she decided to reduce the dose. Immediately she suffered diarrhoea, sickness, and abdominal spasms, which became so bad that she was hospitalised. She was diagnosed with irritable bowel syndrome and referred to a consultant. He was pleased that she was already taking Seroxat, since anti-depressants are recommended for people with IBS for their anti-spasmodic effect. ''He told me to stay on it. I trusted the doctors and none ever raised Seroxat as the possible cause of the problem,'' she says. Her stomach problems continued and she turned to alternative therapies. That brought a diagnosis of candida - an overgrowth of yeast in the bowel. Treatment consisted of a strict diet, plus supplements, and eventually she felt well for the first time in years. She then learned that candida could cause depression and decided to come off Seroxat. Her GP told her to cut down by moving from a daily dose, to every second day, then every third day. She got as far as every fourth day before succumbing to a succession of tonsilitis, flu, and what she thought was food poisoning. After five days her temperature ''went through the roof'', she was in severe abdominal pain, being constantly sick, and suffering severe mood swings. She asked her GP if this could be related to cutting down the Seroxat and was categorically told no. However, she was switched to the liquid form of the drug because it is easier to take small doses and therefore cut down. ''The problem with the liquid was that it made me throw up, even though I took it with food.'' When Reid talks of ''throwing up'' she means running in and out of the bathroom for a couple of hours every morning. It is so bad that she has had to reduce her working hours to start at 10.30am instead of 8.30am. She works in a call centre dealing with pensions and disappears to the toilet between calls. Undeterred, her priority is now getting back to work full-time and so she is starting a new course of Seroxat - at 10mg, half her previous daily dose - and is preparing for a long, slow reduction to a Seroxat-free future. ''I just want my life back. I am young, I should be able to work and be able to go out and see friends, or go to the cinema. I should be able to plan for the future. What I have learned about Seroxat and the other SSRIs has convinced me that it has caused most of my problems,'' she says. She has two friends who have also suffered severe problems. One took 18 months to come off Seroxat, while the other experienced electric-shock-type blinding flashes. Mark Harvey of Hugh James, solicitors in Cardiff, is preparing a class action on behalf of 4000 potential claimants in the UK and Jersey, and expects to submit a letter of claim early next year. He says: ''There are a few cases involving relatives of people who have committed suicide, or committed violent acts against their families, but the vast majority tell remarkably similar stories of being unable to come off the drug without their lives being made a misery.'' The evidence is building. In 1999 the World Health Organisation placed Seroxat at the top of a list of drugs which doctors believe cause marked withdrawal problems. In January this year, GlaxoSmithKline was required by the Food and Drug Administration, which licenses medicines in the United States, to attach a new warning to Seroxat. It says that patients must be monitored for the side-effects of physical dependency and that the dose should be gradually reduced. Recent US trials for new uses of Seroxat found that even with gradual reduction, at least two in every 100 people suffered abnormal dreams or pains resembling electric shocks, and seven in every 100 experienced dizziness. In December 2001, two months after the September 11 disaster, Seroxat, known as Paxil in the US, was approved for treating post- traumatic stress disorder, and was widely prescribed to New Yorkers. The lessons of Valium may be as pertinent to the legal as to the medical profession, however. Attempts to take legal action against the makers of the benzodiazapines, which were also said not to be addictive, collapsed because the legal aid was used up in the investigations of the cases demanded by the companies before the action reached court <> << Copyright ©2002 Financial Times Limited, All Rights Reserved >>

04 Декабрь,2002 | The Guardian/ One big step/ Improved treatment for schizophrenia

