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The objective of this study was to assess the efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) 50 and 100 mg/day for major depressive disorder (MDD). A multicenter, randomized, double-blind, placebo-controlled trial was conducted in Europe and South Africa. Outpatients with MDD received fixed-dose desvenlafaxine (50 or 100 mg/day) or placebo for 8 weeks. The primary efficacy variable was the 17-item Hamilton Rating Scale for Depression total score; secondary measures included Clinical Global Impressions-Improvement scores. The intent-to-treat population included 483 patients: desvenlafaxine 50 mg (n=164), desvenlafaxine 100 mg (n=158), and placebo (n=161). At the last-observation-carried-forward analysis (final evaluation) using analysis of covariance, adjusted mean changes from baseline on the Hamilton Rating Scale for Depression were significantly greater for both desvenlafaxine 50 mg (-13.2; P=0.002) and 100 mg (-13.7; P<0.001) versus placebo (-10.7). Significant differences on the Clinical Global Impressions-Improvement scores were observed for desvenlafaxine 50 mg (P=0.002) and 100 mg (P<0.001) versus placebo. Both doses of desvenlafaxine were generally well tolerated. The most common treatment-emergent adverse events were nausea, dizziness, insomnia, constipation, fatigue, anxiety, and decreased appetite. Fixed doses of desvenlafaxine 50 and 100 mg/day are safe, generally well tolerated, and effective at a clinically relevant level for the treatment of MDD.
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PMID:Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial. 1870 33

Palliative care for cancer patients receiving chemotherapy in the outpatient setting is important. The aims of this study were 1) to identify symptom prevalence and intensity in cancer patients receiving chemotherapy and 2) to describe longitudinal follow-up data obtained from repeated assessment using the distress thermometer (DT). Questionnaires were distributed to consecutive cancer outpatients newly starting chemotherapy at the first appointment and at every hospital visit. The questionnaire included the severity of 11 symptoms (M. D. Anderson Symptom Inventory [MDASI], Japanese version), the DT, and the need for help in four psychosocial areas (decision-making, economic problems, nutrition, and daily activities). In total, 4000 questionnaires were returned by 462 patients. The frequently identified problems were oral problems (21%), insomnia (19%), psychological distress (defined as a DT score of 6 or more; 15%), help with information and decision-making (14%), severe fatigue (8.2%), and severe appetite loss (6.3%). Cluster analysis identified four symptom clusters: 1) fatigue and somnolence; 2) pain, dyspnea, and numbness; 3) nausea, appetite loss, and constipation; and 4) psychological distress. Of 165 patients with a DT of score 6 or more, 115 patients (70%) demonstrated a DT score below 6 at a median of 17 days follow-up. In the remaining 50 patients who had a DT score of 6 or more at follow-up, 34 patients (68%) had one or more physical symptoms rated at 7 or more on an 11-point numeric rating scale. Compared with patients with a DT score below 6 at follow-up, patients with a DT score of 6 or more at follow-up had higher levels of all physical symptoms. Frequent symptoms experienced by cancer outpatients receiving chemotherapy may be categorized as: 1) psychosocial issues (insomnia, psychological distress, decision-making support); 2) nutrition-gastrointestinal issues (oral problems, appetite loss, nausea); 3) fatigue; and 4) pain, dyspnea, and numbness. Developing a systematic intervention program targeting these four areas is urgently required. The DT score may be highly influenced by coexisting physical symptoms, and future studies to develop an appropriate system to identify patients with psychiatric comorbidity are necessary.
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PMID:Symptom prevalence and longitudinal follow-up in cancer outpatients receiving chemotherapy. 1880 46

Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation, or serious adverse events were reported by less than 0.2% of patients. No serious or individual events leading to discontinuation occurred in more than 25 patients. There were 15 (0.1%) deaths; 10 were attributed to a cardiovascular cause. Discontinuations for adverse events were lower than anticipated. Serious adverse events generally reflected sibutramine's known pharmacology or were related to cardiac disorders already present in this high-risk population. When compared with epidemiological data, overall mortality rate was low and sibutramine was well tolerated in this mainly off-label population. No new safety issues were detected.
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PMID:Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial. 1903 18

