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Efficacy and safety of ipragliflozin as add‐on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi‐centre,randomized, placebo‐controlled,double‐blind study 下载免费PDF全文
Hisamitsu Ishihara MD PhD Susumu Yamaguchi Ikko Nakao Akira Okitsu Seitaro Asahina 《Diabetes, obesity & metabolism》2016,18(12):1207-1216
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Efficacy and safety of nortriptyline in functional dyspepsia in Asians: A randomized double‐blind placebo‐controlled trial 下载免费PDF全文
Uayporn Kaosombatwattana Supot Pongprasobchai Julajak Limsrivilai Monthira Maneerattanaporn Somchai Leelakusolvong Tawesak Tanwandee 《Journal of gastroenterology and hepatology》2018,33(2):411-417
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Dsire van der Heijde Alan Kivitz Michael H. Schiff Joachim Sieper Ben A. C. Dijkmans Jürgen Braun Maxime Dougados John D. Reveille Robert L. Wong Hartmut Kupper John C. Davis 《Arthritis \u0026amp; Rheumatology》2006,54(7):2136-2146
Objective
To evaluate the safety and efficacy of adalimumab, a fully human recombinant IgG1 monoclonal antibody that specifically targets human tumor necrosis factor, in patients with active ankylosing spondylitis (AS).Methods
This was a multicenter, randomized (2:1 ratio), double‐blind, placebo‐controlled study to evaluate a subcutaneous injection of adalimumab, 40 mg every other week, compared with placebo for 24 weeks. The primary efficacy end point was the percentage of patients with a 20% response according to the ASsessment in Ankylosing Spondylitis International Working Group criteria for improvement (ASAS20) at week 12. Secondary outcome measures included the ASAS20 at week 24 and multiple measures of disease activity, spinal mobility, and function, as well as ASAS partial remission.Results
At week 12, 58.2% of adalimumab‐treated patients (121 of 208) achieved an ASAS20 response, compared with 20.6% of placebo‐treated patients (22 of 107) (P < 0.001). More patients in the adalimumab group (45.2% [94 of 208]) than in the placebo group (15.9% [17 of 107]) had at least a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index at week 12 (P < 0.001). Significant improvements in the ASAS40 response and the response according to the ASAS5/6 criteria at weeks 12 and 24 were also demonstrated (P < 0.001). Partial remission was achieved by more adalimumab‐treated patients than placebo‐treated patients (22.1% versus 5.6%; P < 0.001). Adalimumab‐treated patients reported more adverse events (75.0% versus 59.8% of placebo‐treated patients; P < 0.05), but there was no statistically significant difference in the incidence of infections. Most adverse events were mild or moderate in severity.Conclusion
Adalimumab was well‐tolerated during the 24‐week study period and was associated with a significant and sustained reduction in the signs and symptoms of active AS.8.
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Henrike van Dongen Jill van Aken Leroy R. Lard Karen Visser H. Karel Ronday Harry M. J. Hulsmans Irene Speyer Marie‐Louise Westedt Andr J. Peeters Cornelia F. Allaart Ren E. M. Toes Ferdinand C. Breedveld Tom W. J. Huizinga 《Arthritis \u0026amp; Rheumatology》2007,56(5):1424-1432
Objective
To determine whether patients with undifferentiated arthritis (UA; inflammatory, nontraumatic arthritis that cannot be diagnosed using current classification criteria) benefit from treatment with methotrexate (MTX).Methods
The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was a double‐blind, placebo‐controlled, randomized, multicenter trial involving 110 patients with UA who fulfilled the American College of Rheumatology (ACR) 1958 criteria for probable RA. Treatment started with MTX (15 mg/week) or placebo tablets, and every 3 months the dosage was increased if the Disease Activity Score was >2.4. After 12 months, the study medication was tapered and discontinued. Patients were followed up for 30 months. When a patient fulfilled the ACR criteria for RA (primary end point), the study medication was changed to MTX. Joint damage was scored on radiographs of the hands and feet.Results
In 22 of the 55 patients (40%) in the MTX group, UA progressed to RA compared with 29 of 55 patients (53%) in the placebo group. However, in the MTX group, patients fulfilled the ACR criteria for RA at a later time point than in the placebo group (P = 0.04), and fewer patients showed radiographic progression over 18 months (P = 0.046).Conclusion
This study provides evidence for the efficacy of MTX treatment in postponing the diagnosis of RA, as defined by the ACR 1987 criteria, and retarding radiographic joint damage in UA patients.10.
Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus: A multicentre randomized double‐blind placebo‐controlled Phase 3 study in mainland China,Taiwan, and Hong Kong 下载免费PDF全文
Changyu Pan Ping Han Qiuhe Ji Chengjiang Li Juming Lu Jinkui Yang Wenhui Li Jiaoe Zeng An‐Tsz Hsieh Juliana Chan 《Journal of Diabetes》2017,9(4):386-395
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E. H. S. Choy D. A. Isenberg T. Garrood S. Farrow Y. Ioannou H. Bird N. Cheung B. Williams B. Hazleman R. Price K. Yoshizaki N. Nishimoto T. Kishimoto G. S. Panayi 《Arthritis \u0026amp; Rheumatology》2002,46(12):3143-3150
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To investigate the safety and efficacy of MRA, a recombinant human anti–interleukin‐6 (anti–IL‐6) receptor monoclonal antibody of the IgG1 subclass that inhibits the function of IL‐6, in patients with established rheumatoid arthritis (RA).Methods
A randomized, double‐blind, placebo‐controlled, dose‐escalation trial was conducted in 45 patients with active RA, as defined by the American College of Rheumatology (ACR) revised criteria. Patients were sequentially allocated to receive a single intravenous dose of either 0.1, 1, 5, or 10 mg/kg of MRA or placebo. The primary efficacy end point was meeting the ACR 20% response criteria at week 2 after treatment.Results
Demographic features were similar between treatment groups. At week 2, a significant treatment difference was observed between the 5 mg/kg of MRA and placebo, with 5 patients (55.6%) in the MRA cohort and none in the placebo cohort achieving ACR 20% improvement. There was no statistically significant difference in the ACR 20% response between the other 3 MRA cohorts and placebo at week 2. The mean disease activity score at week 2 in those who received 5 mg/kg and 10 mg/kg of MRA was 4.8 and 4.7 (P < 0.001 and P < 0.001 by analysis of variance), respectively. These mean scores were statistically significantly lower than those in the 0.1‐ and 1‐mg/kg MRA and the placebo cohorts (6.4, 6.2, and 7.0, respectively). The erythrocyte sedimentation rate and C‐reactive protein values fell significantly in the 5‐ and 10‐mg/kg MRA cohorts and normalized 2 weeks after treatment. Seventeen patients (5, 4, 6, 2, and 0 patients in the placebo, 0.1‐, 1‐, 5‐, and 10‐mg/kg MRA cohorts, respectively) required corticosteroid or disease‐modifying antirheumatic drug treatment because of active disease before study end. They were regarded as nonresponders from the time they received these treatments. Diarrhea was the most common adverse event, occurring in 8% of patients. Seven patients (15.6%) reported a severe adverse event (3, 1, 2, and 2 patients in the placebo, 0.1‐, 1‐, and 10‐mg/kg MRA cohorts). There were no serious adverse events that were thought to be related to the study drug.Conclusion
This is the first randomized controlled trial showing that inhibition of IL‐6 significantly improved the signs and symptoms of RA and normalized the acute‐phase reactants. Further research with multiple dosing is necessary to define the most appropriate therapeutic regimen of MRA in RA.13.
