One-year Treatment Research Articles

Economic Evaluation of Clopidogrel in Acute Coronary Syndrome Patients without ST-Segment Elevation in Greece

Current guidelines recommend treatment with antiplatelet and anticoagulant therapy for the secondary prevention of atherothrombotic events among patients with non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA). The CURE (Clopidogrel in Unstable angina to prevent Recurrent Events) trial has shown that clopidogrel alone or in combination with aspirin is more effective in reducing the risk of atherothrombotic events than aspirin alone in NSTEMI or UA patients. However, in the current climate of financial constraints, the effectiveness of a treatment should be considered in conjunction with its long-term economic costs to determine the best possible care. To evaluate the cost effectiveness of 1 year of treatment with clopidogrel in addition to aspirin in NSTEMI or UA patients from the third-party-payer perspective in Greece. An existing Markov model consisting of six states (NSTEMI/UA/no event, first year with stroke, history of stroke, first year with myocardial infarction [MI], history of MI and death) was adapted and extended to the Greek healthcare setting for year 2012. Utility values obtained from a Greek national study were assigned to each health state in order to estimate the quality-adjusted life-years (QALYs). Costs assigned to each health state included antiplatelet treatment cost, cost for the management of adverse events and the costs for concomitant medication, hospitalization, outpatient visits, rehabilitation and nursing. Cost effectiveness and cost utility was expressed as the cost per life-year (LY) gained and QALY gained, respectively. A probabilistic sensitivity analysis was conducted. The Markov analysis predicts a discounted survival of 8.27 years in the aspirin treatment group and 8.41 years in the aspirin plus clopidogrel treatment group. The corresponding discounted QALYs were 6.88 and 7.00, respectively. The cumulated lifetime costs per patient were € 18 779 and € 19 191, for the aspirin and aspirin plus clopidogrel treatment arms, respectively. The incremental cost-effectiveness ratio (ICER) with the addition of clopidogrel was &U20AC;2951 for each LY saved and &U20AC;3541 for each QALY saved. Finally, clopidogrel plus aspirin was found to be cost effective in more than 95% of simulated samples at a threshold of &U20AC;7000 per discounted QALY gained. One-year treatment with clopidogrel in addition to aspirin is a cost-effective treatment option for secondary prevention in patients with acute coronary syndrome without ST-segment elevation in Greece.

One-Year Treatment Continuation in Patients Prescribed Risperidone Long-Acting Injection in New Zealand: A Retrospective Study

Treatment discontinuation is a major problem in routine clinical settings and is associated with poorer outcomes for conditions like schizophrenia. Risperidone long-acting injection (RLAI) has shown low discontinuation and good tolerability in long-term clinical trials. This retrospective study investigated RLAI continuation in a naturalistic clinical setting in New Zealand. Those starting publicly funded RLAI between October 1, 2005 and October 31, 2006 in five public mental health services were included in the study. Data were retrospectively collected for 443 patients 12 months pre- and post-RLAI initiation. Patient demographics, diagnosis, antipsychotic treatment and treatment setting were obtained from clinical files and patient information systems. Patients were mostly male (64%), the mean age was 35.9 years, and were predominantly European (43%) or Māori (29%). Most started RLAI due to adherence issues (77%). Adverse events due to RLAI were reported by 39%; most commonly, extrapyramidal side effects. Fifty-eight percent of patients continued treatment 12 months after starting; patient choice (either refusal or failure to turn up) was the most common reason for discontinuation (54%), followed by lack of efficacy (29%). Alternative antipsychotic treatment was prescribed for 79% of those who discontinued. Regression analysis found continuation was more common for people started in the community, on a compulsory treatment order, with a dose of >25 mg and for non-Māori. RLAI appears well-tolerated and over half the patients continued treatment for one year or more. Using treatment continuation as an indicator of effectiveness, RLAI appears to be an effective treatment for people with adherence problems in this real world practice setting.

