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Dual therapy with an oral non-vitamin K antagonist and a P2Y12 inhibitor vs triple therapy with aspirin, a P2Y12 inhibitor and a vitamin K antagonist for the treatment of diabetes mellitus patients with co-existing atrial fibrillation following percutaneous coronary intervention: A meta-analysis.
Wang, Q, Yang, K
Medicine. 2021;(15):e25546
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Abstract
BACKGROUND In this analysis, we aimed to compare the efficacy and safety of dual therapy (DT) with a non-vitamin K oral anticoagulant (NOAC) and an adenosine diphosphate receptor antagonist (P2Y12 inhibitor) vs triple therapy (TT) with aspirin, a P2Y12 inhibitor and a vitamin K antagonist for the treatment of diabetes mellitus (DM) patients with co-existing atrial fibrillation (AF) following percutaneous coronary intervention (PCI). METHODS Medical Literature Analysis and Retrieval System Online (MEDLINE), http://www.ClinicalTrials.gov, Excerpta Medical data BASE (EMBASE), Web of Science, Cochrane Central and Google Scholar were the searched databases. Studies that were randomized trials or observational studies comparing DT vs TT for the treatment of DM patients with co-existing AF following PCI were included in this analysis. The adverse cardiovascular outcomes and bleeding events were the endpoints. This meta-analysis was carried out by the RevMan version 5.4 software. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent data and interpret the analysis. RESULTS A total number of 4970 participants were included whereby 2456 participants were assigned to the DT group and 2514 participants were assigned to the TT group. The enrollment period varied from year 2006 to year 2018. Our current results showed that major adverse cardiac events (RR: 1.00, 95% CI: 0.84-1.20; P = .98), mortality (RR: 1.08, 95% CI: 0.78-1.48; P = .66), myocardial infarction (RR: 1.02, 95% CI: 0.74-1.42; P = .90), stroke (RR: 0.94, 95% CI: 0.53-1.67; P = .84) and stent thrombosis (RR: 1.09, 95% CI: 0.56-2.10; P = .80) were similar with DT versus TT in these patients. However, the risks for total major bleeding (RR: 0.66, 95% CI: 0.54-0.82; P = .0001), total minor bleeding (RR: 0.74, 95% CI: 0.64-0.85; P = .0001), Thrombolysis in Myocardial Infarction (TIMI) defined major bleeding (RR: 0.58, 95% CI: 0.35-0.95; P = .03), TIMI defined minor bleeding (RR: 0.62, 95% CI: 0.42-0.92; P = .02), intra-cranial bleeding (RR: 0.34, 95% CI: 0.13-0.95; P = .04) and major bleeding defined by the International Society on Thrombosis and Hemostasis (RR: 0.68, 95% CI: 0.51-0.90; P = .008) were significantly higher with TT. CONCLUSIONS DT with a NOAC and a P2Y12 inhibitor was associated with significantly less bleeding events without increasing the adverse cardiovascular outcomes when compared to TT with aspirin, a P2Y12 inhibitor and a Vitamin K antagonist for the treatment of DM patients with co-existing AF following PCI. Hence, DT is comparable in efficacy, but safer compared to TT. This interesting hypothesis will have to be confirmed in future studies.
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Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: The COVID A to Z Randomized Clinical Trial.
Thomas, S, Patel, D, Bittel, B, Wolski, K, Wang, Q, Kumar, A, Il'Giovine, ZJ, Mehra, R, McWilliams, C, Nissen, SE, et al
JAMA network open. 2021;(2):e210369
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Abstract
IMPORTANCE There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. OBJECTIVE To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. INTERVENTION Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. OUTCOMES The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. RESULTS A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04342728.
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The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 × 20-mg Capsules in Healthy Volunteers.
Lockwood, PA, Le, VH, O'Gorman, MT, Patterson, TA, Sultan, MB, Tankisheva, E, Wang, Q, Riley, S
Clinical pharmacology in drug development. 2020;(7):849-854
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Abstract
Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20-mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early-stage symptomatic ATTR polyneuropathy. This agent, administered as an 80-mg, once-daily dose (4 × 20-mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild-type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single-center, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61-mg free acid capsules (test) and tafamidis meglumine 80-mg (4 × 20-mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125). Both tafamidis regimens had an acceptable safety/tolerability profile in this population.
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CHA2DS2-VASc and SAMe-TT2R2 scores as predictors of recurrence for nonvalvular atrial fibrillation patients on vitamin K antagonists after radiofrequency catheter ablation.
