Clinical drug investigation
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Randomized Controlled Trial Multicenter Study
Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Approximately 75% of postmenopausal women experience vasomotor symptoms (hot flashes). Currently, hormone replacement therapy is the only approved treatment for hot flashes. However, its use has been associated with an increased risk of invasive breast cancer, coronary heart disease, stroke and venous thromboembolic disease. Gabapentin has also been demonstrated to be efficacious in the treatment of vasomotor symptoms in postmenopausal women when administered three times a day. A gastroretentive extended-release formulation of gabapentin (gabapentin-ER) has recently been demonstrated to be efficacious in the treatment of postmenopausal hot flashes. The objective of this paper is to report the steady-state pharmacokinetics and safety of gabapentin with different dosing regimens of gabapentin-ER in postmenopausal women with hot flashes. ⋯ Registered as ClinicalTrials.gov Identifier: NCT00511953.
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Randomized Controlled Trial Multicenter Study Comparative Study
Budesonide/formoterol maintenance and reliever therapy in Asian patients (aged ≥16 years) with asthma: a sub-analysis of the COSMOS study.
The combination of an inhaled corticosteroid (ICS), budesonide, and a rapid long-acting β(2)-agonist (LABA), formoterol, in a single inhaler for use as maintenance and reliever therapy (Symbicort Turbuhaler SMART™) effectively achieves a high level of asthma control and reduces exacerbations and asthma-related hospitalizations. The COSMOS study, a multinational, 12-month study (N = 2143), compared budesonide/formoterol maintenance and reliever therapy with salmeterol/fluticasone propionate plus as-needed salbutamol, allowing physicians to modify maintenance doses of both combinations according to routine clinical practice. ⋯ In patients (aged ≥16 years) enrolled from Asian countries as part of the COSMOS study, the budesonide/formoterol maintenance and reliever regimen was associated with a lower future risk of exacerbations versus the physicians' free choice of salmeterol/fluticasone propionate dose plus salbutamol. Single inhaler combination treatment with maintenance plus as-needed budesonide/formoterol was also at least as efficacious as salmeterol/fluticasone propionate dose plus salbutamol in improving current asthma control.
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The dosing of opioid receptor agonist medications adequately and on an individual basis is crucial in the pharmacotherapy of opioid dependence. Clinical tools that are able to measure dose appropriateness are sorely needed. The recently developed and validated Opiate Dosage Adequacy Scale (ODAS) comprehensively evaluates the main outcomes relevant for methadone dose optimization, namely relapse, cross-tolerance, objective and subjective withdrawal symptoms, craving and overdose. Based on the ODAS, we developed a new assessment tool (BUprenorphine-naloxone Dosage Adequacy eVAluation [BUDAVA]) for evaluating dosage adequacy in patients in treatment with buprenorphine-naloxone. ⋯ These preliminary results suggest that the BUDAVA questionnaire may be useful for guiding buprenorphine-naloxone maintenance dose adjustments in heroin-dependent patients.
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Randomized Controlled Trial Multicenter Study
Early non-response in patients with severe depression: escitalopram up-titration versus switch to duloxetine.
Comparative evidence for second-step treatment strategies in severe depression is scarce. Up-titrating a well tolerated selective serotonin reuptake inhibitor (SSRI) versus switching to a serotonin norepinephrine reuptake inhibitor (SNRI) after initial SSRI non-response are possible treatment options. It is often unclear whether relevant tolerability and efficacy differences exist between SSRI up-titration versus switch to an SNRI. ⋯ Registered at ClinicalTrials.gov as NCT00384436.
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It has been suggested that peripheral neuropathic pain (PNP) may affect up to 3% of the general population. PNP has a substantial negative impact on patient functioning and quality of life, including reduced productivity and increased consumption of healthcare resources. ⋯ These findings suggest that pregabalin could be a valid treatment alternative for the management of patients with gabapentin-refractory peripheral neuropathic pain in primary-care settings under real-life conditions of care. Our data show that patients who were switched to pregabalin, either as monotherapy or in combination with other analgesics, showed substantial and clinically relevant improvements in relieving pain and related symptoms.