Patients Achieved Treatment Success Research Articles

Preliminary research on clinical value of localization of upper airway obstruction with nasopharyngeal airway combined with polysomnography

To investigate the clinical value of localization of upper airway obstructive site with the method of combination of nasopharyngeal airway and polysomnography (PSG). Forty-seven patients diagnosed as obstructive sleep apnea hypopnea syndrome (OSAHS) by PSG were enrolled. Each patient was examined by Somte PSG for the first night, underwent repeated PSG examination with the nasopharyngeal airway in place for the second night and received airway continuous pressure measurements (ApneaGraph) examination for the third night. The standard of treatment success was defined as apnea-hypopnea index (AHI) less than 20/h and a reduction of 50% or more. The patients were divided into success group and failure group. The PSG indices and ApneaGraph data of the two groups were compared. Correlations between AHI with nasopharyngeal airway in place by PSG and lower AHI and constituent ratio of lower obstruction by ApneaGraph were calculated. SPSS 17.0 software was used to analyze the data. Forty-two patients completal three-night examination. With the nasopharyngeal airway in place, AHI, the lowest oxyhemoglobin saturation (LSaO2), average oxyhemoglobin saturation, percent of sleep time with oxyhemoglobin saturation <0.90 (SaO2 < 0.90T%) were improved obviously (P < 0.001). Twenty-nine patients (69.0%) achieved treatment success. There were statistical differences (t = 2.670, P = 0.011; Z = -3.252, P = 0.001 and t = -4.556, P < 0.001) of LSaO2 by PSG, lower AHI and constituent ratio of lower obstruction by ApneaGraph compared success group with failure group. The correlations between AHI with nasopharyngeal airway in place by PSG and lower AHI and constituent ratio of lower obstruction by ApneaGraph were 0.616 (P < 0.001) and 0.526 (P < 0.001). The method of combination of nasopharyngeal airway with PSG is a reliable method of localization of upper airway obstructive site and can be used as a simple means to find out if there's any retroglossal obstruction.

A Randomized Clinical Trial Comparing Methotrexate and Mycophenolate Mofetil for Noninfectious Uveitis

To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Multicenter, block-randomized, observer-masked clinical trial. Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31). There was no statistically significant difference in corticosteroid-sparing control of inflammation between patients receiving methotrexate or mycophenolate mofetil. However, there was a 22% difference in treatment success favoring methotrexate.

Tuberculosis diagnosed in a rural setting in Angola. Accuracy of follow-up sputum smears to predict outcome

Objective: To analyze treatment outcome and the accuracy of positive sputum smear at 2 months to predict treatment failure in a cohort of patients with tuberculosis (TB) in a rural setting in Angola.Design: Observational study of patients with TB from January 2009 to August 2010 in Hospital Nossa Senhora da Paz in Angola. A multivariate analysis was performed to identify variables associated with treatment failure and death. Sensitivity, specificity, positive and negative predictive values and likelihood ratios to define the accuracy of a positive sputum smear at 2 months to predict treatment failure were calculated.Results: One thousand four hundred and twenty-five patients were diagnosed with TB. Overall, 526 patients were cured from TB and 419 had treatment completed, so 945 (66·3%) patients achieved treatment success. The outcomes of the remaining patients were: 91 (6·4%) had treatment failure, 100 (7%) died, 49 (3·4%) interrupted treatment, and 240 (16·8%) were transferred out. Variables associated with a higher risk of treatment failure were previously treated patients (odds ratio, 2·36; 95% confidence interval, 1·32–4·2) and positive sputum smear at 2 months (odds ratio, 9·81; 95% confidence interval, 5·88–16·36). Among the group of 551 patients with sputum smear confirmed at diagnosis and specimens taken at 2 and 5 months, the positive predictive value (31%) and the positive likelihood ratio (3·21) of a positive sputum smear taken at 2 months to predict treatment failure were low.Conclusions: Patients with positive sputum smear at 2 months have a higher risk of treatment failure. However, this by itself is a poor predictor of treatment failure.

