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PubMed2001

Discontinuation of maintenance therapy for cytomegalovirus retinitis in HIV-infected patients receiving highly active antiretroviral therapy.

OBJECTIVE: To study the safety of discontinuing cytomegalovirus (CMV) maintenance therapy among patients with cured CMV retinitis receiving highly active antiretroviral therapy (HAART). METHODS: Patients with a history of CMV retinitis who were receiving anti-CMV maintenance therapy and who had a CD4 cell count > 75 x 10(6) cells/l and a plasma HIV RNA level < 30000 copies/ml while on HAART were included in a multicentre prospective study. Maintenance therapy for CMV retinitis was discontinued at enrolment and all the patients were monitored for 48 weeks by ophthalmological examinations and by determination of CMV markers, CD4 cell counts and plasma HIV RNA levels. T helper-1 anti-CMV responses were assessed in a subgroup of patients. The primary study endpoint was recurrence of CMV disease. RESULTS: At entry, the 48 assessable patients had been taking HAART for a median of 18 months. The median CD4 cell count was 239 x 10(6) cells/l and the median HIV RNA load was 213 copies/ml. Over the 48 weeks, 2 of the 48 patients had a recurrence of CMV disease. The cumulative probability of CMV retinitis relapse was 2.2% at week 48 (95% confidence interval, 0.4-11.3) and that of all forms of CMV disease 4.2%. CMV blood markers remained negative throughout follow-up. The proportion of patients with CMV-specific CD4 T cell reactivity was 46% at baseline and 64% at week 48. CONCLUSIONS: CMV retinitis maintenance therapy may be safely discontinued in patients with CD4 cell counts above 75 x 10(6) cells/l who have been taking HAART for at least 18 months.

AIDS-Related Opportunistic Infections↗

PubMed2002

Effect of grafting technique on the maintenance of coronal and sagittal correction in anterior treatment of scoliosis.

STUDY DESIGN: A retrospective radiographic study was conducted to analyze 50 consecutive adolescents with thoracolumbar-lumbar scoliosis treated with single solid-rod anterior instrumentation and either rib strut or morsellized interbody bone grafting technique. OBJECTIVES: To evaluate the effect of grafting technique on the maintenance of coronal and sagittal plane correction and alignment and the incidence of pseudarthrosis. SUMMARY OF BACKGROUND DATA: Loss of scoliosis correction and progressive kyphosis in the instrumented segment associated with radiographic pseudarthrosis have historically been disadvantages of the anterior technique used to correct thoracolumbar-lumbar scoliosis. METHODS: All the patients underwent anterior discectomy, spinal fusion, and correction with Texas Scottish Rite Hospital instrumentation, with rib strut grafts used in 18 patients to "prop open" disc spaces below L1 and simple morsellized bone graft used in 32 patients. Most of the patients were instrumented from T11-L3 or T10-L2. Maintenance of coronal and sagittal plane correction and alignment was determined from the preoperative, immediate postoperative, and final follow-up radiographs. RESULTS: Scoliosis correction was 72% immediately after surgery, but with an average 6 degrees loss of correction, it was 61% at follow-up evaluation. Final correction of apical vertebral translation was 69%, and trunk shift was 86%. Ten patients lost more than 10 degrees of scoliosis correction. In the sagittal plane, the instrumented segment was corrected initially from a mean of 3 degrees kyphosis to -1 degrees lordosis, but then had settled to 7 degrees kyphosis at follow-up evaluation. Progressive kyphosis exceeding 10 degrees in the instrumented segment was found in 19 patients. The technique of grafting had no effect on the maintenance of correction or sagittal alignment. Rib strut grafting did demonstrate a decreased incidence of pseudarthrosis, as compared with morsellized grafting (P = 0.029). Not unexpectedly, patients with pseudarthrosis had an increased incidence of correction loss, progressive kyphosis in the instrumented segment, instrumentation failure, and revision surgery, which was required in three cases. CONCLUSIONS: Although the rib strut grafting technique improves the pseudarthrosis rate, as compared with morsellized graft, it did not affect the maintenance of correction or sagittal alignment. Adjunctive measures to provide truly structural interbody support (fusion cages, allograft rings, two-rod construct) appear to be required to address the shortcomings of anterior single-rod instrumentation.