Lesley M. Arnold R. Michael Gendreau Robert H. Palmer Judy F. Gendreau Yong Wang 《Arthritis \u0026amp; Rheumatology》2010,62(9):2745-2756
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To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia.Methods
A double‐blind, placebo‐controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4–6 weeks of flexible dose escalation followed by 12 weeks of stable‐dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2‐measure composite response required achievement of ≥30% improvement from baseline in the pain score and a rating of “very much improved” or “much improved” on the Patient's Global Impression of Change (PGIC) scale. The 3‐measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF‐36) physical component summary (PCS) score.Results
After 12 weeks of stable‐dose treatment, a significantly greater proportion of milnacipran‐treated patients compared with placebo‐treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2‐measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3‐measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran‐treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24‐hour and weekly recall pain score, PGIC score, SF‐36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo‐adjusted rate of 15.8%).Conclusion
Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia.14.
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Norihiro Nishimoto Kazuyuki Yoshizaki Nobuyuki Miyasaka Kazuhiko Yamamoto Shinichi Kawai Tsutomu Takeuchi Jun Hashimoto Junichi Azuma Tadamitsu Kishimoto 《Arthritis \u0026amp; Rheumatology》2004,50(6):1761-1769
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Interleukin‐6 (IL‐6) is a pleiotropic cytokine that regulates the immune response, inflammation, and hematopoiesis. Overproduction of IL‐6 plays pathologic roles in rheumatoid arthritis (RA), and the blockade of IL‐6 may be therapeutically effective for the disease. This study was undertaken to evaluate the safety and efficacy of a humanized anti–IL‐6 receptor antibody, MRA, in patients with RA.Methods
In a multicenter, double‐blind, placebo‐controlled trial, 164 patients with refractory RA were randomized to receive either MRA (4 mg/kg body weight or 8 mg/kg body weight) or placebo. MRA was administered intravenously every 4 weeks for a total of 3 months. The clinical responses were measured using the American College of Rheumatology (ACR) criteria.Results
Treatment with MRA reduced disease activity in a dose‐dependent manner. At 3 months, 78% of patients in the 8‐mg group, 57% in the 4‐mg group, and 11% in the placebo group achieved at least a 20% improvement in disease activity according to the ACR criteria (an ACR20 response) (P < 0.001 for 8‐mg group versus placebo). Forty percent of patients in the 8‐mg group and 1.9% in the placebo group achieved an ACR50 response (P < 0.001). The overall incidences of adverse events were 56%, 59%, and 51% in the placebo, 4‐mg, and 8‐mg groups, respectively, and the adverse events were not dose dependent. A blood cholesterol increase was observed in 44.0% of the patients. Liver function disorders and decreases in white blood cell counts were also observed, but these were mild and transient. There was no increase in antinuclear antibodies or anti‐DNA antibodies. Anti‐MRA antibodies were detected in 2 patients.Conclusion
Treatment with MRA was generally well tolerated and significantly reduced the disease activity of RA.16.
