scholarly journals The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany

2020 ◽  
Vol 8 (1) ◽  
pp. e001486 ◽  
Author(s):  
Peter Bramlage ◽  
Sascha R Tittel ◽  
Christian Wagner ◽  
Kerstin König ◽  
Dirk Raddatz ◽  
...  

IntroductionEmpagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin.Research design and methodsData from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014–2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected.ResultsOver time, the proportion of recipients aged <65 years decreased (71.1% vs 54.4% among early and late adopters), male patients increased (from 50.9% to 66.5%), body mass index (mean±SD) decreased (from 35.5±6.7 to 32.7±6.6 kg/m2), proportion with cardiovascular morbidities increased (from 20.4% to 26.4%), and mean estimated glomerular filtration rate decreased (from 83.2±19.5 to 78.5±21.1 mL/min/1.73 m2) (all p<0.001). Patients increasingly received empagliflozin in combination with metformin (60.8% vs 68.6% of early and late adopters; p<0.001), glucagon-like peptide-1 (GLP-1) agonists (11.0 vs 14.1%; p<0.001) or insulin (34.3% vs 49.9%; p<0.001). Empagliflozin was generally added to existing antidiabetic regimens. Six months after empagliflozin initiation, the mean glycated hemoglobin (HbA1c) decreased by 0.4%, the proportion of patients with HbA1c <6.5% increased (19.2% vs 12.8%), and the mean fasting plasma glucose decreased (155.8±49.7 vs 168.0±55.1 mg/dL) (all p<0.001). No significant changes in rates of severe hypoglycemia and no cases of diabetic ketoacidosis were seen.ConclusionsOver time, empagliflozin is being prescribed to a broader patient range in routine practice, is usually added to existing antidiabetic regimens, and is increasingly used in combination with metformin, GLP-1 agonists and/or insulin. Empagliflozin had a beneficial effect on glycemic control, with no increase in hypoglycemia.

2020 ◽  
Vol 40 (11) ◽  
pp. NP613-NP618
Author(s):  
Bilsev Ince ◽  
Munur Selcuk Kendir ◽  
Ibrahim Kilinc ◽  
Mustafa Cihat Avunduk ◽  
Mehmet Dadaci ◽  
...  

Abstract Background Although some studies in the literature report that autologous and homologous platelet-rich plasma (PRP) can be employed in the treatment of androgenic alopecia (AGA), no study, to the authors’ knowledge, has examined the estrogen concentration of prepared PRP. Objectives The authors aimed to determine the presence of estrogen in PRP and to investigate the effect of estrogen concentration of PRP on AGA treatment. Methods Between 2017 and 2018, 30 male patients with hair loss complaints were included in this prospective study. Autologous PRP was injected in patients in Group 1. Homologous PRP with high estrogen levels was injected in the patients in Group 2. PRP was injected in both groups 4 times at 0, 1, 3, and 6 months. The obtained photographs were evaluated and hair densities of each patient at controls were calculated. Results The mean estrogen level measured in PRP was statistically significantly higher in Group 2. In both groups, the increase in hair density was observed from the first month, but this increase was statistically significantly higher in all controls in Group 2. In Group 2, there was a statistically significant increase in the 1st and 3rd months compared with the previous control, but there was no difference between the 6th and 12th months and the 3rd month. Conclusions Increased hair density is greater and earlier in the group receiving estrogen-rich PRP than in the group utilizing autologous PRP. The authors think that estrogen-rich PRP may be employed in the treatment of AGA in the presence of an appropriate donor. Level of Evidence: 2


Author(s):  
David Fluck ◽  
Suzanne Rankin ◽  
Andrea Lewis ◽  
Jonathan Robin ◽  
Jacqui Rees ◽  
...  

