-
1.
Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).
Rayman, G, Vas, P, Dhatariya, K, Driver, V, Hartemann, A, Londahl, M, Piaggesi, A, Apelqvist, J, Attinger, C, Game, F, et al
Diabetes/metabolism research and reviews. 2020;:e3283
Abstract
The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In conjunction with advice from internal and external reviewers and expert consultants in the field, this update is based on a systematic review of the literature centred on the following: the Population (P), Intervention (I), Comparator (C) and Outcomes (O) framework; the use of the SIGN guideline/Cochrane review system; and the 21 point scoring system advocated by IWGDF/EWMA. This has resulted in 13 recommendations. The recommendation on sharp debridement and the selection of dressings remain unchanged from the last recommendations published in 2016. The recommendation to consider negative pressure wound therapy in post-surgical wounds and the judicious use of hyperbaric oxygen therapy in certain non-healing ischaemic ulcers also remains unchanged. Recommendations against the use of growth factors, autologous platelet gels, bioengineered skin products, ozone, topical carbon dioxide, nitric oxide or interventions reporting improvement of ulcer healing through an alteration of the physical environment or through other systemic medical or nutritional means also remain. New recommendations include consideration of the use of sucrose-octasulfate impregnated dressings in difficult to heal neuro-ischaemic ulcers and consideration of the use of autologous combined leucocyte, platelet and fibrin patch in ulcers that are difficult to heal, in both cases when used in addition to best standard of care. A further new recommendation is the consideration of topical placental derived products when used in addition to best standard of care.
-
2.
Blood Pressure Targets Achievement According to 2018 ESC/ESH Guidelines in Three European Excellence Centers for Hypertension.
Tocci, G, Presta, V, Ferri, C, Redon, J, Volpe, M
High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension. 2020;(1):51-59
Abstract
INTRODUCTION The most recent European guidelines on hypertension redefined office blood pressure (BP) treatment targets according to age strata and cardiovascular (CV) risk profile. AIM: To evaluate proportions of adult outpatients achieving office BP treatment targets recommended by current compared to previous hypertension guidelines. METHODS We extracted data from medical databases of adult outpatients followed in three excellence centers in hypertension (Rome, Italy; L'Aquila, Italy; Valencia, Spain). Office BP treatment targets were defined according to either 2013 ESH/ESC guidelines (< 140/90 mmHg in non-diabetic individuals aged 18-80 years, < 150/90 mmHg in those aged ≥ 80 years, and < 140/85 mmHg in diabetic individuals), or 2018 ESC/ESH guidelines: (< 130/80 mmHg in individuals aged 18-65 years, < 140/80 mmHg in those aged 65-79 and ≥ 80 years). SCORE risk was assessed in all patients. RESULTS From an overall sample of 14,229 adult subjects, 4049 (28.5%) resulted normotensive individuals, 3088 (21.7%) were untreated and 7092 (49.8%) treated hypertensive outpatients. Treated hypertensives showed significantly higher ESC score risk (8.3 ± 13.0% vs. 3.9 ± 8.4%; P < 0.001) and lower systolic/diastolic BP (140.6 ± 18.8/83.9 ± 11.5 vs. 148.3 ± 14.2/94.7 ± 10.1 mmHg; P < 0.001) than untreated hypertensives. Compared to previous guidelines, BP control significantly lowered in non-diabetic outpatients (n = 5847) of all age groups [18-65 years: (13.1% vs. 42.9%), 65-79 years (25.8% vs. 42.5%) and ≥ 80 years (29.1% vs. 66.0%); P < 0.001 for all comparisons]; similar reductions were observed in diabetic outpatients (n = 1245) [18-65 years (32.7% vs. 14.8%), 65-79 years (37.3% vs. 24.7%) and ≥ 80 years (47.1% vs. 27.9%); P < 0.001]. CONCLUSIONS According to the recommended new office BP treatment targets, the proportions of treated uncontrolled hypertensive patients substantially increased. These findings should prompt a tighter application of therapeutic recommendations and, thus, highlight the need for improving hypertension management and control strategies.
