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Long-term Maintenance Treatment (long-term + maintenance_treatment)
Selected AbstractsHealth-related utility among adults with atopic dermatitis treated with 0·1% tacrolimus ointment as maintenance therapy over the long term: findings from the Protopic® CONTROL studyBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2009C.D. Poole Summary Background, Long-term maintenance treatment with 0·1% tacrolimus ointment for the prevention of flares has been demonstrated to be well tolerated and effective in adults for the treatment of atopic dermatitis (AD) but its impact on health-related utility has not been reported. Objectives, The purpose of this study was to estimate utility changes associated with the use of tacrolimus ointment in the maintenance treatment of adults with AD. Methods, Data were collected from a clinical trial investigating long-term maintenance treatment with 0·1% tacrolimus ointment in adults with AD. All patients were treated with twice-daily tacrolimus ointment during an open-label period (OLP) of up to 6 weeks, with subsequent randomization to a double-blind disease-control period (DCP) of 12 months comparing tacrolimus ointment, used twice weekly as maintenance treatment, vs. the emollient vehicle as standard treatment. Health-related utility (EQ-5Dindex) was estimated by Monte Carlo simulation from SF-12 responses by application of a published response mapping algorithm and the U.K. tariff for EQ-5D responses and SF-6D responses, respectively. Results, Evaluable data were available for 257 patients stratified into mild, moderate or severe AD with a median age at screening of 28 years [interquartile range (IQR) 22,38] and 40% male. At screening the median EQ-5Dindex across the strata was 0·848 units (IQR 0·704,0·882) for mild cases, 0·796 (0·737,0·876) for moderate cases, and 0·760 (0·661,0·823, P < 0·001) for those with severe disease. At the end of the OLP, mean utility improvement across all strata was 0·027 [95% confidence interval (CI) ,0·011 to 0·065, P = 0·165] for mild cases, 0·046 (95% CI 0·015,0·064, P = 0·002) for moderate cases and 0·076 (95% CI 0·035,0·118, P < 0·001) for those with severe disease. At the end of the blinded DCP, repeated measures analysis showed an age- and sex-adjusted mean change of 0·045 units (P < 0·001) for subjects treated with tacrolimus ointment over those treated with emollient vehicle. Conclusions, Patients with AD of all severities showed considerable decrements in health-related utility. However, treatment with 0·1% tacrolimus ointment was associated with clinically significant improvement in health-related utility for patients with moderate and severe AD, which was sustained over a 12-month maintenance period compared with those using standard treatment with an emollient vehicle. [source] Therapeutic Hotline: Re-induction may be useful to manage psoriasis relapse during long-term maintenance treatment with infliximab: a retrospective analysisDERMATOLOGIC THERAPY, Issue 2 2010Gino Vena ABSTRACT Infliximab is an anti-tumor necrosis factor-alpha monoclonal antibody that is highly effective for the treatment of psoriatic disease. During maintenance treatment, some patients may experience a disease relapse, and, in such circumstances, dose intensification is frequently used to regain efficacy. We report our cumulative experience on the use of infliximab re-induction in patients whose psoriasis relapsed during long-term maintenance treatment with infliximab. From September 2005 to January 2009, 22 patients required re-induction because of a relapse of their psoriasis. Re-induction was effective in restoring response in most patients and was well tolerated in all cases, without occurrence of serious or unexpected adverse events. [source] Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after successful acute treatment of mild to moderate depression , rationale and study designINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2004Chairman, S. Kasper Professor Abstract Unipolar major depression is often a chronic disease that may require lifelong prophylaxis. Recovery from an acute episode is followed by 4-6 months of relapse prevention. After that, long-term maintenance treatment is administered to avoid recurrence. We present the rationale and design of an ongoing double-blind, randomized, placebo-controlled trial investigating the efficacy of Hypericum extract WS® 5570 in