BY OUR PHARMA CORRESPONDENT
18th August,2005: In an effort to regain public trust for its antidepressant drug, Effexor (venlafaxine HCl), Wyeth is planning to launch a telephone support programme for patients taking the medication in the US.
TheDialogues: Time to Talk programme, which includes optional telephone support, is designed to increase patient understanding of their therapy and of depression. The programme also helps patients and physicians better track progress toward achieving the goal of remission, which is the virtual elimination of depression symptoms.
The US drug manufacturer will provide a service in which nurses call Effexor patients to invite them to join the scheme, which attempts to help patients through the challenges of depression. It will include resources for tracking progress in combating depression and also educational programmes for improved psychological wellbeing.
Depression is a serious, chronic medical condition that is not only debilitating but is also associated, in some cases, with mortality. With the advent of modern antidepressants, drug therapy has brought many benefits as well as clinical challenges. In fact, during the past year, the Food and Drug Administration (FDA) has strengthened antidepressant drug labeling for both pediatric and adult patients and recommended that patients be “observed closely” during the critical first few months of therapy. The FDA-approved drug labels also state that, “additional contact by telephone may be appropriate between face-to-face visits.”
The enrollment-based programme helps supplement this interaction by providing resources that can be used to facilitate discussions between patients and physicians. It offers education, motivational and supportive messages, reinforcement of positive patient behaviors and optional telephone support from health care professionals. Patients who enroll receive a packet of information that helps them make a commitment to getting all they can out of their Effexor XR therapy.
“Depression is a serious illness affecting 19 million adults in the US,” said Dr. Norman Sussman, a psychiatrist at New York University. “Of those who are treated, many discontinue antidepressant therapy. This is alarming for several reasons. First, sudden discontinuation of therapy can bring on symptoms that can exacerbate depression. Second, antidepressant therapy, when combined with sustained and appropriate patient follow-up, can be more effective than drug therapy alone. In many cases, the addition of patient education and support may be important contributors to achieving remission.”
Achieving remission, which is a virtual elimination of depression symptoms, is important to long-term clinical outcomes in patients with depression. In fact, according to some research, failure to achieve remission is associated with an approximate tripling of the risk of relapse, which can make achieving remission even more difficult. Furthermore, those who discontinue antidepressant therapy are more likely to experience relapse, which can continue the cycle of depression and make patients less likely to seek treatment a second time.
Treatment for patients with depression can include a combination of antidepressant medication, talk therapy, education and/or telephone contact by medical professionals. In fact, for primary care patients who are beginning antidepressant treatment, enhanced patient support can optimize antidepressant therapy outcomes, according to a report published in the August 2004 issue of the Journal of the American Medical Association (JAMA).
“These findings suggest a new public health model of psychotherapy for depression including active outreach and rigorous efforts to improve access to and motivation for treatment,” the JAMA article notes.
This suggests that patient education and support could become routine in the care of many patients with depression. Wyeth’s Dialogues: Time to Talk program provides patients with support to help deal with the challenges of therapy and manage expectations. Patients have the option to enroll in telephone support services that can be accessed through a series of three calls from nurses or unlimited calls into a Dialogues: Time to Talk helpline.
Patients are asked assessment questions by phone and can enter responses via the touch pad. Within 48 hours, the responses are sent to the patient’s primary physician regarding the patient’s mood, sleep levels, energy, appetite, concentration, social functioning, self-harm and medication adherence.
Over the course of several months, patients who enroll receive education materials that have been developed in consultation with physicians and patients to address common therapeutic needs of patients taking Effexor XR.
Patients enroll via telephone or Internet and receive a Welcome Kit containing a Dialogues: Time to Talk membership card and health-related reminder items. Also included are a Dialogues: Time to Talk magazine that discusses treatment-related issues, brochures that answer questions about depression and possible side effects of their medication, and a helpful checklist of key points to cover at the patient’s next meeting with the physician.
The ongoing support and reinforcement includes a Dialogues: Time to Talk magazine series discussing ways for patients to track their own progress, set goals and balance work and family. A Resource Guide is included that gives patients information on general health and wellbeing as well as information on mental health organizations. “Straight Talk” brochures that deal with progress, managing stress and long-term therapy are also included in the programme, a company release said.
“Research has shown that many people with depression can respond to medication, talk therapy or a combination of both. But some of the hallmark symptoms of the disease, such as pessimism and fatigue, can keep patients from getting the help that they need. Because the benefits of treatment often don’t appear for several weeks, patients who are on antidepressant therapy may believe that the medication is not working. This can cause them to slip back into the crippling cycle of depression,” said Dr. Sussman.
Effexor/Effoxor XR is not indicated for use in pediatric populations and, as such, the Dialogues: Time to Talk program will not be made available to patients under the age of 18.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR (venlafaxine HCl) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor XR is not approved for use in pediatric patients.
Effexor XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms. Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Regular BP monitoring is recommended. Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. The most common adverse events reported in Effexor XR short-term placebo-controlled depression, generalized anxiety disorder (GAD), and/or social anxiety disorder trials (incidence >10 % and > 2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
BY OUR PHARMA CORRESPONDENT