Racial/ethnic differences in the association between menthol cigarette use and mental illness among adults who smoke in the United States.

Data from the National Survey on Drug Use and Health (2012-2018) were used to characterize the association between menthol cigarette use and indicators of Any (AMI) and Serious (SMI) Mental Illness among adults who smoke in the United States. In general, people who smoke menthol cigarettes were more likely to have AMI (aOR = 1.123 [1.063-1.194]) than people who smoke non-menthol cigarettes, but not SMI (aOR = 1.065 [0.966-1.175]). However, among non-Hispanic African American/Black people who smoke, those that used menthol cigarettes had lower adjusted odds of both AMI (aOR = 0.740 [0.572-0.958]) and SMI (aOR = 0.592 [0.390-0.899]) than their counterparts who used non-menthol cigarettes. Results suggest there may be race/ethnicity-specific drivers of the association between menthol cigarette use and mental illness.

What influences demand for cigars among African American adult cigar smokers? Results from a hypothetical purchase task.

African Americans (AA) have historically been targeted by the tobacco industry and have the highest rates of current cigar use among racial/ethnic groups in the U.S. Yet, there is limited evidence on other factors influencing cigar use. Amongst a sample of 78 AA current cigar (any type) smokers, log-linear regression models examined correlates of cigar demand obtained from a validated behavioral economic purchase task. Mean intensity, or cigar demand when free, was 6.68 cigars (standard deviation [SD]: 8.17), while mean breakpoint, or the highest price a participant was willing to pay, was $4.62 (SD: 3.88). Mean maximum daily expenditure, Omax was $15.20 (SD: 25.73) and Pmax, the price at Omax was $5.25 (SD: 3.95). Participants aged 21 to 30 years compared to those aged 18 to 20 years, those with higher levels of dependence, and females compared to males, had a significantly higher intensity. Participants with cannabis use above the sample median in the last 30 days (4 + days) had significantly higher intensity and Omax than those below the median. Further, participants with a high school education or more had a significantly lower intensity, breakpoint, and Omax than those with less than high school education. Individuals with income below the federal poverty line (FPL) also had a significantly lower breakpoint and Omax than those above. Finally, tobacco harm perceptions were inversely associated with Pmax. Stricter policies on cigar products, such as higher taxes and product-specific harm messaging, may have an immediate and sustained impact on health disparities related to cigar use. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Online Pro-Tobacco Marketing Exposure Is Associated With Dual Tobacco Product Use Among Underage US Students.

PURPOSE: To understand the effect of pro-tobacco marketing on electronic cigarette and combustible cigarette dual use among US middle and high school students under 18 years of age. DESIGN: Data were derived from the 2018 National Youth Tobacco Survey, an annual self-administered school-based cross-sectional survey. SETTING: The survey was administered in public and private middle and high schools across the United States. PARTICIPANTS: The probability sample size was 15 238 middle and high school students with complete responses who were under 18 years of age during the study period. MEASURES: The study measured self-reported exposure to online combustible and electronic cigarette advertisements, dual use of combustible and electronic cigarettes during the past 30 days, exposure to the Real Cost antitobacco campaign advertisements, and other sociodemographic factors (eg, race/ethnicity, gender, and grade). ANALYSIS: Logistic regressions were used to measure pro-tobacco marketing exposure and dual use as a function of pro-tobacco marketing exposure. RESULTS: Descriptive analyses show that 59.0% of respondents were exposed to pro-tobacco online marketing, and 2.9% were dual users. Dual users (odds ratio [OR] = 1.73) and high school students (OR = 1.43) were more likely to report exposure to online pro-tobacco marketing. CONCLUSIONS: Findings indicate that a gap in electronic cigarette pro-tobacco marketing regulatory oversight may exist. Further policy action may be warranted to protect the public health of minors and other vulnerable populations who are most susceptible to pro-tobacco marketing.

Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.