Adolescent↗

PubMed1983

Low-dose maintenance prednisone and antilymphoblast globulin for the treatment of acute rejection. A steroid-sparing approach to immunosuppressive therapy.

The purpose of this prospective randomized trial was to evaluate an immunosuppressive protocol involving reduced maintenance and antirejection steroid dosages in cadaver renal transplantation. The study comprises 23 first cadaver graft recipients who experienced an acute rejection episode. All patients received an initial 14-day course of antilymphocyte globulin (ALG) and azathioprine 1.5 to 2.0 mg/kg/day. In 11 patients (group 1), a low maintenance dose of prednisone (30 mg/day) was administered and first rejection episodes were treated with a second 10-day course of ALG. The remaining 12 patients (group 2) received high maintenance doses of prednisone (2 mg/kg/day with tapering) and intravenous methylprednisolone (IVMP) for first rejection episodes. Subsequent rejections in both groups were treated with high doses of steroids. In group 1, all first rejection episodes were reversed with ALG alone, 6 patients experienced no subsequent rejection, and 10 patients currently have a functioning graft. In Group 2, the first rejection episode was reversed with IMVP alone in 10 patients; in two patients in whom IVMP therapy was unsuccessful, ALG was then administered, and subsequent rejection reversal was effected. In group 2, 4 patients experienced no subsequent rejection, and 9 patients currently have a functioning graft. Patients in group 1 received significantly lower (P less than .01) cumulative steroid doses in the first six months following transplantation, which resulted in a reduced number of major infections, as compared with patients in group 2. We conclude that the steroid-sparing regimen of low maintenance prednisone and ALG for first rejection is as effective immunologically as the established high steroid protocol.

Antilymphocyte Serum↗

PubMed1994

Effect of the maintenance immunosuppressive drug regimen on kidney transplant outcome.

Renal transplant recipients require long-term maintenance immunosuppression for prevention of graft rejection. To reduce harmful side effects, combinations of immunosuppressive drugs are used. The effect on long-term outcome of different drug regimen has not been established. Over 12,000 kidney recipients who initially received triple-drug immunosuppressive therapy (cyclosporine, steroids, and azathioprine) after transplantation were studied. Graft and patient survival rates were analyzed over a 5-year period in relation to the 1-year immunosuppressive regimen. Five-year graft survival was significantly higher in 1270 patients who were changed from triple-drug therapy to steroid-free maintenance with cyclosporine (with or without the addition of azathioprine) (87 +/- 1%) than in 8024 patients who remained on triple-drug therapy (76 +/- 1%, P < 0.0001), 2829 patients on cyclosporine and steroids (79 +/- 1%, P < 0.0001), and 830 patients on steroids and azathioprine (63 +/- 2%, P < 0.0001). Patient survival was also significantly higher in patients on steroid-free maintenance (P < 0.0001). Steroid-free patients received significantly higher doses of cyclosporine than patients on regimens containing steroids (P < 0.0001). The immunosuppressive maintenance protocols that are currently most widely used appear to give suboptimal results. We suggest that discontinuation of steroid therapy should be attempted in renal transplant recipients after they have experienced several months of stable graft function on triple-drug immunosuppression.

Azathioprine↗

PubMedDate not supplied

Regular walking and long-term maintenance of outcomes after pulmonary rehabilitation.