-
3.
Conditional prescriptions of oral antihypertensive drugs for the management of hypertension urgencies in the inpatient setting: An observational study.
Pieragostini, R, Perrin, G, Nevoret, C, Amar, L, Jannot, AS, Sabatier, P, Korb-Savoldelli, V, Sabatier, B
Journal of clinical pharmacy and therapeutics. 2020;(2):282-289
Abstract
WHAT IS KNOWN AND OBJECTIVES The management of hypertension urgencies during hospitalization may generally not necessitate urgent care. However, physicians frequently prescribe 'as needed' antihypertensive drugs for which administration is triggered by blood pressure thresholds. The lack of rationale for this hospital practice led us to study oral conditional antihypertensive (OCA) prescriptions. We aimed to estimate the prevalence of OCA prescriptions and to establish their characteristics. METHODS In our institution, prescriptions are computerized. The study was retrospectively performed using a hospital clinical data warehouse over a 5-year period. RESULTS AND DISCUSSION The prevalence of OCA prescriptions was 6.9% among subjects treated with an antihypertensive drug. The median duration of these prescriptions was 4 days, until the day of the patient discharge in 78.8% stays. The calcium channel inhibitors were the main (79.9%) pharmacological class prescribed, with mostly prescriptions of nicardipine. OCA prescriptions were associated with another antihypertensive medication in 58.8% of the prescriptions; for 19.3%, it was a medication belonging to the same pharmacological class than the OCA drug prescribed. Regarding the computerized drafting, 39.6% of the conditional prescriptions were considered uninterpretable. At least one administration by nurses concerned 65.1% of the OCA prescriptions. The mean SBP and DBP before the initiation of an OCA drug was 142.9 ± 28.2 and 75.8 ± 24.5 mm Hg, respectively, relative to 143.0 ± 24.9 and 77.6 ± 19.9 mm Hg after the initiation (P = .8 for SBP and P = .06 for DBP). WHAT IS NEW AND CONCLUSION The originality of this study lies in the use of a clinical data warehouse to evaluate OCA prescriptions in hospital. These prescriptions are current, often uninterpretable and mostly ordered until patient discharge. Such drug orders could be associated with an increased risk of iatrogenic events and/or administration errors. This underlies the need for developing decision support tools and computerized protocols to manage hypertension urgencies.
-
4.
Regional Variations in Alirocumab Dosing Patterns in Patients with Heterozygous Familial Hypercholesterolemia During an Open-Label Extension Study.
Langslet, G, Hovingh, GK, Guyton, JR, Baccara-Dinet, MT, Letierce, A, Manvelian, G, Farnier, M
Cardiovascular drugs and therapy. 2020;(4):515-523
-
-
Free full text
-
Abstract
PURPOSE During the alirocumab open-label extension study ODYSSEY OLE (open-label extension; NCT01954394), physicians could adjust alirocumab dosing for enrolled patients, who were diagnosed with heterozygous familial hypercholesterolemia (HeFH) and who had completed previous phase III clinical trials with alirocumab. This post hoc analysis evaluated the differences in physician-patient dosing decisions between the regions of Western Europe, Eastern Europe, North America, and the rest of the world (ROW). METHODS Patients (n = 909) who received starting dose alirocumab 75 mg every 2 weeks (Q2W) during ODYSSEY OLE (patients from FH I, FH II, and LONG TERM parent studies) were included. Low-density lipoprotein cholesterol (LDL-C) levels were blinded until week 8; subsequently, LDL-C values were communicated to physicians. From week 12, dose adjustment from 75 to 150 mg Q2W, or vice versa, was possible. RESULTS Mean LDL-C values used for the decision to increase dose from 75 to 150 mg Q2W were higher in Eastern Europe (3.7 mmol/L; 144.0 mg/dL) and ROW (3.8 mmol/L; 145.2 mg/dL) compared with Western Europe (3.1 mmol/L; 118.6 mg/dL) and North America (3.3 mmol/L; 126.6 mg/dL). Irrespective of region, the mean LDL-C at the time of decision to maintain at 75 mg Q2W was approximately 1.8 mmol/L (70 mg/dL). During ODYSSEY OLE (median treatment duration of 131.7 weeks), alirocumab was shown to have no unexpected long-term safety concerns. CONCLUSIONS In this OLE study, the observed variations in clinical treatment decisions suggest that physicians may perceive the severity of HeFH and/or the treatment of HeFH differently depending on their region.