Utilization and Costs of Health Care after Geriatric Traumatic Brain Injury

Despite the growing number of older adults experiencing traumatic brain injury (TBI), little information exists regarding their utilization and cost of health care services. Identifying patterns in the type of care received and determining their costs is an important first step toward understanding the return on investment and potential areas for improvement. We performed a health care utilization and cost analysis using the National Study on the Costs and Outcomes of Trauma (NSCOT) dataset. Subjects were persons 55-84 years of age with TBI treated in 69 U.S. hospitals located in 14 states (n=414, weighted n=1038). Health outcomes, health care utilization, and 1-year costs of care following TBI in 2005 U.S. dollars were estimated from hospital bills, patient surveys, medical records, and Medicare claims data. The subjects were further analyzed in three subgroups (55-64, 65-74, and 75-84 years of age). Unadjusted cost models were built, followed by a second set of models adjusting for demographic and pre-injury health status. Those in the oldest category (75-84 years) had significantly higher numbers of re-hospitalizations, home health care visits, and hours per week of unpaid care, and significantly lower numbers of physician and mental health professional visits than younger age groups (age 55-64 and 65-74 years). Significant age-related differences were seen in all health outcomes tested at 12 months post-injury except for incidence of depressive symptoms. One-year total treatment costs did not differ significantly across age categories for brain-injured older adults in either the unadjusted or adjusted models. The unadjusted total mean 1-year cost of care was $77,872 in persons aged 55-64 years, $76,903 in persons aged 65-74 years, and $72,733 in persons aged 75-84 years. There were significant differences in cost drivers among the age groups. In the unadjusted model index hospitalization costs and inpatient rehabilitation costs were significantly lower in the oldest age category, while outpatient care costs and nursing home stays were lower in the younger age categories. In the adjusted model, in addition to these cost drivers, re-hospitalization costs were significantly higher among those 75-84 years of age, and receipt of informal care from friends and family was significantly different, being lowest among those aged 65-74 years, and highest among those aged 75-84 years. Identifying variations in care that these patients are receiving and determining the costs versus benefits is an important next step in understanding potential areas for improvement.

Sa1895 The First Clinical Pilot Study of Adrenomedullin Therapy in Refractory Ulcerative Colitis: the Initial Six Cases

were analyzed. 68.4% of the CD patients received infliximab, 31.6% adalimumab. 21.1% of the CD patients received previous episodic/continuous biological therapy. Extraintestinal manifestations were present in 54.5% of the patients. Concomitant immunosuppressions at induction therapy were steroids in 62% and azathioprine in 81.8% of patients. Medical records were captured prospectively; data of the CD and UC groups were analyzed separately. Results: 78.5% of the patients were in remission after a one-year treatment period. Dose intensification was needed in 13.8% of CD and in 11.4% of UC patients. Biological therapy had to be restarted because of clinical flare after remission in 45.9% of CD patients and in 28.6% of UC patients after a median of 8 months. 41.1% of these IBD patients with restarted biologics were in remission at the end of the second year. In a logistic regression analysis corticosteroid use at induction (p=0.034, OR: 1.58, 95% CI: 1.04-2.41), previous anti-TNFα therapy (p=0.03, OR: 2.84, 95% CI: 1.11-7.30) and dose intensification (p=0.008, OR: 6.25, 95% CI: 1.62-24.2) were associated with the need for restarting biological therapy in CD. Numerically, need for restarting of biological therapy was more common in men, in smokers and in patients who underwent appendectomy. None of the examined factors were associated to the need for restarting biological therapy in UC. Discussion. Biological therapy had to be restarted in almost half of the CD patients after the discontinuation within a median of 8 months after the discontinuation, despite being in remission at one-year. Steroid use, previous biological therapy and dose intensification but not CRP was identified as predictors for the need for restarting biological therapy.

Sa1894 High Restarting Rate Among Patients With Crohn's Disease After Cessation of One-Year Treatment Period With Biologicals: Result of National Rash Study

Sa1894 High Restarting Rate Among Patients With Crohn's Disease After Cessation of One-Year Treatment Period With Biologicals: Result of National Rash Study

Omalizumab Modulates Bronchial Reticular Basement Membrane Thickness and Eosinophil Infiltration in Severe Persistent Allergic Asthma Patients