Francesco Zulian Giorgia Martini Cristina Vallongo Fabio Vittadello Fernanda Falcini Annalisa Patrizi Maria Alessio Francesco La Torre Rosa A. Podda Valeria Gerloni Mario Cutrone Anna Belloni‐Fortina Mauro Paradisi Silvana Martino Giorgio Perilongo 《Arthritis \u0026amp; Rheumatology》2011,63(7):1998-2006
Objective
Juvenile localized scleroderma is a chronic progressive fibrotic disorder of the skin that causes permanent disability and aesthetic damage. This study was undertaken to assess the safety and efficacy of methotrexate (MTX) in the treatment of juvenile localized scleroderma.Methods
In this double‐blind study, patients with active juvenile localized scleroderma were randomized (2:1) to receive oral MTX (15 mg/m2, maximum 20 mg) or placebo once weekly, for 12 months or until treatment failure. Both groups received oral prednisone (1 mg/kg/day, maximum 50 mg) for the first 3 months. A target lesion was evaluated clinically, with infrared thermography and using a computerized scoring system with skin score rate (SSR) evaluation. Response to treatment was defined as the absence of new lesions, SSR ≤1, and a decrease in lesion temperature of at least 10% compared to baseline. Treatment failure was defined as the occurrence of new lesions, SSR >1, or increased lesion temperature. All analyses were done on the intent‐to‐treat population.Results
Of the 85 patients screened, 70 (ages 6–17 years) were randomized (46 to the MTX group, 24 to the placebo group). The mean disease duration was 2.3 years. After an initial response in all patients, disease relapsed in 15 MTX‐treated patients (32.6%) and 17 placebo‐treated patients (70.8%) (P < 0.005). New lesions appeared in 3 MTX‐treated patients (6.5%) versus 4 placebo‐treated patients (16.7%). The mean SSR decreased from 1 to 0.79 in the MTX group and increased from 1 to 1.1 in the placebo group, and the mean target lesion temperature decreased by 44.4% in the MTX group versus 12.1% in the placebo group. Twenty‐six patients in the MTX group (56.5%) and 11 patients in the placebo group (45.8%) developed mild side effects related to treatment. None of the side effects were severe enough to necessitate treatment discontinuation.Conclusion
Our findings indicate that MTX is efficacious in the treatment of juvenile localized scleroderma and is well tolerated.17.
J. Peter Kaltwasser Peter Nash Dafna Gladman Cheryl F. Rosen Frank Behrens Peter Jones Jürgen Wollenhaupt Franziska G. Falk Philip Mease 《Arthritis \u0026amp; Rheumatology》2004,50(6):1939-1950
Objective
Current treatment options for psoriatic arthritis (PsA) are limited. Leflunomide, an oral pyrimidine synthesis inhibitor, is highly effective in the treatment of rheumatoid arthritis, and small studies have suggested similar efficacy in PsA. We undertook this double‐blind, randomized, placebo‐controlled trial to evaluate the efficacy and safety of leflunomide in patients with PsA and psoriasis.Methods
One hundred ninety patients with active PsA and psoriasis (at least 3% skin involvement) were randomized to receive leflunomide (100 mg/day loading dose for 3 days followed by 20 mg/day orally) or placebo for 24 weeks. The primary efficacy end point was the proportion of patients classified as responders by the Psoriatic Arthritis Response Criteria (PsARC). Additional efficacy (joint and skin involvement), safety, and quality‐of‐life assessments were performed.Results
At 24 weeks, 56 of 95 leflunomide‐treated patients (58.9%; 95% confidence interval [95% CI] 48.4–68.9) and 27 of 91 placebo‐treated patients (29.7% [95% CI 20.6–40.2]) were classified as responders by the PsARC (P < 0.0001). Significant differences in favor of leflunomide were also observed in the proportions of patients achieving modified American College of Rheumatology 20% improvement criteria, improvement in the designated psoriasis target lesion, and mean changes from baseline in Psoriasis Area and Severity Index scores and quality‐of‐life assessments. Diarrhea and alanine aminotransferase increases occurred at higher rates in the leflunomide group. No cases of serious liver toxicity were observed.Conclusion
Leflunomide is an effective treatment for PsA and psoriasis, providing a safe and convenient alternative to current therapies.18.
Efficacy and safety of canagliflozin as add‐on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24‐week,randomized, double‐blind,placebo‐controlled trial 下载免费PDF全文
Takashi Kadowaki MD PhD Nobuya Inagaki MD PhD Kazuoki Kondo MD PhD Kenichi Nishimura MS Genki Kaneko MS Nobuko Maruyama B.Pharm Nobuhiro Nakanishi MMath Hiroaki Iijima PhD Yumi Watanabe PhD Maki Gouda B.Sc. 《Diabetes, obesity & metabolism》2017,19(6):874-882
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Rainer H. Straub Peter Hrle Seizo Yamana Takemasa Matsuda Kiyoshi Takasugi Tadamitsu Kishimoto Norihiro Nishimoto 《Arthritis \u0026amp; Rheumatology》2006,54(6):1778-1785