An assessment of adalimumab efficacy in three Phase III clinical trials using the European Consensus Programme criteria for psoriasis treatment goals

The European Consensus Programme (ECP) established pan-European consensus definitions of psoriasis disease severity and treatment goals among 19 psoriasis experts from European nations. To use the ECP treatment goals to retrospectively assess adalimumab efficacy in patients who participated in Phase III clinical trials and met ECP criteria for moderate to severe psoriasis. Three trials were analysed: CHAMPION (n = 108), REVEAL (n = 814) and BELIEVE (n = 364). Moderate to severe psoriasis was defined as Dermatology Life Quality Index (DLQI) score > 10, with either > 10% body surface area involvement or Psoriasis Area and Severity Index (PASI) score > 10. Treatment goals were achieved with either treatment success (≥ 75% PASI score reduction) or intermediate response (PASI response ≥ 50% and < 75%) with DLQI ≤ 5. The percentages of patients who achieved treatment goals at week 16 in CHAMPION, REVEAL and BELIEVE were, respectively, (i) treatment success, 79·3%, 72·1% and 68·2%; (ii) intermediate response, 1·7%, 5·0% and 5·0%; or (iii) either goal, 81·0%, 77·1% and 73·2%. DLQI ≤ 5 at week 16 was achieved by 70·7%, 70·1% and 67·4% of patients, respectively. Differences between the percentages of adalimumab- vs. placebo-treated patients achieving treatment success were statistically significant (P < 0·001) from week 4 and week 8 of REVEAL and CHAMPION, respectively. Treatment success was achieved by > 93% of patients who attained treatment goals. At week 16 > 70% of patients achieved ECP treatment goals and met ECP criteria for continued treatment without modification. These results support the utility of ECP treatment goals for the assessment of therapeutic efficacy in moderate to severe psoriasis.

Efficacy of Erythropoietin Combined With Enteral Nutrition for the Treatment of Anemia in Crohn's Disease

Anemia is a common and serious complication in patients with inflammatory bowel disease. The present study was dedicated to evaluate the therapeutic efficacy of erythropoietin (EPO) combined with enteral nutrition (EN) in anemic Crohn's disease (CD) patients, in terms of hemoglobin level, treatment success rate, adverse events, and predictor of this therapy. We performed a prospective study in CD patients. On the basis of hemoglobin level, all enrolled patients were divided into anemic and nonanemic groups. The anemic group was further divided into EPO and non-EPO subgroups, depending on whether EPO was prescribed. Hematological and other parameters were measured initially and in the first 4 weeks after starting treatment. In total, 109 patients (49 nonanemic and 60 anemic, including 38 EPO and 22 non-EPO) were included. The prevalence of anemia in CD was 55.05%. Age, disease behavior, Crohn's Disease Activity Index scores, C-reactive protein, and erythrocyte sedimentation rate were significantly different between anemic and nonanemic groups. An increase in hemoglobin level and a significant decrease in C-reactive protein level were observed in the EPO treatment group. Treatment success rate was 63.16% in the EPO group, whereas none of patients achieved treatment success in the non-EPO group. EPO combined with EN can improve the hemoglobin level in anemic CD patients.

Biliary Stricture after Adult Right-Lobe Living-Donor Liver Transplantation with Duct-to-Duct Anastomosis: Long-Term Outcome and Its Related Factors after Endoscopic Treatment

