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Initiation of SGLT2 Inhibitors and the Risk of Lower Extremity Minor and Major Amputation in Patients with Type 2 Diabetes and Peripheral Arterial Disease: A Health Claims Data Analysis.
Rodionov, RN, Peters, F, Marschall, U, L'Hoest, H, Jarzebska, N, Behrendt, CA
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2021;(6):981-990
Abstract
OBJECTIVE To assess the association between long term risk of hospitalisation for heart failure (HHF) and lower extremity minor and major amputation (LEA) in patients initiating sodium glucose cotransporter 2 inhibitors (SGLT2i) suffering from type 2 diabetes and peripheral arterial disease (PAD). Outcomes were compared with patients without PAD and evaluated separately for the time periods before and after the official warning of the European Medicines Agency (EMA) in early 2017. METHODS This study used BARMER German health claims data including all patients suffering from type 2 diabetes initiating SGLT2i therapy between 1 January 2013 and 31 December 2019 with follow up until the end of 2020. New users of glucagon like peptide 1 receptor agonists (GLP1-RAs) were used as active comparators. Inverse probability weighting with truncated stabilised weights was used to adjust for confounding, and five year risks of HHF and LEA were estimated using Cox regression. Periods before and after the EMA warning were analysed separately and stratified by presence of concomitant PAD. RESULTS In total, 44 284 (13.6% PAD) and 56 878 (16.3% PAD) patients initiated SGLT2i or GLP1-RA, respectively. Before the EMA warning, initiation of SGLT2i was associated with a lower risk of HHF in patients with PAD (hazard ratio, HR, 0.85, 95% confidence interval, CI, 0.73 - 0.99) and a higher risk of LEA in patients without PAD (HR 1.79, 95% CI 1.04 - 2.92). After the EMA warning, the efficacy and safety endpoints were no longer statistically different between groups. CONCLUSION The results from this large nationwide real world study highlight that PAD patients exhibit generally high amputation risks. This study refutes the idea that the presence of PAD explains the excess LEA risk associated with initiation of SGLT2i. The fact that differentials among study groups diminished after the EMA warning in early 2017 emphasises that regulatory surveillance measures worked in everyday clinical practice.
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Correlation between strength and skin temperature asymmetries in the lower limbs of Brazilian elite soccer players before and after a competitive season.
Rodrigues Júnior, JL, Duarte, W, Falqueto, H, Andrade, AGP, Morandi, RF, Albuquerque, MR, de Assis, MG, Serpa, TKF, Pimenta, EM
Journal of thermal biology. 2021;:102919
Abstract
This study aimed to investigate the correlation between strength and skin temperature (Tsk) asymmetries in the lower limbs of elite soccer players before and after a competitive season. The sample (n = 20) was composed of elite male soccer players. Strength asymmetry and Tsk asymmetry was measured through the countermovement jump (CMJ) test and infrared thermography, respectively. Asymmetries were quantified using the symmetry angle (SA) equation. A strong correlation was found between the SA of rate of force development (RFD) and the SA of Tsk before (baseline) (r = 0.7; r2 = 0.43; p = 0.03) and after (r = 0.6; r2 = 0.42; p = 0.04) the competitive season. Moreover, after the competitive season there were significant decreases in Peak force (p < 0.018), Impulse (p < 0.04), RFD (p = 0.0001) and CMJ height (p = 0.05), and significant increases in Tsk (p < 0.03), C-reactive protein (p = 0.03), Creatine kinase (p = 0.0001) and Cortisol (p = 0.04), even after a 3-day rest interval (no training). These results suggest that the CMJ test can be combined with infrared thermography for monitoring strength asymmetry and contribute to the prevention of muscle injuries.
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Frequency of lower extremity artery disease in type 2 diabetic patients using pulse oximetry and the ankle-brachial index.