Thousands of people with schizophrenia will receive psychological treatments, including behavioural and family therapy, under a move that promises to give them more control over their care. Europe Intelligence Wire via NewsEdge Corporation : Thousands of people with schizophrenia will receive psychological treatments, including behavioural and family therapy, under a move that promises to give them more control over their care. The national institute for clinical excellence (Nice), which judges the effectiveness of health treatments, today recommends that mental health service users diagnosed with schizophrenia should be provided with a wider range of therapy and medication on the NHS. The clinical guidelines, the first to be issued by Nice on the appropriate care and treatment of people with specific conditions, call for cognitive behavioural therapy (CBT) to be made available to everyone with schizophrenia in England and Wales. There are currently long waiting lists for CBT, which enables people to understand and challenge their beliefs. Paul Farmer, director of public affairs at the charity Rethink, formerly the National Schizophrenia Fellowship, says: "This is the first big step on a long road to providing first-class mental health treatment for all." Nice's guidelines also include providing assertive outreach to homeless people with schizophrenia, and family support for service users' relatives. Service users should be able to set out what treatment they want if they become acutely ill; while GPs should provide them with regular physical check-ups, because their wider health needs are often ignored. The guidelines come a day after a Rethink survey suggested that - despite Nice guidance issued in June - thousands of people were still being denied modern psychiatric drugs, with one in five primary care trusts yet to provide six new drugs on the NHS, largely because of financial pressures. Guidelines are at www.nice.org .uk * Treat yourself, p88 <> << Copyright ©2002 Financial Times Limited, All Rights Reserved >>

04 Декабрь,2002 | Newsletter/ Health Watch/ Schizophrenics denied modern drugs

Thousands of people with schizophrenia are being denied the choice of modern drugs, despite guidance from the medicines watchdog to end rationing, it has been claimed. Europe Intelligence Wire via NewsEdge Corporation : Thousands of people with schizophrenia are being denied the choice of modern drugs, despite guidance from the medicines watchdog to end rationing, it has been claimed. In June this year the National Institute for Clinical Excellence (Nice) recommended that people newly diagnosed with schizophrenia should be offered 'atypical' anti-psychotic drugs. It also said those who had treatment-resistant schizophrenia should be given the specialist medicine clozapine at the earliest opportunity. In all cases, Nice said the choice of medicine should be made jointly by the individual and clinician. The medicines watchdog gave health organisations three months in which to comply with this guidance. However a survey released by the charity 'Rethink Severe Mental Illness' suggested many people are still being denied the choice of the new types of medicines. On present trends it warned that it will be October 2005 before the Nice decision is fully implemented. The survey found 97 per cent of Primary Care Trusts who took part in the poll knew of the Nice ruling, but just 80 per cent had implemented it, and 78 per cent said they were experiencing financial pressure from the decision. Some 55 per cent of PCTs surveyed said they had increased choice and 47 per cent of service users and carers said they now felt more involved. Paul Farmer, director of public affairs for Rethink, said: "People with severe mental illness are still being treated like second class citizens despite the Nice ruling that was supposed to ensure they were no longer forced to take cheap, unsuitable medicines. "But Nice is being flouted by cash-strapped health bodies. Even those that are complying report serious financial pressures, threatening unnecessary cuts in services elsewhere to pay for implementation.'' He said Nice should carry out a full compliance audit of prescribers and the Government should pledge the money for full implementation without delay. "Mental health has been the Cinderella service of the NHS for too long,'' he said. "Second class citizenship for people with severe mental illness is no longer an option.'' Rethink is the operating name of the National Schizophrenic Fellowship. The findings of the survey were presented during the charity's conference at Congress House in Great Russell Street, London. A Department of Health spokeswoman said there was already a legal requirement that the NHS had three months, from when guidance was published, to provide funding so clinical decisions can made by doctors involving Nice recommended treatments or drugs. "It is also part of the Commission for Health Improvement's responsibility to look at the implementation of Nice guidance,'' the spokeswoman said. "The whole purpose of Nice is to end the postcode lottery of NHS prescribing and make sure NHS patients get access the most effective drugs and treatments, wherever they happen to live.'' <> << Copyright ©2002 Financial Times Limited, All Rights Reserved >>

