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Statin use and lower extremity amputation risk in nonelderly diabetic patients.
Sohn, MW, Meadows, JL, Oh, EH, Budiman-Mak, E, Lee, TA, Stone, NJ, Pearce, WB
Journal of vascular surgery. 2013;(6):1578-1585.e1
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Abstract
OBJECTIVE To examine the association between use of statin and nonstatin cholesterol-lowering medications and risk of nontraumatic major lower extremity amputations (LEAs) and treatment failure (LEA or death). METHODS A retrospective cohort of patients with Type I and Type 2 diabetes mellitus (diabetes) was followed for 5 years between 2004 and 2008. The follow-up exposure duration was divided into 90-day periods. Use of cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index, and systolic and diastolic blood pressures were observed in each period. Demographic factors were observed at baseline. Major risk factors of LEA including peripheral neuropathy, peripheral artery disease, and foot ulcers were observed at baseline and were updated for each period. LEA and deaths were assessed in each period and their hazard ratios (HRs) were estimated. The study took place in the U.S. Department of Veterans Affairs Healthcare system, and the subjects consisted of cholesterol drug-naïve patients with Type I or II diabetes who were treated in the U.S. Department of Veterans Affairs Healthcare system in 2003 and were <65 years old at the end of follow-up. RESULTS Of 83,953 patients in the study cohort, 217 (0.3%) patients experienced a major LEA and 11,716 (14.0%) patients experienced an LEA or death (treatment failure) after a mean follow-up of 4.6 years. Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60). Users of other cholesterol-lowering medications were not significantly different in LEA risk (HR, 0.95; 95% CI, 0.35-2.60) but had a 41% lower risk of treatment failure (HR, 0.59; 95% CI, 0.51-0.68). CONCLUSIONS This is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes. In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience. For LEA risk, those given nonstatins did not have a statistically significant benefit and its effect on LEA risk was much smaller compared with statins. Unanswered questions to be explored in future studies include a comparison of statins of moderate vs high potency in those with high risk of coronary heart disease and an exploration of whether the effects seen in this study are simply effects of cholesterol-lowering or possibly pleiotropic effects.
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Comparison of a standard and a high-concentration contrast medium protocol for MDCT angiography of the lower limb arteries.
Meyer, BC, Klein, S, Krix, M, Aschoff, AJ, Wacker, FK, Albrecht, T
RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. 2012;(6):527-34
Abstract
PURPOSE To prospectively compare a compact bolus (CB) injection protocol using high-iodine concentration contrast medium with a standard bolus (SB) injection protocol at equi-iodine doses for run-off computed tomographic angiography (CTA). MATERIALS AND METHODS 64 patients with suspected peripheral arterial disease who underwent 40 or 64-slice run-off CTA were included in this IRB-approved study. Patients were randomized to undergo the CB protocol (32 patients, iomeprol 400mgI/mL, 100 mL, 4 mL/sec) or the SB protocol (32 patients, iomeprol 300mgI/mL, 134 mL, 4 mL/sec). Luminal contrast density (CD) values were measured and arterial opacification (AO) was scored (5-point scale). Cases of venous overlay or bolus overriding were documented. RESULTS Overall arterial CD was significantly higher with the compact bolus (CB: 279 ± 57HU, SB: 234 ± 32HU, p = 0.0017). Segmental CD was significantly higher (p< 0.05) in 7 of 16 evaluated segments. Patency-based comparison revealed superior AO in vessels with relevant (50 - 99 %) stenoses (CB: 4.54 vs. SB: 4.18, p = 0.04). Contrast bolus overriding without pathological reasons, i. e., acute occlusions, was noted in one patient in each group. Venous overlay was observed less frequently in the CB group (CB vs. SB: 12 vs. 19 patients, n. s.; 29 of 64 legs [45 %] vs. 44 of 64 legs [69 %], p = 0.01). CONCLUSION At equi-iodine doses, the CB protocol led to a quantitatively and qualitatively higher arterial opacification compared to the SB protocol. Therefore, a CB protocol should be favored for run-off CTA.
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Effect of cold water immersion on repeated cycling performance and limb blood flow.