Abián, MF, Vanesa, BB, Diego, BG, Manuel, GS, Maria, VC, Raquel, VS, Cristina, GM
International journal of medical sciences. 2021;(13):2776-2782
Abstract
Objectives: To determine the of undiagnosed lower extremity artery disease using the pulse oximetry in a type 2 diabetic population sample. Methods: Observational, cross-sectional, descriptive study that included 594 type 2 diabetic patients, with no previous history of lower extremity artery disease. Medical history, physical examination, determination of the ankle-brachial index (portable Doppler) and measurement of oxygen saturation in upper and lower extremities (pulse oximeter) were performed. Results: Frequency of lower extremity artery disease determined by ankle-brachial index was 18.4%. No significant correlations were detected between oxygen saturation and the ankle-brachial index except for the relationship between ankle-brachial index vs. oxygen saturation at 30 cm lower limb elevation vs. the supine position at no elevation (0 cm) in subjects under the age of 40. Pulse oximetry showed little diagnostic value in the screening of lower extremity artery disease. A relationship between lower extremity artery disease and age has been found. Its diagnosis was associated with a lower body mass index and lower systolic blood pressure in the lower extremities and higher in the upper extremities. Conclusions: We conclude that pulse oximetry is not useful in the screening for asymptomatic lower extremity artery disease in type 2 diabetics.
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Neutrophil-to-lymphocyte ratio but not monocyte-to-HDL cholesterol ratio nor platelet-to-lymphocyte ratio correlates with early stages of lower extremity arterial disease: an ultrasonographic study.
Santoro, L, Ferraro, PM, Nesci, A, D'Alessandro, A, Macerola, N, Forni, F, Tartaglione, R, De Vitis, R, Gasbarrini, A, Santoliquido, A
European review for medical and pharmacological sciences. 2021;(9):3453-3459
Abstract
OBJECTIVE The role of inflammatory markers as neutrophil-to-lymphocyte ratio (NLR), monocyte-to-high-density lipoprotein-cholesterol ratio (MHR), and platelet-to-lymphocyte ratio (PLR) in cardiovascular diseases has been widely investigated in recent years. In the context of lower extremity arterial disease (LEAD), this association has been mainly studied in the advanced stages. The aim of our study was to investigate the role of these inflammatory markers in all stages of LEAD, including early ones, using ultrasonography as diagnostic tool, together with ankle-brachial index (ABI) determination. PATIENTS AND METHODS In this cross-sectional observational study, we enrolled 240 patients undergoing ultrasonographic evaluation of the lower limb arteries and ABI determination because of symptoms suggestive of LEAD or presence of known cardiovascular risk factors. RESULTS In our study population, we found that ultrasonographic categories of LEAD were associated with NLR, but not with MHR and PLR. CONCLUSIONS These results confirm that a specific pattern of inflammation can be found in all stages of LEAD, including early ones.
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Different Ultrasound Scoring Methods for Assessing Medial Arterial Calcification: Association with Diabetic Complications.
Tian, J, Tang, G, Xu, X, Yan, L, Liang, M, Zhang, W, Liu, X, Luo, B
Ultrasound in medicine & biology. 2020;(6):1365-1372
Abstract
The aims of the study described here were to evaluate medial arterial calcification (MAC) of the lower limbs, identified on ultrasound, in patients with type 2 diabetes, and to analyze the association of MAC with diabetic complications including peripheral arterial disease, peripheral neuropathy, retinopathy, and nephropathy. Ultrasound was performed in 359 patients, and the severity of MAC was assessed by the length of MAC (score range: 0-8) and the number of arterial segmentations with MAC (score range: 0-6). Our results revealed that MAC scoring based on the segmentation method was an independent predictor of peripheral arterial disease and nephropathy, but not an independent predictor of peripheral neuropathy or retinopathy. MAC scoring based on the length method was not an independent predictor of any complication. The segmentation method for assessing MAC on ultrasound may be a valuable tool in clinical work.