BACKGROUND: Empirical evidence supports the role of exercise as part of pulmonary rehabilitation in improving symptoms of breathlessness (dyspnea), health-related quality of life, and exercise tolerance among patients with chronic lung disease. However, many studies show that these initial benefits tend to diminish 12 to 18 months after rehabilitation. Given the importance of exercise (ie, walking) during rehabilitation, we examined whether patient adherence to regular walking enhanced the long-term maintenance of functional benefits gained from an 8-week pulmonary rehabilitation program. METHODS: One hundred twenty-three patients with moderate to severe chronic lung disease completed an 8-week pulmonary rehabilitation program and participated in a 12-month maintenance intervention trial. Measures of weekly walking, lung function, self-efficacy for walking, dyspnea during activities of daily living, exercise capacity (6-minute walk test, 6MW), perceived breathlessness after the 6MW, and health-related quality of life were obtained at postrehabilitation, and at 6, 12, and 24 months after completing pulmonary rehabilitation. Regular walkers were defined as those active on most days or every single day of the week on the average throughout the 24-month period, whereas irregular walkers walked on some days, rarely, or not at all. RESULTS: The effects of the maintenance program on average frequency of walking were nonsignificant, with 44% of the maintenance patients and 38% of the standard care patients classified as regular walkers. There were no significant differences between walking groups on gender, healthcare utilization over the 24-month follow-up period, and postrehabilitation measures of lung function, 6MW distance, perceived breathlessness after 6MW, health-related quality of life, dyspnea, or age. Repeated measures analyses of variance using a 2 x 4 mixed model approach were applied to examine group differences and changes in outcomes over time. Overall, participants decreased in 6MW distance (P <.001), reported increases in perceived breathlessness after the 6MW (P <.05), and decreased in overall health-related quality of life (P <.001) from postrehabilitation to 24 months. Regular walkers reported significantly better health-related quality of life (P <.05) as compared to irregular walkers, averaging across time points. Irregular walkers declined significantly more than regular walkers on measures of shortness of breath during activities of daily living (P <.01) and walking self-efficacy (P <.001) from postrehabilitation to 24 months. CONCLUSIONS: Findings suggest that participation in regular exercise such as walking after completing pulmonary rehabilitation is associated with slower declines in overall health-related quality of life and walking self-efficacy as well as less progression of dyspnea during activities of daily living. Regular exercise after rehabilitation may be protective against increases in dyspnea symptoms and perceived limitations in walking which are both characteristic of progressing chronic lung disease.

Aged↗

PubMed2005

Erlotinib and chemoradiation followed by maintenance erlotinib for locally advanced pancreatic cancer: a phase I study.

OBJECTIVES: A phase I trial was conducted to determine the maximally tolerated dose of erlotinib with concurrent gemcitabine, paclitaxel, and radiation for patients with locally advanced pancreatic cancer and to gather preliminary data on maintenance erlotinib after chemoradiation. METHODS: Patients received gemcitabine, 75 mg/m2, and paclitaxel, 40 mg/m, weekly for 6 weeks with 50.4 radiation to the primary tumor and draining lymph nodes with a 2- to 3-cm margin. Erlotinib was administered over 3-dose levels (50-100 mg/d) with chemoradiation then all patients received 150 mg/d maintenance until disease progression. RESULTS: Seventeen patients were assessable for toxicity; 13 with locally advanced disease and 4 who had undergone resection but had positive margins. At erlotinib dosages > or =75 mg/d with chemoradiation the dose-limiting toxicities were diarrhea, dehydration, rash, myelosuppression, and small bowel stricture. Maintenance erlotinib, 150 mg/d, was well tolerated. The median survival of the 13 patients with locally advanced disease was 14.0 months and 6 of 13 (46%) had a partial response. CONCLUSIONS: The maximum tolerated dose of erlotinib with gemcitabine, paclitaxel and concurrent radiation is 50 mg/d for patients with locally advanced pancreatic cancer. Full dose maintenance erlotinib is well tolerated. Promising preliminary activity and overall survival were demonstrated.

Adenocarcinoma↗

PubMed2006

A common polymorphism in the SCN1A gene associates with phenytoin serum levels at maintenance dose.

OBJECTIVES: A broad range of phenytoin doses is used in clinical practice, with the final 'maintenance' dose normally determined by trial and error. A common functional polymorphism in the SCN1A gene (one of the genes encoding the drug target) has been previously associated with maximum dose of phenytoin used clinically, and also maximum dose of carbamazepine, another antiepileptic drug with the same drug target. METHODS: We have related variation at the SCN1A IVS5-91 G>A polymorphism to maximum dose and to maintenance dose of phenytoin in 168 patients with epilepsy treated with phenytoin. We also related genotype to phenytoin serum levels at maximum dose and at maintenance dose of phenytoin. We genotyped the polymorphism using an Applied Biosystems Taqman assay. RESULTS: The polymorphism is associated with phenytoin serum concentration at maintenance dose (P=0.03). In a reduced cohort of 71 patients receiving phenytoin monotherapy this association is also significant (P=0.03). Neither association remains significant after Bonferroni correction for multiple testing. CONCLUSIONS: These results are not a replication of the original study. They do, however, support the hypothesis that this polymorphism influences the clinical use of phenytoin. They also demonstrate the utility of using multiple phenotypes in pharmacogenetics studies, particularly when attempting to separate pharmacokinetic and pharmacodynamic effects. As the SCN1A polymorphism affects phenytoin pharmacodynamics, it is particularly useful to obtain data on serum levels in addition to dose because association of a pharmacodynamic variant may be stronger with serum levels than dose as the serum level may eliminate or reduce pharmacokinetic variability.