In clinical studies GS-US-380-1489 (study 1489) and GS-US-380-1490 (study 1490), bictegravir-emtricitabine-tenofovir alafenamide (B-F-TAF), dolutegravir-abacavir-lamivudine (DTG-ABC-3TC), and dolutegravir plus emtricitabine-tenofovir alafenamide (DTG+F-TAF) treatment achieved high rates of virologic suppression in HIV-1 treatment-naive participants through week 48. Preexisting primary drug resistance was present at levels of 1.3% integrase strand transfer inhibitor resistance (INSTI-R), 2.7% nucleoside reverse transcriptase inhibitor resistance (NRTI-R), 14.1% nonnucleoside reverse transcriptase inhibitor resistance (NNRTI-R), and 3.5% protease inhibitor resistance (PI-R) in the 1,274 participants from these studies. These mutations did not affect treatment outcomes. Resistance analyses in 13 virologic failures found no emergent resistance to study drugs.

Health Behaviors and Lifestyle Interventions in African American Breast Cancer Survivors: A Review.

Background: African American breast cancer survivors have a higher incidence of estrogen receptor negative and basal-like (e.g., triple negative) tumors, placing them at greater risk for poorer survival when compared to women of other racial and ethnic groups. While access to equitable care, late disease stage at diagnosis, tumor biology, and sociodemographic characteristics contribute to health disparities, poor lifestyle characteristics (i.e., inactivity, obesity, and poor diet) contribute equally to these disparities. Lifestyle interventions hold promise in shielding African American survivors from second cancers, comorbidities, and premature mortality, but they are often underrepresented in studies promoting positive behaviors. This review examined the available literature to document health behaviors and lifestyle intervention (i.e., obesity, physical activity, and sedentary behavior) studies in African American breast cancer survivors. Methods: We used PubMed, Academic Search Premier, and Scopus to identify cross-sectional and intervention studies examining the lifestyle behaviors of African American breast cancer survivors. Identified intervention studies were assessed for risk of bias. Other articles were identified and described to provide context for the review. Results: Our systematic review identified 226 relevant articles. The cross-sectional articles indicated poor adherence to physical activity and dietary intake and high rates of overweight and obesity. The 16 identified intervention studies indicated reasonable to modest study adherence rates (>70%), significant reductions in weight (range -1.9 to -3.6%), sedentary behavior (-18%), and dietary fat intake (range -13 to -33%) and improvements in fruit and vegetable intake (range +25 to +55%) and physical activity (range +13 to +544%). The risk of bias for most studies were rated as high (44%) or moderate (44%). Conclusions: The available literature suggests that African American breast cancer survivors adhere to interventions of various modalities and are capable of making modest to significant changes. Future studies should consider examining (a) mediators and moderators of lifestyle behaviors and interventions, (b) biological outcomes, and (c) determinants of enhanced survival in this population.

Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI.

BACKGROUND: HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF). OBJECTIVE: We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen. METHODS: STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA < 50 copies/mL) on an NNRTI + TVD regimen. Participants were randomized to switch or remain on their NNRTI-based regimen (no-switch). RESULTS: At Week 96, 87% (251/290) of switch and 80% (115/143) of no-switch participants maintained HIV-1 RNA < 50 copies/mL (difference 6.1%; 95% CI -1.3 to 14.2%; p = 0.12) according to the FDA-defined snapshot algorithm. Both groups had similar proportions of subjects with virologic failure (2.8% switch, 1.4% no-switch). Discontinuations resulting from adverse events were infrequent (3% [9/291] switch, 2% [3/143] no-switch). Three switch participants (1%) discontinued due to renal adverse events (2 of the 3 before Week 48). Switch participants reported significant improvements in neuropsychiatric symptoms by as early as Week 4, and which were maintained through Week 96. CONCLUSIONS: E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen.

Pharmacokinetics and Safety of Tenofovir Alafenamide in HIV-Uninfected Subjects with Severe Renal Impairment.