Severe persistent asthma causes a substantial morbidity and mortality burden and is frequently not well controlled, despite intensive guideline-based therapy. The unique monoclonal antibody approved for patients with severe allergic asthma is omalizumab: a recombinant humanised murine against IgE antibodies. The aim of the present study is to investigate the effect of long-term anti-IgE on the thickening of the reticular basement membrane (RBM) and eosinophil infiltration in bronchial biopsies from patients with severe persistent allergic asthma. Biopsies were obtained from 11 patients with severe persistent allergic asthma before and after (12 months) treatment with omalizumab. RBM thickness and eosinophils were measured by using light microscope image analysis. A significant mean reduction in RBM thickness and eosinophil infiltration were measured after one-year omalizumab treatment. No correlation between eosinophil reduction and RBM thickness reduction was found. No correlation between each of the previous two parameters and clinical parameters was detected. In conclusion, our study showed that a substantial proportion of severe asthmatics reduced the original bronchial RBM thickness and eosinophil infiltration after one-year treatment with anti-IgE, thus emphasizing the possible role of omalizumab in affecting airway remodeling in severe persistent allergic asthma.

Abstract 92: One-Year Health Status Benefits Following Invasive Treatment for Lower-Extremity Peripheral Arterial Disease: The Importance of Patients' Baseline Health Status

Introduction: The decision-making process for invasive treatment in lower-extremity peripheral arterial disease (PAD) is ambiguous. There is a lack of appropriateness criteria and limited information available on health status gains to be expected following invasive treatment. We compared 1-year health status outcomes by the receipt of invasive treatment among patients with PAD and evaluated whether baseline health status was indicative of the 1-year health status gains, assuming that patients with lower baseline health status scores would receive the highest benefit. Methods: Baseline and 1-year health status (SF-12, Physical Component Score [PCS]) was assessed in 380 patients with newly diagnosed PAD (Rutherford 1-3) enrolled from 2 Dutch vascular clinics (March ‘06-November ’10). The 1-year treatment strategy (invasive [endovascular, surgery] vs. non-invasive [exercise therapy]) and clinical information was abstracted. Mean 1-year health status scores were compared by invasive treatment. Propensity weights were calculated for the receipt of invasive treatment using baseline characteristics and included in a linear regression analysis to predict 1-year PCS scores, with 1-year treatment strategy, baseline PCS scores, and the interaction between 1-year treatment strategy and PCS scores as predictors, while adjusting for demographics, lesion location, clinical risk factors, and depression. Results: Invasive treatment was performed in 38% (192 of 380). Patients with baseline health status scores in the lowest quartile undergoing invasive treatment had the greatest health status improvement (11.6±10.5 vs. 4.2±8.1, P<.0001), whereas those in the highest quartile did not improve significantly, regardless of the treatment strategy (0.1±6.3 vs. -2.5±8.4, P=.17) (Figure). One-year invasive treatment (B=5.51; 95%CI 0.55;10.48; P=.03) and lower baseline health status scores (B=-.44; 95%CI -.57;-.33; P<.0001) were independently associated with greater 1-year health status gains. The interaction with baseline health status and treatment strategy failed to reach significance (P=.36). Conclusions: Although invasive treatment in lower-extremity PAD is associated with clinically relevant 1-year health status benefits, we found that patients with lower starting levels of their health status had more to gain. Whether or not this will imply that only patients below a certain health status threshold should be offered invasive treatment needs to be subject of further research.

Endovascular treatment of descending thoracic aortic rupture

To update our experience with descending thoracic aortic rupture (DTAR) endovascular repair over a 6-year period. This was a prospective, non-randomized, single-centre study. We included all patients diagnosed with rupture of the thoracic aorta, who underwent endovascular grafting between January 2005 and January 2011. Data were analysed using SPSS version 15.0. During the study interval 25 patients were diagnosed with DTAR. Sixteen patients with ruptured degenerative aneurysm (64%), four traumatic transection (16%), three acute complicated type B dissection (12%) and two acute complicated penetrating ulcer (8%). Nineteen patients (76%) were men, six women; the mean age was 62.96 (±19.75) years. At admission, mean standard euroSCORE was 8.46 (±3.55), and mean APACHE II 14.96 (±8.53). Emergent endovascular stent grafting was successfully performed in all patients, no conversion to open repair was necessary. Mortality at Intensive Care Unit was 16% (four patients). Overall follow-up (mean 26.6 months, range 3-68) mortality in our series was 28%. Only one patient suffered a severe neurological complication (stroke). Late complications of endovascular procedure and need for reoperation appeared in one patient because of a secondary leak. Although this study is not a comparative analysis of DTAR, mortality and morbidity rates were lower than previously reported with emergent open surgical repair. One-year treatment results indicate a low incidence of graft-related complications. Endovascular treatment of the thoracic aortic rupture should be considered feasible and well tolerated in the short and medium term.