02 Декабрь,2002 | Abortion pill relieves psychotic depression

Vithal C Nadkarni 12/01/2002 : According to some feminists, if it weren't for the anti-abortion groups, the drug mifepristone, commonly known as RU486, would be a candidate for the Nobel Prize. The Economic Times via NewsEdge Corporation : Vithal C Nadkarni 12/01/2002 : According to some feminists, if it weren't for the anti-abortion groups, the drug mifepristone, commonly known as RU486, would be a candidate for the Nobel Prize. The story of Viagra for men, on the other hand, is strikingly different. The three scientists whose work led to the use of the wildly popular anti-impotence drug have already won the Nobel Prize. However, not all is lost. Research with mifepristone in recent years has uncovered a plethora of possible health-care benefits-- some for diseases that no other drug can treat. So, Dr Etienne- Emile Baulieu, the French scientist who invented RU486, could possibly end up having the last laugh at his opponents. The abortion pill may have use as an anti-depressant, small-scale study recently carried out by him along with a team from Stanford University in California has shown. Moreover, the US Food & Drug Administration is fasttracking approval for the pill's new avatar, a first for a psychiatric drug in America, after a study in the 'Journal of Biological Psychiatry' concluded that RU486 brought remarkably fast relief to people suffering from acute psychotic depression. Psychotic symptoms affect about 15 per cent of patients suffering from major depression who experience paranoid delusions and hallucinations, such as guilt for imaginary crimes, along with the usual features of depression such as hopelessness and a crippling sense of anxiety. Anti-depressant drugs alone are usually ineffective. Combining anti-depressants with anti- psychotics improves symptoms for only about 60 per cent of patients, according to Stanford researchers. The good news is that electro-convulsive or shock therapy works in roughly 80 per cent of the patients who try it. However, many decline the treatment because of its widespread stigma. In addition, researchers say patients undergoing shock therapy or drug combinations may not see results for weeks or even months after starting treatment. Because of the high risk of suicide involved these cases, experts have long been rooting for quicker-acting alternatives. Against this backdrop, Dr Baulieu told the news agency Agence France Presse that RU486 can save lives. "A week's treatment with the drug helps the patient to overcome the danger and return to normal medication," he added. In a phase-II multi-centric study conducted by Dr Baulieu and his American colleagues, 30 patients received a low, medium or high dose of mifepristone each day for a week, in addition to their standard medicines. More than two-thirds of patients in the medium- and high-dose groups showed significant reductions in psychotic symptoms within seven days, according to the researchers. During the week, more than 40 per cent of the patients in these groups saw their symptoms of their depression reduced by half or better, based on standard clinical measures of the disease. The social implications of the treatment are profound, according to Dr Alan Schatzberg, chairman of Stanford's psychology department, both because mifepristone might eliminate the need for shock treatments and because it comes from a drug with other uses that some people don't like. RU486 was originally developed as a steroid treatment for Cushing's disease, to block the hormone cortisol secreted by the adrenal glands. However, since cortisol receptors and progesterone receptors are structurally related, scientists found that at lower doses, the drug also blocks progesterone, which is required for implanting a fertilised egg in the lining of the uterus. This made it useful as an abortifacient and, in even smaller doses, as an emergency contraceptive. Cortisol, on the other hand, plays a critical role in the body's response to stress. Research in last two decades has revealed that cortisol is extremely elevated in psychotically depressed patients. In these patients, the natural feedback loop involving the stress hormone is thought to be awry, with sustained levels of the chemical leading to symptoms such as hallucinations, sleep disturbances and memory problems. Meanwhile, doctors and researchers have been heartened by other potential uses of mifepristone that have emerged in recent years. These include treatments for uterine fibroids and several types of cancer and even ailments such as Alzheimer's and AIDS. Says Dr Beth Jordon, medical director of the US-based Feminist Majority Foundation, "It's high time that the life-saving potential of mifepristone was released from the shackles of anti-abortion politics", even as the so-called anti-choice organisations continue to mount fresh assaults against the abortion pill. Copyright 2002. All Rights Reserved. Financial Times Information Limited - Asia Africa Intelligence Wire <> << Copyright ©2002 Financial Times Limited, All Rights Reserved >>

