Duloxetine is a balanced serotonin-norepinephrine reuptake inhibitor. Duloxetine-induced liver injury in patients with preexisting liver disease or chronic alcohol use is known. However, we have found that duloxetine can also induce liver injury in cases without those risk factors. We recommend that clinicians should monitor liver function carefully following duloxetine treatment.
Depressive Disorder, Major ; Humans ; Liver ; Liver Diseases ; Organothiophosphorus Compounds ; Risk Factors ; Thiophenes ; Duloxetine Hydrochloride

OBJECTIVE: To assess the relative severity of nausea in patients from Korea with major depressive disorder (MDD) who were treated with duloxetine at low (30 mg) or high (60 mg) doses, with or without food, for the first week of an 8 week treatment. METHODS: Adult patients (n=249), with MDD and a 17-item Hamilton Rating Scale for Depression (HAMD17) score of > or =15, received open-label once daily duloxetine. At Week 0, patients were randomized to 4 groups: 30 mg with food (n=63), 60 mg with food (n=59), 30 mg without food (n=64), and 60 mg without food (n=63). At Week 1, all patients switched to duloxetine 60 mg for 7 weeks. The primary outcome measure was item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale. Effectiveness was assessed by change in HAMD17 total score. RESULTS: Overall, 94.4% (235/249) of patients completed Week 1 and 55.0% (137/249) of patients completed the study. For Week 1, nausea was significantly less severe for patients who received 30 mg compared with 60 mg duloxetine (p=0.003), regardless of food intake. In all groups, nausea severity was highest at Week 1 and declined throughout the study. HAMD17 score was reduced in all groups and the most common adverse event reported was nausea (145/249; 58.2%). CONCLUSION: To minimize nausea, Korean patients with MDD who require duloxetine treatment could be given 30 mg once daily, regardless of food, for the first week followed by 60 mg once daily for the course of therapy.
Adult ; Depression ; Depressive Disorder, Major ; Eating ; Humans ; Korea ; Nausea ; Outcome Assessment (Health Care) ; Thiophenes ; Duloxetine Hydrochloride

Fibromyalgia syndrome (FMS) is characterized by chronic widespread pain and various accompanying symptoms including fatigue, sleep disturbances, and cognitive dysfunction. While the etiology of fibromyalgia is unclear, accumulating data suggest that disordered central pain processing likely plays a role in the pathogenesis of symptoms. Although the 1990 American College of Rheumatology (ACR) classification criteria for FMS were originally developed for research purposes and were not intended for clinical diagnosis, the criteria have become the de facto diagnostic criteria in clinical settings. Recently, an improved clinical case definition for FMS was proposed by ACR in 2010 to overcome several limitations of 1990 ACR criteria. Further studies are needed to assess the acceptance, reliability, and validity of the new criteria in epidemiologic and clinical studies. Many randomized controlled trials and meta-analyses confirm the therapeutic efficacy of pregabalin, duloxetine, and milnacipran, in the treatment of FMS. In view of the currently available evidence, a combination of pregabalin, duloxetine, or milnacipran as pharmacological interventions and aerobic exercise or CBT as non-pharmacological interventions seems most promising.
Cyclopropanes ; Exercise ; Fatigue ; Fibromyalgia ; gamma-Aminobutyric Acid ; Rheumatology ; Thiophenes ; Duloxetine Hydrochloride ; Pregabalin

Here we report a case of serotonin syndrome caused by fluoxetine 20 mg and duloxetine 60 mg independently eight week apart. A 65-year old man developed fever, agitation and change of mental status after two weeks treatment with 20 mg of fluoxetine for depressive disorder. He was diagnosed unknown fever origin and discharged when fever subsided as antidepressant stopped. Eight weeks later he was prescribed 60 mg of duloxetine for the treatment of depressed mood. After 18 days on duloxetine he developed fever, agitation, myoclonus and change in mental status again. He improved rapidly after discontinuation of offending drug with supportive care. Despite serotonin syndrome is usually caused by poly-pharmacy of serotonergic drugs, this case shows unusual serotonin syndrome developed by therapeutic dose of two drugs of different classes independently.
Depressive Disorder ; Dihydroergotamine ; Fever ; Fluoxetine ; Humans ; Myoclonus ; Serotonin ; Serotonin Agents ; Serotonin Syndrome ; Thiophenes ; Duloxetine Hydrochloride

