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Ulrich Mrowietz - One of the best experts on this subject based on the ideXlab platform.
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efficacy of a fixed combination of calcipotriol betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis blinded interim analysis of a Phase IV multicenter randomized controlled prospectIVe study
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: K Reich, I Zschocke, H Bachelez, Paolo Gisondi, Lluis Puig, R B Warren, Ulrich MrowietzAbstract:BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of indIViduals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspectIVe) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/betamethasone dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this Phase IV, international, multicentre, randomized, controlled, prospectIVe, parallel group study, adult patients with actIVe, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/betamethasone dipropionate gel is highly efficacious and preferred by the majority of analysed patients.
Thaddeus H Grasela - One of the best experts on this subject based on the ideXlab platform.
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adverse events in a multicenter Phase IV study of propofol evaluation by anesthesiologists and postanesthesia care unit nurses
Anesthesia & Analgesia, 1993Co-Authors: Charles H Mcleskey, Cynthia A Walawander, Michael L Nahrwold, Jeffrey L Apfelbaum, Michael F Roizen, Ronald A Thisted, Theodore H Stanley, Paul F. White, Thaddeus H GraselaAbstract:Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug. However, because postapproval Phase IV studies involve a much larger and more complex population, the true nature of adverse effects can be seen. We analyzed Phase IV data for the new drug propofol with regard to the incidence of adverse events, and evaluations of such events by anesthesiologists versus postanesthesia care unit (PACU) nurses. Data pertained to 25,981 patients, 1722 institutions, and 1819 anesthesiologists gIVing propofol in three anesthetic regimens. Inclusion criteria were liberal: age, 18-80 yr; ASA physical status I-III; no continuing pregnancy; and no prior adverse anesthetic experience
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adverse events in a multicenter Phase IV study of propofol evaluation by anesthesiologists and postanesthesia care unit nurses
Anesthesia & Analgesia, 1993Co-Authors: Charles H Mcleskey, Cynthia A Walawander, Michael L Nahrwold, Jeffrey L Apfelbaum, Michael F Roizen, Ronald A Thisted, Thaddeus H Grasela, Theodore H Stanley, Paul F. White, Carl C HugAbstract:Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug. However, because postapproval Phase IV studies involve a much larger and more complex population, the true nature of adverse effects can be seen. We analyzed Phase IV data for the new drug propofol with regard to the incidence of adverse events, and evaluations of such events by anesthesiologists versus postanesthesia care unit (PACU) nurses. Data pertained to 25,981 patients, 1722 institutions, and 1819 anesthesiologists gIVing propofol in three anesthetic regimens. Inclusion criteria were liberal: age, 18-80 yr; ASA physical status I-III; no continuing pregnancy; and no prior adverse anesthetic experience. Anesthesiologists and PACU nurses used data collection forms to record demographic, perioperatIVe, and outcome variables; to evaluate recovery (excellent, good, or poor); and to describe adverse events. Adverse events were reported for 2813 patients (10.8%); the most common events were pain on injection (5.2%), hypotension (1.1%), nausea/vomiting (1.9%), and excitement (1.3%). The incidences of pain on injection and nausea/vomiting were approximately one-half and one-fifth, respectIVely, the values reported in earlier studies. Six hundred thirty-three patients (2.4%) had a "poor" recovery according to one or both of the evaluators (the anesthesiologist or PACU nurse). The PACU nurse was more influenced by nausea, vomiting, or postoperatIVe pain; and the anesthesiologist was more influenced by postoperatIVe confusion or delayed emergence from anesthesia. For only 0.6% of patients did both evaluators rate recovery as poor. Anesthesiologists gave more weight to intraoperatIVe adverse events, and nurses to postoperatIVe events.(ABSTRACT TRUNCATED AT 250 WORDS)
Charles H Mcleskey - One of the best experts on this subject based on the ideXlab platform.