relapse prevention in recurrent unipolar depression. An estimated sample of 425 adults with recurrent, mild to moderate major depression (ICD-10 and DSM-IV criteria), ,3 previous episodes (last 5 years) and a total score ,20 points on the 17-item Hamilton Rating Scale for Depression (HAMD) will be included. After a one-week wash out patients receive 3 × 300 mg/day WS® 5570 single-blind for 6 weeks. Responders are randomized to 26 weeks of double-blind continuation treatment with 3 × 300 mg/day WS® 5570 or placebo. Patients completing continuation treatment without relapse enter 52 weeks of double-blind maintenance treatment, where those treated with WS® 5570 are re-randomized to 3 × 300 mg/day WS® 5570 or placebo. The primary outcome measure is the time to relapse during continuation treatment (HAMD ,16, clinical diagnosis of depression, or premature treatment termination for inefficacy). Hypericum extract, with its favourable tolerability profile, could be an interesting option for long-term prophylaxis. The trial was designed according to current consensus and guidance. Notably, it includes long-term prophylactic treatment with the same drug and the same therapeutic dose applied during acute treatment, uses well-defined outcome measures and provides a clear distinction between relapse and recurrence. Copyright © 2004 Whurr Publishers Ltd. [source] Effectiveness of mood stabilizers and antipsychotics in the maintenance phase of bipolar disorder: a systematic review of randomized controlled trialsBIPOLAR DISORDERS, Issue 4 2007Lesley A Smith Background:, Bipolar disorder (BD) is a leading cause of disability. Systematic reviews of randomized trials for the treatment of the maintenance phase of BD are lacking. Objectives:, To determine the efficacy and tolerability of mood stabilizers and antipsychotics in the maintenance treatment of BD. Methods:, We systematically reviewed randomized controlled trials of licensed medications for the treatment of any phase of BD. We included randomized controlled trials comparing a medication to placebo or another medication. Comprehensive searches of electronic databases were conducted to March 2005. Outcomes investigated were relapse due to mania, depression or any mood episode, and withdrawal due to any reason or due to an adverse event. Data were combined through meta-analysis. Results:, Fourteen studies (n = 2,526) met the inclusion criteria. Lithium, lamotrigine, olanzapine and valproate semisodium each demonstrated evidence to support long-term use. Compared with placebo, all medications were more effective at preventing relapse because of any mood episode. Hazard ratios (HR) were 0.68 [95% confidence interval (CI) = 0.53,0.86] for lithium, 0.68 (95% CI = 0.55,0.85) for lamotrigine, and 0.82 (95% CI = 0.57,1.20) for valproate semisodium; for olanzapine, the risk ratio (RR) was 0.58 (95% CI = 0.49,0.69). Lithium and olanzapine significantly reduced manic relapses (HR = 0.53; 95% CI = 0.35,0.79 and RR = 0.37; 95% CI = 0.24,0.57, respectively). Lamotrigine and valproate semisodium significantly reduced depressive relapses (HR = 0.65; 95% CI = 0.46,0.91 and RR = 0.40; 95% CI = 0.20,0.82, respectively). Lithium significantly reduced manic relapses compared with lamotrigine (HR = 0.56; 95% CI = 0.34,0.92) and olanzapine significantly reduced manic relapses compared with lithium (RR = 1.69; 95% CI = 1.12,2.55). Withdrawal due to an adverse event was approximately twice as likely with lithium compared with valproate semisodium (RR = 1.81; 95% CI = 1.08,3.03) and lamotrigine (RR = 2.20; 95% CI = 1.31,3.70). There were few data for carbamazepine or medications given as adjunct therapy. Conclusions:, Mood stabilizers have differing profiles of efficacy and tolerability, suggesting complementary roles in long-term maintenance treatment. [source] Health-related utility among adults with atopic dermatitis treated with 0·1% tacrolimus ointment as maintenance therapy over the long term: findings from the Protopic® CONTROL studyBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2009C.D. Poole Summary Background, Long-term maintenance treatment with 0·1% tacrolimus ointment for the prevention of flares has been demonstrated to be well tolerated and effective in adults for the treatment of atopic dermatitis (AD) but its impact on health-related utility has not been reported. Objectives, The purpose of this study was to estimate utility changes associated with the use