Blog For Free!
Archives
Home
2008 February
2008 January
My Links
Online pharmacy
tBlog
My Profile
Send tMail
My tFriends
My Images
Sponsored
Blog
|
| Depakote(R) ER Approved For Acute Manic Or Mixed Episodes Associated With Bipolar Disorder |
| 02.12.08 (1:55 am) [edit] |
Abbott announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Depakote(R) ER (divalproex sodium extended-release tablets) for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
Depakote ER offers patients the convenience of taking this medication once a day. Compared with Depakote(R) (divalproex sodium delayed-release tablets), Depakote ER taken once a day helps provide more consistent levels of medication in the body.
"Successful treatment for mania depends upon maintaining steady levels of medication in the blood throughout the day," said Charles Bowden, M.D., professor of Psychiatry and Pharmacology, Department of Psychiatry, University of Texas Health Science Center at San Antonio. "Depakote ER produces consistent concentrations of medication throughout a 24-hour period. Depakote has been trusted by psychiatrists for a decade, and this once-a-day formulation is important for patients."
Approximately 2.3 million American adults have bipolar disorder, also known as manic-depressive illness. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. The symptoms of bipolar disorder can be severe. Symptoms of acute mania may include, among others, abnormally elevated mood, irritability, marked increase in energy, grandiose thinking and thought disorders. Mixed mania is a state of mind characterized by symptoms of both mania and depression. Patients may feel agitated, angry, irritable and depressed all at once. Like other serious illnesses, bipolar disorder can have a negative impact on spouses, family members, friends and the workplace. Depakote ER now provides a useful treatment option for the acute manic and mixed episodes of bipolar disorder.
Depakote ER in Acute Mania Associated with Bipolar Disorder The effectiveness of Depakote ER was confirmed in a randomized, double-blind, placebo-controlled parallel group, three-week, multi-center study. The primary efficacy measurement was the Mania Rating Scale (MRS) total score evaluated on Day 21 as mean change from baseline to final evaluation (Day 21). Depakote ER was significantly more effective than placebo in the reduction of the MRS total score (mean change of -11.5 vs. -9.0 with placebo). The approval of Depakote ER for the treatment of acute mania associated with bipolar disorder was based in part on studies establishing the effectiveness of Depakote.
In Depakote ER acute mania trials, adverse events with a frequency of greater than 5 percent and at least twice as frequent as those seen with placebo were dyspepsia (23 percent vs. 11 percent), vomiting (13 percent vs. 5 percent) and abdominal pain (10 percent vs. 5 percent).
"This expansion of the use of Depakote ER is another important step in Abbott's commitment to developing innovative, effective and simpler treatments for neurological and psychological disorders," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "In addition to our focus on bipolar disorder, Abbott scientists are investigating new therapeutic approaches to depression, schizophrenia and cognitive disorders, such as attention-deficit hyperactivity disorder and Alzheimer's disease."
About Depakote(R) ER
Depakote(R) ER is the once-daily formulation of Depakote(R) (divalproex sodium delayed-release tablets), which has been a leading medication for the treatment of mania associated with bipolar disorder since its approval in 1995. Depakote ER is also approved as monotherapy and adjunctive therapy in the treatment of adults and children 10 years of age or older with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote ER is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures. Additionally, Depakote ER is approved for migraine prevention in adults.
Important Product Safety Information for Depakote ER in Acute Mania
Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment.
Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of Depakote should be weighed against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions have been reported after the initiation of valproate therapy. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with Depakote ER or Depakote in clinical studies of acute mania patients were somnolence, dyspepsia, nausea, vomiting, diarrhea, dizziness, pain, abdominal pain, accidental injury, asthenia and pharyngitis.
|
|
|
| |
| Symptoms Disappear With The Right Prevention |
| 02.04.08 (2:21 am) [edit] |
Migraines and chronic headaches are wide-spread phenomena. Twelve percent of the population, three quarters of them women, suffer at least occasionally from migraines and about 5 percent from chronic headaches. New effective methods of treatment were presented at the Congress of the European Neurological Society (ENS) in Rhodos. According to Greek researchers, migraine sufferers can eliminate symptoms altogether if they take higher doses of anti-migraine medicine for a longer period of time than is now customary. Another team of researchers has found that certain psychopharmaceuticals could serve as a new therapy option for persistent chronic headaches.