Duloxetine is a relatively balanced selective serotonin and noradrenaline reuptake inhibitor. We report a case of hyponatremia induced by duloxetine developed rapidly after starting the medication in a middle-aged male with multiple somatic symptoms and depression. Two days after discontinuation of duloxetine and management with hypertonic saline as well as fluid restriction, the serum sodium level normalized. The patient had two risk factors for developing hyponatremia, such as severe body weight loss and pneumonia. Therefore, when treating patients with depression and somatic symptoms, especially with risk factors for developing hyponatremia, close monitoring for clinical and laboratory evidence of hyponatremia may be essential.
Body Weight ; Depression ; Humans ; Hyponatremia ; Male ; Norepinephrine ; Pneumonia ; Risk Factors ; Serotonin ; Sodium ; Thiophenes ; Duloxetine Hydrochloride

Stent thrombosis is a very serious problem after drug-eluting stent (DES) implantation even though its incidence is about or less than 1%. As the clopidogrel resistance is expected to play an important role in the occurrence of stent thrombosis, new anti-platelet agents overcoming this issue can give us another choice. We experienced a case of a 58-year-old male with successful prasugrel rescue therapy in a patient with clopidogrel resistance who had recurrent stent thrombosis following DES implantation.
Drug-Eluting Stents ; Humans ; Incidence ; Male ; Piperazines ; Stents ; Thiophenes ; Thrombosis ; Ticlopidine ; Prasugrel Hydrochloride

Duloxetine is a balanced and potent serotonin and noradrenaline reuptake inhibitor which is known to be effective in depression and anxiety disorders. The common adverse effects include dry mouth, nausea, insomnia, somnolence, dizziness and constipation. Reported adverse effects of the extra pyramidal symptoms (EPS) are rare. In this case, a patient who suffered from acute dystonia, after only one dose of 30 mg duloxetine is presented.
Anxiety Disorders ; Constipation ; Depression ; Dizziness ; Dystonia ; Humans ; Mouth ; Nausea ; Norepinephrine ; Serotonin ; Sleep Initiation and Maintenance Disorders ; Thiophenes ; Duloxetine Hydrochloride

Duloxetine is a balanced serotonin and norepinephrine reuptake inhibitor available for treating peripheral neuropathic pain. The occurrence of hyponatremia as an adverse event of duloxetine treatment, but it has not yet been reported in Korea. Here, we report two cases of hyponatremia induced by duloxetine for treatment of peripheral neuropathic pain. Our findings highlight the need for special attention when using duloxetine in elderly patients taking thiazide diuretics.
Aged ; Humans ; Hyponatremia ; Korea ; Neuralgia ; Norepinephrine ; Serotonin ; Serotonin Uptake Inhibitors ; Sodium Chloride Symporter Inhibitors ; Thiophenes ; Duloxetine Hydrochloride

PURPOSE: To compare the hematologic changes and the rates of transfusion of patients using rivaroxaban or aspirin for venous thromboembolism prophylaxis after a total knee arthroplasty. MATERIALS AND METHODS: Among patients with total knee arthroplasty from July 2010 to March 2011, two groups of 100 consecutive cases were enrolled in this study, 50 patients with Rivaroxaban group and 50 patients with Aspirin group for venous thromboembolism prophylaxis after a total knee arthoplasty. Hematologic changes and transfusion rates were calculated in each group. RESULTS: The mean of decreased hemoglobin was 4.7 (3.1-6.6) in the Rivaroxaban group and 3.6 (2.0-5.1) in the Aspirin group (p<0.05). The number of patients with decreased hemoglobin of less than 8 g/dl was observed in 23 cases (46%) in the Rivaroxaban group, and 9 cases (18%) in the Aspirin group. The numbers of patients who needed transfusion were 12 in the Rivaroxaban group, and 2 in the Aspirin group (p<0.05). CONCLUSION: Rivaroxaban group revealed more significant decrease of hemoglobin and needed more transfusion than the Aspirin group did. For the prevention of venous thromboembolism after total knee arthroplasty, we should be careful using Rivaroxaban for the standard risk patients of venous thromboembolism.
Arthroplasty ; Aspirin ; Hemoglobins ; Humans ; Knee ; Morpholines ; Thiophenes ; Venous Thromboembolism ; Rivaroxaban

BACKGROUNDDuloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain (DPNP) in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain.

METHODSThis double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory (BPI) 24-hour average pain severity ratings ≥ 4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator's judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol: 5 Dimensions, Athens Insomnia Scale, and safety measures.

RESULTSOf 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively, completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups (P = 0.124). Duloxetine- treated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1, 2, and 4 (P = 0.004, P = 0.009, and P = 0.006, respectively), but not at weeks 8 (P = 0.125) and 12 (P = 0.107). Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo.

CONCLUSIONSAlthough the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.

Adrenergic Uptake Inhibitors ; therapeutic use ; Aged ; Diabetic Neuropathies ; drug therapy ; Double-Blind Method ; Duloxetine Hydrochloride ; Female ; Humans ; Male ; Middle Aged ; Placebos ; Thiophenes ; therapeutic use ; Treatment Outcome