scholarly journals A Randomized, Double-Blind, Crossover Comparison of the Efficacy and Safety of Oral Controlled-Release Tramadol and Placebo in Patients with Painful Osteoarthritis

2008 ◽  
Vol 13 (2) ◽  
pp. 93-102 ◽  
Author(s):  
Carter Thorne ◽  
André D Beaulieu ◽  
Denis J Callaghan ◽  
William F O’Mahony ◽  
John M Bartlett ◽  
...  
Keyword(s):  
Controlled Release ◽  
Short Form ◽  
Term Treatment ◽  
Visual Analogue Scale Pain ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Analogue Scale Pain ◽  
Lower Visual Analogue Scale

OBJECTIVE: To compare the efficacy and safety of controlled-release (CR) tramadol (Zytram XL, Purdue Pharma, Canada) and placebo in patients with painful osteoarthritis.METHODS: Patients underwent analgesic washout for two to seven days before random assignment to 150 mg daily of CR tramadol or placebo, and were titrated weekly to 200 mg, 300 mg or a maximum of 400 mg once daily. After four weeks, patients crossed over to the alternate treatment for another four weeks. Plain acetaminophen was provided as a rescue analgesic. All patients who completed the crossover study were eligible to receive open label CR tramadol for six months.RESULTS: Seventy-seven of 100 randomly assigned patients were evaluable for efficacy. CR tramadol resulted in significantly lower visual analogue scale pain intensity scores (37.4±23.9 versus 45.1±24.3, P=0.0009). Western Ontario and McMaster Universities osteoarthritis index subscale scores for pain (189.0±105.0 versus 230.0±115.4; P=0.0001) and physical function (632.4±361.3 versus 727.4±383.4; P=0.0205) were significantly better with CR tramadol. Total pain and disability (22.8±14.5 versus 27.2±14.8; P=0.0004), and overall pain and sleep (104.7±98.0 versus 141.0±108.2; P=0.0005) scores in the Pain and Sleep Questionnaire were significantly lower for CR tramadol. Short-form 36 Health Survey scores were significantly better during CR tramadol treatment for the pain index (38.8±10.8 versus 35.6±9.0; P=0.0100), general health perception (46.5±11.2 versus 44.4±11.6; P=0.0262), vitality (43.1±13.2 versus 40.2±13.7; P=0.0255) and overall physical components (40.8±8.9 versus 37.8±7.7; P=0.0002). CR tramadol treatment was preferred by 55.8% of patients (P=0.0005) versus 20.8% and 23.4% of patients who chose placebo or had no preference, respectively. These improvements were sustained for up to six months, and 86.5% of patients reported at least moderate benefit from CR tramadol during long-term treatment.CONCLUSION: CR tramadol is effective for the management of painful osteoarthritis.

Long-term treatment with agomelatine: prevention of relapse in patients with generalised anxiety disorder over 6 months

2011 ◽  
Vol 26 (S2) ◽  
pp. 181-181 ◽  
Author(s):  
D. Stein ◽  
A. Ahokas ◽  
C. Allgulander ◽  
J. Soegaard ◽  
I. Bitter ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Treatment Period ◽  
Term Treatment ◽  
Rank Test ◽  
Open Label ◽  
Double Blind ◽  
Good Tolerability ◽  
Long Term Treatment ◽  
Open Label Phase ◽  
Prevention Of Relapse

AimThis study assessed the efficacy of agomelatine (1,2,3), in the prevention of relapse in non-depressed out-patients with DSM-IV-TR defined Generalized Anxiety Disorder (GAD) and the tolerability.MethodsGAD patients received open label agomelatine (25–50 mg/day). At week 4 the dose was increased for patients with insufficient improvement (blinded criteria). At week 16, responders were randomised to maintenance treatment with either agomelatine, or placebo for a 26 week period. Then, agomelatine treated-patients were re-randomised to an agomelatine arm or to a placebo arm, to confirm the lack of discontinuation symptoms (on the DESS check-list).The primary outcome was the time to relapse (days) during the 26 week double-blind treatment period, as estimated using the Kaplan-Meier method. Relapse was defined as HAMA total score > = 15 or withdrawal for lack of efficacy (in the investigator's opinion, based on both HAM-A and CGI scores).Results477 patients entered the open-label phase and 329 completed this period. 228 patients were randomly assigned to receive agomelatine (114 patients) or placebo (114 patients).The incidence over time of relapse was significantly lower with agomelatine compared to placebo (19.7% versus 31.7% log rank test p = 0.046) during the double-blind treatment period.During the double-blind treatment period 12.4% patients with agomelatine and 9.6% with placebo reported at least one emergent adverse event related to the study treatment. There was no discontinuation syndrome in agomelatine treated patients.ConclusionAgomelatine was efficacious in preventing relapse in GAD, with maintenance of efficacy over 6 months, and good tolerability.