Zhao, J, Zhou, D, Chen, M, Zhuo, C, Lin, Z, Zheng, L, Wang, Q
Journal of cardiovascular medicine (Hagerstown, Md.). 2020;(3):200-208
Abstract
AIMS: Atrial fibrillation is the most common sustained arrhythmia in the general population, and circumferential pulmonary vein isolation has emerged as a cornerstone in the treatment of drug-resistant atrial fibrillation. However, there is a paucity of data regarding the CHA2DS2-VASc and SAMe-TT2R2 scores as predictors of outcomes among patients with nonvalvular atrial fibrillation on vitamin K antagonists after radiofrequency catheter ablation (RFCA). METHODS The current prospective observational study enrolled 304 consecutive patients with atrial fibrillation who underwent RFCA. Warfarin was maintained for at least 3 months after RFCA. The 1-year atrial fibrillation recurrence rate was documented. RESULTS Persistent atrial fibrillation (P = 0.003), heart failure (P < 0.001), an enlarged left atrium (P = 0.003), current smoking (P < 0.001), the CHA2DS2-VASc score (P = 0.001), and the SAMe-TT2R2 score (P < 0.001) were univariate associated with recurrent atrial fibrillation. Cutoff analysis showed that a CHA2DS2-VASc score at least 3 (areas under the curve = 0.612; 95% confidence interval 0.537-0.687) and a SAMe-TT2R2 score at least 5 (areas under the curve = 0.642, 95% confidence interval 0.575-0.708) had the highest predictive value for atrial fibrillation recurrence. Patients with a CHA2DS2-VASc score at least 3 (P < 0.001) and a SAMe-TT2R2 score at least 5 (P = 0.001) had a higher probability of experiencing atrial fibrillation recurrence after RFCA compared with patients with a CHA2DS2-VASc score less than 3 and a SAMe-TT2R2 score less than 5. CONCLUSION CHA2DS2-VASc and SAMe-TT2R2 scores were associated with 1-year recurrence of atrial fibrillation in patients on vitamin K antagonists after RFCA. For CHA2DS2-VASc and SAMe-TT2R2 scores, a cutoff value of at least 3 and at least 5 had the highest predictive value for atrial fibrillation recurrence, respectively.
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Comparing the individual effects of metformin and rosiglitazone and their combination in obese women with polycystic ovary syndrome: a randomized controlled trial.
Li, Y, Tan, J, Wang, Q, Duan, C, Hu, Y, Huang, W
Fertility and sterility. 2020;(1):197-204
Abstract
OBJECTIVE To compare the effects of metformin, rosiglitazone, and their combination in obese polycystic ovary syndrome (PCOS) patients with insulin resistance. DESIGN Prospective randomized controlled trail. SETTING Tertiary teaching hospital. PATIENT(S): Obese Chinese women (body mass index [BMI] ≥25 kg/m2) with insulin resistance who fulfilled the Rotterdam criteria of PCOS. INTERVENTION(S): In group 1, 68 patients administered metformin (1,500 mg/day); in group 2, 67 patients administered rosiglitazone (4 mg/day); in group 3, 69 patients administered metformin (1,000 mg/day) and rosiglitazone (4 mg/day) for 6 months, all with the same diet and regular exercise lifestyle recommendation. MAIN OUTCOME MEASURE(S): Average menstrual interval, anthropometric measurements, androgen-related parameters, and metabolic features of insulin, carbohydrates, and lipids, with intention-to-treat analysis. RESULT(S): The baseline parameters showed no statistically significant differences. After the 6-month treatment, most participants showed an improved menstrual pattern. There were statistically significant decreases in acne scores, weight, BMI, waist circumference, waist-to-hip ratio, and serum testosterone. The metabolic indexes of insulin, carbohydrates, and lipids were improved obviously compared with the baseline in each group. Among the three groups, the patients administered 1,500 mg/day metformin experienced greater reductions in weight. However, the rosiglitazone users (alone or combined with metformin) showed a more notable decline in total cholesterol and triglyceride levels. CONCLUSION(S): Considering the benefits of metformin on weight loss, high-dose metformin (1,500 mg/day) along with lifestyle modification should be recommended for obese, insulin-resistant women with PCOS. Rosiglitazone alone or combined with low-dosage metformin plus lifestyle modification should be considered for the women with abnormal lipid profiles. CLINICAL TRIAL REGISTRATION NUMBER ChiCTR-TRC-13003642 (Chinese Clinical Trial Registry).
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Long-term Effects of Moderate versus High Durations of Aerobic Exercise on Biomarkers of Breast Cancer Risk: Follow-up to a Randomized Controlled Trial.