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Circulating Receptor Activator of Nuclear Factor kB Ligand and triglycerides are associated with progression of lower limb arterial calcification in type 2 diabetes: a prospective, observational cohort study.
Bourron, O, Phan, F, Diallo, MH, Hajage, D, Aubert, CE, Carlier, A, Salem, JE, Funck-Brentano, C, Kemel, S, Cluzel, P, et al
Cardiovascular diabetology. 2020;(1):140
Abstract
BACKGROUND Lower limb arterial calcification is a frequent, underestimated but serious complication of diabetes. The DIACART study is a prospective cohort study designed to evaluate the determinants of the progression of lower limb arterial calcification in 198 patients with type 2 diabetes. METHODS Lower limb arterial calcification scores were determined by computed tomography at baseline and after a mean follow up of 31.20 ± 3.86 months. Serum RANKL (Receptor Activator of Nuclear factor kB Ligand) and bone remodeling, inflammatory and metabolic parameters were measured at baseline. The predictive effect of these markers on calcification progression was analyzed by a multivariate linear regression model. RESULTS At baseline, mean ± SD and median lower limb arterial calcification scores were, 2364 ± 5613 and 527 respectively and at the end of the study, 3739 ± 6886 and 1355 respectively. Using multivariate analysis, the progression of lower limb arterial log calcification score was found to be associated with (β coefficient [slope], 95% CI, p-value) baseline log(calcification score) (1.02, 1.00-1.04, p < 0.001), triglycerides (0.11, 0.03-0.20, p = 0.007), log(RANKL) (0.07, 0.02-0.11, p = 0.016), previous ischemic cardiomyopathy (0.36, 0.15-0.57, p = 0.001), statin use (0.39, 0.06-0.72, p = 0.023) and duration of follow up (0.04, 0.01-0.06, p = 0.004). CONCLUSION In patients with type 2 diabetes, lower limb arterial calcification is frequent and can progress rapidly. Circulating RANKL and triglycerides are independently associated with this progression. These results open new therapeutic perspectives in peripheral diabetic calcifying arteriopathy. Trial registration NCT02431234.
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Risk factors analysis of thromboembolectomy for acute thromboembolic lower extremity ischemia in native arteries.
Piffaretti, G, Angrisano, A, Franchin, M, Ferrario, M, Rivolta, N, Bacuzzi, A, Castelli, P, Tozzi, M
The Journal of cardiovascular surgery. 2018;(6):810-816
Abstract
BACKGROUND Aim of this study is to report the results of thromboembolectomy (ThEmb) for acute thromboembolic lower limb ischemia (ATLI) in native arteries and to create a predictive score for amputation-free survival (AFS) at 30 days. METHODS It is a single center, retrospective analysis of a four years period. All patients had ThEmb: adjunctive procedures included femoral and/or popliteal endarterectomy in 30 (18.3%) cases, PTA-stent in 24 (14.6%), and femoral endarterectomy plus PTA-stent in 12 (7.3%). Fasciotomies were performed in 6 (3.6%) patients. Predictors of AFS identified on univariate screen (inclusion threshold, P<.20) were included in a multivariable model. The resulting significant predictors were assigned an integer score to stratify patients into risk groups. RESULTS Authors analyzed 164 limbs in 164 patients. Mean age was 80±10 years (range, 40-99). In-hospital mortality was 9.8% (N.=16); AFS at 30 days was 84.7% (N.=139). The anatomic level (iliac vs. femoropopliteal vs. infrapopliteal) of the occlusion did not affect AFS (P=.326). Multivariable analysis identified six significant predictors of AFS at 30 days: age >85 (P=0.050), chronic obstructive pulmonary disease (P=0.008), chronic renal insufficiency (P=0.019), late (>6 hours) onset (P=0.004), the presence of major neurologic deficit (P=0.023), and an increased (>800IU/L) level of creatine phosphokinase (P=0.001). An integer score generated two risk groups (low-risk 0-2 [70.1% of cohort], and high-risk ≥3 [29.9% of cohort]): stratification of the patients according to risk category yielded significantly different AFS at 30 days (low-risk 5.2% vs. high-risk 38.8%, P<0.0001). CONCLUSIONS Among patients selected to undergo ThEmb for ATLI in native arteries, this risk score identified a group of patients with a 40% chance of death or major amputation at 30 days. The score can help to optimize the operative strategy, but further prospective validation is needed.