Outcomes of patients with first-episode schizophrenia at one-year follow-up: Findings from the National Mental Health Registry in Malaysia

Introduction This first outcome study for people with first-episode schizophrenia (FES) in Malaysia was based on data collected from the National Mental Health Registry (NMHR). The aim of the study was to assess the outcome of patients diagnosed with schizophrenia, one year after contact with mental health services; and to evaluate treatments as well as the utilization of medical and other services in the country. Methods All patients with FES registered in NMHR between 1 March 2004 and 28 February 2005 were included and 79 centers carried out outcome assessments. Socio-demographic and clinical data were collected and compared with the data in NMHR that was gathered one year ago. Descriptive statistic was used to analyze the data. Results Of 2604 registered patients with FES, only 37.7% had their outcomes successfully assessed. Among those assessed, 25.5% were lost to follow-up and 45.8% were followed-up in different centers. Only two patients committed suicide. Increases in weight gain and body mass index were major concerns. On a positive note, employability improved. Forty percent of the patients had their antipsychotics changed over the one-year period but about 20% of patients were on polytherapy at baseline and after one year. The use of anticholinergic medication dropped remarkably after the one-year treatment period. Discussion This study has shown that one of the great barriers in conducting a nationwide outcome assessment of FES patients was the high attrition rate. Nevertheless, these findings provided an important glimpse into the socio-demographic and clinical outcomes of the patients.

Evaluation of treatment continuation with alosetron by IBS-D severity criteria

Objectives:This article evaluates the characteristics and treatment patterns of female patients with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who were treated with alosetron under a risk management program.Methods:Patients prescribed alosetron (2002–2009) and who voluntarily enrolled in the follow-up study were evaluated. Questionnaires were administered at baseline, Wk 5, Wk 10, and quarterly thereafter for ≤1 year. Subgroup analyses were conducted in female patients with IBS-D ≥6 months, stratified by IBS-D severity criteria met (1–3) from the alosetron prescribing information (treatment recommended in female patients meeting ≥1 severity criterion). The voluntary and observational nature of the study are potential limitations, such that eligible patients in the clinical practice setting may have had more severe IBS-D, possibly representing a more motivated and homogeneous subpopulation of patients than the broader IBS-D population.Results:A total of 7841 patients enrolled in the study; 92.4% were adult females; 79.4% (n = 6229) met label criteria. Mean follow-up time was ∼10.3 months; 50.3% completed 1 year. Of the 6229 female patients, 76.9% met 3/3 severity criteria; 21.5% met 2/3 severity criteria; 1.4% met 1/3 severity criteria. The most common complaint was restriction of daily activities, followed by accidents/fecal incontinence, and stomach cramps/bloating. One-year treatment continuation was ≥64% across IBS-D severity groups.Conclusions:One-year treatment continuation with alosetron was high, irrespective of the number of IBS-D severity criteria met. Restriction of daily activities was the primary indicator of disease severity. These findings demonstrate that alosetron continues to be safely and effectively used under the risk management program, and appears to provide long-term benefit in appropriate patients with IBS-D.

P378 High restarting rate among patients with Crohn's disease after cessation of one-year treatment period with biologicals: Result of national RASH study

