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| |  APA MEETING: Early Response To Zoloft Indicative Of Future Success In Panic Disorder Treatment WASHINGTON, DC -- May 18, 1999 -- Results of a retrospective analysis found that a significant majority of patients whose panic disorder symptoms improved after one or two weeks of treatment with 50 mg of Pfizer Inc.’s Zoloft(R) (sertraline HCl) continued to benefit from treatment at the same dose, successfully achieving remission (such as a subsiding of symptoms), after 12 weeks. The results were presented today at the annual meeting of the American Psychiatric Association (APA) This retrospective analysis examined patients who had been suffering from panic disorder for an average of nine years. Seventy-three percent of these patients experienced fewer panic attacks after just two weeks of treatment with 50 mg of Zoloft. "It would be useful in clinical decision making to be able to obtain early indicators that might predict eventual response or nonresponse," said Mark Pollack, M.D., director, anxiety disorders program, Massachusetts General Hospital, Harvard Medical School, and lead author of the poster. "If early signs of response are found to be predictive of eventual full response, this would prove useful in assisting clinicians in determining optimal treatment regimens." There are few studies that examine the relationship between early response to treatment for panic disorder and eventual outcome. For this analysis, the researchers used data from two multi-centre, double-blind, fixed-dose studies of patients taking Zoloft. They examined the data from 67 patients who met criteria for panic disorder with or without agoraphobia who were randomised to take 50 mg of Zoloft. Specifically, they analysed patients' response to treatment, measured by reduction in frequency of panic attacks (greater than or equal to 50 percent and less than 50 percent) at weeks one, two and three and how that was predictive of remission at the end of the study. Endpoint remission was defined as a Clinical Global Improvement -- Severity (CGI-S) score of 1 (not ill) or 2 (mild severity) and no panic attacks. "The data demonstrate that Zoloft can help patients with panic disorder see a rapid improvement in their condition within two weeks of treatment and that this early response is associated with achieving remission with treatment at 12 weeks," Dr. Pollack said. "This is encouraging for patients who have suffered from panic disorder for many years. "With proper treatment, most patients can find relief from their symptoms and lead healthy, productive lives." Overall, of the patients whose condition improved (with at least a 50 percent reduction in panic attacks) within one week of initiating therapy at 50 mg, 79 percent reached remission after 12 weeks while maintaining the same dose. Of the patients whose condition improved after two weeks of initiating therapy, 69 percent reached remission. In addition, the researchers found that when the patients whose panic attacks did not drop by 50 percent within one week received a higher dose, 16 percent achieved remission after 12 weeks. The lack of an initial response after two weeks on 50 mg of Zoloft was strongly associated with failure to achieve remission at that dose after 12 weeks of treatment. Researchers concluded that this lack of a partial panic attack response by the end of two weeks, may suggest that additional intervention could be beneficial, such as increasing the dosage or augmenting therapy with another agent or cognitive behavioural therapy. In this analysis, there were no clinically significant differences in attrition rates or adverse events leading to discontinuation between two groups of patients, one randomised to Zoloft 50 mg and the other to placebo. According to the Diagnostic and Statistical Manual of Mental Disorders(TM) (DSM-IV), panic disorder is characterised by the presence of recurrent panic attacks that are accompanied by the following symptoms for at least one month following the attack: severe anxiety or concern about having another attack, and constant worry about the consequences of an attack; significant change in behaviour due to the attack Panic attacks that are not due to the effects of a substance or a general medical illness and are not better accounted for by another mental disorder. During a panic attack, a patient must experience four out of 13 symptoms, some of which can include sudden onset of heart palpitations, feeling of choking, dizziness, fear of losing control or going crazy and derealisation (feelings of unreality) or depersonalisation (being detached from oneself). Agoraphobia is anxiety about being in places or situations from which escape might be difficult (or embarrassing) or in which help may not be available if the person had panic symptoms. Between two and four million Americans -- or one to two percent of the general population -- may suffer from panic disorder (with or without agoraphobia) within any given year. Women are two to three times more likely than men to be diagnosed with panic disorder. Although age of onset may vary, panic disorder typically develops between late adolescence and the mid-30s, with one peak in late adolescence and a second smaller peak in the mid-30s. Some of the symptoms of panic disorder are similar to those in other medical conditions, such as palpitations, difficulty breathing, chest pain and dizziness, leading patients to believe they are suffering from these other conditions. Before a diagnosis of panic disorder can be made, an appropriate medical evaluation must be performed to rule out any underlying cardiovascular or other illness. This is one reason that as many as half of panic disorder sufferers are undiagnosed, misdiagnosed or untreated. If panic disorder is not properly treated, symptoms may continue for months and sometimes years and may impair a person's physical and emotional well-being, as well as their ability to function at normal activities. Zoloft is member of the class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), which affect the neurotransmitter serotonin, an important chemical messenger in the brain. Zoloft is indicated for the treatment of major depression, obsessive-compulsive disorder (OCD) and panic disorder, with or without agoraphobia. Like all medicines, Zoloft can cause side effects. The most common side effects of Zoloft include nausea, having trouble sleeping, diarrhea, ejaculatory problems (mainly delayed ejaculation) and feeling unusually sleepy. Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI), another class of antidepressants. A patient should never take Zoloft at the same time as an MAOI. A patient must wait at least two weeks before switching from Zoloft to an MAOI or from an MAOI to Zoloft. Related Links: Zoloft, Pfizer Inc.
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