Bupropion Sustained Release Versus Paroxetine for the Treatment of Depression in the Elderly
Department of Psychiatry, George Washington University, Washington, DC 20037, USA. The Journal of Clinical Psychiatry
(Impact Factor: 5.5).
04/2000; 61(3):196-202. DOI: 10.4088/JCP.v61n0309
Depression is a serious and widespread emotional disorder among the elderly. This study compared the efficacy and safety of bupropion sustained release (SR) with the selective serotonin reuptake inhibitor paroxetine in the treatment of major depression in elderly outpatients.
Elderly (> or = 60 years) outpatients with major depressive disorder (DSM-IV criteria) were evaluated in this 6-week multicenter, randomized, double-blind study comparing bupropion SR, 100-300 mg/day, and paroxetine, 10-40 mg/day. Efficacy was assessed by changes in scores on the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and the Clinical Global Impressions-Severity of Illness and -Improvement scales. Safety was assessed by monitoring adverse events, vital signs, and body weight.
A total of 100 patients ranging in age from 60 to 88 years were randomly assigned to treatment with bupropion SR (N = 48) or paroxetine (N = 52). Measurements of efficacy were similar between the 2 treatment groups, with both groups showing improved scores on all depression rating scales. Headache, insomnia, dry mouth, agitation, dizziness, and nausea occurred in > 10% of patients in both groups; somnolence, diarrhea, constipation, and anorexia occurred in > 10% of patients in the paroxetine group. No statistically significant differences between groups in vital signs or weight were found.
Both bupropion SR and paroxetine were safe and effective for the treatment of depression in the elderly. Because of its favorable side effect profile, bupropion SR may provide a safe and effective nonserotonergic treatment alternative that is well suited as an antidepressant for the elderly.
Available from: Bernd Mühlbauer
- "Finally, three trials were identified as suitable for EVITA evaluation. In a six-week study of 100 depressed patients , bupropion did not show superiority with respect to the Hamilton-scale (HAMD-17) over paroxetin, an antidepressant acceptable as established therapy. In two three-arm studies, only available online in the GSK Clinical Trial Register [25,26], bupropion was compared to placebo and venlafaxin using the "Montgomery-Asberg Depression Rating Scale"(MADRS) measuring changes after 8 or 10 weeks. "
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ABSTRACT: New drugs are generally claimed to represent a therapeutic innovation. However, scientific evidence of a substantial clinical advantage is often lacking. This may be the result of using inadequate control groups or surrogate outcomes only in the clinical trials. In view of this, EVITA was developed as a user-friendly transparent tool for the early evaluation of the additional therapeutic value of a new drug.
EVITA does not evaluate a new compound per se but in an approved indication in comparison with existing therapeutic strategies. Placebo as a comparator is accepted only in the absence of an established therapy or if employed in an add-on strategy on top. The evaluation attributes rating points to the drug in question, taking into consideration both therapeutic benefit and risk profile. The compound scores positive points for superiority in efficiency and/or adverse effects as demonstrated in randomized controlled trials (RCTs), whilst negative points are awarded for inferiority and/or an unfavorable risk profile. The evaluation follows an algorithm considering the clinical relevance of the outcomes, the strength of the therapeutic effect and the number of RCTs performed. Categories for therapeutic aim and disease severity, although essential parts of the EVITA assessment, are attributed but do not influence the EVITA score which is presented as a color-coded bar graph. In case the available data were unsuitable for an EVITA calculation, a traffic-type yield sign is assigned instead to criticize such practice. The results are presented online http://www.evita-report.de together with all RCTs considered as well as the reasons for excluding a given RCT from the evaluation. This allows for immediate revision in response to justified criticism and simplifies the inclusion of new data.
As examples, four compounds which received approval within the last years were evaluated for one of their clinical indications: lenalidomide, pioglitazone, bupropion and zoledronic acid. Only the first achieved an EVITA score above zero indicating therapeutic advantage.
The strength of EVITA appears to lie in its speedy assessment of the potential therapeutic advantage of a new drug for a given indication. At the same time, this approach draws attention to the typical deficits of data used for drug approval. EVITA is not intended to replace classical health technology assessment reports but rather serves as a screening tool in the sense of horizon scanning.
Available from: Crispian Scully
- "Drug effects on salivary glands: dry mouth C Scully to smoke, but dry mouth is common (Zwar and Richmond, 2002). A comparison of bupropion sustained release (SR) with the SSRI paroxetine in the treatment of major depression showed headache, insomnia, dry mouth, agitation, dizziness, and nausea in >10% of patients in both groups (Weihs et al, 2000). Dry mouth occurred more frequently with bupropion SR (19%) than with the SSRI sertraline (14%) or placebo (12%), although the differences were not significant (Croft et al, 1999). "
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ABSTRACT: To identify drugs associated with the complaint of dry mouth.
MEDLINE was searched for papers 1980-2002 using keywords, oral, mouth, salivary, drugs, dry mouth and xerostomia, and relevant secondary references were hand-searched.
Evidence was forthcoming for a number of xerogenic drugs, especially antimuscarinic agents, some sympathomimetic agents, and agents affecting serotonin and noradrenaline uptake, as well as a miscellany of other drugs such as appetite suppressants, protease inhibitors and cytokines.
Dry mouth has a variety of possible causes but drugs--especially those with anticholinergic activity against the M3 muscarinic receptor--are the most common cause of reduced salivation.
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ABSTRACT: Many of the patients with depression fail to achieve an adequate response to a given antidepressant. Depression is often overlooked in elderly persons, which may produce a greater risk of suicide in this age group. The antidepressive characteristic of bupropion has been already validated in several studies. However, to the best of our knowledge, there is no research concerning treatment-resistant depressive elderly patients with bupropion.
We present a consecutive series of elderly patients (13 subjects: 6 men and 7 women) with major depression. All patients were older than 60 years, with diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition and were treatment resistant. Patients were treated openly for 6 weeks with bupropion XR (300 mg/d). Efficacy was assessed at baseline and every 3 weeks using the Hamilton Depression Rating Scale, the Montgomery-Asberg Depressive Rating Scale, and the Clinical Global Impression--Severity of Illness Scale.
The treatment was generally well tolerated without serious events. In all patients, the average Hamilton Depression Rating Scale scores diminished from 41.1 to 17.2 at the sixth week (P < 0.0001), the Montgomery-Asberg Depressive Rating Scale scores diminished from 44.0 to 19.9 (P < 0.0001), and Clinical Global Impression-Severity of Illness scores diminished from 5.7 to 3.2 (P < 0.0001). Of the 13 patients, 9 patients had marked and very marked improvement, and 4 patients did not demonstrate any mental state change.
Treatment-resistant depressive elderly patients positively responded to and tolerated bupropion XR well. This case series demonstrates that bupropion could be a promising alternative therapy for elderly patients with treatment-resistant major depressive disorder. Further randomized controlled studies are necessary.
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