Vaile, J, O'Hagan, C, Stefanovic, B, Walker, M, Gill, N, Askew, CD
British journal of sports medicine. 2011;(10):825-9
Abstract
The purpose of the present study was to compare the effects of cold water immersion (CWI) and active recovery (ACT) on resting limb blood flow, rectal temperature and repeated cycling performance in the heat. Ten subjects completed two testing sessions separated by 1 week; each trial consisted of an initial all-out 35-min exercise bout, one of two 15-min recovery interventions (randomised: CWI or ACT), followed by a 40-min passive recovery period before repeating the 35-min exercise bout. Performance was measured as the change in total work completed during the exercise bouts. Resting limb blood flow, heart rate, rectal temperature and blood lactate were recorded throughout the testing sessions. There was a significant decline in performance after ACT (mean (SD) -1.81% (1.05%)) compared with CWI where performance remained unchanged (0.10% (0.71%)). Rectal temperature was reduced after CWI (36.8°C (1.0°C)) compared with ACT (38.3°C (0.4°C)), as was blood flow to the arms (CWI 3.64 (1.47) ml/100 ml/min; ACT 16.85 (3.57) ml/100 ml/min) and legs (CW 4.83 (2.49) ml/100 ml/min; ACT 4.83 (2.49) ml/100 ml/min). Leg blood flow at the end of the second exercise bout was not different between the active (15.25 (4.33) ml/100 ml/min) and cold trials (14.99 (4.96) ml/100 ml/min), whereas rectal temperature (CWI 38.1°C (0.3°C); ACT 38.8°C (0.2°C)) and arm blood flow (CWI 20.55 (3.78) ml/100 ml/min; ACT 23.83 (5.32) ml/100 ml/min) remained depressed until the end of the cold trial. These findings indicate that CWI is an effective intervention for maintaining repeat cycling performance in the heat and this performance benefit is associated with alterations in core temperature and limb blood flow.
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Short-term lower leg growth in 5- to 11-year-old asthmatic children using beclomethasone dipropionate inhalers with chlorofluorocarbon or hydrofluoroalkane propellants: a 9-week, open-label, randomized, crossover, noninferiority study.
Wolthers, OD, Walters, EG
Clinical therapeutics. 2011;(8):1069-76
Abstract
BACKGROUND Beclomethasone dipropionate-hydrofluoroalkane (BDP-HFA) is a non-chlorofluorocarbon (CFC)-propelled metered dose inhaler. Data is needed to support the registration of BDP-HFA in pediatric populations for countries in the European Union. OBJECTIVE The aim of the study was to assess short-term lower leg growth in children with asthma during treatment with BDP-HFA 100 μg BID compared with BDP-CFC 200 μg BID. METHODS Children with asthma were included in this open-label, randomized, crossover study with 2-week run-in, active treatment, and washout periods. Lower leg length was measured every second week. As a secondary outcome parameter, 24-hour urine was collected for assessment of free cortisol. Interventions were inhaled BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer. RESULTS In 63 patients with asthma aged 5 to 11 years, BDP-HFA 100 μg BID was noninferior to BDP-CFC 200 μg BID, as the lower margin of CI (-0.03 to 0.10 mm/wk) of the estimated difference (0.03 mm/wk) was greater than the prespecified lower limit for noninferiority of -0.12 mm/wk. Mean (SD) lower leg growth rate during run-in, BDP-HFA 100 μg BID, and BDP-CFC 200 μg BID was 0.36 (0.17), 0.27 (0.21), and 0.23 (0.18) mm/wk, respectively (BDP-HFA estimate of difference, -0.09 [95% CI, -0.16 to -0.03 mm/wk; P < 0.01]; BDP-CFC estimate of difference, -0.13 [95% CI, -0.19 to -0.06 mm/wk; P < 0.001]). No statistically significant differences were seen in urinary free cortisol assessments. Eight and 6 mild to moderate adverse events in 10 children were reported during treatment with BDP-HFA and BDP-CFC, respectively. One event in each group was judged to be probably related to the study medication; no others were judged to be related. CONCLUSIONS No statistically significant differences were found in lower leg growth between BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer during 2-week treatment. Evidence of differences in systemic activity between the treatments was not found. EudraCT registration: 2007-007455-14.
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High-density lipoprotein cholesterol and objective measures of lower extremity performance in older nondisabled persons: the InChianti study.