Background: Infliximab has been shown to be effective for moderate-to-severe ulcerative colitis (UC). We evaluated the long-term outcome after Infliximab treatment in patients with distal steroids-dependent refractory UC. Methods: From January 2007 to October 2011 109 consecutive patients (median age 32 years, range 15 65) with distal active refractory UC (mean Mayo score 6, range 4 9) were treated with Infliximab (induction with 5mg/kg at week 0, 2, 6 and maintenance at the same dose every 8 weeks) and prospectively followed. Primary end-point was colectomy free survival. Secondary end-points were sustained clinical response and mucosal healing. Results: Thirty-one patients (28.5%) underwent colectomy during a median follow-up of 40 months (range 6 56). Mean time to colectomy was 24 months (range 12 45) after first infliximab infusion. Indipendent predictors of colectomy were absence of short-term endoscopic response and steroidsdependency. Short-term clinical response (defined as a decrease in the partial Mayo score of at least 3 points at week 12) was obtained in 73 patients (67%) and short-term mucosal healing (endoscopic portion of Mayo score 1 or less) in 62 patients (57%). Sustained clinical response was observed in 78 patients (71.5%). No serious adverse events were observed during the follow-up. Conclusions: Our single-center experience shows that 67% of patients have a clinical improvement after 6 weeks-treatment and 71.5% have colectomy-free survival during follow up. Infliximab is an effective treatment in moderate to severe distal ulcerative colitis in patients refractory to standard treatments.

Relation between augmentation index and adiponectin during one-year metformin treatment for nonalcoholic steatohepatosis: effects beyond glucose lowering?

BackgroundInsulin resistance (IR) is the major driving force behind development and progression of atherosclerosis in patients with nonalcoholic fatty liver disease (NAFLD). Therefore, correction of IR is a relevant therapeutic target.We performed the current trial to evaluate whether 12- month metformin therapy improves vascular stiffness in patients with NAFLD and to assess if this improvement is associated with change in glucose control, insulin resistance or circulating adiponectin.MethodsIn randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Central aortic augmentation index (AI) was performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline, at 4-and 12-month treatment period. Metabolic parameters, insulin resistance markers and serum adiponectin levels were determined.ResultsIn placebo group: AI did not improve during the treatment period. Liver function and adiponectin levels did not change during the study.In multiple linear regression analysis, the independent predictors of arterial stiffness improvement were metformin treatment and increase in circulating adiponectin levels.Among metformin treated patients: AI decreased significantly during the study. ALP and ALT decreased during initial 4-month treatment period, however raised to the pretreatment levels after 12 months. Serum adiponectin level tended to increase during treatment period with metformin.ConclusionsMetformin treatment was associated with significant decrease in AI during one year treatment in NAFLD patients. These beneficial vascular effects was associated with exposure to metformin per se as well as change in adiponectin levels suggesting that metformin may mediate its vascular effects via glicemic control-independent mechanisms.Trial registryno: NCT01084486

Topical Tacrolimus is Useful for Avoiding Suction-blister Epidermal Grafting Depigmentation in Non-segmental Vitiligo: A Case Report

Current therapy for vitiligo is largely unsatisfactory; hence there is a need for new treatment combinations to be assessed. Whereas stable vitiligo can benefit from surgical therapies, such as suction-blister epidermal grafting (SBEG) (1), the non-segmental counterpart usually shows a poor response to this treatment (2). To overcome this issue, for high-risk patients affected by both focal and generalized vitiligo, a combined ap-proach of epidermal graft and systemic corticosteroids has been advocated in order to reduce the risk of graft depigmentation (3, 4).We report here the case of a patient affected by ge-neralized vitiligo who was treated successfully with SBEG after a prolonged course of topical 0.1% tacro-limus treatment (Protopic, Astellas Pharma US, Inc.). It is noteworthy that maintaining topical tacrolimus treatment allowed and preserved graft pigmentation for more than one year, whereas, after its discontinuation, graft depigmentation began to develop.CASE REPORTA 62-year-old Caucasian woman presented with well-defined white patches on her face (Fig. 1a), hands and elbows of 2 years duration. She had first noted the skin depigmentation as a side-effect during interferon α-2a treatment for chronic active hepatitis C. This treatment was successful, since viral eradication was reached, but the skin lesions persisted after discontinuation of interferon. She had not had diabetes or any autoim-mune disease such as thyroiditis, as documented by extensive laboratory work-up. She was diagnosed with generalized vitiligo and she commenced applying 0.1% tacrolimus ointment to the facial lesions at bedtime, combined with narrow-band ultravio-let B (NB-UVB) phototherapy twice a week. Topical tacrolimus used in conjunction with ultraviolet (UV) light is effective in increasing the extent of overall repigmentation and in reducing the cumulative NB-UVB dose needed to achieve a therapeutic benefit (5, 6). After one-year treatment she achieved an acceptable level of repigmentation (Fig. 1b) with no further improvement, although treatment continued for an-other year. This finding was consistent with the reported time to reach signi-ficant pigmentation during tacrolimus treatment (7).We proposed a trial with SBEG to co-ver her left forehead, after we had fully informed her about the high chance of graft depigmentation reported for generalized vitiligo. After the grafting procedure, the patient followed the same therapeutic regimen, based on topical tacrolimus at bedtime plus NB-UVB phototherapy twice a week. After 3 months the grafts reached a good pigmentation, so phototherapy treat-ment was stopped (Fig. 1c). We recom-mended the patient to apply tacrolimus treatment each night to help centrifugal pigmentation to spread from the grafts.