Anticonvulsants↗

PubMed2005

Effect of the self-monitoring approach on exercise maintenance during cardiac rehabilitation: a randomized, controlled trial.

OBJECTIVE: To evaluate the effect of the self-monitoring approach (SMA) on self-efficacy for physical activity (SEPA), exercise maintenance, and objective physical activity level over a 6-mo period after a supervised 6-mo cardiac rehabilitation (CR) program. DESIGN: We conducted a randomized, controlled trial with 45 myocardial infarction patients (38 men, seven women; mean age, 64.2 yrs) recruited after completion of an acute-phase, exercise-based CR program. Patients were randomly assigned to an SMA group (n = 24) or control group (n = 21). Along with CR, the subjects in the SMA group self-monitored their weight and physical activity for 6 mos. The SMA used in this study was based on Bandura's self-efficacy theory and was designed to enhance confidence for exercise maintenance. The control group participated in CR only. All patients were evaluated with the SEPA assessment tool. Exercise maintenance, SEPA scores, and objective physical activity (average steps per week) as a caloric expenditure were assessed at baseline and during a 6-mo period after the supervised CR program. RESULTS: Mean period from myocardial infarction onset did not differ significantly between the SMA and control groups (12.1 +/- 1.3 vs. 12.2 +/- 1.2 mos, P = 0.692). All patients maintained their exercise routine in the SMA group. Mean SEPA score (90.5 vs. 72.7 points, P < 0.001) and mean objective physical activity (10,458.7 vs. 6922.5 steps/wk, P < 0.001) at 12 mos after myocardial infarction onset were significantly higher in the SMA than control group. SEPA showed significant positive correlation with objective physical activity (r = 0.642, P < 0.001). CONCLUSIONS: SMA during supervised CR may effectively increase exercise maintenance, SEPA, and objective physical activity at 12 mos after myocardial infarction onset.

Analysis of Variance↗

PubMed2006

Resolution of SPECT-determined anterior cerebral hypoperfusion correlated with maintenance ECT-derived improvement in residual symptoms in a case of late-life psychotic depression.

A 70-year-old widow with recurrent psychotic depression was successfully treated with maintenance electroconvulsive therapy (ECT) for 4 years up to the present. Anterior cerebral hypoperfusion visualized by single photon emission computerized tomography (SPECT) before ECT persisted (second SPECT study 14 days after the last ECT session) despite a response to the first course of acute ECT. Only mild symptoms remained. Relapse occurred 2 weeks after the post-ECT SPECT study. The hypoperfusion improved after response to a second course of acute ECT (per SPECT 5 days after the last ECT session), and perfusion was normalized after 2-year maintenance ECT (per SPECT 14 days after the last ECT session). The normalization coincided with improvement in depressive symptoms remaining after the second course of acute ECT. We speculate that the effectiveness of maintenance ECT might have been in part the result of the improvement in residual symptoms and that resolution of the persistent anterior hypoperfusion, which might underlie medical refractoriness, illness chronicity, and relapse tendency in late-life depression, might have been associated with the improvement in residual symptoms achieved by maintenance ECT.

Affective Disorders, Psychotic↗

PubMed2004

Long-term immunosuppression, without maintenance prednisone, after kidney transplantation.