Twelve percent of the population, three quarters of them women, suffer at least bouts of migraines, that much-feared type of paroxysmal pulsating headache that generally occurs in just one half of the skull and is accompanied by unpleasant symptoms like nausea and vomiting, dizziness or sensitivity to light and sound.
New tools that could relieve these discomforts for millions of people were just presented at the annual Congress of the European Neurology Society (ENS), held this year on the Greek island of Rhodos from June 16 to 20 June.
The new findings are from a group of researchers led by the psychiatrist Dr. Nikolaos Kouroumalos from the Second Department of Neurology of the General Hospital in Chania on the Greek island of Crete: "In treating migraines, optimizing the effect of already available agents is at least as important a task as developing new substances."
Symptoms Eliminated with a Different Rhythm of Preventive Drug Therapy
The experts have in fact achieved a breakthrough in the effectiveness of preventive therapies. The standard procedure today is to give migraine patients preventive drug therapy at a dose that just suffices to protect them from further attacks or at least to stabilize their recovery. To avoid habituation effects and side-effects, this therapy is successively reduced after a time and finally ended (gradual reduction of the dose to zero). Dr. Kouroumalos: "As a result, most patients suffer a recurrence or worsening of migraine attacks after a certain time and the preventive therapy has to be started over from the beginning again. Our idea was to resume the preventive treatment after a break of two months and administer the previous maximum dose. This dose was then reduced after four weeks and, after a total of six weeks, another break in treatment occurred, this time lasting three months, and so forth until we arrived at a six-month cycle that we constantly repeated for a minimum of three years. Thereafter it was eventually continued according to each patient's needs.
The approach was a definite success. By regularly "reviving" the preventive therapy, the researchers fully maintained the desired effect of bringing about an end to migraine attacks or at least to reduce their extent over the 24 to 36 month period of observation.
Psychopharmaceuticals Bring Relief from Chronic Headache Pain
Four to five percent of the population suffers from chronic headaches. This condition is defined as headaches occurring on average on at least 15 days of the previous three months. They have the disadvantage of having widely diverging causes and of thus requiring widely diverging drugs for treatment.
Dr. Kouroumalos and his team administered neuroleptic drugs, i.e. drugs that are actually used for treating psychoses, to patients who had failed to respond to several attempts of conventional preventive therapy. The retrospective study involved the files of 20 patients who had tried traditional therapy with at least three different migraine agents which did not avail. Half of them were then treated with the conventional neuroleptic Perphenazine and the other half with the atypical neuroleptic Olanzapine.
Both substances brought dramatic relief from headache pain, with Olanzapine doing so to an even greater extent than Perphenazine. "However," Dr. Nikolaos Kouroumalos explained, "more patients broke off the treatment with Olanzapine." The atypical antipsychotic causes fewer motor disturbances than its conventional counterpart but is associated with greater weight gains than is the case with conventional neuroleptics. This side-effect is less significant medically but for many patients, it was too high a price to pay for the peace and quiet in their heads.
|
|
|
| |
| Migraines And Visual Symptoms In Women May Signal Increased Risk Of Stroke |
| 01.28.08 (1:57 am) [edit] |
Women who have migraine headaches with visual symptoms (or aura) may be at increased risk for stroke compared to women who do not have migraines, researchers reported in Stroke: Journal of the American Heart Association.
The risk association between stroke and migraines also increases when other factors are added, such as recent onset of these headaches, smoking and oral contraceptive use.
"Women with recent onset of probable migraine with visual symptoms (within the prior year) were almost seven times more likely to have a stroke compared to women with no history of migraine," said Steven Kittner, M.D., M.P.H., senior author of the study and staff physician at Baltimore Veterans Affairs (VA) Medical Center. "Eight percent of stroke cases had onset of probable migraine with visual symptoms in the prior year compared to one percent of controls.
"Second, and probably the most important finding, women who had probable migraine with visual symptoms who also smoked and used oral contraceptives had seven times the risk of stroke than women who had probable migraine with visual symptoms alone."
