Incidence Of Serious Side Effects Research Articles

Exploring the therapeutic benefits of paliperidone in the management of schizophrenia: A promising approach for the mental well-being of this population

Paliperidone is a safe and effective option for the treatment of schizophrenia, with long-acting oral or intramuscular administration. Its low hepatic metabolization and renal excretion minimize complications in patients with pre-existing liver disease, providing greater adherence and therapeutic efficacy. The current study is a literature review, with an active search for “Paliperidone” and “Schizophrenia” on national and international platforms. Twenty-one articles were analyzed in the PubMed and Scielo databases. Twenty-one articles were selected based on an evaluation of the title, abstract and relevance to the study. The period of publication ranged from 2007 to 2024, and all were organized in terms of title, authorship, year of publication and methodology used. The data shows the consistent efficacy of paliperidone in relieving schizophrenic symptoms, its safety and tolerability, highlighting its ability to improve patients' quality of life. Although adverse events were observed, these were generally mild and did not compromise the continuity of treatment. In summary, the data support paliperidone as an effective and safe therapeutic option for schizophrenia, with the potential to improve patients' clinical and psychosocial outcomes. Paliperidone is an effective and well-tolerated option for treating schizophrenia, with studies indicating improved patient compliance and clinical stability. Its low incidence of serious side effects increases long-term safety. This reduces relapse and hospitalization rates, improving quality of life.

Overview of Tendinopathy, Peripheral Neuropathy, Aortic Aneurysm, and Hypoglycemia Caused by Fluoroquinolones

Abstract Background Fluoroquinolones (FQs) are widely used in the management of several bacterial infections including urinary tract infections (UTIs), upper respiratory tract infections (URTIs), lower respiratory tract infections (LRTIs), skin and soft tissue, gastrointestinal tract infections (GITIs), and many other infections. Objective This review article focuses on some serious side effects notified by United States Food and Drug Administration (US FDA) in different warning statements. Methods The literature was searched, in databases such as Medline/PubMed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of science, Embase, and reference lists to identify publications relevant to the serious side effects associated with the use of FQs. Results Several epidemiological studies and meta-analyses have documented the occurrence of serious side effects of FQs including tendinopathy, peripheral neuropathy, aortic aneurysm/dissection, hypoglycemia, QT prolongation, retinal detachment, and worsening of myasthenia gravis. Conclusion The clinicians should be aware of serious side effects of FQs. The US FDA and European Medicines Agency recommend against the use of FQs as first-line therapies to treat infections such as acute sinusitis, acute bronchitis, and uncomplicated UTIs, as the risks outweigh the benefits. The risk of incidence of serious side effects of FQs is higher among patients with advanced age, renal insufficiency, and certain concomitant medications. To avoid occurrence of any serious side effects of FQs, the clinicians should prefer non-FQ antibacterial drugs to manage uncomplicated UTIs, respiratory tract infections, and other infections for which alternatives available.

Investigating patients’ preferences for new anti-diabetic drugs to inform public health insurance coverage decisions: a discrete choice experiment in China

BackgroundDiabetes is a major public health concern with a considerable impact on healthcare expenditures. Deciding on health insurance coverage for new drugs that meet patient needs is a challenge facing policymakers. Our study aimed to assess patients’ preferences for public health insurance coverage of new anti-diabetic drugs in China.MethodsWe identified six attributes of new anti-diabetic drugs and used the Bayesian-efficient design to generate choice sets for a discrete choice experiment (DCE). The DCE was conducted in consecutive samples of type 2 diabetes patients in Jiangsu Province. The mixed logit regression model was applied to estimate patient-reported preferences for each attribute. The interaction model was used to investigate preference heterogeneity.ResultsData from 639 patients were available for analysis. On average, the most valued attribute was the improvement in health-related quality of life (HRQoL) (β = 1.383, p < 0.001), followed by positive effects on extending life years (β = 0.787, p < 0.001), and well-controlled glycated haemoglobin (β = 0.724, p < 0.001). The out-of-pocket cost was a negative predictor of their preferences (β = -0.138, p < 0.001). Elderly patients showed stronger preferences for drugs with a lower incidence of serious side effects (p < 0.01) and less out-of-pocket costs (p < 0.01). Patients with diabetes complications favored more in the length of extended life (p < 0.01), improvement in HRQoL (p < 0.05), and less out-of-pocket costs (p < 0.001).ConclusionThe new anti-diabetic drugs with significant clinical effectiveness and long-term health benefits should become the priority for public health insurance. The findings also highlight the value of accounting for preference heterogeneity in insurance policy-making.