Rosuvastatin effect on intima media thickness in adult vs elderly patients

The benefits of cardiovascular therapies such as statins for the treatment of atherosclerosis have been well documented. Many studies have demonstrated important benefits in patients with asymptomatic carotid atherosclerosis. We have evaluated the effect of low dose of rosuvastatin on asymptomatic carotid atherosclerosis in elderly versus adult subjects. Among 640 participants in the Asymptomatic Carotid Atherosclerotic Disease In Manfredonia Study (ACADIM Study) forty-five patients (21 adults, 24 elderly) with hypercholesterolemia and asymptomatic carotid atherosclerosis on baseline carotid ultrasound investigation (CUI) were examined with repeat CUI after one treatment year with rosuvastatin (ROS) (10 mg/day). Total and low density lipoprotein cholesterol decreased significantly (p<0.001) while high density lipoprotein cholesterol increased significantly (p<0.001) during the intervention. Mean decrease in carotid intima media thickness (CIMT) of the right and left common carotid arteries were higher in adult versus elderly subjects (p<0.04 for each), even if in both group there was a significant regression in carotid atherosclerosis respect to baseline values (P<0.001). These results confirm the reduction in IMT of the CCAs in response to ROS at a low dose in a one-year treatment period, even if in elderly subjects this effect is lower respect to adult. The treatment of asymptomatic carotid atherosclerosis defined by CIMT started in the adult age is more effective.

Treatment of Upper Limb Spasticity after Stroke: One-Year Safety and Efficacy of Botulinum Toxin Type A NT201

A new preparation of botulinum toxin type A called NT 201, free from complexing proteins, potentially with low antigenicity has been used in the therapy of spasticity in stroke patients. This was an open-label study reported the safety and the efficacy of one-year treatment with NT 201 evaluating the therapeutic effect on functional disability and on quality of life in upper limb spasticity after stroke. Patients received a botulinum toxin therapy in the upper injected intramuscularly. After inoculation, patients were submitted to a motor rehabilitation program for upper limb injected three times/week. Re-treatment was permitted at 12 weeks after the prior treatment. Safety assessment included evaluation of adverse events and efficacy was measured by Modified Ashworth Scale for spasticity (MAS), Spasm Frequency Score (SFS) for the daily spasms, and Disability Assessment Scale (DAS) for disability. Of 35 consecutive patients (13 women and 12 men) screened for study eligibility, 20 (6 women and 14 men) patients (mean age 63,4±7,03) were included in this study and were submitted to NT 201 therapy for one year. At the baseline, botulinum toxin dose in the upper limb ranged from 160 to 450U, whereas total dose in the last treatment administrated was reduced respect the first injections ranging from 120 to 350U. All the enrolled patients completed the year-long study and reported an improvement of clinical picture. MAS, was statistically (px003C;0,001) reduced in all muscles at T1 (mean score ±SD: 2.65±0.67) and T2 (mean score±SD: 2.55±0.60) in comparison to the baseline T0 (mean score±SD: 3.9 ±0.78). Significant reduction (px003C;0,001) from baseline T0 (mean score ±SD: 3.25±0.78) was also noted in SFS at T1 (mean score ±SD: 1.55±0.51) and T2 (mean score±SD :1.30±0.47). The DAS score showed a reduction of the T1score (mean score ±SD: 1.70±0.47) and T2 score (mean score ±SD: 1,40 ±0,50) respect to baseline T0 score (mean score ±SD: 2,65 ±0,48) statistically significant (p≤003C;0,001). No adverse effects were observed in these patients. NT 201 appeared to be an efficacious and well-tolerated long-term treatment option for patients with upper limb spasticity after stroke, obtaining a substantial improvement in functional disability, muscle hypertone, and daily spasms.