Volpato, S, Ble, A, Metter, EJ, Lauretani, F, Bandinelli, S, Zuliani, G, Fellin, R, Ferrucci, L, Guralnik, JM
Journal of the American Geriatrics Society. 2008;(4):621-9
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Abstract
OBJECTIVES To evaluate the independent association between high-density lipoprotein cholesterol (HDL-C) levels and objective measures of lower extremity performance. DESIGN Cross-sectional cohort study. SETTING Community-based. PARTICIPANTS Eight hundred thirty-six nondisabled women and men aged 65 and older enrolled in the Invecchiare in Chianti study. MEASUREMENTS Lower extremity performance was assessed using 4-m walking speed at fast pace, 400-m walking speed, and knee extension torque. Fasting HDL-C levels were determined using commercial enzymatic tests. RESULTS The mean age of participants was 73.7 (65-92), and 55.6% were women. After adjusting for potential confounders (sociodemographic factors, smoking, physical activity, body composition, and clinical conditions including cardiovascular and cerebrovascular disease, inflammatory markers, and serum testosterone) HDL-C levels were significantly associated with knee extension torque in men and women and with 4-m and 400-m walking speed in men. Men in the highest tertile of the HDL-C distribution (>55 mg/dL) had, on average, a three times greater probability of belonging to the best tertile of all indexes of lower extremity performance, including 4-m fast walking speed (odds ratio (OR)=2.57, 95%=confidence interval (CI)=1.07-6.17), 400-m walking speed (OR=3.74, 95% CI=1.20-11.7), and knee extension torque (OR=3.63, 95%=CI 1.41-9.33). Path analysis suggested a direct relationship between HDL-C and knee extension torque. CONCLUSION In older nondisabled persons, HDL-C levels are highly correlated with knee extension torque and walking speed. Further research should focus on the biological mechanism of this association.
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Effect of silver-threads-containing compression stockings on the cutaneous microcirculation: a double-blind, randomized cross-over study.
Jaccard, Y, Singer, E, Degischer, S, Imfeld, S, Aschwanden, M, Thalhammer, C, Labs, KH, Jäger, KA
Clinical hemorheology and microcirculation. 2007;(1):65-73
Abstract
Recently silver fiber-containing compression stockings for the use in patients with chronic venous insufficiency (CVI) were introduced to the market. In order to gain some first insight into the effects of these new fabrics on the cutaneous microcirculation, a double-blind, randomized cross-over trial was performed in 10 healthy volunteers. A 3 days run-in phase preceded the (2 x10 days) treatment phases and was used to assess the reproducibility of the primary endpoint, which was the transcutaneous partial oxygen pressure (tcpO(2)) measured at a probe temperature of 44 degrees C in the perimalleolar region of the reference leg in supine and dependent leg positions. Coefficients of variation for double measured tcpO(2) values were 4.2% (3.1 SD) and 5.8% (6.0 SD) for the leg in supine and dependent position. The intra-individual comparison of the effects from both treatment phases (value end of treatment - start of treatment) resulted in a negative tcpO(2) net balance for the regular hosiery (-0.93 (2.7 SD) mmHg, supine; -1.1 (3.5 SD) mmHg, dependent) but a positive net balance for the silver fibers containing stockings (0.25 (4.0 SD) mmHg, supine; 1.7 (3.9 SD) mmHg, dependent). The inter-treatment differences were statistically significant for the leg in a dependent position. The trial provides first evidence that interweaving silver threads into regular compression stockings may result in a positive effect regarding the nutritive skin perfusion.
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High-dose ascorbic acid infusion abolishes chronic vasoconstriction and restores resting leg blood flow in healthy older men.
Jablonski, KL, Seals, DR, Eskurza, I, Monahan, KD, Donato, AJ
Journal of applied physiology (Bethesda, Md. : 1985). 2007;(5):1715-21
Abstract
Resting whole leg blood flow and vascular conductance decrease linearly with advancing age in healthy adult men. The potential role of age-related increases in oxidative stress in these changes is unknown. Resting leg blood flow during saline and ascorbic acid infusion was studied in 10 young (25 +/- 1 yr) and 11 older (63 +/- 2 yr) healthy normotensive men. Plasma oxidized LDL, a marker of oxidative stress, was greater in the older men (P < 0.05). Absolute resting femoral artery blood flow at baseline (iv saline control infusion) was 25% lower in the older men (238 +/- 25 vs. 316 +/- 38 ml/min; P < 0.05), and it was inversely related to plasma oxidized LDL (r = -0.56, P < 0.01) in all subjects. Infusion of supraphysiological concentrations of ascorbic acid increased femoral artery blood flow by 37% in the older men (to 327 +/- 52 ml/min; P < 0.05), but not in the young men (352 +/- 41 ml/min; P = 0.28), thus abolishing group differences (P = 0.72). Mean arterial blood pressure was greater in the older men at baseline (86 +/- 4 vs. 78 +/- 2 mmHg; P < 0.05), but it was unaffected by ascorbic acid infusion (P ≥ 0.70). As a result, the lower baseline femoral artery blood flow in the older men was mediated solely by a 32% lower femoral artery vascular conductance (P < 0.05). Baseline femoral vascular conductance also was inversely related to plasma oxidized LDL (r = -0.65, P < 0.01). Ascorbic acid increased femoral vascular conductance by 36% in the older men (P < 0.05) but not in the young men (P = 0.31). In conclusion, ascorbic acid infused at concentrations known to scavenge reactive oxygen species restores resting femoral artery blood flow in healthy older adult men by increasing vascular conductance. These results support the hypothesis that oxidative stress plays a major role in the reduced resting whole leg blood flow and increased leg vasoconstriction observed with aging in men.