Treatment of keratosis pilaris rubra with 577-nm pro-yellow laser.

Keratosis pilaris rubra (KPR) is a rare group of idiopathic hereditary disorders of keratinization, and it is considered as variants of keratosis pilaris. It is characterized by a well-defined erythema and small, keratotic follicular papules that are seen on the cheeks and preauricular area. Keratosis pilaris rubra is an aesthetically distressed situation, and especially vascular erythema is the most common complaint. In recent years, pro-yellow (577 nm) laser, laser system with yellow light wavelength, has been used as an alternative for seeking more effective treatment especially in vascular lesions. However, in the literature, pro-yellow laser therapy has never been used before in keratosis pilaris rubra. Therefore, we wanted to evaluate the effectiveness of the pro-yellow laser in keratosis pilaris rubra patients. In our study, four patients with keratosis pilaris rubra treated with pro-yellow laser in our Cosmetology Unit between December 2017 and March 2019 were evaluated. The first session was started with 20 j/cm2 and the dose increased 2 j/cm2 at each session. The dose was increased up to 26 j/cm2 , a total of four sessions (20-22-24-26 j/cm2 ) was applied in treatment. All the sessions were used in treatment scanner mode. Objectifying a clearance of erythema >75% was clinically evident in three patients, in the fourth patient, erythema regressed approximately 50%. There has been no recurrence of the lesions after a minimum three months follow-up. There was no permanent side effect in any patient. Pro-yellow laser is a well option for the treatment of keratosis pilaris rubra, and we think that it could be a safety choice therapy. In addition, a well tolerance to treatment and a low incidence of serious side effects make it a very reliable therapy. Further clinical studies are needed to improve our findings.

The Role of Heat Shock Proteins in Cisplatin Resistance.

Cisplatin (CDDP), a small molecule platinum-based compound, is an effective anticancer drug used against a wide range of human neoplasms. Long-term clinical use of CDDP is however limited due to the development of drug resistance and the possible incidence of serious side effects including nephrotoxicity and ototoxicity. The mechanisms underlying resistance of cells to CDDP are complex, and among them, the cytoprotective involvement of proteins referred to as Heat Shock Proteins (HSP) seems potentially important. We searched various electronic databases including PubMed and selected the reports concerning the contribution of HSPs to CDDP resistance of cancer cells and to minimize the CDDP-induced nephrotoxicity and ototoxicity. This critical review of data collected so far summarizes the results on the major HSPs: HSP27/HSPB1, HSP70/HSPA1, HSP90/HSPC and GRP78/HSPA5, because only these have been the subject of the most intense research in the matter discussed here. We also provide relevant information concerning some other HSPs, namely HSPA9/mortalin, HSPA2, HSP110 and DNAJ. A possible role of HSPs in counteracting CDDP-induced neprho- and ototoxicity is mentioned. This review shows that no universal relationship between the levels of expression of HSPs and sensitivity of cancer cells to CDDP can be confirmed. Multiple observations indicate however that such correlation can rather manifest as a molecular or cellular context-dependent phenomenon. Thus, HSPs can be viewed as an important component of the multifactorial, complex response of cancer cells to CDDP. However, to strengthen such a conviction, more extensive studies are needed.