Migraine and stroke share some common risk factors, including high blood pressure and patent foramen ovale (PFO); both have a hereditary basis. While a baby grows in the womb, he or she has a normal opening between the heart's left and right atria (upper chambers). If this opening doesn't close naturally soon after the birth, the hole is called PFO.
Furthermore, migraine has long been regarded as a risk factor for ischemic stroke (stroke caused by a blot clot blocking blood flow to the brain). Few prior studies have addressed the different potential reasons for an association between migraine and stroke.
Researchers analyzed stroke incidence among 386 women 15-to 49-years-old with a first ischemic stroke and 614 women of similar ages and ethnicities who had not had stroke. Based on their responses to a questionnaire, the women were classified into three categories: having no migraine; probable migraine without visual aura; or probable migraine with visual aura.
Kittner and colleagues also reported that, compared to women with no history of migraine, women with probable migraine with visual symptoms had a 1.5 greater risk of ischemic stroke.
"Young women with probable migraine with visual symptoms can reduce their risk of stroke by stopping smoking and finding alternatives to the use of estrogen-containing contraceptives," said Kittner, who is also professor of neurology at the University of Maryland School of Medicine and director of the Maryland Stroke Center in Baltimore, Md.
As alarming as the findings sound, the chance that a woman in the 15-to-44-age group will have an ischemic stroke is very low -- one-to-two for every 10,000 people each year, Kittner said.
However, neurologists and other doctors should encourage their patients who have migraine with associated visual symptoms to minimize other stroke risk factors, he said.
"More work is also needed regarding whether patent foramen ovale mediates the association between probable migraine with visual symptoms and ischemic stroke," Kittner said. "We did not find evidence that this was the case, but had limited data to address this question.
"Other investigators should confirm our findings of an increased risk of stroke associated with recent onset of probable migraine with visual symptoms."
|
|
|
| |
| Migraines With Aura Associated With Increased Risk For Cardiovascular Disease |
| 01.24.08 (5:38 am) [edit] |
Women age 45 years or older who experience migraines with aura (associated neurologic symptoms such as temporary visual disturbances) are at a higher risk for heart attack, ischemic stroke, angina and death due to ischemic cardiovascular disease compared to women who do not report a migraine history, according to a study in the July 19 issue of JAMA. In contrast, migraine without aura, the most common form of migraine, was not associated with increased risk of any cardiovascular event.
In the United States, the 1-year prevalence of migraine is approximately 18 percent in women and 6 percent in men; an estimated 28 million Americans have severe and disabling migraines, according to background information in the article. Migraine with aura has been previously linked with increased risk of ischemic stroke. Since some studies have suggested that migraine, particularly migraine with aura, is associated with an unfavorable cardiovascular risk profile, an association with other cardiovascular disease (CVD) is plausible but has not been firmly established.
Tobias Kurth, M.D., Sc.D., of Brigham and Women's Hospital and the Harvard School of Public Health, Boston, and colleagues evaluated the association of migraine with or without aura and subsequent risk of overall and specific CVD. The study included 27,840 women, age 45 years or older, who were participating in the Women's Health Study, were free of CVD and angina at study entry (1992-1995), and who had information on self-reported migraine and aura status and lipid measurements.
At baseline, 5,125 women (18.4 percent) reported a history of migraine; of the 3,610 with active migraine (migraine in the prior year), 1,434 (39.7 percent) indicated aura symptoms. During an average of 10 years of follow-up, 580 major CVD events occurred.
The researchers found that any history of migraine was associated with increased risk of major CVD. This increased risk differed according to aura status. Compared with no migraine history, women who reported active migraine with aura had a significantly increased risk of subsequent major cardiovascular events, ischemic stroke, heart attack, coronary revascularization, angina, and death due to ischemic CVD. These increased risks, which remained after adjusting for a large number of cardiovascular risk factors, ranged from a 1.7-fold increase for coronary revascularization to a 2.3-fold increase for ischemic cardiovascular disease death. In contrast, women who reported active migraine without aura did not have significantly increased risk for any ischemic vascular event.
|
|
|
| |
|
|