02 Декабрь,2002 | Drug Trends - Analysis/ Company hopes to find growth in depression market with duloxetine

Decision Resources, Inc., forecasts that Eli Lilly's new serotonin norepinephrine reuptake inhibitor , duloxetine, will be the most promising drug to be launched between 2001-201. Drug Week via NewsEdge Corporation : Decision Resources, Inc., forecasts that Eli Lilly's new serotonin norepinephrine reuptake inhibitor (SNRI), duloxetine, will be the most promising drug to be launched between 2001-201. Duloxetine posses a mechanism of action similar to that of venlafaxine, a popular SNRI already on the market. "Although both Wyeth's venlafaxine and Lilly's duloxetine will share approximately 20% of the depression market in 2011, duloxetine will be favored over venlafaxine because it is not as likely as venlafaxine to cause high blood pressure," said Anathea Waitekus, analyst at Decision Resources. She concluded: "Duloxetine's favorable safety profile will be especially appealing to general practitioners and primary care physicians, who treat the majority of depression sufferers worldwide." This article was prepared by Drug Week editors from staff and other reports. <> << Copyright ©2002 NewsRx.com >>

02 Декабрь,2002 | Eli Lilly/ New ADHD Medication Strattera Effective in Girls...

Business Editors, Health & Medical Writers INDIANAPOLIS----Dec. 2, 2002--Strattera is effective in treating Attention-Deficit/Hyperactivity Disorder in school-age girls, according to a study published in the December online issue of the journal Pediatrics . Business Wire via NewsEdge Corporation : Business Editors, Health & Medical Writers INDIANAPOLIS--(BUSINESS WIRE)--Dec. 2, 2002--Strattera(tm) (atomoxetine HCl) is effective in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in school-age girls, according to a study published in the December online issue of the journal Pediatrics (Volume 110, Number 6). This study seeks to augment the limited amount of data available on the efficacy of pharmacologic treatments in girls specifically. "This is one of the largest studies of treatment effects of medication in this (school-age girls) population," said John Heiligenstein, M.D., Medical Advisor, Eli Lilly and Company, a study co- author. "The study confirms the efficacy of Strattera in treating ADHD in boys and girls." The lack of information regarding ADHD treatment in girls is likely because many more boys than girls are referred for treatment. Boys have greater rates of more noticeable disruptive behaviors that affect others, often as a result of comorbid oppositional defiant disorder and conduct disorder, which are less common in girls.(1) Core ADHD symptoms seen in girls are similar to those seen in boys.(2) ADHD affects 3-7 percent of school age children(3) and manifests itself in levels of attention, concentration, activity, distractibility, and impulsivity that are inappropriate to the child's age.(4) Experts estimate 60 percent of children with the disorder carry their symptoms into adulthood.(5) The Pediatrics study was a subset analysis of 51 girls (Strattera n=30, placebo n=21) that found Strattera efficacy superior to placebo on all parent and investigator rating scales. The data come from two identical, double-blind, placebo-controlled 9-week clinical trials of 291 children conducted in the United States. Results Patients treated with Strattera experienced a decrease in their ADHD RS Total Score that was statistically significant compared to placebo (15.8 vs 5.8, respectively). Strattera- and placebo- treated patients' ratings on the Inattentive subscale (-8.8 and -3.4, respectively) and Hyperactive/ Inattentive subscale (-7.0 and -2.3, respectively) showed a significant drug effect as well. CPRS-R and CGI-ADHD-S scores also showed significant improvement for Strattera patients. According to the authors, Strattera significantly decreased ADHD signs and symptoms in girls with ADHD. The data reported from this subset analysis addresses an important void in what is known about treatment of school-age girls with ADHD. The study found that Strattera was generally safe and well-tolerated in school-age girls. The most commonly-reported side effects of patients taking Strattera were abdominal pain, rhinitis and headache. Only one patient each from the Strattera and placebo groups discontinued due to an adverse event (chest pain and somnolence, respectively). Study Design The study included 291 children and adolescents, ages 7-13, who met criteria for ADHD as spelled out in the Diagnostic and Statistical Manual for Mental Disorders, 4th edition (DSM-IV). The DSM-IV includes 18 core symptoms of ADHD - nine related to inattention and nine related to hyperactivity and impulsivity. All diagnoses were confirmed through clinical interviews. Exclusion criteria included poor metabolism of the cytochrome P450 2D6 isoenzyme; weight less than 25 kg at the initial visit; a documented history of bipolar I or II disorder or history of psychosis; history of an organic brain disease or a seizure disorder; currently taking psychotropic medication; history of alcohol or drug abuse within the past 3 months; positive screening for drugs of abuse; or significant previous or current medical conditions (e.g., human immunodeficiency virus positive, surgically corrected congenital heart defects, leukemia in remission). After a two-week medication washout period, patients were divided into two groups based on their previous exposure to psychostimulants. Patients never treated with psychostimulants were randomized to double-blind treatment with Strattera, placebo or methylphenidate, while patients with a history of psychostimulant use were randomized to double-blind treatment with Strattera or placebo. The methylphenidate arm of the study was included to validate the study design. The Strattera dose was titrated based on clinical response to a maximum daily dose of 2.0 mg/kg/day. The ADHD Rating Scale-IV-Parent Version: Investigator Administered (ADHD RS), an 18-item scale based on an interview with the patient's primary caretaker was the primary measure of symptom response. Each item on the ADHD RS corresponds to one of the 18 DSM-IV criteria. The ADHD Index subscale of the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R) and the Clinical Global Impressions of Severity of ADHD (CGI-ADHD-S) scales were also used. A limitation of this data is the lack of teacher-rated efficacy measurements. Strattera Strattera is a selective norepinephrine reuptake inhibitor marketed by Eli Lilly and Company (NYSE:LLY) for treatment of ADHD in children, adolescents and adults. Strattera is the only noncontrolled medication approved for the treatment of ADHD. The precise mechanism of action of Strattera is unknown, however, scientists believe it works by selectively blocking the reabsorption of norepinephrine into certain nerve cells in the brain. Norepinephrine is a neurotransmitter, a chemical that moves messages from brain cell to brain cell, and is thought to be important in regulating attention and controlling impulses. Strattera should not be taken at the same time as, or within two weeks of taking, a monoamine oxidase inhibitor, or by patients with narrow angle glaucoma. Patients with a history of high or low blood pressure, increased heart rate, or any heart or blood vessel disease should tell their doctor before taking Strattera. Strattera has not been tested in children less than 6 years of age. Some children may lose weight when starting treatment with Strattera. As with all ADHD medications, growth should be monitored during treatment. Most people in clinical studies who experienced side effects were not bothered enough to stop using Strattera. The most common side effects in children and adolescents were decreased appetite, nausea, vomiting, tiredness and upset stomach. In adults, the most common side effects were problems sleeping, dry mouth, decreased appetite, upset stomach, nausea or vomiting, dizziness, problems urinating, and sexual side effects. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. (1) Biederman J, Newcorn J, Sprich S. Comorbidity of attention deficit hyperactivity disorder with conduct, depressive, anxiety, and other disorders. Am J Psychiatry. 1991:148:564-577 (2) Biederman J, Faraone SV, Mick E, et al. Clinical correlates of ADHD in females: findings from a large group of girls ascertained from pediatric and psychiatric referral sources. J Am Acad Child Adolesc Psychiatry. 1999;38:966-975 (3) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Washington, DC, American Psychiatric Association, 2000 (4) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Washington, DC, American Psychiatric Association, 1994. (5) American Psychiatric Association: DSM-IV-TR.2000.85-93 Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3):757-777 --30--slb/cl* CONTACT: Eli Lilly and Company David Shaffer, 317/651-3710 KEYWORD: INDIANA INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL SOURCE: Eli Lilly and Company Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com BWviaNewsEdge <> << Copyright ©2002 Business Wire >>








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