Phacoemulsification and endocyclophotocoagulation in uncontrolled glaucoma: Three-year results

To describe the 3-year outcomes of combined cataract surgery and 360-degree endocyclophotocoagulation (ECP) in eyes with uncontrolled glaucoma and no previous glaucoma drainage surgery. University Hospital Eye Department, Exeter, United Kingdom. Retrospective case series. The study included patients who had combined cataract surgery and 360-degree ECP. The primary outcome measure was intraocular pressure (IOP) reduction at 3years postoperatively. Secondary outcome measures were the cumulative probability of failure of the surgical procedure at 3years and the complications of surgery. Failure was defined by 1 of 2 criteria: (1) IOP higher than 21mm Hg or lower than 6mm Hg or not reduced by 20% from baseline at the 1-, 2-, or 3-year timepoint and (2) further laser or other surgery to reduce IOP at any timepoint. The study comprised 84 patients (84 eyes). The mean IOP dropped from 18.7mm Hg preoperatively to 13.3mm Hg, 13.8mm Hg, and 14.0mm Hg at 1, 2, and 3years postoperatively, respectively. By the 3-year timepoint, 58.3% had met the criteria for failure. The mean number of glaucoma medications was similar at 2.5 at 3years postoperatively compared with 2.6 preoperatively. Nine patients (10.7%) had a significant complication, but all resolved without long-term sequelae. At 3years postoperatively, combined cataract surgery and 360-degree ECP achieved a modest but significant drop in IOP in phakic patients with uncontrolled glaucoma and no previous drainage surgery. There was a low incidence of serious side effects but nearly 60% were classified as failures by 3years.

The adverse effects of interferon-free regimens in 149816 chronic hepatitis C treated Egyptian patients.

Interferon-free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. To evaluate the adverse effects associated with the different direct-acting antiviral drug (DAA) regimens in Egyptian patients. This multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149816 chronic hepatitis C treated Egyptian patients. Patients received sofosbuvir (SOF)/ribavirin (RBV) (n=21835), SOF/simeprevir (n=24 215) SOF/daclatasvir (DCV) (n=58477), SOF/DCV/RBV (n=45 188) and paritaprevir/ombitasvir/ritonavir/RBV (n=101). The duration of treatment varied between 12 and 24weeks. All changes in the treatment regimens, discontinuation, mortality, and serious side effects were reported. Adverse effects developed in 2475 (1.7%) (mean age [54±9], male gender [53%]) patients. Serious side effects developed in 68% of these patients, and SOF/RBV was the most common causing regimen (73%, P<0.001). Anaemia and hyperbilirubinemia were the most common side effects (731/149816, 0.5% and 463/149816, 0.3%, respectively) and SOF/RBV (588/21835, 3% and 353/21835, 1.6%, respectively) showed the highest incidence in the treated patients. Hepatocellular carcinoma and mortality were reported in 0.02% and 0.06% of all treated patients, respectively. Patients with liver cirrhosis showed higher incidence of serious side effects (Log rank P=0.045) and mortality (Log rank P=0.025) than patients without liver cirrhosis. Male gender (P=0.012), lower haemoglobin (P<0.001), platelets (P<0.001) and albumin (P=0.001), higher bilirubin (P=0.002) and cirrhosis (P<0.001) were factors associated with serious side effects development. Adverse effects associated with DAAs are few, anaemia being the most common. SOF/RBV regimen showed the highest rate of side effects while SOF/DCV showed the least.

