scholarly journals Comparison of Efficacy and Safety of Calcipotriol and Apremilast Combination Against Cacipotriol Monotherapy in Psoriasis

2021 ◽  
Vol 14 (4) ◽  
pp. 2319-2326
Author(s):  
Fazeel Zubair Ahmed
Keyword(s):  
Adverse Events ◽  
Treatment Success ◽  
Local Application ◽  
Age Group ◽  
Efficacy And Safety ◽  
Single Centre ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Parallel Group

Background Potentiating activity of tablet apremilast 30mg BD against psoriasis in combination with 0.005% calcipotriol ointment was studied in comparison with calcipotriol monotherapy. Methods Single centre, prospective, parallel group, open label study compared efficacy and safety of calcipotriol+apremilast combination with calcipotriol monotherapy. Patients of mild to severe psoriasis in age group 18-60 years were randomized to two groups – calcipotriol+apremilast group and calcipotriol group. Calcipotriol+apremilast group received apremilast 30 mg BD p.o. and 0.005% calcipotriol ointment local application BD for 8 weeks. While calcipotriol group received 0.005% calcipotriol ointment local application BD for 8 weeks. Primary endpoint for efficacy was percentage of patients in whom mPASI decreased by 75% from baseline. Safety was also monitored throughout. Results 106 patients were randomized: calcipotriol+apremilast (n = 56) and calcipotriol group (n = 53). More patients of calcipotriol+apremilast achieved treatment success compared to calcipotriol was also higher (51.85% vs 34.61%; p < 0.001). Similar percentage of patients reported adverse events: Calcipotriol+apremilast 45.49% (n = 23) and calcipotriol 42.30% (n = 22) Conclusion Addition of apremilast to calcipotriol is significantly more efficacious than calcipotriol monotherapy. This combination is as safe as monotherapy.

scholarly journals P732 The clinical efficacy and safety of indigo naturalis in induction & maintenance therapy for moderate-to-severe ulcerative colitis: A single-centre prospective uncontrolled open-label study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S588-S588
Author(s):  
Y Matsuno ◽  
A Hirano ◽  
T Torisu ◽  
Y Fuyuno ◽  
Y Okamoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Mucosal Healing ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Indigo Naturalis

Abstract Background Recently, several studies have shown the high efficacy of Indigo naturalis (IN) in the induction therapy for ulcerative colitis (UC). However, the efficacy and safety in the maintenance therapy remain unclear. Thus, we performed this prospective study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with moderate to severe active UC. Methods We conducted a prospective uncontrolled open-label study at Kyushu university hospital. A total of 33 patients with moderate to severe active UC (clinical activity index (CAI) ≥8) received 2 g per day of IN for 52 weeks. We assessed CAI at week 0, 4, 8, 52, and Mayo endoscopic score (MES) was evaluated at weeks 0, 4, 52. We calculated the clinical remission (CAI ≤4) rate and mucosal healing (MES ≤1) rate at each point. Overall adverse events (AEs) during the follow-up were also estimated. Results Clinical remission rates at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. Mucosal healing rates at weeks 4 and 52 were 48% and 70%. Seventeen patients experienced adverse events (AEs) during the follow-up. Seven severe AEs, including intussusceptions, acute severe colitis, infectious colitis, portal thrombosis, appendicitis, were observed in 4 patients. Conclusion Our prospective study indicated that IN was a promising option for induction and maintenance therapy in UC. However, possible AEs of IN should be paid attention.

scholarly journals Efficacy and Safety of Calcipotriol/Betamethasone Dipropionate Ointment for the Treatment of Trachyonychia: An Open-Label Study

2015 ◽  
Vol 27 (4) ◽  
pp. 371 ◽  
Author(s):  
Jung-Min Park ◽  
Hyun-Ho Cho ◽  
Won-Jeong Kim ◽  
Je-Ho Mun ◽  
Margaret Song ◽  
...  
Keyword(s):  
Betamethasone Dipropionate ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Calcipotriol Betamethasone

scholarly journals Efficacy and Safety of Thirst-Quenching Lozenges for Xerostomia in Patients Undergoing Hemodialysis: A Prospective, Single-Arm, Open-Label Study

2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Sahay Manisha ◽  
Almeida Alan ◽  
Naqvi Syed Mujtaba Hussain ◽  
Venugopal Hariharan ◽  
Kale Ravindra Machhindra ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals A179 CANADIAN INVOLVEMENT IN THE EVALUATION OF NOVEL THERAPY FOR DIABETIC GASTROPARESIS: OVERVIEW OF PLEDGE TRIALS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 45-47
Author(s):  
L W Liu ◽  
M Syrzycka ◽  
P Janiszewski ◽  
L Kemps ◽  
B Degeronimo
Keyword(s):  
Diabetic Gastroparesis ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
The Third ◽  
Parallel Group