One-Year Treatment Persistence and Potential Adverse Events Among Patients With Atrial Fibrillation Treated With Amiodarone or Sotalol: A Retrospective Claims Database Analysis

Background The risk–benefit profile of antiarrhythmic drugs (AADs) affects the choice of pharmacotherapy for maintenance of sinus rhythm. Adverse events (AEs) associated with AADs may influence patient compliance and compromise the management of atrial fibrillation (AF). There are limited data on the incidence of AEs or persistence with AADs outside the clinical trial environment. Objective This study provides treatment persistence and AE data for patients with AF receiving treatment with amiodarone or sotalol, 2 of the most widely used AADs in the United States. Methods In this retrospective cohort study, patients satisfying the following criteria were identified from the US MarketScan claims databases: (1) age ≥18 years with a pharmacy claim for oral amiodarone or sotalol between 2004 and 2007; (2) ≥1 inpatient/outpatient medical claim with an AF diagnosis <90 days before the earliest (index) pharmacy claim; and (3) ≥12 months' continuous enrollment before and after the index pharmacy claim. Prespecified AE rates were compared between treatment cohorts during active treatment. Results Among 77,093 AF patients with ≥1 claim for amiodarone or sotalol, 3459 met all inclusion criteria (mean age, 70.8 years; 61.6% male; mean Charlson Comorbidity Index [CCI], 1.58), of whom 2392 received amiodarone (mean age, 72.2 years; 62.5% male; mean CCI, 1.8) and 1067 received sotalol (mean age, 67.5 years; 59.7% male; mean CCI, 1.1). Persistence was higher among the sotalol cohort than the amiodarone cohort (53.2% vs 30.6% at 12 months; P < 0.001). Postindex versus preindex comparisons revealed increases in cardiovascular AE rates in both cohorts. Intercohort comparisons showed higher rates of cardiovascular AEs (594 vs 339 patients/1000 patient-years; P < 0.001) and pulmonary AEs (128 vs 61 patients/1000 patient-years; P < 0.001) during active amiodarone treatment. Conclusions Among the population analyzed, patients with AF receiving amiodarone versus sotalol therapy had differing clinical characteristics. Patients experienced frequent AEs (particularly cardiovascular events) with amiodarone and sotalol, and many discontinued treatment during the first year.

Longitudinal treatment outcome of African American and Caucasian patients with first episode psychosis

The purpose of our analyses to examine the outcome differences between African American and Caucasian first-episode psychotic patients over the course of one year, to explore the interactive effects of gender, diagnosis, and race on treatment outcome. A consecutive series of patients ( N = 199) were recruited into our study from the inpatient and outpatient services at a psychiatric clinic. Global functioning, positive, negative, affective, and depression symptoms and treatment adherence were assessed at baseline prior to treatment and during follow-up up to one year. African American patients ( N = 62) were found to experience significantly less improvement in symptoms, bizarre behavior, avolition, anhedonia, and functional performance, and affective symptoms than their Caucasian counterparts ( N = 137). In addition, African American female patients experienced less improvement in affective flattening. While both groups of patients have experienced significant improvement during the one-year treatment, that of the African American patients was less optimal.

The changes of Th17, Tr cells and IL-17 in the process of antiviral treatment of Hunan AIDS patients