-
5.
Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato-Oncology (HOLA) Observational Study, 2008-2016.
de Moraes Hungria, VT, Martínez-Baños, DM, Peñafiel, CR, Miguel, CE, Vela-Ojeda, J, Remaggi, G, Duarte, FB, Cao, C, Cugliari, MS, Santos, T, et al
British journal of haematology. 2020;(3):383-393
-
-
Free full text
-
Abstract
Limited data are available regarding contemporary multiple myeloma (MM) treatment practices in Latin America. In this retrospective cohort study, medical records were reviewed for a multinational cohort of 1103 Latin American MM patients (median age, 61 years) diagnosed in 2008-2015 who initiated first-line therapy (LOT1). Of these patients, 33·9% underwent autologous stem cell transplantation (ASCT). During follow-up, 501 (45·4%) and 129 (11·7%) patients initiated second- (LOT2) and third-line therapy (LOT3), respectively. In the LOT1 setting, from 2008 to 2015, there was a decrease in the use of thalidomide-based therapy, from 66·7% to 42·6%, and chemotherapy from, 20·2% to 5·9%, whereas use of bortezomib-based therapy or bortezomib + thalidomide increased from 10·7% to 45·5%. Bortezomib-based therapy and bortezomib + thalidomide were more commonly used in ASCT patients and in private clinics. In non-ASCT and ASCT patients, median progression-free survival (PFS) was 15·0 and 31·1 months following LOT1 and 10·9 and 9·5 months following LOT2, respectively. PFS was generally longer in patients treated with bortezomib-based or thalidomide-based therapy versus chemotherapy. These data shed light on recent trends in the management of MM in Latin America. Slower uptake of newer therapies in public clinics and poor PFS among patients with relapsed MM point to areas of unmet therapeutic need in Latin America.
-
6.
Bisphosphonate and denosumab initiation in older adults in Ontario, Canada: a population-based cohort study.
Clemens, KK, Jeyakumar, N, Ouédraogo, AM, Thain, J, Khan, T
Archives of osteoporosis. 2020;(1):133
Abstract
UNLABELLED We provide an update on how commonly prescribed osteoporosis therapies are being initiated in older adults in Ontario. Patients newly prescribed denosumab are older, more often female, and have more comorbidities than those prescribed bisphosphonates. Their characteristics, monitoring, and persistence with prescribed therapy differ from clinical trial participants. Real-world studies on oral bisphosphonates and denosumab might be valuable. PURPOSE To provide a contemporary view on oral bisphosphonate and denosumab prescribing to older adults in routine care. METHODS Using linked healthcare databases, we conducted a population-based cohort study of adults ≥ 66 years newly prescribed oral bisphosphonates or denosumab between February 2013 and March 2017 in Ontario, Canada. We captured their clinical characteristics, monitoring, and continuous use of prescribed therapies. We illustrate how "real-world" new users of bisphosphonates and denosumab differ from randomized controlled trial (RCT) participants. RESULTS There were 107,847 individuals newly prescribed oral bisphosphonates (n = 59,996) or denosumab (n = 47,851) over the study period. Compared with new users of oral bisphosphonates, denosumab users were older (mean age 79.1 vs. 75.7 years), more often female (97.2 vs. 71.8%), from non-rural areas (93.9 vs. 89.9%), and resided in long-term care (10.9 vs. 3.3%). They had more comorbidities including dementia, falls, and fractures. Following their new prescription, denosumab users had more frequent testing of serum calcium. Duration of continuous use of denosumab was longer than bisphosphonates, and more bisphosphonate users had evidence of treatment discontinuation (56.7 bisphosphonate vs. 33.8% denosumab users discontinued therapy at 365 days). Compared with RCT participants, a higher proportion of "real-world" bisphosphonate and denosumab users had comorbidities including advanced kidney disease. CONCLUSION The clinical characteristics and monitoring of new users of bisphosphonates and denosumab generally align with practice guidelines, product monographs, and drug reimbursement criteria. Given differences between real-world users and RCT participants, there may be a role for safety and effectiveness studies of bisphosphonates and denosumab in routine care.