Duloxetine, a medication with effects on both serotonin and noradrenaline transporter molecules, has recently been approved for the treatment of generalized anxiety disorder. The evidence for its efficacy lies in a limited number of double blind, placebo controlled comparisons. Statistically significant improvements in the Hamilton Anxiety Rating Scale from baseline were demonstrated in all studies at doses of 60 to 120 mg per day. The significance of such changes in terms of clinical improvements compared to placebo is less certain, particularly when the effect size of the change is calculated. In comparative trials with venlafaxine, duloxetine was as effective in providing relief of anxiety symptoms. In addition to improvements in clinical symptoms duloxetine has also been associated with restitution of role function as measured by disability scales. Duloxetine use is associated with nausea, dizziness, dry mouth, constipation, insomnia, somnolence, hyperhidrosis, decreased libido and vomiting. These treatment emergent side effects were generally of mild to moderate severity and were tolerated over time. Using a tapered withdrawal schedule over two weeks in the clinical trials, duloxetine was associated with only a mild withdrawal syndrome in up to about 30% of patients compared to about 17% in placebo treated patients. Duloxetine in doses of up to 200 mg twice daily did not prolong the QTc interval in healthy volunteers. Like other agents with dual neurotransmitter actions duloxetine reduces the symptoms of generalized anxiety disorder in short term treatments. Further evidence for its efficacy and safety in long term treatment is required.
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PMID:Duloxetine in the treatment of generalized anxiety disorder. 1933 57

The purpose of this report is to describe the overall safety profile of both short- and longer-term duloxetine treatment of fibromyalgia. Data from four double-blind, randomized, placebo-controlled studies (two with 6-month open-label extension phases) and a 1-year, open-label safety study were included. Safety measures included treatment-emergent adverse events (TEAEs), adverse events leading to discontinuation, serious adverse events (SAEs), clinical laboratory tests, vital signs, and electrocardiograms. The most common TEAEs for short-term treatment with duloxetine were nausea (29.3%), headache (20.0%), dry mouth (18.2%), insomnia (14.5%), fatigue (13.5%), constipation (14.5%), diarrhea (11.6%), and dizziness (11.0%; all p < 0.05 vs. placebo). Most TEAEs emerged early and were mild to moderate in severity. The profile of adverse events in patients enrolled at least 6 months, and for patients in the 1-year study, was similar to that found in the short-term treatment studies, with no new adverse events emerging at a notable rate. About 20% of patients discontinued due to adverse events in the short-term treatment studies and in the 1-year study. SAEs were uncommon, and none occurred at a significantly higher frequency for duloxetine compared with placebo. Mean changes in vital signs and weight were small. Rates of treatment-emergent potentially clinically significant (PCS) vital sign, laboratory, and electrocardiogram measures were low, with only PCS rates of alanine aminotransferase being significantly higher for duloxetine compared with placebo in the placebo-controlled treatment studies. In the 1-year study, four patients (1.1%) had suicide-related behavior. The data provided here summarize short- and long-term safety from five clinical studies in patients treated with duloxetine for fibromyalgia. In addition, postmarketing surveillance continues for adverse events reported with duloxetine in fibromyalgia, as in other indications.
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PMID:Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials. 1953 10

One of the most widespread aspects of psychosomatic pathology of gastrointestinal tract is irritable bowel syndrome (IBS). Over 70% of functional pathology of large intestine falls at IBS. The aim of the investigation was the assessment of depression rate in patients with IBS. Taking into consideration the age of individuals, 100 patients 50 men and 50 women aged 21 to 75 years were examined by using clinical, psychological and statistic (correlation) analysis to determine whether there were relations between clinical manifestations of the irritable bowel syndrome and personality. Diarrhea variant of IBS syndrome was detected in 17 (34%) men and in 21 (42%) females. Diarrhea and pain variant of IBS syndrome was detected in 12 (24%) men and 17 (34%) female. Pain variant of IBS syndrome was detected in 5 (10%) men and 12 (24%) females. Constipation variant was detected in 16 (32%) men and 3 (6%) female. In 84% of patients with IBS was found dysphoria; weight loss and bed appetite - in 44%, insomnia - in 40%, general lethargy and adynamia - in 80%; loss of interest - in 38%; asthenia - in 70%, devoured by guilt - 43%, uncertainty - 80%. Depression in patients with IBS was treated with serotonin selective antidepressants. Investigation revealed that the best result is achieved with serotonin-selective antidepressant therapy.
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PMID:[Psychological aspects of psychosomatic pathology of large intestine]. 1957 11