Tenofovir alafenamide (TAF) is an oral prodrug of tenofovir (TFV) that has greater stability in plasma than TFV disoproxil fumarate (TDF) and circulates as intact TAF, resulting in the direct and higher lymphatic loading of and exposure to TFV diphosphate, the active moiety. Unlike TFV, TAF is minimally eliminated in urine. The pharmacokinetics (PK) of TAF and TFV in HIV-uninfected subjects with severe renal impairment and matched healthy controls were evaluated. Subjects with severe renal impairment (RI; estimated glomerular filtration rate [eGFR], 15 to 29 ml/min) and controls (eGFR, ≥90 ml/min) matched for age, gender, and body mass index received a single dose of TAF at 25 mg. Blood and urine samples for TAF and TFV PK determinations were collected over 7 days postdosing, and subjects were followed up at 14 days. A total of 14 renally impaired subjects and 13 control subjects enrolled and completed the study. The TAF maximum observed concentration in plasma (Cmax) and the area under the concentration-versus-time curve (AUC) extrapolated to infinite time (AUCinf) were 79% and 92% higher, respectively, in subjects with severe RI than the controls, primarily due to higher absorption. The TFV Cmax and AUCinf were 2.8-fold and 5.7-fold higher, respectively, in subjects with severe RI than the controls. In subjects with severe RI, TAF at 25 mg provided a TFV AUC 10 to 40% lower than that from historical TDF-based TFV exposures in subjects with normal renal function. There were no discontinuations due to adverse events. In subjects with severe RI receiving TAF at 25 mg, TAF exposures were higher than those for the controls; these differences are unlikely to be clinically meaningful. TFV exposures were higher than those for the controls but lower than the exposures in nonrenally impaired subjects on TDF-based regimens.

Protein Disulfide Levels and Lens Elasticity Modulation: Applications for Presbyopia.

PURPOSE: The purpose of the experiments described here was to determine the effects of lipoic acid (LA)-dependent disulfide reduction on mouse lens elasticity, to synthesize the choline ester of LA (LACE), and to characterize the effects of topical ocular doses of LACE on mouse lens elasticity. METHODS: Eight-month-old mouse lenses (C57BL/6J) were incubated for 12 hours in medium supplemented with selected levels (0-500 µM) of LA. Lens elasticity was measured using the coverslip method. After the elasticity measurements, P-SH and PSSP levels were determined in homogenates by differential alkylation before and after alkylation. Choline ester of LA was synthesized and characterized by mass spectrometry and HPLC. Eight-month-old C57BL/6J mice were treated with 2.5 µL of a formulation of 5% LACE three times per day at 8-hour intervals in the right eye (OD) for 5 weeks. After the final treatment, lenses were removed and placed in a cuvette containing buffer. Elasticity was determined with a computer-controlled instrument that provided Z-stage upward movements in 1-µm increments with concomitant force measurements with a Harvard Apparatus F10 isometric force transducer. The elasticity of lenses from 8-week-old C57BL/6J mice was determined for comparison. RESULTS: Lipoic acid treatment led to a concentration-dependent decrease in lens protein disulfides concurrent with an increase in lens elasticity. The structure and purity of newly synthesized LACE was confirmed. Aqueous humor concentrations of LA were higher in eyes of mice following topical ocular treatment with LACE than in mice following topical ocular treatment with LA. The lenses of the treated eyes of the old mice were more elastic than the lenses of untreated eyes (i.e., the relative force required for similar Z displacements was higher in the lenses of untreated eyes). In most instances, the lenses of the treated eyes were even more elastic than the lenses of the 8-week-old mice. CONCLUSIONS: As the elasticity of the human lens decreases with age, humans lose the ability to accommodate. The results, briefly described in this abstract, suggest a topical ocular treatment to increase lens elasticity through reduction of disulfides to restore accommodative amplitude.

Comparability of weight loss reporting after gastric bypass and sleeve gastrectomy using BOLD data 2008-2011.

