News Author: Yael Waknine
CME Author: Yael WaknineComplete author affiliations and disclosures, and other CME information, are available at the end of this activity.Release Date: June 15, 2006; Valid for credit through June 15, 2007
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June 15, 2006 — The US Food and Drug Administration (FDA) has approved a new indication for bupropion HCl extended-release tablets, allowing their use for the prevention of major depressive episodes in patients with a history of seasonal affective disorder; and 5-mg/40-mg and 10-mg/40-mg formulations of amlodipine besylate/benazepril HCl capsules for the treatment of uncontrolled hypertension.
On June 12, the FDA approved a new indication for bupropion HCl extended-release tablets (Wellbutrin XL, made by GlaxoSmithKline), allowing their use for the prevention of major depressive episodes in adult patients with a history of seasonal affective disorder (SAD).According to a company news release, it is the first and only medication to be approved for this disorder, which affects approximately 6% of US adults.The approval was based on data from 3 placebo-controlled clinical trials in 1042 outpatients who were enrolled in the autumn prior to experiencing symptoms. Two of the studies were conducted during the 2002-2003 autumn-winter seasons and the third trial during the 2003-2004 season.Data from a Seasonal Pattern Assessment Questionnaire administered at baseline showed that although patients had experienced an average of 13 previous seasonal major depressive episodes, only 41% reported having received prior treatment for their chronic condition.Of these, 23% had received light therapy, and 76% had been given antidepressants. More than 50% of patients reported that their seasonal symptoms constituted a marked or severe problem, and 61% reported weight changes of 8 lbs or more that occurred primarily during autumn and winter months.For the study, patients were randomized to receive placebo or extended-release bupropion at a dose of 150 mg/day for the first week followed by uptitration to 300 mg/day as tolerated. Therapy was discontinued following a 2-week taper that began during early spring.Results of the 3 studies showed that the depression-free rate at the end of 4 to 6 months of therapy was higher in patients administered extended-release bupropion compared with placebo (81.4% vs 69.7%, 87.2% vs 78.7%, and 84.0% vs 69.0%, respectively; combined rates, 84.3% vs 72.0%).According to a company news release, the time-to-onset of a seasonal SAD episode also favored the extended-release bupropion group over placebo across the 3 studies, a difference that gained statistical significance during the 2003-2004 trial (P < .001).The tolerability of extended-release bupropion was consistent with that observed in previous trials for major depressive disorder. The most commonly reported adverse events occurring in greater than 5% of patients and at a rate exceeding 1.5 times that for placebo included dry mouth (26% vs 15%), nausea (13% vs 8%), constipation (9% vs 2%), and flatulence (6% vs 3%).The FDA notes that extended-release bupropion is indicated only for patients who meet strict diagnostic criteria for SAD episodes, including a seasonal pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning.Treatment of such individuals should generally be initiated in the autumn prior to the onset of depressive symptoms and continue through the winter season before being tapered and discontinued in early spring. The timing of initiation and duration of therapy should be individualized based on the patient's historical pattern of SAD episodes; those whose depressive episodes are infrequent or not associated with significant impairment are generally not eligible for prophylactic treatment.Therapy should be initiated with a 150-mg dose administered once daily in the morning and uptitrated to 300 mg/day (target dose) after 1 week if tolerated. For patients taking 300-mg/day extended-release bupropion during the autumn-winter season, the dose should be tapered to 150 mg/day for 2 weeks prior to discontinuation. The safety and efficacy of doses greater than 300 mg/day have not been evaluated for use in SAD prophylaxis.Bupropion extended-release tablets were approved previously for the treatment of major depressive disorder.
On April 11, the FDA approved 5-mg/40-mg and 10-mg/40-mg amlodipine besylate/benazepril HCl capsules (Lotrel, made by Novartis Pharmaceuticals Corp) for use in the management of hypertension.The fixed-dose combination capsules were approved previously in 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg, and 10-mg/20-mg strengths.According to a company news release, the higher-strength benazepril capsules are intended to expand dosing flexibility and offer new treatment options for patients who previously received no control and who may benefit from use of the highest available dose of the angiotensin-converting enzyme inhibitor benazepril. The new doses are expected to be available later this month.Amlodipine/benazepril capsules are indicated for use in those whose hypertension is not adequately controlled with either drug alone; they are not intended for first-line use.http://www.fda.gov/cder/whatsnew.htm
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
- Evaluate the efficacy of bupropion extended-release tablets in the treatment of seasonal affective disorder.
- Describe the appropriate use of extended-release bupropion for seasonal affective disorder.
- Identify 2 new fixed-dose combinations for amlodipine/benazepril capsules in the treatment of uncontrolled hypertension.
Pearls for Practice
- The FDA has approved bupropion extended-release tablets for the prevention of seasonal affective disorder in patients with a seasonal pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. Combined results of 3 clinical trials showed that use of the drug was linked to an increased depression-free rate at the end of the winter season relative to placebo (84.3% vs 72.0%). Time to onset of a seasonal affective disorder episode also favored the treatment group over placebo and achieved statistical significance in 1 study.
- Extended-release bupropion therapy for seasonal affective disorder should generally be initiated in the autumn prior to the onset of depressive symptoms with a single dose of 150 mg administered each morning. If tolerated, patients should be uptitrated to the target dose of 300 mg/day after 1 week. Therapy should continue through the winter season before being tapered to 150 mg/day for 2 weeks prior to discontinuation in early spring.
- The FDA has approved 5-mg/40-mg and 10-mg/40-mg dosage strengths of amlodipine/benazepril capsules for the treatment of uncontrolled hypertension. The highest approved dose of the angiotensin-converting enzyme inhibitor benazepril is provided to improve dosing options and flexibility. The combination capsules are not intended for first-line use.
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This article is intended for primary care clinicians, psychiatrists, cardiologists, and other specialists who care for patients with seasonal affective disorder and uncontrolled hypertension.
The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.