Friedenreich, CM, Wang, Q, Yasui, Y, Stanczyk, FZ, Duha, A, Brenner, DR, Courneya, KS
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2019;(10):1725-1734
Abstract
BACKGROUND The optimal lifestyle for breast cancer prevention over the long term is unclear. We aimed to determine whether or not the amount of exercise prescribed in a year-long exercise intervention influences breast cancer biomarker levels 1 year later. METHODS We conducted a 24-month follow-up study (2012-2014) to the Breast Cancer and Exercise Trial in Alberta (BETA), a 12-month, two-armed (1:1), two-center randomized controlled trial of exercise in 400 cancer-free, postmenopausal women. The exercise prescription was moderate-vigorous aerobic exercise, 5 days/week (3 days/week supervised) for 30 minutes/session (MODERATE) or 60 minutes/session (HIGH). Participants were asked not to change their usual diet. We used linear mixed models to compare biomarker concentrations (C-reactive protein, insulin, glucose, HOMA-IR, estrone, sex hormone binding globulin, total estradiol, and free estradiol) over time (0, 12, and 24 months) by group (MODERATE, HIGH), using group-time interactions. RESULTS After 12 months of no intervention, 24-month fasting blood samples were available for 84.0% and 82.5% of MODERATE and HIGH groups, respectively (n = 333/400). We found no evidence that 0 to 24- or 12 to 24-month biomarker changes differed significantly between randomized groups (HIGH:MODERATE ratio of mean biomarker change ranged from 0.97 to 1.06, P values >0.05 for all). We found more favorable biomarker profiles among participants who experienced greater than the median fat loss during the trial. CONCLUSIONS Prescribing aerobic exercise for 300 versus 150 minutes/week for 12 months to inactive, postmenopausal women had no effects on longer-term biomarkers. IMPACT Exercise may lead to larger improvements in breast cancer biomarkers after intervention among women who also experience fat loss with exercise.
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Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: A randomized, double-blind, 8-week study.
Huo, Y, Li, W, Webb, R, Zhao, L, Wang, Q, Guo, W
Journal of clinical hypertension (Greenwich, Conn.). 2019;(1):67-76
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This study assessed the efficacy and safety of angiotensin receptor neprilysin inhibitor sacubitril/valsartan vs olmesartan in Asian patients with mild-to-moderate hypertension. Patients (N = 1438; mean age, 57.7 years) with mild-to-moderate hypertension were randomized to receive once daily administration of sacubitril/valsartan 200 mg (n = 479), sacubitril/valsartan 400 mg (n = 473), or olmesartan 20 mg (n = 486) for 8 weeks. The primary endpoint was reduction in mean sitting systolic blood pressure (msSBP) from baseline with sacubitril/valsartan 200 mg vs olmesartan 20 mg at Week 8. Secondary endpoints included msSBP reduction with sacubitril/valsartan 400 mg, and reductions in clinic and ambulatory BP and pulse pressure (PP) vs olmesartan. In addition, changes in msBP from baseline in the Chinese subpopulation, elderly (≥65 years), and in patients with isolated systolic hypertension (ISH) were assessed. Sacubitril/valsartan 200 mg provided a significantly greater reduction in msSBP than olmesartan 20 mg at Week 8 (between-treatment difference: -2.33 mm Hg [95% confidence interval (CI) -4.00 to -0.66 mm Hg], P < 0.05 for non-inferiority and superiority). Greater reductions in msSBP were also observed with sacubitril/valsartan 400 mg vs olmesartan 20 mg (-3.52 [-5.19 to -1.84 mm Hg], P < 0.001 for superiority). Similarly, greater reductions in msBP were observed in the Chinese subpopulation, in elderly patients, and those with ISH. In addition, both doses of sacubitril/valsartan provided significantly greater reductions from baseline in nighttime mean ambulatory BP vs olmesartan. Treatment with sacubitril/valsartan 200 or 400 mg once daily is effective and provided superior BP reduction than olmesartan 20 mg in Asian patients with mild-to-moderate hypertension and is generally safe and well tolerated.
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The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus.
Wang, LL, Wang, Q, Hong, Y, Ojo, O, Jiang, Q, Hou, YY, Huang, YH, Wang, XH
Nutrients. 2018;10(6)
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Dietary intervention is a strategy to manage diabetes mellitus, as it can reduce the burden on islet cells and thus improve blood glucose levels, lipid profiles, and cognitive status. The aim of the study was to find out the effectiveness of the ‘six-point formula’ and the effects of a low-fat diet and low-carbohydrate diet on hyperglycaemia. The study is a prospective, single-blind randomized controlled trial which recruited 56 participants with type 2 diabetes mellitus. The participants were randomly allocated to receive either a low-fat diet or a low-carbohydrate diet. Results show that HbA1c levels (the average blood glucose levels in the last 2 – 3 months) in low-carbohydrate diet decreased significantly compared to the low-fat diet. The body mass index and the total cholesterol levels of the participants following the low-carbohydrate diet also decreased. Authors conclude that a low-carbohydrate diet can improve blood glucose, regulate blood lipids, reduce body mass index and decrease insulin doses more than a low-fat diet in Chinese patients with type 2 diabetes mellitus.