BACKGROUND: Concern exists that prednisone-free maintenance immunosuppression in kidney transplant recipients will increase acute and/or chronic rejection. METHODS: From October 1, 1999, through February 29, 2004, at our center, 477 kidney transplant recipients (341 living donor, 136 cadaver) discontinued prednisone on postoperative day 6, per our protocol. Immunosuppression consisted of polyclonal antibody (Thymoglobulin) for 5 days, prednisone intraoperatively and for 5 days, a calcineurin inhibitor, and either sirolimus or mycophenolate mofetil. We compared outcome with that of historical controls who did not discontinue prednisone. RESULTS: The recipients on prednisone-free maintenance immunosuppression had excellent 4-year actuarial patient survival (92%), graft survival (90%), acute rejection-free graft survival (86%), and chronic rejection-free graft survival (95%). The mean serum creatinine level (+/- SD) at 1 year was 1.6 +/- 0.6; at 4 years, 1.6 +/- 0.6. We noted that 8% of recipients had cytomegalovirus (CMV) disease; 4.5%, fractures; 2.8%, cataracts; 1%, posttransplant diabetes; 0.2%, avascular necrosis; 0.2%, posttransplant lymphoproliferative disease; and 0%, polyomavirus. In all, 85% of kidney recipients with functioning grafts remain prednisone-free as of April 1, 2004. As compared with historical controls, the recipients on prednisone-free maintenance immunosuppression had better patient (P = 0.02) and graft survival (P < 0.0001) and lower rates of acute (P = 0.0004) and chronic (P = 0.02) rejection. In addition, they had a significantly lower rate of CMV disease (P < 0.0001), cataracts (P < 0.0001), posttransplant diabetes (P < 0.0001), and avascular necrosis (P = 0.0003). CONCLUSIONS: Prednisone-related side effects can be minimized without maintenance immunosuppression; our prednisone-free recipients do not have increased acute or chronic rejection.

Adult↗

PubMed1984

Experimental determination of the respiration associated with soybean/rhizobium nitrogenase function, nodule maintenance, and total nodule nitrogen fixation.

The total metabolic cost of soybean (Glycine max L. Mer Clark) nodule nitrogen fixation was empirically separated into respiration associated with electron flow through nitrogenase and respiration associated with maintenance of nodule function.Rates of CO(2) evolution and H(2) evolution from intact, nodulated root systems under Ar:O(2) atmospheres decreased in parallel when plants were maintained in an extended dark period. While H(2) evolution approached zero after 36 hours of darkness at 22 degrees C, CO(2) evolution rate remained at 38 degrees of the rate measured in light. Of the remaining CO(2) evolution, 62% was estimated to originate from the nodules and represents a measure of nodule maintenance respiration. The nodule maintenance requirement was temperature dependent and was estimated at 79 and 137 micromoles CO(2) (per gram dry weight nodule) per hour at 22 degrees C and 30 degrees C, respectively.The cost of N(2) fixation in terms of CO(2) evolved per electron pair utilized by nitrogenase was estimated from the slope of H(2) evolution rate versus CO(2) evolution rate. The cost was 2 moles CO(2) evolved per mole H(2) evolved and was independent of temperature.In this symbiosis, nodule maintenance consumed 22% of total respiratory energy while the functioning of nitrogenase consumed a further 52%. The remaining respiratory energy was calculated to be associated with ammonia assimilation, transport of reduced N, and H(2) evolution.

Journal Article↗

PubMed1996

The improved organ maintenance of the human sebaceous gland: modeling in vitro the effects of epidermal growth factor, androgens, estrogens, 13-cis retinoic acid, and phenol red.

We have previously reported that human sebaceous glands can be maintained for up to 14 d as whole organs with full retention of the physiological rate and pattern of new cell formation, but we have also reported that the newly formed cells did not differentiate normally, causing a progressive loss of lipogenesis in vitro. We now show that this abnormal sebocyte differentiation was attributable to the presence of epidermal growth factor (EGF) and phenol red in our maintenance medium. In their absence, human sebaceous glands apparently retain in vivo rates of cell division and lipogenesis over 7 d of maintenance in addition to a retention of in situ morphology. This is reversible on the re-addition of 10 ng EGF/ml and 10 mg phenol red/ml. The addition of 600 pM 17 beta-estradiol results in a significant fall in the rate of lipogenesis over 7 d of maintenance, without affecting the rate of cell division. This effect is apparently due to abnormal differentiation of newly formed sebocytes. Neither 1 nM testosterone nor 1 nM dihydrotestosterone (DHT) has any effect on rates of cell division of lipogenesis over 7 d. In the presence of phenol red, however, 1 nM testosterone or 1 nM DHT cause a significant reduction in the rate of lipogenesis over 7 d of maintenance. One micromolar 13-cis retinoic acid caused a significant reduction in the rate of lipogenesis over 7 d in both the presence and absence of phenol red. These findings show that we can model the physiological effects of steroids, EGF, and 13-cis retinoic acid in vitro.