of tacrolimus ointment in the maintenance treatment of adults with AD. Methods, Data were collected from a clinical trial investigating long-term maintenance treatment with 0·1% tacrolimus ointment in adults with AD. All patients were treated with twice-daily tacrolimus ointment during an open-label period (OLP) of up to 6 weeks, with subsequent randomization to a double-blind disease-control period (DCP) of 12 months comparing tacrolimus ointment, used twice weekly as maintenance treatment, vs. the emollient vehicle as standard treatment. Health-related utility (EQ-5Dindex) was estimated by Monte Carlo simulation from SF-12 responses by application of a published response mapping algorithm and the U.K. tariff for EQ-5D responses and SF-6D responses, respectively. Results, Evaluable data were available for 257 patients stratified into mild, moderate or severe AD with a median age at screening of 28 years [interquartile range (IQR) 22,38] and 40% male. At screening the median EQ-5Dindex across the strata was 0·848 units (IQR 0·704,0·882) for mild cases, 0·796 (0·737,0·876) for moderate cases, and 0·760 (0·661,0·823, P < 0·001) for those with severe disease. At the end of the OLP, mean utility improvement across all strata was 0·027 [95% confidence interval (CI) ,0·011 to 0·065, P = 0·165] for mild cases, 0·046 (95% CI 0·015,0·064, P = 0·002) for moderate cases and 0·076 (95% CI 0·035,0·118, P < 0·001) for those with severe disease. At the end of the blinded DCP, repeated measures analysis showed an age- and sex-adjusted mean change of 0·045 units (P < 0·001) for subjects treated with tacrolimus ointment over those treated with emollient vehicle. Conclusions, Patients with AD of all severities showed considerable decrements in health-related utility. However, treatment with 0·1% tacrolimus ointment was associated with clinically significant improvement in health-related utility for patients with moderate and severe AD, which was sustained over a 12-month maintenance period compared with those using standard treatment with an emollient vehicle. [source] Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trialADDICTION, Issue 9 2009Anthony DeFulio ABSTRACT Context Due to the chronic nature of cocaine dependence, long-term maintenance treatments may be required to sustain abstinence. Abstinence reinforcement is among the most effective means of initiating cocaine abstinence. Practical and effective means of maintaining abstinence reinforcement programs over time are needed. Objective To determine whether employment-based abstinence reinforcement can be an effective long-term maintenance intervention for cocaine dependence. Design Participants (n = 128) were enrolled in a 6-month job skills training and abstinence initiation program. Participants who initiated abstinence, attended regularly and developed needed job skills during the first 6 months were hired as operators in a data entry business and assigned randomly to an employment-only (control, n = 24) or abstinence-contingent employment (n = 27) group. Setting A non-profit data entry business. Participants Unemployed welfare recipients who used cocaine persistently while enrolled in methadone treatment in Baltimore. Intervention Abstinence-contingent employment participants received 1 year of employment-based contingency management, in which access to employment was contingent upon provision of drug-free urine samples under routine and then random drug testing. If a participant provided drug-positive urine or failed to provide a mandatory sample, then that participant received a temporary reduction in pay and could not work until urinalysis confirmed recent abstinence. Main outcome measure Cocaine-negative urine samples at monthly assessments across 1 year of employment. Results During the 1 year of employment, abstinence-contingent employment participants provided significantly more cocaine-negative urine samples than employment-only participants [79.3% and 50.7%, respectively; P = 0.004, odds ratio (OR) = 3.73, 95% confidence interval (CI) = 1.60,8.69]. Conclusions Employment-based abstinence reinforcement that includes random drug testing is effective as a long-term maintenance intervention, and is among the most promising treatments for drug dependence. Work-places could serve as therapeutic agents in the treatment of drug dependence by arranging long-term employment-based contingency management programs. [source] | ||||||||||||||||||||||