scholarly journals Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis

Neurology ◽  
2017 ◽  
Vol 88 (9) ◽  
pp. 832-841 ◽  
Author(s):  
Linard Filli ◽  
Björn Zörner ◽  
Sandra Kapitza ◽  
Katja Reuter ◽  
Lilla Lörincz ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Drug Efficacy ◽  
Term Treatment ◽  
Considerable Proportion ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Drug Responsiveness ◽  
Over Time

Objective:To expand upon the limited knowledge of the long-term effects of prolonged-release (PR) fampridine in patients with multiple sclerosis (PwMS) regarding safety, walking improvements, and changes in drug responsiveness.Methods:Fifty-three PwMS who completed the FAMPKIN core study were included in this extension trial. Drug efficacy was assessed in an open-label and randomized double-blind, placebo-controlled study design with regular baseline assessments over a period of 2 years using the Timed 25-Foot Walk (T25FW), 6-Minute Walk Test (6MWT), and 12-item MS Walking Scale (MSWS-12) as outcome measures.Results:The data showed good tolerability and persisting efficacy of PR fampridine during long-term treatment in PwMS. Significant improvements in walking speed, endurance, and self-perceived ambulatory function were observed during open-label (T25FW: +11.5%; 6MWT: 10.7%; MSWS-12: 6.1 points) and double-blind controlled treatment with PR fampridine (T25FW: +13.1%; 6MWT: 11.9%; MSWS-12: 7.4 points). Several patients showed changes in drug responsiveness over time, resulting in an increased proportion of patients exceeding 10% or 20% improvements in walking measures after long-term treatment.Conclusions:Efficacy and tolerability data confirmed PR fampridine as a valuable long-term treatment for improving ambulatory function in gait-impaired PwMS. Similar results in open-label and double-blind phases reveal that the walking tests used are objective and reliable. The considerable proportion of patients in whom responsiveness to PR fampridine changed over time emphasizes the importance of regular reassessment of drug efficacy in clinical practice to optimize treatment. Such reassessments seem to be particularly important in patients with poor initial drug responses, as this group demonstrated enhanced responsiveness after long-term treatment.Clinicaltrials.gov identifier:NCT01576354.Classification of evidence:This study provides Class II evidence that PR fampridine significantly improved gait compared to placebo in a 2-week study in PwMS who had been using PR fampridine for 2 years.

scholarly journals Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)

2008 ◽  
Vol 68 (5) ◽  
pp. 702-709 ◽  
Author(s):  
P J Mease ◽  
P Ory ◽  
J T Sharp ◽  
C T Ritchlin ◽  
F Van den Bosch ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Term Treatment ◽  
Joint Disease ◽  
Short Term ◽  
Open Label ◽  
Short Term Treatment ◽  
Double Blind ◽  
Long Term Treatment ◽  
Adalimumab Treatment

Objective:To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA).Methods:Patients with PsA who completed a 24-week, double-blind study of adalimumab versus placebo were eligible to enroll in an open-label extension study and receive adalimumab 40 mg subcutaneously every other week for up to an additional 120 weeks. At the time of this analysis, available efficacy evaluations throughout 2 years of treatment (n  =  245) included American College of Rheumatology (ACR) 20%, 50% and 70% improvement scores, measures of joint disease and skin disease, disability and quality of life; modified total Sharp scores (mTSS) were available for 2.75 years of treatment for patients who received adalimumab in the 24-week study.Results:After 24 weeks of double-blind treatment, the mean change in mTSS was −0.2 for the adalimumab group (N  =  144) and 1.0 for the placebo group (N  =  152; p<0.001), and outcomes for all individual ACR component variables were significantly improved in adalimumab compared with placebo-treated patients. Compared with 24-week responses, inhibition of radiographic progression and improvements in joint disease were maintained in most patients during long-term, open-label adalimumab treatment. Also, improvements in skin disease were maintained, with >20% of patients achieving the strict criterion of psoriasis area and severity index 100. The nature and frequency of adverse events during long-term adalimumab treatment were consistent with the safety profile during short-term treatment.Conclusions:The clinical and radiographic efficacy of adalimumab demonstrated during short-term treatment was sustained during long-term treatment. Adalimumab has a favourable risk–benefit profile in patients with PsA.Trial registration number:NCT00195689.