A Study of the Association between Helicobacter Pylori, on Steroidal Anti Inflammatory Drugs and Peptic Ulcer Disease

NASID induced gastro intestinal injury represent the most frequent adverse drug event worldwide. Despite the large number of drug used, the incidence of serious side effects due to NSAIDs is considerably low. The wide spectrum of side effects includes of those affecting renal, hepatic and haematological functions. The major gastrointestinal adverse effects include peptic ulcer disease, gastrointestinal bleeding and perforation. Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum affecting approximately 15% of people the world over. The two causative factors are Helicobactor pylori and NSAID. Helicobacter pylori and NSAID are independent risk factors for the developments of gastroduodenopathy.The two factors together do not increase the risk of peptic ulcer disease. Asymptomatic individuals with normal endoscopy are associated with histological changes of gastritis. Antral ulcers are associated with low prevalence of HP. Predicting which patients taking chronic NSAID s are at risk of ulceration; bleeding or perforation needs further evaluation.

Evaluation of anti-acne property of purified bee venom serum in humans.

Acne vulgaris is a chronic dermatologic disease with four factors involved in the development of lesions. Treatments need to address as many of these underlying factors as possible in order to reduce acne lesions. As such, purified bee venom (PBV™ ) serum is an attractive therapeutic option for acne, but little data exist on the efficacy of this treatment strategy. In this prospective, noncomparative study, 30 subjects having mild-to-moderate acne vulgaris were enrolled and treated with PBV™ serum twice daily for a period of 6 weeks. Clinical evaluation of lesions by expert visual grading and image analysis were made at weeks 0 (baseline), 3, and 6. The average visual acne grade of all volunteers significantly improved with the PBV™ serum treatment at weeks 3 (P < 0.05) and 6 (P < 0.001) when compared with the baseline grade at week 0. In addition, there was a mean percent improvement of 8.6% and 52.3% in acne grade observed after 3 and 6 weeks of PBV™ serum use, with 20% and 77% of the subjects showing improvement, respectively, when compared with baseline. Moreover, the subjects showed improvement in open comedones, closed comedones, papules, pustules, and nodules after 3 and 6 weeks of PBV™ serum use. Six weeks of treatment with PBV™ serum was found to be effective in the treatment of mild-to-moderate acne vulgaris, with no incidence of serious side effects or irritation.

Clinical significance of CYP2C9-status guided valproic acid therapy in children.

Valproic acid (VPA)-induced adverse effects, which are sometimes serious in children, can be associated with alterations in VPA metabolism. VPA-evoked toxicity is attributed to both the parent compound and its unsaturated metabolites, primarily formed by the cytochrome P450 (CYP)2C9 enzyme. Thus, patients' CYP2C9-status may account for the predisposition to adverse reactions, and testing CYP2C9-status may contribute to the improvement and rationalization of VPA therapy in children. In the CYPtest group, children's CYP2C9-status was screened before initiating antiepileptic therapy. CYP2C9-status was estimated by the identification of defective CYP2C9 allelic variants (CYP2C9*2, CYP2C9*3) and current CYP2C9 expression in patients' leukocytes, which reflects hepatic CYP2C9 activities. When the results of CYP2C9 genotyping and CYP2C9 expression were combined, the patients' VPA-metabolizing capacity was predicted, and VPA dosing was adjusted to the patients' CYP2C9-status. Clinical and biochemical parameters, such as VPA serum levels, blood cell counts, liver function parameters, and adverse effects in patients of CYPtest group were compared with those of the control group treated with VPA according to conventional clinical practice. CYP2C9-guided treatment significantly reduced VPA misdosing and consequently decreased the ratio of patients out of the range of target VPA blood concentrations. In the CYPtest group of children who received CYP2C9-status adapted dose, serum alkaline phosphatase (ALP) level and the ratio of patients with abnormal ALP levels were substantially lower than in the control group. The incidence of serious side effects, notably hyperammonemia, was reduced in the CYPtest group; however, some other side effects, such as weight changes and somnolence, could not be avoided. The knowledge of pediatric patients' CYP2C9-status can contribute to the optimization of VPA dosing and to the avoidance of misdosing-induced side effects.