BACKGROUND: Weight loss after bariatric surgery is commonly reported as either a percentage of initial body weight (%IBW) or 100% minus %IBW which is a percentage of total weight loss (%TWL). These are basically equivalent expressions. Weight loss is also reported as %EWL or as a percentage of excess body mass index loss (%EBMIL). These last two expressions incorporate the concepts of ideal body weight and BMI = 25 as reference points. More straightforward but less commonly used is absolute weight loss. This study compares these various measures using the Bariatric Outcomes Longitudinal Database (BOLD). METHODS: BOLD data, 2008-2011, was accessed for outcomes on 239,659 gastric bypass (GB) and sleeve gastrectomy (SG) patients with approval of the Surgical Review Corporation. The outcome data was converted into %TWL, %EWL, and %EBMIL. %EBMIL was varied by changing the reference BMI from 1 to 25 kg/m(2). The post operation data was analyzed for both procedures. Variation coefficients (VC) were compared using different measurements on the same data pool. We assumed that the lesser the variation, the more reliable the measure is, and therefore, we made use of the VC to compare the different reporting methods. RESULTS: There were 164,247 patients who remained after removal of errors and missing data. Demographics are as follows: 78.1% female, 73.1% white, 12.5% black, 8.71% Hispanic, 81.6% GB, 18.4% SG, mean age of 44.8 years, height of 167.0 cm, weight of 132.0 kg, and BMI of 47.1 kg/m(2). GB patients had 26.8%TWL at 6 months (VC = 21.5) and 34.2%TWL at 12 months (VC = 27.0). %EWL was 54.7 at 6 months (VC = 27.3) and 69.4 at 12 months (VC = 30.9). Varying the reference BMI for %EBMIL showed the lowest VC to be 0-2 kg/m(2) for GB up to 12 months post operation. SG patients had 24.0%TWL at 6 months (VC = 25.4) and 29.5 at 12 months (VC = 30.5). %EWL was 50.0% at 6 months (VC = 31.4) and 60.2% at 12 months (VC = 34.5). Varying the reference BMI for %EBMIL showed that the lowest VC occurred when the reference weight was chosen as 0 kg/m(2) for both GB and SG. %TWL or, equivalently, %IBW had the lowest variation coefficient and therefore is the more accurate measure of weight loss following bariatric surgery. CONCLUSIONS: For ease and accuracy of comparison, the percentage of initial body weight or percentage of total weight loss should be used for the expression of weight loss after surgery.

Phase IIIb, open-label single-arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV-1-infected treatment-nave adults.

INTRODUCTION: COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug-drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers. MATERIALS AND METHODS: This 48-week, phase IIIb, open-label, single-arm, US multicentre study (NCT01440569) included HIV-infected treatment-nave and experienced adults with no DRV RAMs, viral load (VL) ≥1000 c/mL, eGFR ≥80 mL/min and genotypic sensitivity to investigator-selected N[t]RTIs. Patients received DRV/COBI 800/150 mg qd (as single agents) plus two fully active N[t]RTIs. The primary endpoint was any treatment-emergent grade 3 or 4 AEs through Week 24. We report 48-week safety, efficacy and PK/PD results in treatment-nave patients. RESULTS: Of 313 ITT patients, 295 were treatment-nave (94%). In the treatment-nave cohort, 90% were male, 60% white and 294 (99.7%) received a TDF-containing regimen. Median baseline (BL) VL was 4.8 log10 c/mL and CD4(+) 370 cells/mm(3). Treatment-emergent grade 3 or 4 AEs regardless of causality were reported in 21 (7%) patients. AEs regardless of causality (any grade; ≥10% of patients) were: diarrhoea (27%), nausea (23%), URTI (15%) and headache (12%). Sixteen (5%) patients had AEs leading to study drug discontinuation, most frequently rash (three patients), hypersensitivity and nausea (two patients each). Consistent with the known inhibition of tubular creatinine secretion by COBI, there was a mean increase from BL in serum creatinine by week 2 (0.09 mg/dL), remaining stable through week 48 (mean 0.10 mg/dL increase from BL). At week 48, 83% of patients achieved VL<50 c/mL; FDA Snapshot); median increase in CD4(+) was 169 cells/mm(3). Eight patients met the criteria for resistance testing. M184V was detected in one pt receiving FTC. New primary RAMs were not detected in the other seven patients. The mean population PK-derived DRV AUC24h was 100,620 ng.h/mL and C0h 2,105 ng/mL (n=281). There were no clinically relevant relationships between DRV exposure and virologic response, AEs or laboratory parameters. CONCLUSIONS: The DRV PK of DRV/COBI was consistent with historical data for DRV/RTV. DRV/COBI 800/150 mg qd plus two N(t)RTIs had an 83% response and was well tolerated through Week 48. These results are similar to published data for DRV/RTV 800/100 mg qd, and support the use of DRV/COBI 800/150 mg qd in treatment-nave patients.

Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial.