scholarly journals Acute response to cholinergic challenge predicts long-term response to galantamine treatment in patients with Alzheimer's Disease

2021 ◽  
Author(s):  
Anne Catrien Baakman ◽  
Carmen Gavan ◽  
Lotte Van Doeselaar ◽  
Marieke de Kam ◽  
Karen Broekhuizen ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Single Dose ◽  
Term Treatment ◽  
Subsequent Treatment ◽  
Analysis Of Covariance ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment

Cholinesterase inhibitors have been shown to improve cognitive functioning in patients with Alzheimer’s Disease (AD), but are associated with side effects and only 20-40% of the patients clinically improve. In this study, we aimed to investigate the acute pharmacodynamic (PD) effects of a single dose of galantamine on CNS functioning in mild to moderate AD patients and its potential to predict long-term treatment response. This study consisted of a challenge phase, in which a single dose of 16 mg galantamine was administered to 50 mild to moderate AD patients in a double-blind, placebo-controlled cross-over fashion. Acute PD effects were monitored with use of a CNS test battery. In the subsequent treatment phase of the study, patients were treated with open-label galantamine according to regular care. After 6 months of galantamine treatment, patients were categorized as either responder or as non-responder based on their MMSE, NPI and DAD scores. An analysis of covariance was performed to study the difference in acute PD effects between responders and non-responders. Acute decreases of absolute frontal alpha (-20.4; 95%CI=-31.6,-7.47; p=.0046), beta (-15.7; 95% CI=-28.3,-0.93; p=.0390) and theta (-25.9; 95%CI=-38.4,-10.9; p=.0024) EEG parameters and of relative frontal theta power (-3.27%; 95%CI=-5.96,-0.58; p=.0187) on EEG after a single dose administration of galantamine significantly distinguished long-term treatment responders (n=11) from non-responders (n=32) after 6 months. This study demonstrates that patients who demonstrate a reduction in EEG power in the alpha and theta frequency after a single administration of galantamine 16 mg will most likely respond to treatment.

Long-Term, Open-Label Extension Study of Guanfacine Extended Release in Children and Adolescents with ADHD

CNS Spectrums ◽  
2008 ◽  
Vol 13 (12) ◽  
pp. 1047-1055 ◽  
Author(s):  
Joseph Biederman ◽  
Raun D. Melmed ◽  
Anil Patel ◽  
Keith McBurnett ◽  
Jessica Donahue ◽  
...  
Keyword(s):  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Multicenter Trial ◽  
Term Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Open Label Extension

ABSTRACTIntroduction:Guanfacine is a noradrenergic agonist that is believed to improve symptoms of attention-deficit/hyperactivity disorder (ADHD) through selective actions at α2A-adrenoceptors in the prefrontal cortex. A recent double-blind, multicenter trial supports the efficacy and safety of guanfacine extended release (GXR) for pediatric ADHD. This long-term, open-label extension was conducted to study the safety profile and effectiveness of GXR for up to 2 years.Methods:Subjects were 240 children 6–17 years of age with a diagnosis of ADHD who participated in the preceding randomized trial. GXR was initiated at 2 mg/day and titrated as needed in 1-mg increments to a maximum of 4 mg/day to achieve optimal clinical response.Results:The most common adverse events were somnolence (30.4%), headache (26.3%), fatigue (14.2%), and sedation (13.3%). Somnolence, sedation, and fatigue were usually transient. Cardiovascular-related adverse events were uncommon, although small reductions in mean blood pressure and pulse rate were evident at monthly visits. ADHD Rating Scale, Version IV, total and subscale scores improved significantly from baseline to endpoint for all dose groups (P<.001 for all comparisons, intent-to-treat population).Conclusion:Long-term treatment with GXR was generally safe for up to 24 months of treatment, and effectiveness was maintained over this treatment period.

