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Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab.

Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-κB ligand (RANKL), a member of the tumor necrosis … clinical trials, including the extension of FREEDOM trial for up to 5 years, are reassuring for its safety. However, given its brief post-market period, vigilance regarding adverse events related to putative RANKL inhibition in tissues other than bone, as well as those related to bone turnover oversuppression, is advised.

Safety of anti-TNFα agents in the treatment of psoriasis and psoriatic arthritis.

CONTEXT: The efficacy and favorable safety profile of anti-tumor necrosis factor (TNF) agents in the treatment of psoriasis and psoriatic arthritis (PsA) are supported by several randomized controlled studies and meta-analyses. However, some concerns on the long-term safety of these drugs still exist, as these studies generally included small patient numbers and were performed in selected patient populations. OBJECTIVE: This review presents and discusses current evidence on the safety of anti-TNFα agents in patients with psoriasis and PsA, with a focus on European registry studies and case re…

The definition of the V zone for the safety space of functional surgery of the tongue.

OBJECTIVES/HYPOTHESIS: To define safety space for functional surgery of the tongue. STUDY DESIGN: Prospective nonrandomized study. METHODS: Computed tomographic angiography of the lingual artery was performed in 107 in-patients with obstructive sleep apnea syndrome and 17 controls. The safety space was ascertained according to the course of lingual artery. RESULTS: The course of the lingual artery, termed the Big Dipper bowl of the tongue, was similar in each group. The tissue above the lingual artery and the vacuity of the hypoglossal/lingual artery neurovascular bundle (HLNVB) formed a th…

Pharmacokinetics and safety of 0.5% ivermectin lotion for head louse infestations.

The safety of a novel 0.5% ivermectin lotion (IVL) and potential for ivermectin absorption after application was investigated in an open-label study in young children, and a human repeat insult patch test (HRIPT) and cumulative irritation test (CIT) assessed any potential for cumulative dermal irritation and contact sensitization. In the pharmacokinetic and safety study, 30 head louse-infested children ages 6 months to 3 years received a 10-minute application of IVL on day 1. Blood was collected before application; 0.5, 1, and 6 hours after rinsing; and on days 2 and 8. Samples from 20 subject…

Safety and efficacy of mesenchymal stromal cell therapy in autoimmune disorders.

Mesenchymal stromal cells (MSCs) are being employed in clinical trials to facilitate engraftment and to treat steroid-resistant acute graft-versus-host disease after hematopoietic stem cell transplantation, as well as to repair tissue damage in inflammatory/degenerative disorders, in particular, in inflammatory bowel diseases (IBDs). When entering the clinical arena, a few potential risks of MSC therapy have to be taken into account: (i) immunogenicity of the cells, (ii) biosafety of medium components, (iii) risk of ectopic tissue formation, and (iv) potential in vitro transformation of the ce…

Efficacy and safety of pharmacological interventions for the treatment of the Alcohol Withdrawal Syndrome.

BACKGROUND: Alcohol abuse and dependence represents a very serious health problem worldwide with major social, interpersonal and legal interpolations. Pharmacological treatments presently used are of uncertain effectiveness and there is even more doubt on the comparative effects and value for money. OBJECTIVES: To summarize Cochrane reviews that assess the effectiveness and safety of pharmacological interventions in the treatment of alcohol withdrawal. METHODS: We searched the Cochrane Database of Systematic Reviews (30 November 2010). Two authors independently screened, extracted data, summ…

[The efficacy and safety of limited incision technique in carpal tunnel release].

OBJECTIVES: This study aims to determine the safety and symptomatic and functional efficacy of median nerve decompression with 3 cm limited incision in carpal tunnel syndrome surgery. PATIENTS AND METHODS: Carpal tunnel release with a 3 cm limited palmar incision was performed on 91 hands in 83 patients. Patients were evaluated with Boston Carpal Tunnel Questionnaire, grip strength and pinch strength measurements, Semmes-Weinstein Monofilament test and two-point discrimination tests preoperatively, and at postoperative 3rd and 6th months. The pre- and postoperative mean values for these asses…

Research needs and opportunities for reducing the adverse safety consequences of fatigue.

Although there has been a significant amount of research on fatigue globally, it remains a major contributor to workplace and highway mortal … ndations from this process. These are organized into five topic areas: the link between fatigue and safety, demographic issues in fatigue, modeling and predicting fatigue, technological approaches to fatigue management, and organizational factors in fatigue management.

Efficacy and safety of azathioprine and dapsone as an adjuvant in the treatment of bullous pemphigoid.

BACKGROUND: Bullous pemphigoid is a chronic, blistering and autoimmune disease, common in old age. The treatment usually includes systemic steroids, however, these cause high morbidity rates, and then different products that function as adjuvants have been tried. At present, there are no studies to determine which adjuvant offers a better efficacy and safety profile. METHODS: We performed a retrospective study which included the records of patients with bullous pemphigoid, treated either with azathioprine or dapsone. We evaluated the time to achieve complete remission, the time to inhibit dis…

Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Treatment with the iron chelator, deferoxamine mesylate (DFO), improves neurological recovery in animal models of intracerebral hemorrhage (ICH). We aimed to evaluate the feasibility, safety, and tolerability of varying dose-tiers of DFO in patients with spontaneous ICH, and to determine the maximum tolerated dose to be adopted in future efficacy studies. METHODS: This was a multicenter, phase-I, dose-finding study using the Continual Reassessment Method. DFO was administered by intravenous infusion for 3 consecutive days, starting within 18 hours of ICH onset. Subject…

Pilot safety trial of deferiprone in 10 subjects with superficial siderosis.