Asystole following regadenoson infusion in stable outpatients

Regadenoson is a selective A2A receptor agonist approved for use as a pharmacologic stress agent for myocardial perfusion imaging after several multicenter trials demonstrated its equivalence in diagnostic accuracy for the detection of coronary artery disease and a decreased incidence of serious side effects as compared to adenosine. Recently, the FDA released a safety announcement advising of the rare but serious risk of heart attack and death associated with regadenoson and adenosine in cardiac stress testing, particularly in patients with unstable angina or cardiovascular instability. We report two cases of asystole with hemodynamic collapse in stable outpatients soon after receiving a standard regadenoson injection. The prevalence of potentially life threatening bradycardia, including asystole, associated with the use of regadenoson may be greater than previously expected. These cases highlight the need for cardiac stress labs to anticipate the potential for serious side effects with all patients during the administration of coronary vasodilators.

Safety and efficacy of low-dose isotretinoin in the treatment of moderate to severe acne vulgaris.

Background:Isotretinoin is indicated for moderate to severe cases of acne which are unresponsive to conventional therapy. The classical recommended dose is 0.5 to 1.0 mg/kg/day. As the side effects are dose related, low-dose isotretinoin therapy for acne is an attractive option; however, but little data exists on the safety and efficacy of this strategy.Materials and Methods:In this prospective, non-comparative study, 50 participants, both male and female, having moderate to severe acne vulgaris were enrolled and treated with isotretinoin at a dose of 20 mg/day (approximately 0.3-0.4 mg/kg/day), for a period of 3 months. Participants were evaluated by means of clinical and laboratory investigations before starting isotretinoin. Investigations were repeated at the end of the first and third months following completion of treatment, and participants were followed up for 6 months to look for any relapse.Results:At the end of the treatment, very good results were observed in 90% of participants. Cheilitis was the most common among the side effects observed and was seen in 98% of the participants. One participant developed vitiligo as a side effect, which is a new finding, and has not reported in literature before. Elevated serum lipid levels were observed in 6% of the participants, and relapse occurred in 4% of the participants over a 6 month follow up period.Conclusion:Three months of treatment with low-dose isotretinoin (20 mg/day) was found to be effective in the treatment of moderate to severe acne vulgaris, with a low incidence of serious side effects. This dose also was more economical than the higher doses.

Abiraterone Acetate for the Treatment of Castrate-Refractory Prostate Cancer

Patients with de novo metastatic prostate cancer are primarily treated with androgen deprivation with very high (&gt;95%) response rates, but all patients eventually develop castrate-refractory prostate cancer, which has a poor prognosis. Accumulating evidence suggests that continued androgen receptor signaling remains critical for survival and growth, with adrenal and intratumoral sources of androgens contributing to disease activation. Abiraterone acetate is a novel androgen biosynthesis inhibitor that has been shown to improve survival for patients with metastatic castrate-refractory prostate cancer who have progressed on docetaxel chemotherapy. It is a well-tolerated orally administered drug with a low incidence of serious side effects, taken with prednisone to reduce the secondary effects of mineralocorticoid excess. In the chemo-naive population, a recent trial has also shown improved outcomes, and ongoing studies are investigating its role even earlier in the disease course and in combination with other drugs.

Perioperative iron administration as an alternative to blood transfusion in major surgery

SUMMARYIn the surgical setting, anemia is a common feature and an independent risk factor for blood transfusion, inpatient complications, delayed hospital discharge and poorer functional recovery. Despite adverse side effects and the increasing costs to health systems, allogeneic blood transfusion is the standard of care for anemia. Within this context, NATA (Network for the Advancement of Transfusion Alternatives) guidelines advocate steps towards prevention, diagnosis of anemia and stimulation of erythropoiesis in surgical patients. These include iron – p.o. and i.v. formulations – and recombinant human erythropoietin (rHuEPO) as viable alternatives pre‐, peri‐ and/or postoperatively. The combination of these methods with restrictive transfusion triggers, tranexamic acid and blood salvage techniques may reduce perioperative transfusion rates. The main objective of this article is to briefly review the use of iron in surgical patients, with special focus on orthopedic surgery. From the analyzed information, it can be concluded that, despite the lack of large randomized controlled trials, results indicate that because of the low incidence of serious side effects and the rapid increase of hemoglobin levels, i.v. iron emerges as a safe and effective drug for treating and preventing perioperative anemia. In addition, i.v. iron administration reduces rHuEPO dose requirements. The use of new i.v. iron formulations will allow the administration of large doses in a single session, thus facilitating a more widespread use of this therapeutic option.