scholarly journals Efficacy and Safety of Once-Weekly Thyroxine for Thyroxine-Resistant Hypothyroidism

2019 ◽  
Vol 3 (12) ◽  
pp. 2184-2193 ◽  
Author(s):  
Chellama Jayakumari ◽  
Abilash Nair ◽  
Jabbar Puthiyaveettil Khadar ◽  
Darvin V Das ◽  
Nandini Prasad ◽  
...  
Keyword(s):  
Term Treatment ◽  
Efficacy And Safety ◽  
Poor Control ◽  
Open Label ◽  
Thyroxine Therapy ◽  
Real World Setting ◽  
Long Term Treatment ◽  
Lost To Follow Up

Abstract Context Noncompliance with thyroxine therapy is the most common cause of poor control of hypothyroidism. An open-label prospective study to compare once-weekly thyroxine (OWT) with standard daily thyroxine (SDT) was undertaken. Design Patients taking thyroxine doses of >3 μg/kg/d, with or without normalization of TSH, were included and administered directly observed OWT or nonobserved SDT according to patient preference based on their weight for 6 weeks. Furthermore, patients on OWT were advised to continue the same at home without supervision. Results Twenty six of 34 patients on OWT and 7 of 18 patients on SDT achieved a TSH <10 μIU/mL (P < 0.05), and 2 patients from the SDT arm were lost to follow-up. During home treatment, 15 of 25 at 12 weeks and 19 of 23 contactable patients at a median follow-up of 25 months maintained TSH below target. Thyroxine absorption test was unable to predict normalization of TSH at 6 weeks of OWT therapy. No adverse events were seen with OWT-treated patients over the 12-week follow-up period. OWT has significantly higher efficacy (OR = 5.1) than SDT for patients with thyroxine-resistant hypothyroidism and is not associated with side effects. Conclusion OWT benefits a majority of patients in the long-term treatment of thyroxine-resistant hypothyroidism, in the real-world setting.

scholarly journals Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study

Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2427-2434 ◽  
Author(s):  
Yoshikazu Nakaoka ◽  
Mitsuaki Isobe ◽  
Yoshiya Tanaka ◽  
Tomonori Ishii ◽  
Seido Ooka ◽  
...  
Keyword(s):  
Takayasu Arteritis ◽  
Short Form ◽  
Efficacy And Safety ◽  
Short Form Health Survey ◽  
Open Label ◽  
Double Blind ◽  
Form Health ◽  
Short Form Health ◽  
Steroid Sparing

Abstract Objective To investigate the long-term efficacy and safety of the IL-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK). Methods Patients completing the randomized, double-blind, placebo-controlled period of the TAKT (Takayasu arteritis Treated with Tocilizumab) trial were followed up during open-label extended treatment with weekly s.c. tocilizumab 162 mg for up to 96 weeks or longer, with oral glucocorticoid tapering performed at the investigators’ discretion. Endpoints of the extension analysis included steroid-sparing effects of tocilizumab, imaging data, patient-reported outcomes (36-Item Short Form Health Survey) and safety. Results All 36 patients enrolled in the double-blind period entered the open-label extension; 28 patients received tocilizumab for 96 weeks. The median glucocorticoid dose was 0.223 mg/kg/day at the time of relapse before study entry, 0.131 mg/kg/day (interquartile range 0.099, 0.207) after 48 weeks and 0.105 mg/kg/day (interquartile range 0.039, 0.153) after 96 weeks. Overall, 46.4% of patients reduced their dose to &lt;0.1 mg/kg/day, which was less than half the dose administered at relapse before study entry (mean difference –0.120 mg/kg/day; 95% CI −0.154, −0.087). Imaging evaluations indicated that most patients’ disease was improved (17.9%) or stable (67.9%) after 96 weeks compared with baseline. Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96 weeks of tocilizumab treatment. No unexpected safety issues were reported. Conclusion These results in patients with Takayasu arteritis provide evidence of a steroid-sparing effect and improvements in well-being during long-term treatment with once-weekly tocilizumab 162 mg, with no new safety concerns. Trial registration JAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-142616.

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