-
7.
Real-world prescribing and switching patterns of non-calcium containing phosphate binders in dialysis patients in South Korea
.
Kim, JJ, Kim, MG, Park, SC, Hwang, J, Sohn, HS
International journal of clinical pharmacology and therapeutics. 2020;(3):166-173
Abstract
OBJECTIVE Non-calcium containing phosphate binders (non-CPBs) are useful for the treatment of hyperphosphatemia without a concern of hypercalcemia in patients undergoing dialysis. However, due to their relatively high cost, prescribing non-CPBs is restricted in South Korea. This study was conducted to investigate prescribing patterns, especially switching between CPBs and non-CPBs, in dialysis patients in a real-world setting. MATERIALS AND METHODS This is an observational study using the National Health Insurance Service claim data. The study population included patients who initiated dialysis between July 2012 and June 2013 and were prescribed phosphate binders at least once during the observation period (2012 - 2016) (n = 10,073). Medication costs and prescribing patterns including switching of phosphate binders were investigated. RESULTS Compared with the first year of dialysis, the costs of phosphate binders more than doubled during the 4th year of dialysis (from US$ 28.4 to US$ 60.1), largely due to an increase in the cost of non-CPBs (from US$ 117.5 to US$ 237.8). Many patients continued to change drugs between CPBs and non-CPBs. The continuous prescription period of CPBs was shortened each time a drug was changed. A total of 551 patients (13.4%) changed their medication three times between CPBs and non-CPBs. CONCLUSION Over time on dialysis, use of non-CPB increased and medication costs increased accordingly. Many patients continued to change drugs between CPBs and non-CPBs due to the restricted criteria of the health insurance. Further outcome research is necessary to evaluate the appropriateness of the clinical practice in which CPBs and non-CPBs are alternately used.
-
8.
Time-trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF-STENT Registry.
Boivin-Proulx, LA, Deneault-Marchand, A, Matteau, A, Mansour, S, Gobeil, F, Camm, JA, Fox, KAA, Potter, BJ
Clinical cardiology. 2020;(3):216-221
Abstract
BACKGROUND The management of atrial fibrillation and flutter (AF) patients undergoing percutaneous coronary intervention (PCI) has undergone a rapid recent evolution. In 2016, the Canadian Cardiovascular Society (CCS) published expert recommendations to help guide clinicians in balancing bleeding and thrombotic risks in these patients. HYPOTHESIS Antithrombotic regimen prescriptions for AF patients undergoing PCI evolved after the publication of the 2016 CCS AF guidelines. METHODS A prospective cohort of AF patients undergoing PCI with placement of a coronary stent from a single tertiary academic center was analyzed for the recommended antithrombotic regimen at discharge. Prescribing behavior was compared between three time periods (Cohort A [2010-2011]; Cohort B [2014-2015]; Cohort C [2017]) using the χ2 test. In addition, antithrombotic management in Cohorts B and C were compared to guideline-recommended therapy. RESULTS A total of 459 patients with AF undergoing PCI were identified. Clinical and procedural characteristics were similar between cohorts, with the exception of an increase in drug-eluting stent (DES) use over time (P < .01). Overall, the rate of oral anticoagulation (OAC) increased over time (P < .01), associated with an increase in nonvitamin K OAC prescription (P < .01) and a concomitant decrease in vitamin K antagonist prescription (P < .01). Despite this, the overall rate of anticoagulation remains below what would be predicted with perfect guideline compliance (75% vs 94%, P < .01). CONCLUSION There has been a dramatic shift in clinical practice for AF patients requiring PCI, with increases in prescription of OAC even in the context of an increase in the use of DES. However, room for further practice optimization still exists.