Incidence of serious side effects with intravenous bisphosphonate: a clinical audit

Bisphosphonates (BP) have been associated with osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFF). The prevalence of these side effects in intravenous (IV) BP-treated subjects is not well understood. This audit aimed to delineate the prevalence of ONJ, thigh pain and AFF in patients having regular IV BP and its effect on bone mineral density (BMD). Design and Patients attending for IV BP over a 3-month period completed a questionnaire about thigh pain and dental health. Data concerning BMD, treatment indication and treatment history were obtained from medical records. There were 201 patients between 28 and 94 years (74.1% female) mostly on zoledronate (ZOL) (102) or pamidronate (PAM) (97). Osteoporosis (75.6%) and Paget's disease (16.5%) were the main indications for treatment; median length of IV BP was 4 years (range 0.25-25). One patient had ONJ (0.5%) while oral pain was reported by 6.5% and 12.7% noted tooth loosening. Twenty-seven subjects (13.4%) complained of current thigh pain. AFF occurred in four patients (2%), none of whom had idiopathic osteoporosis. At time of AFF, only one patient had a femoral neck T-score less than -2.5. All four had received pamidronate treatment; median 12.5 years (range 7-22). IV BP treatment significantly increased lumbar spine BMD but not femoral neck BMD. Classical ONJ was rare (0.5%), although tooth loss was more frequent. Thigh pain was frequent while AFF occurred in 2.0% of subjects and was associated with long treatment periods and non-osteoporotic bone.

Modafinil for excessive daytime sleepiness in myotonic dystrophy type 1 – The patients’ perspective

Excessive daytime sleepiness (EDS), of very similar pattern to that seen in narcolepsy syndrome, is extremely common in myotonic dystrophy type 1 (DM1). In a significant minority it has a profound disabling effect on employment, social functioning and activities of daily living. Limited published studies have shown inconsistent results from use of the psychostimulant drug modafinil. A recent European Medicines Agency (EMA) review concluded that on current evidence regarding safety and efficacy, modafinil’s use should be restricted to the treatment of narcolepsy. In other conditions (although DM1 was not specifically considered) it was concluded that there was insufficient evidence of benefit to outweigh potentially serious side-effects, including severe skin reactions and cardiac arrhythmia. Clinicians with extensive experience in the management of DM1 have found modafinil to be extremely effective in appropriately selected patients with a very low incidence of serious side-effects. Given the recent EMA review, patients have expressed concern about the potential restriction of the use of modafinil in DM1. This brief review is an audit of the experience of a large group of patients and their clinicians concerning EDS and DM1 and concludes that despite the limited literature there is strong evidence to support the use of modafinil in carefully selected patients.

Severe Pulmonary Complication in Chemotherapy-Naive African-American Patient Following Bortezomib Therapy: a Case Report