BACKGROUND: Cobicistat is an alternative pharmacoenhancer to ritonavir. In healthy volunteers, darunavir exposure was comparable when darunavir 800 mg once daily was co-administered with cobicistat 150 mg once daily (as single agents or a fixed-dose combination) vs. with ritonavir 100 mg once daily. METHODS: This 48-week, Phase IIIb, single-arm, US multicenter study (NCT01440569) evaluated safety, efficacy and pharmacokinetics of darunavir/cobicistat 800/150 mg once daily (as single agents) plus two investigator-selected nucleoside/tide reverse transcriptase inhibitors (N[t]RTIs) in HIV-1-infected adults. Patients had no darunavir resistance-associated mutations (RAMs), plasma viral load (VL) ≥1000 HIV-1 RNA copies/ml, eGFR ≥80 ml/min and genotypic sensitivity to the two N[t]RTIs. The primary endpoint was any treatment-emergent grade 3 or 4 adverse events (AEs) through Week 24. RESULTS: The majority of the 313 intent-to-treat patients were treatment-naïve (295/313; 94%), male (89%), White (60%) and received a tenofovir-based regimen (99%). Median baseline VL and CD4(+) count overall were 4.8 log10 HIV-1 RNA copies/ml and 361 cells/mm(3), respectively. Overall, 86% of patients (268/313) completed the study. The majority of discontinuations were for AEs (15/313; 5%). The incidence of treatment-emergent grade 3 or 4 AEs regardless of causality was 6% through Week 24 and 8% through Week 48. Most common AEs through Week 48 were diarrhea (27%) and nausea (23%), which were grade 1 or 2 in severity. Week 48 virologic response rates (% with VL <50 HIV-1 RNA copies/ml; Snapshot analysis) were 81% overall and 83% in treatment-naïve patients; median increases in CD4(+) count at 48 weeks were 167 and 169 cells/mm(3), respectively. Of 15/313 patients who met the criteria for resistance analysis, one developed a darunavir RAM as a mixture with wild-type (I84I/V), without phenotypic resistance to darunavir. The mean population pharmacokinetic-derived darunavir areas under the plasma concentration-time curve were 102,000 overall and 100,620 ng•h/ml in treatment-naïve patients. No clinically relevant relationships were seen between darunavir exposure and virologic response, AEs or laboratory parameters. CONCLUSION: Darunavir/cobicistat 800/150 mg once daily was generally well tolerated through Week 48, with no new safety concerns. Pharmacokinetics, virologic and immunologic responses for darunavir/cobicistat were similar to previous data for darunavir/ritonavir 800/100 mg once daily.

The clinical utility of bivalirudin in patients with coronary artery disease.

Bivalirudin, a direct thrombin inhibitor, is an anticoagulant commonly used in invasive cardiology procedures. It has evolved from relative obscurity, as an anticoagulation option only utilized in rare instances of allergy or resistance to heparin products, to the now preferred antithrombotic anticoagulant in the cardiac catheterization laboratory. On the way to displacing unfractionated heparin as the preferred anticoagulant for percutaneous coronary intervention, multiple studies comparing bivalirudin with heparin have consistently shown equivalent ischemic efficacy endpoints (i.e. cardiovascular death, myocardial infarction, etc.), with significant reductions in bleeding. Bleeding has been directly linked to worse hospital outcomes in cardiac patient's undergoing invasive coronary artery revascularization procedures. More recent bivalirudin studies now demonstrate reductions in mortality, which has led to a paradigm shift to bivalirudin as the anticoagulant choice both in elective and emergent coronary procedures. We present the major studies that have brought bivalirudin to the forefront of coronary artery disease, specifically coronary interventional procedures.

A simpler method for predicting weight loss in the first year after Roux-en-Y gastric bypass.

Factors postulated to predict weight loss after gastric bypass surgery, include race, age, gender, technique, height, and initial weight. This paper contained 1551 gastric bypass patients (85.9% female). Operations were performed by one surgeon (MLO) at community hospitals in Southern California from 1989 to 2008 with 314 being laparoscopic and 1237 open. We created the following equation: In[percent weight] = At(2) - Bt, where t was the time after operation (days) and A and B are constants. Analysis was completed on R-software. The model fits with R(2) value 0.93 and gives patients a realistic mean target weight with a confidence interval of 95% for the first year. Conclusion. We created a curve predicting weight loss after surgery as a percentage of initial weight. Initial weight was the single most important predictor of weight loss after surgery. Other recorded variables accounted for less than 1% of variability. Unknown factors account for the remaining 6-7%.

Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis.