This manuscript reviews the pharmacodynamics and pharmacokinetics of duloxetine and its efficacy and safety in women with stress urinary incontinence. Duloxetine is a selective inhibitor of neuronal serotonin and norepinephrine uptake which increases urethral striated muscle activity and bladder capacity. Duloxetine is readily absorbed and extensively metabolized; cytochrome P450 1A2 (CYP1A2) inhibiting drugs can markedly increase duloxetine exposure. The clinical efficacy of duloxetine has consistently been demonstrated in several randomized, double-blind studies in women with moderate-to-severe stress urinary incontinence, but the additional benefit relative to placebo was moderate. Duloxetine treatment is frequently associated with adverse events such as nausea, dry mouth, fatigue, insomnia and constipation, but serious adverse events are rare. Therefore, duloxetine appears suitable for the treatment of stress urinary incontinence.
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PMID:Duloxetine in the treatment of stress urinary incontinence. 1980 76

The current study sought to test the efficacy and safety of the novel selective norepinephrine reuptake inhibitor LY2216684 compared to placebo in patients with major depressive disorder (MDD). Escitalopram was used as a control for assay sensitivity. Adult outpatients with MDD, confirmed at screening by the Mini International Neuropsychiatric Interview, a Self-Rated Quick Inventory of Depressive Symptomatology (QIDS-SR) score of at least 12 and a Clinical Global Impression-Severity Score of at least 4, were randomly assigned to LY2216684 (N=269), placebo (N=138), or escitalopram (N=62). Efficacy, safety, and tolerability outcomes were compared during 8 weeks of double-blind treatment. LY2216684 plasma concentrations were measured. LY2216684 did not show statistically significant improvement from baseline compared to placebo in the primary analysis of the Hamilton depression rating scale (HAM-D(17)) total score. Escitalopram demonstrated significant improvement compared to placebo on the HAM-D(17) total score, suggesting adequate assay sensitivity. Both LY2216684 and escitalopram showed statistically significant improvement from baseline on the patient-rated QIDS-SR total score compared to placebo. Headache, nausea, constipation, dry mouth, and insomnia were the most frequently reported adverse events in the LY2216684 group. A 3-6 beats per minute mean increase from baseline in pulse rate was observed in the LY2216684 group. LY2216684 plasma concentrations increased as the dose increased from 3 mg to 12 mg. The results of this initial investigation of LY2216684's efficacy suggest that it may have antidepressant potential. More definitive data to confirm this is necessary. Its safety profile does not preclude further clinical development.
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PMID:A study of the effects of LY2216684, a selective norepinephrine reuptake inhibitor, in the treatment of major depression. 1990 80

A combination of sustained release (SR) naltrexone (32 mg/day) and bupropion SR (360 mg/day) plus behavioral counseling was evaluated for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain. Thirty overweight or obese nicotine-dependent subjects were enrolled in a 24-week, open-label study; 85% and 63% completed 12 and 2 4weeks, respectively. The target quit date was Week 4. Week 4-12 continuous abstinence rate was 48%, 78% of subjects achieved CO < or = 10 ppm, serum cotinine decreased from 185 to 48 microg/L, and tobacco use decreased from 129 to 14 cigarettes/week. Similar results were seen at Week 24. Body weight was essentially unchanged (Week 12: -0.1%; Week 24: +0.4%). Except for a transient significant increase 1 week after the target quit date (p<0.05), nicotine withdrawal scores did not change. The most common adverse events were nausea, insomnia, and constipation. These tended to be transient and mild or moderate in severity. In overweight or obese smokers, naltrexone/bupropion combination therapy with behavioral counseling was associated with decreased nicotine use, limited nicotine withdrawal symptoms, and no significant weight gain.
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PMID:An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects. 1992

We describe the effectiveness of traditional Chinese medicine in treating minor preoperative and postoperative complaints in four patients. The first was a 54-year-old woman with a preoperative complaint of chapped hands before phylebeurysm evulsion surgery. Hachimiziougan was prescribed, and symptoms were ameliorated by postoperative day two. The second patient was a 77-year-old man with a complaint of cryptogenic palpitation during the preoperative morning for prostate biopsy. Hangekoubokutou was prescribed, and his symptoms were abated. The third patient was a 58-year-old woman with a postoperative complaint of sleeplessness due to cough following cranial laminoplasty. Bakumondoutou was prescribed, and she reported that both coughing and sleeplessness were abated. The fourth patient was a 65-year-old man with a preoperative complaint of constipation and a chill in his leg prior to cranial laminoplasty. Hachimiziougan and Mashiningan were prescribed, and symptoms were abated by postoperative day five. All patients were satisfied with traditional Chinese medicine, even though it was a short-term treatment. Traditional Chinese medicine thus may provide effective treatment for minor perioperative complaints.
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PMID:[Four case studies of perioperative treatment using traditional Chinese medicine]. 1992 17


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