BACKGROUND AND PURPOSE: Superficial siderosis is a neurodegenerative disease caused by toxic accumulation of hemosiderin on the surface of the brain and spinal cord for which there is no known effective treatment. METHODS: Oral deferiprone, a lipid-soluble iron chelator with ability to cross the blood-brain barrier, at a dose of 30 mg/kg per day was tested for safety in an open pilot study in 10 subjects with superficial siderosis. RESULTS: Over a 90-day period, deferiprone had no significant adverse effects on hematologic, liver, or neurological function. Ad hoc MRI assessments of the brain…

[The efficacy and safety of tolvaptan on treating heart failure patients with hyponatremia].

OBJECTIVE: To evaluate the efficacy and safety of tolvaptan on treating congestive heart failure patients with hyponatremia. METHODS: This randomized double-blind placebo-controlled multicenter trial enrolled 65 patients with congestive heart failure and hyponatremia. On top of standard therapy, patients were randomized to receive either tolvaptan 15 - 60 mg daily or placebo according to the serum sodium concentration. The primary end points were the change of average daily serum sodium concentration from baseline to day 4 and to day 7 respectively. Patients' weight, urine volume, sign of hea…

[Efficacy, safety and cost of sedation with sevoflurane in intensive care unit].

OBJECTIVES: To study efficacy, systemic and cerebral haemodynamic, and cost of sedation with sevoflurane after midazolam failure. STUDY DESIGN: Prospective observational study in a mixed intensive care unit. PATIENTS AND METHODS: Mechanically ventiled patients in whom deep sedation failed (Ramsay score<5 despite midazolam 10mg/h and fentanyl 400μg/h) were enrolled. Sedation with sevoflurane and fentanyl (200μg/h) was performed during 48 hours. Sevoflurane was administered with a dedicated filter (AnaConDa™) and sevoflurane infusion rate was adjusted in order to achieve a Ramsay score ≥5. Ram

Долговременная безопасность и эффективность фильтра вены "OptEase".

Для оценки долгосрочной безопасности и эффективности фильтра OptEase ниже вены cava (IVC). 71 пациентов, которые получили фильтр OptEase в нашем учреждении от 2002 в адрес 2007. Thirty-nine (В тыс.55%) у пациентов были симптомы венозного тромбоэмболизма до установки фильтра. Указания на фильтр включали противокоагуляцию в 31 (В тыс.44%) пациенты, профилактические меры против легочной эмболии (ПЭ) 29 (В тыс.41%) пациентов и отказ от антикоагуляции 11 (В тыс.15%) пациентов. Были зарегистрированы такие связанные с процедурой осложнения, как симптоматические постфильтровые PE, глубокий венозный тр

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PurposeTo assess the long-term safety and effectiveness of the OptEase inferior vena cava (IVC) filter.Materials and methodsIn this Institutional Review Board-approved, retrospective study, we reviewed data of 71 patients who received an OptEase filter at our institution from 2002 to 2007. Thirty-nine (55%) patients had symptoms of venous thromboembolism bef…

Bendamustine: safety and efficacy in the management of indolent non-hodgkins lymphoma.

Bendamustine (Treanda, Ribomustin) was recently approved by the US Food and Drug Administration (FDA) for treatment of patients with rituximab refractory indolent lymphoma and is expected to turn into a frontline therapy option for indolent lymphoma. This compound with amphoteric properties was designed in the former Germany Democratic Republic in 1960s and re-discovered in 1990s with multiple successive well-designed studies. Bendamustine possesses a unique mechanism of action with potential antimetabolite properties, and only partial cross-resistance with other alkylators. Used in combinatio

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… Taking a step further to see if this combination would benefit patients if used upfront, a multicenter randomized phase-III study was initiated in October 2003 to compare efficacy and safety of B-R versus CHOP plus rituximab (CHOP-R) as first-line therapy for patients with follicular (FL), indolent and … Researchers at MD Andersen Cancer Center (MDACC) are evaluating the safety and efficacy of Fludarabine, Bendamustine and Rituximab conditioning in an open label trial 68 with the primary aim of reporting the MTD of Bendamustine when given with a stem cell transplant and chemotherapy (fludarabine and …

Cannabinoid effects on ventilation and breathlessness: a pilot study of efficacy and safety.

Based on the neurophysiology of dyspnoea and the distribution of cannabinoid receptors within the central nervous system, we hypothesize that the unpleasantness of breathlessness will be ameliorated in humans by cannabinoids, without respiratory depression. Five normal and four chronic obstructive pulmonary disease (COPD) subjects entered a double blind, randomized, placebo-controlled crossover study with two test days. Subjects received sublingual cannabis extract or placebo. A maximum of 10.8 mg tetrahydrocannabinol and 10 mg cannabidiol were given. Breathlessness was simulated using fixed c

The feasibility and safety of laparoscopic splenectomy for massive splenomegaly: a comparative study.

BACKGROUND: Laparoscopic splenectomy used for massive splenomegaly is still controversial. The purpose of our current study was to identify the feasibility and safety of laparoscopic splenectomy for massive splenomegaly. METHODS: From January 2006 to January 2010, laparoscopic splenectomy was performed on 33 patients with massive splenomegaly in our hospital, compared with 29 patients who received open splenectomy (group 2) and 48 patients with normal-size spleens who underwent laparoscopic splenectomy (group 3). Perioperative outcomes of these patients were compared. RESULTS: Compared with …