AbstractIn this study of patients admitted with COVID-19, we examined differences between the two waves in patient characteristics and outcomes. Data were collected from the first COVID-19 admission to the end of study (01/03/2020–31/03/2021). Data were adjusted for age and sex and presented as odds ratios (OR) with 95% confidence intervals (CI). Among 12,471 admissions, 1452 (11.6%) patients were diagnosed with COVID-19. On admission, the mean (± SD) age of patients with other causes was 68.3 years (± 19.8) and those with COVID-19 in wave 1 was 69.4 years (± 18.0) and wave 2 was 66.2 years (± 18.4). Corresponding ages at discharge were 67.5 years (± 19.7), 63.9 years (± 18.0) and 62.4 years (± 18.0). The highest proportion of total admissions was among the oldest group (≥ 80 years) in wave 1 (35.0%). When compared with patients admitted with other causes, those admitted with COVID-19 in wave 1 and in wave 2 were more frequent in the 40–59 year band: 20.8, 24.6 and 30.0%; consisted of more male patients: 47.5, 57.6 and 58.8%; and a high LACE (Length of stay, Acuity of admission, Comorbidity and Emergency department visits) index (score ≥ 10): 39.4, 61.3 and 50.3%. Compared to wave-2 patients, those admitted in wave 1 had greater risk of death in hospital: OR = 1.58 (1.18–2.12) and within 30 days of discharge: OR = 2.91 (1.40–6.04). Survivors of COVID-19 in wave 1 stayed longer in hospital (median = 6.5 days; interquartile range = 2.9–12.0) as compared to survivors from wave 2 (4.5 days; interquartile range = 1.9–8.7). Patient characteristics differed significantly between the two waves of COVID-19 pandemic. There was an improvement in outcomes in wave 2, including shorter length of stay in hospital and reduction of mortality.


2020 ◽  
Vol 16 (6) ◽  
pp. 628-634
Author(s):  
Moustafa Younis ◽  
John Pham ◽  
Hussein Asad ◽  
Majdi S. Hamarshi

Background:: Paper-based and computer-based insulin infusion algorithms facilitate appropriate glycemic therapy. The data comparing these algorithms in the management of diabetic ketoacidosis in the intensive care unit (ICU) setting are limited. We aimed to determine the differences in time to diabetic ketoacidosis resolution and incidence of hypoglycemia between computer and paper-based insulin infusion. Methods:: Single-institution retrospective review of patients admitted to the ICU with diabetic ketoacidosis between 4/1/2015 and 7/20/2018. Our institution introduced computer-based insulin infusion (Glucommander) to the intensive care unit on 3/28/2016. Patients were grouped into either paper-based group (preintervention) or a computer-based group (postintervention). Summary and univariate analyses were performed. Results:: A total of 620 patients (paper-based=247; computer-based=373) with a median (IQR) age of 40 (26-56) years were included; 46% were male. Patients in the computer-based group were significantly older (p=0.003); otherwise, there were no significant differences in gender, race, body mass index and HbA1c. The mean (±SD) time to diabetic ketoacidosis resolution in the computer-based group was significantly lower than the paper-based group (p=0.02). The number of patients in the paper-based group who developed severe hypoglycemia (<50 mg/dl) was significantly higher 8% vs 1%; p<0.0001. Conclusions:: Our analyses demonstrate statistically significant decreases in time to DKA resolution and hypoglycemic events in DKA patients who were managed using a computer-based insulin infusion algorithm providing a more effective and safer option when compared to paper-based insulin infusion.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Kwannapas Saengsin ◽  
Minmin Lu ◽  
Lynn Sleeper ◽  
Tal Geva ◽  
Ashwin Prakash

Abstract Background Right ventricular (RV) late gadolinium enhancement (LGE) occurs due to surgical scarring and RV remodeling, and has been shown to be associated with clinical outcomes in Tetralogy of Fallot (TOF). However, it is not known if cardiovascular magnetic resonance (CMR) LGE extent progresses over time, and therefore, it is not known if serial reassessment of LGE is necessary. We determined the rate of progression in the extent of RV LGE on serial CMR examinations in repaired TOF. Methods Retrospective review of 127 patients after TOF repair (49% male, median age at first CMR 18.9 years (Interquartile range (IQR) 13.3,27.0) who had at least two CMRs (median follow-up duration of 4.0 years (IQR 2.1,5.9)) was performed. 84/127 patients had no interventions between serial CMRs (Group 1) while 43/127 patients had transcatheter or surgical intervention between CMRs (Group 2). The extent of RV LGE was assessed using 2 methods: a semiquantitative RV LGE score and a quantitative RV LGE extent expressed as % of RV mass. Mixed effects linear regression modeling to estimate changes in LGE over time. Results RV LGE was present in all patients on the first CMR. % RV LGE extent and LGE score did not increase over time in either patient group. The mean 5 year rates of change were small and negative for both % RV LGE extent [− 2.3 (95% CI − 2.9, − 1.8, p < 0.001) in Group 1, and − 1.9 (95% CI − 3.2, − 0.7, p = 0.004) in Group 2], and RV LGE score [− 0.9 (95% CI − 1.1, − 0.6, p < 0.001) in Group 1, and − 0.5 (95% CI − 1.1, − 0.0, p = 0.047) in Group 2]. Conclusions In this serial CMR evaluation of children and adults with repaired TOF, no significant progression in the extent of RV LGE was seen on intermediate term follow-up. Given recent concerns regarding the safety of gadolinium-based contrast agents, frequent assessment of LGE may not be necessary in follow-up.