INTRODUCTION: It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency, frequency, and pain associated with interstitial cystitis (IC). This combination has also been reported to relieve pain associated with sex in patients with IC. AIM: The aim of this study was to corroborate these findings in a multicenter setting. METHODS: The study design was a multicenter prospective, double-blind, crossover, placebo-controlled trial. Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria (excluding cystoscopy) for IC. Each patient received drug and control, in random order, within 48 hours of enrolling in the study. MAIN OUTCOME MEASURES: The primary outcome measure was percent change in pain score (11-point analog pain scale) 12 hours after receiving the drug or control. Secondary measures were the global assessment response (GAR) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales. RESULTS: Eighteen (18) patients completed the trial. The average reduction of pain over 12 hours was 21% for control and 42% for active drug (P = 0.0363). GAR was 13% for control and 50% for drug (P = 0.0137). Average urgency reduction was 13% for control and 35% for drug (P = 0.0328). CONCLUSIONS: The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC. This combination provides significant immediate relief of symptoms for patients with IC.

The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study.

Beta-blockers are currently contraindicated in asthma because their acute administration may be associated with worsening bronchospasm. However, their effects and safety with their chronic administration are not well evaluated. The rationale for this pilot study was based on the paradigm shift that was observed with the use of beta-blockers in congestive heart failure, which once contraindicated because of their acute detrimental effects, have now been shown to reduce mortality with their chronic use. We hypothesized that certain beta-blockers may also be safe and useful in chronic asthma therapy. In this prospective, open-label, pilot study, we evaluated the safety and effects of escalating doses of the beta-blocker, nadolol, administered over 9 weeks to 10 subjects with mild asthma. Dose escalation was performed on a weekly basis based on pre-determined safety, lung function, asthma control and hemodynamic parameters. The primary objective was to evaluate safety and secondary objectives were to evaluate effects on airway hyperresponsiveness, and indices of respiratory function. The escalating administration of nadolol was well tolerated. In 8 out of the 10 subjects, 9 weeks of nadolol treatment produced a significant, dose-dependent increase in PC20 that reached 2.1 doubling doses at 40 mg (P<0.0042). However, there was also a dose-independent 5% reduction in mean FEV1 over the study period (P<0.01). We conclude that in most patients with mild asthma, the dose-escalating administration of the beta-blocker, nadolol, is well tolerated and may have beneficial effects on airway hyperresponsiveness. Our findings warrant further testing in future larger trials.

Percutaneous coronary artery stenting of unprotected left main coronary artery disease using drug-eluting stents: the initial Baylor University Medical Center experience.

Significant narrowing of the left main coronary artery is a high-risk condition with significant mortality risk. Bypass surgery is the current gold-standard treatment for unprotected left main (ULM) disease. Stenting utilizing drug-eluting stents (DES) is another therapeutic option for patients with ULM disease considered too high risk for bypass surgery or for patients who simply refuse bypass surgery. We have had great initial success with ULM stenting using DES in 10 selected patients at Baylor University Medical Center. Ongoing multicenter, international randomized studies comparing percutaneous coronary intervention with DES and bypass surgery will shed more light on the best treatment strategy for ULM coronary disease.

Valve structure and survival in octogenarians having aortic valve replacement for aortic stenosis (+/- aortic regurgitation) with versus without coronary artery bypass grafting at a single US medical center (1993 to 2005).

The purpose of this study was to determine the effect of simultaneous coronary artery bypass grafting (CABG) and valve structure on both early and late survival in octogenarians having aortic valve replacement (AVR) for aortic stenosis (AS) (with or without aortic regurgitation). Although a number of reports are available in octogenarians having AVR for AS, none have described aortic valve structure. Most have limited numbers of patients and few have described late results. We analyzed survival and valve structure in 196 octogenarians having AVR for AS from 1993 to 2005 at Baylor University Medical Center, including 118 (60%) with and 78 (40%) without simultaneous CABG. Sixty-day mortality, which was identical to 30-day mortality, was similar (10% and 11%) in the groups with and without simultaneous CABG. Unadjusted analysis of late survival (up to 13 year follow-up) was not affected by gender (male vs female), aortic valve structure (bicuspid vs tricuspid) or preoperative severity of the AS (transvalvular peak pressure gradient > 50 vs < or =50 mm Hg), or by performance of CABG. Of the 196 patients, 54 (28%) had a congenitally bicuspid aortic valve, and 142 (72%) had a tricuspid aortic valve. In conclusion, gender, valve structure, preoperative severity of the AS, or performance of simultaneous CABG did not effect survival in octogenarians having AVR for AS.