Abstract 5144 BACKGROUNDBortezomib is widely used to treat multiple myeloma (MM). It is also used in the management of recurrent, relapsed and chemotherapy-refractory other hematological malignancies. Bortezomib is considered to be a safe drug with manageable adverse side effects including peripheral neuropathy, thrombocytopenia and gastrointestinal symptoms. Rare but severe pulmonary complication has been reported in four Japanese and two African-American (AA) patients after bortezomib treatment for multiple myeloma refractory to multiple other regimens. To the best of our knowledge, this is the first case of chemotherapy-naïve AA patient who developed severe pulmonary complication after receiving bortezomib. CASE REPORTA 51-year-old AA female known for hypothyroidism, was diagnosed with IgG kappa MM after she presented with low back pain and was found to have a lytic lesion and compression fracture at the tenth thoracic vertebra. She was started on palliative radiation therapy to T5 to T12 (to a total of 2500 cGY). Four days after starting the radiation therapy, she received bortezomib (1.3 mg / m2) on days 1, 4, 8 and 11 combined with low dose dexamethasone (40 mg IV weekly). On day 12, she developed a dry cough, dyspnea and fever of 101.4 0F. On physical examination, she had coarse crackles in all lung fields. Her white blood cell count remained within normal limit. Computed tomography of the chest with contrast identified new diffuse patchy opacities throughout the lung fields and small bilateral pleural effusions, but no evidence of pulmonary embolism. She became progressively hypoxic and was transferred to the Intensive Care Unit (ICU). Echocardiogram confirmed normal left ventricular function. She was subsequently intubated. Bronchoscopy was done, bronchioalveolar lavage failed to show any infectious organisms or malignancy, whereas transbronchial biopsy showed organizing pneumonia. The patient was treated with intravenous antibiotics and high dose steroid (methylprednisolone 1000mg/24hrs) for 3 days with rapid clinical improvement and was quickly weaned off the ventilator. DISSCUSIONThe incidence of serious side effects of bortezomib was reported to be less than 5%. Severe pulmonary complications after bortezomib treatment are particularly rare (Richardson PG et al, 2003). In 2006, Miyakoshi S. and colleagues described four Japanese patients who presented with severe pulmonary complication after bortezomib treatment. A genetic predisposition and previous auto peripheral blood stem cell transplant (PBSCT) have been attributed to the adverse effect seen exclusively in Japanese patients. Ohri, Boyer and their colleagues reported similar pulmonary complications in two African-American patients treated with bortezomib (Ohri A et al, 2006; Boyer JE et al, 2006). The clinical symptoms and radiological manifestations of our patient are similar to the previously reported African-American patients. However our case is chemotherapy-naïve whereas previously reported cases were pre-treated with various cytotoxic agents.Our patient had transient fever, no leuckocytosis and negative blood and urine cultures; she also had a negative bronchoalveolar lavage, all argue against the possibility of infection. She had rapid improvement after high dose steroids, which support drug reaction rather than infection. Moreover, organizing pneumonia is a recognized type of drug-induced lung disease (Vahid B et al, 2008) and confirms the adverse event of bortezomib since our patient had no prior chemotherapies and was not on other medication at the time of event. Even if we admit the possibility of spillover effect from the limited field radiation the patient received, the extent of the lung parenchyma injury was far more conspicuous to be explained solely by radiation therapy alone. CONCLUSIONThis report reinforces the possibility of predictable manifestation of severe pulmonary complication due to bortezomib therapy in chemotherapy-naive African American patients. Clinicians should be aware of this potentially fatal complication and need to cautiously monitor their patients for early signs of respiratory problems. It also highlights the reversible nature of the pulmonary complication with high dose steroids. Patients who get radiation therapy to the chest while receiving bortezomib may need special attention. Disclosures:No relevant conflicts of interest to declare.

Comparing the clinical efficacy and safety of high doses of beclomethasone inhaler with medium doses of beclomethasone inhaler combined with oral aminophylline or montelukast tablets in persistent asthmatic Iraqi patients.

Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The treatment guidelines recommend theuse of a second controller drug in addition to medium doses of inhaled corticosteroids (ICSs) rather than the use of high doses ICS alone in the treatment of moderate-severe persistent asthma. This study was conducted to compare the clinical efficacy and safety of three treatment regimens in Iraqi patients with moderate-severe persistent asthma.The study included three groups; each group included 15 patients. Patients were administered beclomethasone inhaler alone 1500-2000 μg/day, beclomethasone inhaler 750-1000 μg/day plus oral controlled release aminophylline tablets 450 mg/day or beclomethasone inhaler 750-1000 μg/dayplus oral montelukast tablets 10 mg/day for 4-5 weeks. Patients were followed 2 weeks and 4-5 weeks after the baseline visit. In all of the three groups,significant improvements were noticed in pulmonary function test parameters (FEV1, FVC, FEF50%) and the asthma symptom records (day-time symptoms,night-time symptoms, number of salbutamol puffs per 24 hours), while there were no significant differences among the groups. Regarding side effects, onlythe group of inhaled steroid plus aminophylline tablets showed discontinuation of drug therapy in some patients which could be attributed to the development of serious side effects.It was concluded that the administration of a second controller agent was important to use lower doses of inhaled beclomethasone. It was concluded alsothat montelukast was associated with a lower incidence of serious side effects than aminophylline which could make aminophylline an alternative to montelukast as combination therapy with medium doses ICS in the treatment of moderate-severe persistent asthma

Phase I clinical trial outcomes in 93 patients with brain metastases: The M. D. Anderson Cancer Center experience.

e16546 Background: Patients with brain metastases are often excluded from clinical trials, but it is unclear if they pose an enhanced risk. Methods: We reviewed the records of 1,181 consecutive patients with and without brain metastases treated in the Phase I Clinical Trials Program. We compared clinical outcomes in patients who presented with and without brain metastases during the same time period. Results: Of 1,181 patients, 93 had brain metastases at the time of referral (median: age, 54 yrs, number of prior therapies, n=4). The rates of stable disease ≥ 4 months/ partial/ complete response in patients with and without brain metastases were 17% and 27%, respectively (p= 0.03). Although the median survival for patients with brain metastases was shorter than for that of patients without brain metastases (7.5 vs. 10.3 months; p = 0.002), in multivariate analysis the presence of brain metastases was not an independent factor predicting survival. There was no difference in time-to-treatment failure (TTF) (1.74 vs. 1.84 months, respectively; p = 0.61) or in Grade 3-4 toxicity (including neurologic) between patients with and without brain metastases (12% vs. 10%, p = 0.77). When treatment-related neurotoxicity ≥Grade 3-4 was compared between 93 patients with brain metastases and 527 patients without brain metastases treated in the same protocols, the respective rates were 4.3% (n=4) and 2.27% (n=12) (p 0.435). Conclusions: The rates of survival and response of patients with brain metastases were lower than those for other patients in the Phase I setting, but the presence of brain metastases was not an independent prognostic factor predicting survival, indicating that other covariates that co-exist with brain metastases were more significant. TTF for patients with brain metastases was not decreased, nor was the incidence of serious side effects (including neurotoxicity) increased, suggesting that these patients should be eligible for early clinical trials.

Galantamine (Reminyl) once daily outcome and satisfaction survey (RODOS) in mild to moderate Alzheimer's disease: A study in a real life population

To record in real life the appreciation of elderly patients, their caregivers and physicians of a once daily formulation of prolonged release of galantamine in the treatment of mild to moderate Alzheimer's disease. A prospective, multicenter, observational study was conducted in 128 elderly patients, treated for 6 months with galantamine, donepezil or rivastigmine. Of the patients treated with galantamine, 82 of the 97 (84.5%) were continuing their treatment after 6 months. These patients reported their condition as improved in 49%, unchanged in 47% and worsened in 4%. Caregivers rated global evaluation as 37% better, 41% unchanged and 22% worse. Physicians rated global clinical impression of change as 46% better, 34% unchanged and 20% worse. Measurements of cognition and behavior remained stable. The appreciation of physicians and caregivers corresponded well (P<0.001). The incidence of serious side-effects possibly related to galantamine was 9.3%, which was not different from that in patients treated with other cholinesterase inhibitors. In a real life setting, galantamine once daily is safe and is favorably appreciated by patients, their caregivers and physicians.