Biliary stricture is the most common and important complication after right-lobe living-donor liver transplantation (RL-LDLT) with duct-to-duct biliary anastomosis. This study evaluated the efficacy and long-term outcome of endoscopic treatment for biliary stricture after LDLT, with the aim of identifying the factors that influence the outcome. Three hundred and thirty-nine adults received RL-LDLTs with duct-to-duct biliary anastomosis between January 2000 and May 2008 at Kangnam St. Mary's Hospital. Endoscopic retrograde cholangiography (ERC) was performed in 113 patients who had biliary stricture after LDLT. We evaluated the incidence of post-LDLT biliary stricture and the long-term outcome of endoscopic treatment for biliary stricture. The factors related to the outcome were analyzed. Biliary strictures developed in 121 (35.7%) patients, 95 (78.5%) of them within 1 year of surgery. The mean number of ERCs performed per patient was 3.2 (range, 1 to 11). The serum biochemical markers decreased significantly after ERC (p<0.001). Stent insertion or stricture dilatation during ERC was successful in 90 (79.6%) patients. After a median follow-up period of 33 months from the first successful treatment with ERC, 48 (42.5%) patients achieved treatment success and 12 (10.6%) patients remained under treatment. The factors related to the outcome of endoscopic treatment were nonanastomotic stricture and stenosis of the hepatic artery (p=0.016). Endoscopic treatment is efficacious and has an acceptable long-term outcome in the management of biliary strictures related to RL-LDLT with duct-to-duct biliary anastomosis. Nonanastomotic stricture and stenosis of the hepatic artery are correlated with a worse outcome of endoscopic treatment.

Sacral nerve stimulation for intractable constipation

ObjectiveTraditional surgical procedures for intractable idiopathic constipation are associated with a variable outcome and substantial morbidity. The symptomatic response, physiological effect and effect on quality of life of sacral nerve...

An open-label study evaluating the efficacy and tolerability of alefacept for the treatment of scalp psoriasis

Almost 50% of patients with psoriasis also have scalp psoriasis. Although alefacept is safe and effective for the treatment of generalized plaque psoriasis, its efficacy specifically for treating scalp psoriasis has not been formally evaluated. We sought to evaluate the efficacy and tolerability of alefacept in treating scalp psoriasis. Patients (n = 30) with psoriatic plaques covering 30% or more of scalp surface received 15 mg of intramuscular alefacept once weekly for 16 weeks (course 1), followed by 12 weeks of rest. Patients were evaluated for the condition of their scalp psoriasis using the scalp Physician's Global Assessment, a modified Psoriasis Area and Severity Index for the scalp, and scalp Patient's Global Assessment 6 weeks after course 1. Patients who had scalp Physician's Global Assessment scores greater than or equal to 1 at any time between this evaluation and 5 months after the rest period received an additional 12-week course of once-weekly intramuscular alefacept (15 mg) (course 2). Treatment success was defined as attaining scalp Physician's Global Assessment of clear (0) or almost clear (1) at 6 weeks after either treatment course. Six weeks after course 1, 5 (16.7%) patients achieved clear or almost clear status of their scalp psoriasis. All 3 patients whose scalp psoriasis cleared remained clear until the end of the study. Six weeks after course 2, cumulatively, 8 (26.7%) patients achieved treatment success. Not all patients received both courses. There were no treatment-related serious adverse events. This was a single-arm, open-label, noncomparative trial. Alefacept is effective in a subset of patients with scalp psoriasis and is well tolerated.

The Real-Life Safety and Efficacy of Vardenafil

To assess the safety, efficacy and patient acceptability of vardenafil treatment under real-life conditions in patients with erectile dysfunction (ED). The present publication shows the results of a subgroup analysis of a multinational post-marketing surveillance study, including 2824 Middle East patients with ED whose attending physician chose vardenafil as the most appropriate therapy. Patients were assessed at an initial visit for demographic and baseline characteristics. At one or two follow-up visits, covering a period of approximately 2 months or eight vardenafil intakes, patients were interviewed about overall treatment success (general improvement of erection, number of tablets taken until improvement, patient's satisfaction with overall efficacy and tolerability, comparison with last ED treatment). All adverse events were recorded and assessed for a possible relationship to treatment, and for severity. An overall improvement in erections was reported in 94.3% of patients. Most patients achieved treatment success after the first (67.0%) or second (83.6% cumulative) tablet. Diabetic patients had a similar improvement rate (92.2%) and 73.5% of patients who had undergone radical prostatectomy reported an overall improvement. The rate of adverse drug reactions (ADRs) was low (9.1% of patients). The most common ADRs were headache (5.8%), flushing (1.6%), nasal congestion (1.0%), dyspepsia (0.6%) and nausea (0.5%). In total, 88.9% of patients wanted to continue treatment with vardenafil. Vardenafil was effective, reliable and well tolerated in patients with ED treated under real-life conditions.