Objective To observe the Th17, IL-17 and Tr cells equilibrium state as well as their changes of HIV infected or AIDS suffered patients in one-year HAART treatment. Methods Select 33 HIV/AIDS patients received HAART treatment while 33 healthy volunteers as controls. Flow cytometry was used to analyze Th17 and Tr cells in venous blood at the time of pre-therapy, 6th, 12th month when IL-17 levels in serum are tested by ELISA. Results The ratio of Th17 cells in CD4 cells in HIV/AIDS patients and volunteers were (1.20±0.37)%, (2.50±1.03)%, (3.70±1.56)%, (4.70±1.43)%, respectively; The ratio of Tr cells were (9.16±3.33)%, (7.19±2.91)%, (5.53±1.88)%, (4.43±0.97)%, respectively; The levels of IL-17 in serum were (5.3±2.5) pg/ml, (7.7±2.4) pg/ml, (10.4±3.1) pg/ml, (17.7±6.6) pg/ml respectively. The Th17 cells' level was positively correlative with the amount of CD4 cells, negatively correlate with the count of viral load. However, the Tr cells level is positively correlative with the count of viral load, negatively relate to the quantity of CD4 cells. Conclusion HIV could make IL-17, Th17 cells and Tr cells lost their balance, but the immune equilibrium state may gradually recover after HAART treatment. Which indicates the IL-17, Th17 cells and Treg cells may play an important role in the pathogenesis of AIDS, and they are likely to be the effective indexes to observe the progress of AIDS and the treatment effect of highly active antiretroviral therapy(HAART). Key words: AIDS; HIV; Th17 cell; IL-17; HAART

Frequency and predictors of loss of response to biological therapy in Crohn’s disease after one-year treatment period

Secondary loss of response (initial good response followed by loss of response and flare up) is a frequent event occurring during biological therapy. The aim of this study was to assess loss of efficacy in patients with Crohn’s disease treated with infliximab or adalimumab for a year. Secondary goals were to identify clinical or laboratory predictors of loss of response and to evaluate whether the frequency of dose escalation differs in patients receiving infliximab or adalimumab. Data were provided by a computerized database. Patients and methods: Sixty-one patients with Crohn’s disease achieved remission after induction therapy and received regular maintenance treatment. 35 of them were on infliximab, and 26 on adalimumab therapy. None of the patients treated with infliximab received previous biological therapy, while 10 of the adalimumab-treated patients were naïve to biological therapy. Authors compared the data of patients who relapsed with those who remained in remission and also the characteristics of infliximab-treated patients with adalimumab-naïve patients. Data were analyzed using Chi-square test. Kaplan Meier curve was used to show the time of loss of efficacy. Results: Remission was achieved in 70.5%, and response was achieved in 29.5% of the patients after induction. Loss of response occurred in 22 of the 61 patients after a year of therapy. The proportion of remission after induction was significantly lower in patients who lost response vs. those who remained in remission. More patients with sustained remission received immunosuppressive therapy before and during the biological therapy vs. those with loss of response. Loss of response was significantly more frequent and occurred earlier in adalimumab-naive patients vs. infliximab-treated patients. Conclusion: The need for dose escalation should be calculated in the budget in the majority of patients, especially in adalimumab-treated patients. Orv. Hetil., 2011, 152, 951–957.

Beneficial Effects of Probiotic Bifidobacterium and Galacto-Oligosaccharide in Patients with Ulcerative Colitis: A Randomized Controlled Study

Background/Aim: In previous studies, we described the beneficial effects of bifidobacteria-fermented milk in patients with ulcerative colitis (UC). Here, we examined the effects of a live Bifidobacterium breve strain Yakult, a probiotic contained in bifidobacteria-fermented milk, and galacto-oligosaccharide (GOS) as synbiotics in UC patients. Methods: Forty-one patients with mild to moderate UC were assigned to two groups; one group was treated with the synbiotics and the other was not (control). The treatment group ingested 1 g of the probiotic powder (10⁹ CFU/g) three times a day, and 5.5 g of GOS once a day for one year. At the start and the end of this study, colonoscopic index and the amount of myeloperoxidase in a lavage solution were used as disease activity indices. Bacterial counts in the feces at the start and the end of this study were also examined. Results: After a one-year treatment with the synbiotics, the clinical status of the UC patients as assessed by colonoscopy, significantly improved. Furthermore, the amount of myeloperoxidase in the lavage also decreased in these patients after the synbiotic treatment. The synbiotics significantly reduced the fecal counts of Bacteroidaceae and fecal pH. Conclusion: Administration of live B. breve strain Yakult and GOS can improve the clinical condition of patients with UC. These results encouraged us to perform a large-scale randomized, placebo-controlled trial.