Adult↗

PubMed2005

Fractionating working memory: consolidation and maintenance are independent processes.

In the present study, we required subjects to remember simple objects that were masked to interrupt consolidation and allow us to estimate the rate of information accrual in visual working memory. We compared a consolidation-baseline condition with a consolidation-during-maintenance condition in which subjects needed to remember a set of unmasked items and then were shown to-be-remembered masked items. We hypothesized that if the control processes of consolidation and maintenance are performed by common mechanisms, then consolidation should be less efficient when performed during maintenance than when performed alone. However, we found that an identical amount of information was encoded per unit time in the two conditions. These results indicate that working memory consolidation is not slowed by maintenance and suggest a two-step model of encoding in visual working memory.

Adolescent↗

PubMed2006

Addressing the efficacy of dihydrocodeine versus methadone as an alternative maintenance treatment for opiate dependence: A randomized controlled trial.

AIM: The aim of this study is to define the efficacy of dihydrocodeine as an alternative to methadone in the maintenance treatment of opiate dependence. DESIGN: A pragmatic open-label randomized controlled study of patients recommended for opiate maintenance treatment to test equivalence of the two treatment options with follow-up continuing for up to 42 months after recruitment. SETTING: Assessment at either Edinburgh's Community Drug Problem Service or at two general practitioner practices with specialist drug community psychiatric nurses, then with shared care follow-up. PARTICIPANTS: Two hundred and thirty-five subjects (168 male, 67 female) with opiate dependence syndrome were recruited. Subjects selected were suitable for opiate maintenance treatment. Routine treatment was offered throughout. INTERVENTION: Patients were randomized to receive either methadone mixture 1 mg/ml or dihydrocodeine, 30 mg or 60 mg tablets. MEASUREMENTS: The primary outcome measure was retention in treatment. Eight secondary outcomes included total illicit opiate use, reported crime, physical health, mental health, injecting drug use, overdoses, selling drugs and being in education or work. Measures were compared over 42 months follow-up. FINDINGS: There was no difference in groups for retention in treatment at follow-up and there was improvement in all secondary outcomes from baseline. No significant difference in outcomes was found between randomized groups over time. Compliance with randomized treatment differed by randomized group and was affected by experiences in custody during follow-up. Those randomized to dihydrocodeine were more likely to switch treatments. CONCLUSIONS: These results, combined with existing clinical experience, provide evidence that dihydrocodeine is a viable alternative to methadone as a maintenance treatment for opiate dependence. Indirect comparisons with other studies show dihydrocodeine (and methadone) to be superior to placebo.

Administration, Oral↗

PubMed2005

Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease.

BACKGROUND: Quality of life has been assessed in a large, multicentre randomized, open label study. AIM: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. METHODS: Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II-IV oesophagitis according to Savary-Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. RESULTS: A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%). CONCLUSIONS: Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy.

Acute Disease↗

PubMed2005

Esomeprazole 20 mg vs. pantoprazole 20 mg for maintenance therapy of healed erosive oesophagitis: results from the EXPO study.

BACKGROUND: Following initial healing of erosive oesophagitis, most patients require maintenance therapy to prevent relapse. AIM: To compare endoscopic and symptomatic remission rates over 6 months' maintenance therapy with esomeprazole or pantoprazole (both 20 mg once daily) in patients with healed erosive oesophagitis. METHODS: Patients with symptoms of gastro-oesophageal reflux disease and endoscopically confirmed erosive oesophagitis at baseline were randomized to receive esomeprazole 40 mg or pantoprazole 40 mg for up to 8 weeks. Patients with healed erosive oesophagitis and free of moderate/severe heartburn and acid regurgitation at 4 weeks or, if necessary, 8 weeks entered the 6-month maintenance therapy phase of the study. RESULTS: A total of 2766 patients (63% men; mean age 50 years) received esomeprazole 20 mg (n = 1377) or pantoprazole 20 mg (n = 1389) and comprised the intention-to-treat population. Following 6 months of treatment, the proportion of patients in endoscopic and symptomatic remission was significantly greater for those receiving esomeprazole 20 mg (87.0%) than pantoprazole 20 mg (74.9%, log-rank test P < 0.0001). Esomeprazole 20 mg produced a higher proportion of patients free of moderate to severe gastro-oesophageal reflux disease symptoms and fewer discontinuations because of symptoms than pantoprazole 20 mg (92.2% vs. 88.5%, P < 0.001). CONCLUSIONS: Esomeprazole 20 mg is more effective than pantoprazole 20 mg for maintenance therapy following initial healing of erosive oesophagitis and relief of gastro-oesophageal reflux disease symptoms.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2004

