A previous Delphi survey from the Rational Use of Analgesics (RUA) project involving Italian palliative care specialists revealed some discrepancies between current guidelines and clinical practice with a lack of consensus on items regarding the use of strong opioids in treating cancer pain. Those results represented the basis for a new Delphi study addressing a better approach to pain treatment in patients with cancer.
The study consisted of a two-round multidisciplinary Delphi study. Specialists rated their agreement with a set of 17 statements using a 5-point Likert scale (0 = totally disagree and 4 = totally agree). Consensus on a statement was achieved if the median consensus score (MCS) (expressed as value at which at least 50% of participants agreed) was at least 4 and the interquartile range (IQR) was 3-4.
This survey included input from 186 palliative care specialists representing all Italian territory. Consensus was reached on seven statements. More than 70% of participants agreed with the use of low dose of strong opioids in moderate pain treatment and valued transdermal route as an effective option when the oral route is not available. There was strong consensus on the importance of knowing opioid pharmacokinetics for therapy personalization and on identifying immediate-release opioids as key for tailoring therapy to patients' needs. Limited agreement was reached on items regarding breakthrough pain and the management of opioid-induced bowel dysfunction.
These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.
These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.
Basal-bolus (BB) and premixed insulin regimens may lower fasting plasma glucose (FPG) and postprandial plasma glucose (PPG), but are complex to use and associated with weight gain and hypoglycaemia. Although randomized controlled trials and prospective observational studies in insulin-naïve Japanese patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs) initiating these regimens have been conducted, real-world data are lacking. This study describes the characteristics of patients initiating these regimens in routine clinical practice and identifies the course and outcomes of therapy in the year following initiation.
Adults with T2D initiating BB or premixed regimens following OAD therapies held in a Japanese electronic medical record database were identified (2010-2019). Subcohorts were determined by treatment changes during ≤ 12months of follow-up (no change, intensified, switched, discontinued). Outcomes included change in glycated haemoglobin levels (HbA1c), proa limited duration to improve FPG and PPG control.
Greater HbA1c reductions, but a higher incidence of hypoglycaemia, were reported with BB versus premixed regimens, while both cohorts demonstrated clinically meaningful reductions in HbA1c during follow-up. After initiation, most premixed regimens remained unchanged, whereas switches from BB to less intensive regimens were numerous, in accordance with the use of BB for a limited duration to improve FPG and PPG control.
STELLA-LONGTERM is a post-marketing surveillance study evaluating the safety and effectiveness of ipragliflozin in Japanese patients with type2 diabetes mellitus.
Patients were classified by age at ipragliflozin initiation (< 65 and ≥ 65years), and elderly patients were subclassified by baseline body mass index (BMI) < 25.0 or ≥ 25.0kg/m
. Incidence of adverse drug reactions (ADRs) and effectiveness were evaluated over 3years.
Among 11,051 patients, 7894 (71.4%) were aged < 65years and 3157 (28.6%) ≥ 65years. https://www.selleckchem.com/products/pf-06882961.html The 3-year ADR incidence was similar in patients aged ≥ 65 (19.04%) and < 65years (19.36%; P = 0.701). Serious ADRs were more frequent in the subgroup ≥ 65years (2.79% vs 1.55%; P < 0.001). In terms of ADRs of special interest, a significantly greater proportion of elderly patients had skin complications (2.22% vs 1.62%, P = 0.033), renal disorders (2.28% vs 1.51%, P = 0.005), hypoglycemia (0.73% vs 0.43%, P = 0.048), or malignant tumors (1.01% vs 0.24%, P < 0.001), while the incidence of polyuria/pollakiuria (5.97% vs 4.47%, P = 0.002) and hepatic disorders (1.39% vs 0.73%, P = 0.004) was significantly higher in non-elderly than elderly patients. In patients aged ≥ 65years, the incidence of ADRs was higher when baseline BMI was ≥ 25kg/m
versus < 25kg/m
(24.40% vs 17.68%; P < 0.001). Glycosylated hemoglobin, fasting blood glucose, and body weight significantly decreased from baseline in both age groups at each evaluation up to 3years (all P < 0.001).
Ipragliflozin was well tolerated and effective for 3years in routine clinical use in elderly and non-elderly patients, although elderly patients had a higher rate of serious ADRs. No new safety concerns were identified.
ClinicalTrials.gov identifier NCT02479399.
ClinicalTrials.gov identifier NCT02479399.
We aimed to examine the impact of the severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) pandemic on diabetic ketoacidosis (DKA) rates in children with type1 diabetes (T1D).
A retrospective cross-sectional study of 11 Israeli pediatric emergency departments (ED) was conducted. Children with T1D who attended the ED between March1, 2020 and May31, 2020 were compared with those who attended the ED between March1, 2019 and May31, 2019.
Overall, 150 and 154 children with T1D attended the EDs during the 3-month study periods in 2020 and 2019, respectively. Among patients with established T1D, DKA rates significantly increased in 2020 compared to 2019 [38/64 (59.3%) vs 31/74 (41.9%); p < 0.043]. There was a non-statistically significant trend toward a higher rate of DKA in patients with newly diagnosed T1D [46/86 (53.4%) vs 31/80 (38.7%); p = 0.063]. No differences were observed in the rates of severe DKA in 2020 compared to 2019 among patients with established T1D [10/64 (15.6%) vs 6/74 (8.1%); p = 0.