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SGLT2 inhibitors for diabetes are linked to increased risk of lower limb amputation.
Kmietowicz, Z
BMJ (Clinical research ed.). 2018;:k4828
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Reversal of Lower-Extremity Intermittent Claudication and Rest Pain by Hydration.
Fernández, S, Parodi, JC, Moscovich, F, Pulmari, C
Annals of vascular surgery. 2018;:1-7
Abstract
BACKGROUND Medical treatment of disabling intermittent claudication or critical limb-threatening ischemia causing rest pain often fails or has partial response. METHODS In this pilot study, 36 patients (12 females) affected by disabling intermittent claudication or rest pain of the lower extremities were exposed to a daily 3-L water intake for up to 6 weeks. Cutaneous foot temperature, ankle/brachial index, time and distance of claudication, and pain intensity were recorded before and at the completion of the hydration period. RESULTS Patients with a mean ± SE age of 71 ± 2 years (range, 40-86) had disabling claudication (less than 100 meters) for more than 5 months while 11% reported pain at rest. A 6-week water intake of more than 2,500 mL/24 hr was achieved in 35 of the 36 patients enrolled in the study. Increased water intake was associated with significant improvements in median ankle/brachial index (from 0.60 to 0.76; P < 0.0001) and skin temperature (first dorsal right toe, from 29.95°C to 30.0°C, P < 0.001). Time and distance to report claudication of supervised treadmill exercise improved from 1.25 to 6.25 min (P < 0.0001) and from 100 meters to 535 meters (P < 0.0001), respectively. CONCLUSIONS This study suggests that hydration attained by daily water consumption of more than 2.5 L has a robust impact on reducing the symptoms of disabling claudication and rest pain caused by peripheral vascular disease.
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Towards Upright Pedalling to drive recovery in people who cannot walk in the first weeks after stroke: movement patterns and measurement.
Hancock, NJ, Shepstone, L, Rowe, P, Myint, PK, Pomeroy, VM
Physiotherapy. 2017;(4):400-406
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Abstract
OBJECTIVES To examine whether people who are within 31days of stroke onset are able to produce controlled lower limb movement, and phasic activity in antagonistic lower limb muscle groups, during Upright Pedalling (UP). DESIGN Observational study. SETTING Acute stroke unit within a University Hospital. PARTICIPANTS Eight adults between 3 and 30days from stroke onset, with unilateral lower limb paresis and unable to walk without assistance. Participants were considered fit to participate as assessed by a physician-led medical team and were able to take part in UP for one, one minute session. INTERVENTION Participants took part in one session of instrumented UP at their comfortable cadence, as part of a feasibility study investigating UP early after stroke. OUTCOME MEASURES Reciprocal activation of lower limb muscles derived from muscle activity recorded with surface EMG, quantified using Jaccards Coefficient (J); smoothness of pedalling determined from standard deviations of time spent in each of eight 45° wheel position bins ("S-Ped"). Motor behavioural measures: Motricity Index, Trunk Control Test, Functional Ambulatory Categories. RESULTS Participants were all unable to walk (FAC 0) with severe to moderate lower limb paresis (Motricity Index score/100 median 48.5, IQR 32 to 65.5). Smooth pedalling was observed; some participants pedalling similarly smoothly to healthy older adults, with a variety of muscle activation patterns in the affected and unaffected legs. CONCLUSION These observational data indicate that people with substantial paresis early after stroke and who cannot walk, can produce smooth movement during UP using a variety of muscle activation strategies.