Subjective and physiological responses among racemic-methadone maintenance patients in relation to relative (S)- vs. (R)-methadone exposure.

AIMS: To investigate the possibility that (S)-methadone influences therapeutic and adverse responses to rac-methadone maintenance treatment, by examining how subjective and physiological responses among rac-methadone maintenance patients vary in relation to relative exposure to (S)- vs. (R)-methadone. METHODS: Mood states (Profile of Mood States), opioid withdrawal (Methadone Symptoms Checklist), physiological responses (pupil diameter, heart rate, respiration rate, blood pressure), and plasma concentrations (CP) of (R)- and (S)-methadone were measured concurrently 11-12 times over a 24-h interdosing interval in 55 methadone maintenance patients. Average steady-state plasma concentrations (C(av)) and pharmacodynamic responses were calculated using area under the curve (AUC). Linear regression was used to determine whether variability in pharmacodynamic responses was accounted for by (S)-methadone C(av) controlling for (R)-methadone C(av) and rac-methadone dose. Ratios of (S)-:(R)-methadone using AUC(CP) and trough values were correlated with pharmacodynamic responses for all subjects and separately for those with daily rac-methadone doses > or = 100 mg. RESULTS: (S)-methadone C(av) accounted for significant variability in pharmacodynamic responses beyond that accounted for by (R)-methadone C(av) and rac-methadone dose, showing positive associations (partial r) with the intensity of negative mood states such as Tension (0.28), Fatigue (0.31), Confusion (0.32), and opioid withdrawal scores (0.30); an opposite pattern of relationships was evident for (R)-methadone. The plasma (S)-:(R)-methadone AUC(CP) ratio (mean +/- SD 1.05 +/- 0.21, range 0.65-1.51) was not significantly related to pharmacodynamic responses for the subjects as a whole but showed significant positive associations (r) with the intensity of negative mood states such as Total Mood Disturbance (0.61), Tension (0.69), Fatigue (0.65), Confusion (0.64), Depression (0.49) and heart rate (0.59) for the > or = 100-mg dose range. CONCLUSIONS: These findings agree with previous evidence that (S)-methadone is associated with a significant and potentially adverse profile of responses distinct from that of (R)-methadone. Individual variability in relative (S)- vs. (R)-methadone exposure may be associated with variability in response to rac-methadone maintenance treatment.

Adult↗

PubMed1994

Intensive induction/consolidation therapy without maintenance in adult acute lymphoblastic leukaemia: a pilot assessment. Working Party on Leukaemia of the Swiss Group for Epidemiologic and Clinical Cancer Research (SAKK).

Maintenance chemotherapy for up to 3 years is traditionally given to patients with acute lymphoblastic leukaemia (ALL) achieving complete remission. We questioned the value of such maintenance therapy in adult patients treated with intensive induction/consolidation. In a phase II study (SAKK 33/86) 63 patients between 17 and 72 years of age (median 27 years) with newly diagnosed ALL were treated with three intensive cycles of marrow-ablative chemotherapy. All subtypes were included. No maintenance phase was added. 53 patients (84%) entered a complete remission (CR) and 21 (33%) continue to be in unmaintained remission for 11-69 months (median 21 months). The disease-free survival of patients achieving CR and completing all three cycles is 40% at 3 years, with a 95% confidence interval of +/- 19%. These findings are comparable to the results of conventional studies. We conclude that maintenance therapy might not be needed in all adult ALL patients. Its value should be tested in a randomized trial. For patients failing, novel approaches are needed to improve outcome in adult ALL.

Adolescent↗