Abstract
OBJECTIVE In China, a low-fat diet (LFD) is mainly recommended to help improve blood glucose levels in patients with type 2 diabetes mellitus (T2DM). However, a low-carbohydrate diet (LCD) has been shown to be effective in improving blood glucose levels in America and England. A few studies, primarily randomized controlled trials, have been reported in China as well. METHOD Firstly, we designed two 'six-point formula' methods, which met the requirements of LCD and LFD, respectively. Fifty-six T2DM patients were recruited and randomly allocated to the LCD group (n = 28) and the LFD group (n = 28). The LCD group received education about LCD's six-point formula, while the LFD group received education about LFD's six-point formula. The follow-up time was three months. The indicators for glycemic control and other metabolic parameters were collected and compared between the two groups. RESULTS Forty-nine patients completed the study. The proportions of calories from three macronutrients the patients consumed met the requirements of LCD and LFD. Compared to the LFD group, there was a greater decrease in HbA1c level in the LCD group (-0.63% vs. -0.31%, p < 0.05). The dosages of insulin and fasting blood glucoses (FBG) in the third month were lower than those at baseline in both groups. Compared with baseline values, body mass index (BMI) and total cholesterol (TC) in the LCD group were significantly reduced in the third month (p < 0.05); however, there were no statistically significant differences in the LFD group. CONCLUSIONS LCD can improve blood glucose more than LFD in Chinese patients with T2DM. It can also regulate blood lipid, reduce BMI, and decrease insulin dose in patients with T2DM. In addition, the six-point formula is feasible, easily operable, and a practical educational diet for Chinese patients with T2DM.
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Comparative study of Cu-based bimetallic oxides for Fenton-like degradation of organic pollutants.
Wang, Q, Ma, Y, Xing, S
Chemosphere. 2018;:450-456
Abstract
In order to provide useful information for the rational design of effective Fenton-like catalyst, a series of Cu-based bimetallic oxides were synthesized and their Fenton-like performances for the degradation of Orange II and ciprofloxacin were compared. The structure, chemical oxidation state, surface charge property and redox ability of the catalysts were also investigated by different characterization techniques. Among them, NiCu exhibited the highest adsorption capacity towards Orange II and the highest activity for the production of OH from H2O2 decomposition, which could be attributed to its high surface area and highly positively charged surface. However, FeCu exhibited the highest activity for the degradation of Orange II. The reason might be that FeCu has more unpaired electrons and higher redox ability, thus promoting the activation of adsorbed Orange II through the electron transfer process. By contrast, NiCu exhibited the highest activity for the removal of ciprofloxacin because ciprofloxacin was mainly degraded by OH. Finally, the main degradation intermediates of Orange II and ciprofloxacin were determined by liquid chromatography-mass spectrometry.
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Comparing the measured basal metabolic rates in patients with chronic disorders of consciousness to the estimated basal metabolic rate calculated from common predictive equations.
Xiao, G, Xie, Q, He, Y, Wang, Z, Chen, Y, Jiang, M, Ni, X, Wang, Q, Murong, M, Guo, Y, et al
Clinical nutrition (Edinburgh, Scotland). 2017;(5):1397-1402
Abstract
BACKGROUND Accurately predicting the basal metabolic rate (BMR) of patients in a vegetative state (VS) or minimally conscious state (MCS) is critical to proper nutritional therapy, but commonly used equations have not been shown to be accurate. Therefore, we compared the BMR measured by indirect calorimetry (IC) to BMR values estimated using common predictive equations in VS and MCS patients. METHODS Body composition variables were measured using the bioelectric impedance analysis (BIA) technique. BMR was measured by IC in 82 patients (64 men and 18 women) with VS or MCS. Patients were classified by body mass index as underweight (<18.5 kg/m2, n = 34) or normal-weight (18.5 ≤ BMI < 25 kg/m2, n = 48). BMR was estimated for each group using the Harris-Benedict (H-B), Schofield, or Cunningham equations and compared to the measured BMR using Bland-Altman analyses. RESULTS For the underweight group, there was a significant difference between the measured BMR values and the estimated BMR values calculated using the H-B, Schofield, and Cunningham equations (p < 0.05). For the normal-weight group, the BMR values estimated using the H-B and Cunningham equations were different significantly from the measured BMR (p < 0.05 and p < 0.01 respectively). Of the predictive equations, only Schofield was not significantly different from the measured BMR in the normal-weight group. The Schofield equation showed the best concordance (only 41.5%) with the BMR values measured by IC. CONCLUSIONS None of the commonly used equations to estimate BMR were suitable for the VS or MCS populations. Indirect calorimetry is the preferred way to avoid either over or underestimate of BMR values.