-
9.
Clinical management patterns of advanced and metastatic gastro-oesophageal carcinoma after fluoropyrimidine/platinum treatment in France, Germany, Spain and the United Kingdom.
Brown, J, Liepa, AM, Bapat, B, Madhwani, S, Lorenzen, S, García-Foncillas, J, Candrilli, SD, Kaye, JA
European journal of cancer care. 2020;(2):e13213
Abstract
OBJECTIVE To describe treatment patterns and resource utilisation in France, Germany, Spain and the United Kingdom (UK) in patients with unresectable locally advanced and/or metastatic gastro-oesophageal adenocarcinoma (GEA), who failed first-line fluoropyrimidine/platinum treatment. METHODS Treating physicians completed a web-based chart review (2013-2015). Eligible patients were ≥ 18 years old; had unresectable locally advanced and/or metastatic gastric adenocarcinoma including the gastro-oesophageal junction; received first-line fluoropyrimidine/platinum-based therapy; and had ≥ 3 months of follow-up after first-line discontinuation. Data were summarised descriptively for each country. RESULTS There were n = 201 patients in France, n = 202 in Germany, n = 208 in Spain and n = 200 in the UK whose charts were reviewed. Percentages of patients receiving second-line therapy were 55% (France), 48% (Germany), 54% (Spain) and 29% (UK). At the start of second-line therapy, most patients had an ECOG performance status of 1 (range 0-3). Second-line therapy was primarily monotherapy, but agents used varied within and across countries. Supportive care use and resource utilisation were frequent whether receiving additional therapy or not; >60% patients had clinic visits unrelated to chemotherapy administration, and > 30% has ≥ 1 hospital admission. CONCLUSIONS For the time of study, established GEA treatment guidelines were generally followed. However, therapies varied widely in the second-line setting.
-
10.
Decrease in primary but not in secondary abdominal surgery for Crohn's disease: nationwide cohort study, 1990-2014.
Kalman, TD, Everhov, ÅH, Nordenvall, C, Sachs, MC, Halfvarson, J, Ekbom, A, Ludvigsson, JF, Myrelid, P, Olén, O
The British journal of surgery. 2020;(11):1529-1538
-
-
Free full text
-
Abstract
BACKGROUND Treatment of patients with Crohn's disease has evolved in recent decades, with increasing use of immunomodulatory medication since 1990 and biologicals since 1998. In parallel, there has been increased use of active disease monitoring. To what extent these changes have influenced the incidence of primary and repeat surgical resection remains debated. METHODS In this nationwide cohort study, incident patients of all ages with Crohn's disease, identified in Swedish National Patient Registry between 1990 and 2014, were divided into five calendar periods of diagnosis: 1990-1995 and 1996-2000 with use of inpatient registries, 2001, and 2002-2008 and 2009-2014 with use of inpatient and outpatient registries. The cumulative incidence of first and repeat abdominal surgery (except closure of stomas), by category of surgical procedure, was estimated using the Kaplan-Meier method. RESULTS Among 21 273 patients with Crohn's disease, the cumulative incidence of first abdominal surgery within 5 years of Crohn's disease diagnosis decreased continuously from 54·8 per cent in 1990-1995 to 40·4 per cent in 1996-2000 (P < 0·001), and again from 19·8 per cent in 2002-2008 to 17·3 per cent in 2009-2014 (P < 0·001). Repeat 5-year surgery rates decreased from 18·9 per cent in 1990-1995 to 16·0 per cent in 1996-2000 (P = 0·009). After 2000, no further significant decreases were observed. CONCLUSION The 5-year rate of surgical intervention for Crohn's disease has decreased significantly, but the rate of repeat surgery has remained stable despite the introduction of biological therapy.