2013 ◽  
Vol 127 (9) ◽  
pp. 842-847 ◽  
Author(s):  
F Celenk ◽  
T Baglam ◽  
E Baysal ◽  
C Durucu ◽  
Z A Karatas ◽  
...  

AbstractObjective:This study aimed to compare the hearing results of incus interposition and bone cement ossiculoplasty in patients with incus long process defects.Materials and methods:Ninety-nine patients with incus long process defects were included. Incus interposition was performed in 49 patients (group 1) and bone cement ossiculoplasty was performed in 50 patients (group 2). Group 1 included 29 female and 20 male patients, with a mean age ± standard deviation of 29.43 ± 12.5 years (range, 8–58 years). Group 2 comprised 32 female and 18 male patients, with a mean age ± standard deviation of 29.1 ± 14.89 years (range, 8–67 years).Results:The mean hearing gain ± standard deviation was 15.2 ± 9.01 dB in group 1 and 19.36 ± 9.08 dB in group 2. Hearing gain was significantly greater in the bone cement group than in the incus interposition group (p = 0.0186). Successful hearing results (i.e. air–bone gap < 20 dB) were achieved by 63.2 per cent of group 1 patients and 78 per cent of group 2 patients.Conclusion:Incus interposition and bone cement ossiculoplasty are safe and reliable methods with which to manage incus long process defects. Bone cement ossiculoplasty gives a greater hearing gain in appropriate cases.


2018 ◽  
Vol 6 (3) ◽  
pp. 463-466 ◽  
Author(s):  
Muhamed Djedović ◽  
Bilal Imširović ◽  
Samed Djedović ◽  
Amel Hadžimehmedagić ◽  
Haris Vukas ◽  
...  

AIM: Compare the basic characteristics of patients and to examine the existence of higher rates of perioperative complications (0 - 30 days) in women versus men after carotid endarterectomy (CEA).METHODS: This is a retrospective-prospective study included 270 patients with significant stenosis of carotid in whom CEA was performed, during the period from 2012 to 2017. Patients they were divided: group 1 - 100 female patients, group 2 - 170 male patients.RESULTS: No statistically significant age difference was observed between the two groups, group 1 - 66.01 years (SD 8.42, 46 to 86 years), group 2 - 66.46 years (SD 8.03, 47 to 85 years) (p = 0.659). Risk factors represent a greater prevalence in group 2, but the observed difference is not statistically significant. The average duration of surgery and the time of carotid artery clamping time were longer in group 1: (p = 0.002; p = 0.005). The number of classic endarterectomy with the patch was higher in women (41 (41%) versus 31 (18. 2%), p = 0.005), while the number of bilateral CEAs was not statistically significant.CONCLUSION: The results of this study of this study did not indicate a greater presence of perioperative complications (< 30 days) in women versus male patients after CEA.


2021 ◽  
Vol 10 (35) ◽  
pp. 2989-2993
Author(s):  
Subhashini Ramasubbu ◽  
Shivangi Gaur ◽  
Abdul Wahab PU ◽  
Madhulaxmi Marimuthu

BACKGROUND Perioperative haemorrhage is an important concern during any surgical procedure. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative haemorrhage during the surgical removal of impacted mandibular third molar. METHODS In this double-blind, randomized controlled clinical trial, 120 participants who underwent surgical removal of horizontally impacted mandibular third molar were divided into 2 groups. The patients in the Group 1 received 0.9 % normal saline for irrigation during the procedure and the patients in the Group 2 received TXA irrigation with normal saline (1 mg / mL), age, gender, operation duration, amount of blood loss and visual assessment of surgical field were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. RESULTS Each group consisted of 60 patients. Group 1 consisted of 31 male patients (51.7 %) and 29 female patients (48.3 %) and group 2 consisted of 30 male patients (50 %) and 30 female patients (50 %). There was no difference in the distribution of the variables between the 2 groups, except for the duration of the operation. The mean operative time was 20.94 ± 0.61 minutes in group 1 and 26.17 ± 0.98 minutes in group 2 (P > .05) which was not statistically significant. The mean intraoperative blood loss was 44.47 ± 6.416 mL in group 1 and 84.73 ± 7.861 in group 2 (P < .05). The mean volume of irrigation was 100.08 ± 7.658 mL in group 1 and 140.33 ± 12.332 mL in group 2 (P < .05). CONCLUSIONS TXA is effective in reducing the risk of intraoperative blood loss in patients for whom substantial blood loss is anticipated. KEY WORDS Tranexamic Acid, TXA, Blood Loss, Third Molar Surgery, Impacted Tooth Removal.