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adverse events in a multicenter Phase IV study of propofol evaluation by anesthesiologists and postanesthesia care unit nurses
Anesthesia & Analgesia, 1993Co-Authors: Charles H Mcleskey, Cynthia A Walawander, Michael L Nahrwold, Jeffrey L Apfelbaum, Michael F Roizen, Ronald A Thisted, Theodore H Stanley, Paul F. White, Thaddeus H GraselaAbstract:Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug. However, because postapproval Phase IV studies involve a much larger and more complex population, the true nature of adverse effects can be seen. We analyzed Phase IV data for the new drug propofol with regard to the incidence of adverse events, and evaluations of such events by anesthesiologists versus postanesthesia care unit (PACU) nurses. Data pertained to 25,981 patients, 1722 institutions, and 1819 anesthesiologists gIVing propofol in three anesthetic regimens. Inclusion criteria were liberal: age, 18-80 yr; ASA physical status I-III; no continuing pregnancy; and no prior adverse anesthetic experience
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adverse events in a multicenter Phase IV study of propofol evaluation by anesthesiologists and postanesthesia care unit nurses
Anesthesia & Analgesia, 1993Co-Authors: Charles H Mcleskey, Cynthia A Walawander, Michael L Nahrwold, Jeffrey L Apfelbaum, Michael F Roizen, Ronald A Thisted, Thaddeus H Grasela, Theodore H Stanley, Paul F. White, Carl C HugAbstract:Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug. However, because postapproval Phase IV studies involve a much larger and more complex population, the true nature of adverse effects can be seen. We analyzed Phase IV data for the new drug propofol with regard to the incidence of adverse events, and evaluations of such events by anesthesiologists versus postanesthesia care unit (PACU) nurses. Data pertained to 25,981 patients, 1722 institutions, and 1819 anesthesiologists gIVing propofol in three anesthetic regimens. Inclusion criteria were liberal: age, 18-80 yr; ASA physical status I-III; no continuing pregnancy; and no prior adverse anesthetic experience. Anesthesiologists and PACU nurses used data collection forms to record demographic, perioperatIVe, and outcome variables; to evaluate recovery (excellent, good, or poor); and to describe adverse events. Adverse events were reported for 2813 patients (10.8%); the most common events were pain on injection (5.2%), hypotension (1.1%), nausea/vomiting (1.9%), and excitement (1.3%). The incidences of pain on injection and nausea/vomiting were approximately one-half and one-fifth, respectIVely, the values reported in earlier studies. Six hundred thirty-three patients (2.4%) had a "poor" recovery according to one or both of the evaluators (the anesthesiologist or PACU nurse). The PACU nurse was more influenced by nausea, vomiting, or postoperatIVe pain; and the anesthesiologist was more influenced by postoperatIVe confusion or delayed emergence from anesthesia. For only 0.6% of patients did both evaluators rate recovery as poor. Anesthesiologists gave more weight to intraoperatIVe adverse events, and nurses to postoperatIVe events.(ABSTRACT TRUNCATED AT 250 WORDS)
Rupert R A Bourne - One of the best experts on this subject based on the ideXlab platform.
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changes in ocular signs and symptoms in patients switching from bimatoprost timolol to tafluprost timolol eye drops an open label Phase IV study
BMJ Open, 2019Co-Authors: Kai Kaarniranta, Carlo Enrico Traverso, Rupert R A Bourne, Katrin Lorenz, Jouni Vuorinen, Auli RopoAbstract:ObjectIVes Bimatoprost–timolol (bimatoprost 0.03%–timolol 0.5% fixed-dose combination [FDC]) and tafluprost–timolol (tafluprost 0.0015%–timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservatIVe-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost–timolol to PF tafluprost–timolol eye drops. Design This was a 12-week, open-label, Phase IV study. Setting Sixteen centres in Finland, Germany, Italy and the UK. Participants Patients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost–timolol for ≥4 weeks before screening, and presenting with conjunctIVal hyperaemia and ≥1 ocular symptom. Interventions Patients were switched to PF tafluprost–timolol once daily in the treated eye(s). Primary and secondary outcome measures The primary endpoints were change from screening to week 12 in conjunctIVal hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctIVal hyperaemia) and symptoms at week 12. Results Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost–timolol and 45 used PF drops. ConjunctIVal hyperaemia and severity of worst ocular symptom following switch to PF tafluprost–timolol significantly reduced from screening to week 12 in all patients (p Conclusions Switching from BAK-preserved or PF bimatoprost–timolol to tafluprost–timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP. Trial registration number EudraCT2014-005273-37; Results.
K Reich - One of the best experts on this subject based on the ideXlab platform.
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efficacy of a fixed combination of calcipotriol betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis blinded interim analysis of a Phase IV multicenter randomized controlled prospectIVe study
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: K Reich, I Zschocke, H Bachelez, Paolo Gisondi, Lluis Puig, R B Warren, Ulrich MrowietzAbstract:BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of indIViduals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspectIVe) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/betamethasone dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this Phase IV, international, multicentre, randomized, controlled, prospectIVe, parallel group study, adult patients with actIVe, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/betamethasone dipropionate gel is highly efficacious and preferred by the majority of analysed patients.