A previous Delphi survey from the Rational Use of Analgesics (RUA) project involving Italian palliative care specialists revealed some discrepancies between current guidelines and clinical practice with a lack of consensus on items regarding the use of strong opioids in treating cancer pain. Those results represented the basis for a new Delphi study addressing a better approach to pain treatment in patients with cancer.
The study consisted of a two-round multidisciplinary Delphi study. Specialists rated their agreement with a set of 17 statements using a 5-point Likert scale (0 = totally disagree and 4 = totally agree). Consensus on a statement was achieved if the median consensus score (MCS) (expressed as value at which at least 50% of participants agreed) was at least 4 and the interquartile range (IQR) was 3-4.
This survey included input from 186 palliative care specialists representing all Italian territory. Consensus was reached on seven statements. More than 70% of participants agreed with the use of low dose of strong opioids in moderate pain treatment and valued transdermal route as an effective option when the oral route is not available. There was strong consensus on the importance of knowing opioid pharmacokinetics for therapy personalization and on identifying immediate-release opioids as key for tailoring therapy to patients' needs. Limited agreement was reached on items regarding breakthrough pain and the management of opioid-induced bowel dysfunction.
These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.
These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.
Basal-bolus (BB) and premixed insulin regimens may lower fasting plasma glucose (FPG) and postprandial plasma glucose (PPG), but are complex to use and associated with weight gain and hypoglycaemia. Although randomized controlled trials and prospective observational studies in insulin-naïve Japanese patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs) initiating these regimens have been conducted, real-world data are lacking. This study describes the characteristics of patients initiating these regimens in routine clinical practice and identifies the course and outcomes of therapy in the year following initiation.
Adults with T2D initiating BB or premixed regimens following OAD therapies held in a Japanese electronic medical record database were identified (2010-2019). Subcohorts were determined by treatment changes during ≤ 12months of follow-up (no change, intensified, switched, discontinued). Outcomes included change in glycated haemoglobin levels (HbA1c), proa limited duration to improve FPG and PPG control.
Greater HbA1c reductions, but a higher incidence of hypoglycaemia, were reported with BB versus premixed regimens, while both cohorts demonstrated clinically meaningful reductions in HbA1c during follow-up. After initiation, most premixed regimens remained unchanged, whereas switches from BB to less intensive regimens were numerous, in accordance with the use of BB for a limited duration to improve FPG and PPG control.
STELLA-LONGTERM is a post-marketing surveillance study evaluating the safety and effectiveness of ipragliflozin in Japanese patients with type2 diabetes mellitus.
Patients were classified by age at ipragliflozin initiation (< 65 and ≥ 65years), and elderly patients were subclassified by baseline body mass index (BMI) < 25.0 or ≥ 25.0kg/m
. Incidence of adverse drug reactions (ADRs) and effectiveness were evaluated over 3years.
Among 11,051 patients, 7894 (71.4%) were aged < 65years and 3157 (28.6%) ≥ 65years. https://www.selleckchem.com/products/pf-06882961.html The 3-year ADR incidence was similar in patients aged ≥ 65 (19.04%) and < 65years (19.36%; P = 0.701). Serious ADRs were more frequent in the subgroup ≥ 65years (2.79% vs 1.55%; P < 0.001). In terms of ADRs of special interest, a significantly greater proportion of elderly patients had skin complications (2.22% vs 1.62%, P = 0.033), renal disorders (2.28% vs 1.51%, P = 0.005), hypoglycemia (0.73% vs 0.43%, P = 0.048), or malignant tumors (1.01% vs 0.24%, P < 0.001), while the incidence of polyuria/pollakiuria (5.97% vs 4.47%, P = 0.002) and hepatic disorders (1.39% vs 0.73%, P = 0.004) was significantly higher in non-elderly than elderly patients. In patients aged ≥ 65years, the incidence of ADRs was higher when baseline BMI was ≥ 25kg/m
versus < 25kg/m
(24.40% vs 17.68%; P < 0.001). Glycosylated hemoglobin, fasting blood glucose, and body weight significantly decreased from baseline in both age groups at each evaluation up to 3years (all P < 0.001).
Ipragliflozin was well tolerated and effective for 3years in routine clinical use in elderly and non-elderly patients, although elderly patients had a higher rate of serious ADRs. No new safety concerns were identified.
ClinicalTrials.gov identifier NCT02479399.
ClinicalTrials.gov identifier NCT02479399.
We aimed to examine the impact of the severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) pandemic on diabetic ketoacidosis (DKA) rates in children with type1 diabetes (T1D).
A retrospective cross-sectional study of 11 Israeli pediatric emergency departments (ED) was conducted. Children with T1D who attended the ED between March1, 2020 and May31, 2020 were compared with those who attended the ED between March1, 2019 and May31, 2019.
Overall, 150 and 154 children with T1D attended the EDs during the 3-month study periods in 2020 and 2019, respectively. Among patients with established T1D, DKA rates significantly increased in 2020 compared to 2019 [38/64 (59.3%) vs 31/74 (41.9%); p < 0.043]. There was a non-statistically significant trend toward a higher rate of DKA in patients with newly diagnosed T1D [46/86 (53.4%) vs 31/80 (38.7%); p = 0.063]. No differences were observed in the rates of severe DKA in 2020 compared to 2019 among patients with established T1D [10/64 (15.6%) vs 6/74 (8.1%); p = 0.
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