2021 ◽  
Author(s):  
Yusaku Miura ◽  
Ken Fukuda

Abstract Purpose. To compare the clinical outcomes of ab interno microhook trabeculotomy (µLOT) before and after cataract surgery for the combination of µLOT and cataract surgery. Methods. This retrospective case series included 24 eyes that underwent µLOT combined with cataract surgery at Kochi University Hospital. Groups 1 and 2 included eyes that underwent µLOT before and after cataract surgery (12 eyes each), respectively. The patient characteristics and clinical outcomes were also analyzed.Results. The mean preoperative intraocular pressure (IOP) in Groups 1 and 2 (25.3 ± 11.0 mmHg and 22.4 ± 10.5 mmHg) were reduced significantly to 14.5 ± 3.6 mmHg and 12.3 ± 3.0 mmHg, respectively, at 5–7 months postoperatively. The mean preoperative number of antiglaucoma medications in Groups 1 and 2 (4.3 ± 1.4 and 3.7 ± 1.5) had also decreased significantly to 2.7 ± 0.9 and 1.7 ± 1.6 at 5–7 months postoperatively. Postoperative hyphema with niveau formation was observed in five eyes in Group 2 (41.7%) but not in Group 1. Conclusion. For the combination of µLOT and cataract surgery, performing µLOT before cataract surgery may be less likely to result in postoperative hyphema with niveau.


Author(s):  
Shivananda B Nayak ◽  
Dharindra Sawh ◽  
Brandon Scott ◽  
Vestra Sears ◽  
Kareshma Seebalack ◽  
...  

Purpose: i) To determine the relationship between the cardiac biomarkers ST2 and NT-proBNP with ejection fraction (EF) in heart failure (HF) patients. ii) Assess whether a superiority existed between the aforementioned cardiac markers in diagnosing the HF with reduced EF. iii) Determine the efficacy of both biomarkers in predicting a 30-day cardiovascular event and rehospitalization in patients with HF with reduced EF iv) To assess the influence of age, gender, BMI, anaemia and renal failure on the ST2 and NT-proBNP levels. Design and Methods: A prospective double-blind study was conducted to obtain data from a sample of 64 cardiology patients. A blood sample was collected to test for ST2 and NT-proBNP. An echocardiogram (to obtain EF value), electrocardiogram and questionnaire were also obtained. Results: Of the 64 patients enrolled, 59.4% of the population had an EF less than 40%. At the end of the 30- day period, 7 patients were warded, 37 were not warded, one died and 17 were non respondent. Both biomarkers were efficacious at diagnosing HF with a reduced EF. However, neither of them were efficacious in predicting 30-day rehospitalization. The mean NT-proBNP values being: not rehospitalized (2114.7486) and 30 day rehospitalization (1008.42860) and the mean ST2 values being: not rehospitalized (336.1975), and 30-day rehospitalization. (281.9657). Conclusion: Neither ST2 or NT-proBNP was efficacious in predicting the short- term prognosis in HF with reduced EF. Both however were successful at confirming the diagnosis of HF in HF patients with reduced EF.


2021 ◽  
pp. 112067212110177
Author(s):  
Ayse Gul Kocak Altintas ◽  
Cagri Ilhan

Purpose: To compare the phaco time parameters including ultrasound time (UST), effective phaco time (EPT), and average phaco power (APP) in eyes with pseudoexfoliation glaucoma (PEG) and had or had not glaucoma filtration surgery. Methods: In this retrospective comparative study, Group 1 was constructed with 84 PEG patients who had not operated previously, and Group 2 was constructed with 49 PEG patients who had glaucoma filtration surgery. The mean values of UST, EPT, and APP were compared. The preoperative clinical characteristics and surgical manipulations were also compared. Results: The mean ages and male-to-female ratios of the groups were similar ( p > 0.05, for both). There was no difference in the preoperative clinical characteristics, including biometric values between the groups ( p > 0.05, for all). Some surgical manipulations, including pupillary stretching ( p = 0.004), pupillary membrane peeling ( p = 0.021), iris hook using ( p = 0.041), and capsular tension ring implantation ( p = 0.041), were significantly performed more commonly in Group 2. Although the mean UST and EPT values were similar ( p > 0.05, for both), the mean APP value was significantly lower in Group 2 ( p = 0.011). Conclusion: The lower APP parameter was observed in PEG patients having had glaucoma filtration surgery. Needing more surgical manipulation to overcome poor pupillary dilation and weak zonular instability can be a reason for this result.


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