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Optimal duration of treatment in surgical patients with calf venous thrombosis involving one or more veins.
Ferrara, F, Meli, F, Amato, C, Cospite, V, Raimondi, F, Novo, G, Novo, S
Angiology. 2006;(4):418-23
Abstract
The aim of this study was to evaluate different durations of treatment in patients with calf venous thrombosis (CVT) involving 1 or more deep veins. The authors studied 2 groups of patients with postsurgical CVT diagnosed by echo-color Doppler. The first group consisted of 68 patients with CVT involving a single vein, and the second group consisted of 124 patients with CVT involving 2 or more veins. Immediately after diagnosis, all patients were treated with nadroparin calcium and sodium warfarin. Heparin treatment was withdrawn after 5-6 days of treatment, when the international normalized ratio (INR) was stabilized between 2 and 3. Each group was divided into 2 subgroups receiving anticoagulation treatment for 6 or 12 weeks, respectively. The endpoint was proximal extension of the thrombotic lesion, defined as the extension of the thrombus to the popliteal and/or femoral vein. In patients with single-vessel CVT there was no significant difference between the 2 subgroups, whereas in patients with CVT involving 2 or more vessels, a statistically significant difference was observed, the number of cases showing proximal extension of the thrombus being higher among patients treated for 6 weeks. Twelve weeks of anticoagulation treatment is better than 6 weeks only in patients with postsurgical CVT involving 2 or more veins.
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[Drug therapy of chronic venous insufficiency with Venza].
Bogdanets, LI, Arakelian, VS, Sapelkin, SV, Kalinina, EV
Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery. 2005;(3):55-9
Abstract
An open prospective study on the use of the drug Venza for complex variceal disease treatment was conducted. The study included 125 patients aged from 21 to 75. The outcome measures were: patient complaints and medical history, as well as Doppler ultrasound of lower limb veins, arteriovenous index (AVI) and leg circumference at the ankle level for the objective assessment of therapeutic effectiveness. Malleolar circumference decreased by average 0.8+/-0.3 cm. The drug therapy resulted in the regression of clinical signs (leg fatigue heaviness and edema, night palsies). Venza had a positive effect on all evaluated parameters of patient's quality of life. Its clinical effectiveness was estimated as "very good" and "good" in 27.5% and 57.5%, respectively. The study proved the Venza's effectiveness in treatment of patients with lower limb chronic venous insufficiency.
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Results of the clinical examination of an ointment with marigold (Calendula officinalis) extract in the treatment of venous leg ulcers.
Duran, V, Matic, M, Jovanovć, M, Mimica, N, Gajinov, Z, Poljacki, M, Boza, P
International journal of tissue reactions. 2005;(3):101-6
Abstract
The aim of this study was to determine the therapeutic efficacy of marigold (Calendula officinalis) extract on the epithelialization of lower leg venous ulcers. The experiment was carried out in 34 patients with venous leg ulcers. The patients were divided into two groups. In the first (experimental) group, patients were treated with an ointment containing marigold extract, which was prepared in an apparatus devised by Soxleth and was incorporated into a neutral base. Twenty-one patients with 33 venous ulcers were treated. Therapy was applied twice a day for 3 weeks. The second group was a control group that consisted of 13 patients with 22 venous ulcers. In the control group, saline solution dressings were applied to ulcers for 3 weeks. In the experimental group the total surface of all the ulcers at the beginning of the therapy was 67,544 mm2. After the third week the total surface of all the ulcers was 39,373 mm2 (a decrease of 41.71%). In seven patients, complete epithelialization was achieved. In the control group the total surface of all the ulcers at the beginning of the therapy was 69,722 mm2. After the third week the total surface of all the ulcers was 58,743 mm2 (a decrease of 14.52%). In four patients, complete epithelialization was achieved. There was a statistically significant acceleration of wound healing in the experimental group (p < 0.05). The results obtained are preliminary, but they suggest the positive effects of the ointment with marigold extract on venous ulcer epithelialization.