Abstract Background Diabetic gastroparesis(DG) is a serious, chronic complication of type 1 or 2 diabetes mellitus(DM) presenting with a delay in gastric emptying(GE). An estimated 3 million Canadians have been diagnosed with DM; up to 5% of these patients may develop DG. DG can result in poor glycemic control, recurrent nausea and vomiting, often resulting in hospitalization. To date, no effective treatments are available. A phase 2 study showed that relamorelin (RLM), a synthetic ghrelin agonist, was safe and effective in treating DG. Investigators across Canada are participating in a set of phase 3 international trials of RLM in the treatment of DG. Aims To report the Canadian involvement in the international effort to evaluate the safety and efficacy of RLM in the treatment of DG. PLEDGE is a set of 5 trials: two identical 12-week studies, a 46-week extension study, a 52-week exposure study, and an open-label extension study. Collectively, the data from these studies will help to evaluate the safety and efficacy of RLM, a novel treatment for Canadian patients living with DG. Methods Four global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies compare the efficacy of RLM with placebo in participants with DG using composite endpoints of nausea, abdominal pain, postprandial fullness, bloating. Participants are randomized to RLM 10μg or placebo subcutaneously (SC) twice daily groups. The open-label continuation of treatment will follow participants until RLM becomes commercially available to provide long-term safety information to support the safe use of RLM as a chronic treatment of DG. As seen in Figure 1, participants from the two 12-week studies will rollover into the third study that will continue for 46 weeks. The fourth study will enroll participants that were not randomized in the first two studies because their symptoms were less severe and will also accept new participants. Participants will be randomized 2:1 to RLM 10μg or placebo SC twice daily groups. Participants from the third and fourth studies have the option to enroll in the open-label study. Results Target enrollment is approx. 1800 participants for the 4 global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies and 1000 participants for the open label study. 700 sites are expected to participate globally; 15 Canadian sites in 6 provinces are participating. Conclusions Canadian centers are actively involved in the PLEDGE trials to help determine the efficacy and safety of RLM, a potential new treatment for DG. This publication increases awareness of the Canadian gastroenterology community, providing an option to refer interested patients to PLEDGE study centers. PLEDGE Studies (NCT03285308, NCT03426345, NCT03420781, NCT03383146, NCT03786380): Placebo-controlled, randomized RLM-MD-01/02/03/04 and open-label study 3071-305-020 to study the safety and efficacy of relamorelin for the treatment of diabetic gastroparesis Funding Agencies None

scholarly journals P129: A phase IV real world study on the use of low dose methoxyflurane (PENTHROX™) for the treatment of moderate to severe trauma pain in the Canadian emergency department (ADVANCE-ED): an interim report on secondary outcomes

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S111-S111
Author(s):  
S. Campbell ◽  
E. Simard ◽  
A. Arcand ◽  
L. Blagrove ◽  
P. Piraino ◽  
...  
Keyword(s):  
Pain Relief ◽  
Adverse Events ◽  
Acute Pain ◽  
Real World ◽  
Rescue Medication ◽  
Low Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Phase Iv

Introduction: Inhaled low dose methoxyflurane (MEOF) was recently approved in Canada for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in conscious adult patients. ADVANCE-ED is an ongoing phase IV, prospective open label study undertaken to generate real-world evidence to complement the global clinical development program through evaluation of the effectiveness of low dose MEOF in Canadian emergency departments (EDs). Methods: This multi-centre study is enrolling adult (≥18 yrs) patients with moderate to severe acute pain (NRS0-10 ≥ 4) associated with minor trauma. To address limitations from the pivotal study, this study allows patients who were excluded in the pivotal trials: namely, those with severe (≥7) pain, and those using OTC or stably dosed analgesics for other conditions, including chronic pain. Eligible patients receive a single treatment of up to 2 x 3 mL MEOF (2nd 3 mL to be provided only upon request), self-administered by the patient under medical supervision. Rescue medication is permitted at any time, if required. Results: Here we describe the patient demographics and treatment satisfaction (Global Medication Performance, GMP) at 50% enrolment (n = 49). Mean (SD) patient age is 48.0 (17.1) yrs and 55.1% are female. Mean pain (SD) reported at enrolment is 8.3 (1.5), with 73.4% of patients with NRS0-10 ≥ 8. Injuries are overwhelmingly limb trauma (87.8%). The most common type is sprain/strain (40.8%), followed by fracture (32.7%). At 5 minutes post-start of administration (STA) of MEOF, 80.4% of patients reported pain relief; this increased to 91.3% at 15 minutes, and 100% of patients reported pain relief by 30 minutes post-STA. GMP was assessed as “good”, “very good” or “excellent” by ≥80% of patients both 20 minutes post-start of administration (STA) of MEOF (83.3%) and at discharge (85.8%). When asked to what extent their expectation of pain relief had been met, 32.7% responded good, 26.5% responded “very good” and 22.4% responded “excellent”. Three quarters of enrolled patients (75.5%) did not require rescue medication. The most common (≥5%) treatment-related adverse events were dizziness (n = 14, 28.6%) and euphoric mood (n = 4, 8.2%). No serious adverse events have been reported. Conclusion: Based on 50% of the patients enrolled in this prospective, open label study, responses to inhaled low-dose MEOF are within expectation for both effectiveness and tolerability.

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