Incorporating Durability Information in the Comparison of Proportions of Patients with HIV Suppression

In some HIV clinical trials, the proportion of patients who achieve treatment success at a clinically meaningful time point (e.g., 16 or 24 weeks) and the subsequent durability of the treatment success after that time point are collected from two exclusive followup intervals. Two treatments are usually compared in terms of the proportion of patients achieving treatment success at the pre-defined time point and the subsequent durability information is ignored. However, combining the failure/success proportion at the pre-defined time point and the subsequent durability information in one test statistic could be more powerful if the experimental treatment is more efficacious than the control in that either fewer patients fail the experimental treatment at this time point or the responding patients have longer duration of viral suppression. In this paper, we propose a time-to-event type potency/durability endpoint which captures the information from the two exclusive followup intervals. A linear rank statistic to compare the two treatments in terms of this potency/durability endpoint can be interpreted as a weighted statistic to incorporate the potency information at a clinically meaningful time point (e.g., 16 or 24 weeks) and the durability information after that time point. The statistical hypotheses being tested by using this potency/durability endpoint and their clinical interpretations are discussed. A clinical endpoint study in antiretroviral treatment naïve patients is used to illustrate this method. Simulation studies show that this method is more powerful than comparing the success rates alone when the experimental treatment is also more durable in maintaining long term success.

Photographic documentation of the efficacy of oral tazarotene in nodulocystic acne

The clinical potential of oral tazarotene for nodulocystic acne has been assessed in two dose-ranging studies that involved 277 patients and evaluated once-daily doses of 0.4 mg to 2.8 mg (for 12 weeks plus 4 weeks follow-up) and 0.75 mg to 6 mg (for 24 weeks plus 12 weeks follow-up). The results from these studies show that the higher doses of oral tazarotene offer clinically significant superiority over placebo in terms of overall acne severity, the incidence of patients achieving treatment success ( 50% global improvement), and the incidence of patients achieving at least 90% clearing of nodulocystic lesion counts. A total of 53% of patients receiving the 6 mg dose had either no acne or mild acne by the end of the 24-week treatment phase, compared with 19% in the comparative placebo arm. At the end of the 12-week post-treatment phase, the incidence of no acne or mild acne in the 6 mg group remained unchanged relative to the end of the treatment phase (at 53%) and had declined slightly from 19% to 17% in the placebo group.

Optimizing therapy: tazarotene in combination with phototherapy

Phototherapy is often used in combination with other antipsoriatic treatments in an attempt to improve efficacy and reduce patients' cumulative exposure to radiation. Although this aim has been achieved with some combinations, the additional therapies often introduce a potential risk of other tolerability and safety problems. The efficacy of tazarotene reported in clinical trials to date suggest that this drug may help to improve the efficacy of phototherapy, and perhaps reduce the ultraviolet light exposure required without introducing additional, clinically significant problems. Preliminary results from the first 10 patients in a clinical trial investigating such combination therapy are reported here. They demonstrate that the addition of tazarotene to UVB phototherapy increases the percentage of patients achieving treatment success (> or = 50% global improvement in psoriasis) from 60% to 100% at Day 81. The UVB plus tazarotene combination achieved consistently greater reductions in the elevation and scaling of difficult-to-treat psoriatic plaques than UVB phototherapy alone or UVB phototherapy plus vehicle gel. The tazarotene combination therapy also achieved initial treatment success in less than half the time needed with phototherapy alone (median of 32 vs. 67 days). Combining UVB phototherapy with tazarotene treatment appears to offer a valuable therapeutic option that is more efficacious and faster than UVB phototherapy alone.