Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

An Assessment of Vape Shop Products in California before and after Implementation of FDA and State Regulations

Vape shops specialize in sales of e-cigarettes and related products. This study examines whether vape shops adapted their products and services in response to changes in federal and state policies that affect the tobacco retail environment between 2014–2022. In this multicohort study, four waves of study data were used to examine the trends in products sold in vape shops in Southern California. Items sold were assessed through systematic store product observations and included categories of e-cigarettes, device modification equipment, and other products (e.g., Cannabidiol (CBD), paraphernalia). Descriptive statistics are reported. The availability of disposable devices increased from 18% at Wave 1 to 98% of shops at Wave 4. Pod mods were first observed in 79% of the shops beginning at Wave 3. Device modification drills later become obsolete, from 60% at Wave 1 to 0 by Wave 4; self-service sampling displays declined from 83% of shops to 9%. Vape shops did not carry CBD products until Wave 3 (2017/2018), when 19.0% of shops carried CBD products and 72.9% at Wave 4. Future research should examine how e-cigarette retailers and manufacturers respond to changing state and federal regulations to better understand the implications of regulatory efforts

Commentary: The Emergence of Pod Mods at Vape Shops.

The vape shop industry is a rapidly growing market sector with a constantly changing product landscape. The rapid evolution of nicotine delivery systems, most notably the emergence of salt nicotine e-juice and pod mod devices, have resulted in a sudden shift in the product market, suggesting new implications for the health professions in addressing electronic cigarette use

Ice Flavor–Related Discussions on Twitter: Content Analysis

BackgroundThe US Food and Drug Administration (FDA) recently restricted characterizing flavors in tobacco products. As a result, ice hybrid–flavored e-cigarettes, which combine a cooling flavor with fruit or other flavors (eg, banana ice), emerged on the market. Like menthol, ice-flavored e-cigarettes produce a cooling sensory experience. It is unclear if ice hybrid–flavored e-cigarettes should be considered characterizing flavors or menthol, limiting regulatory action. Monitoring the public’s conversations about ice-flavored e-cigarettes on Twitter may help inform the tobacco control community about these products and contribute to the US FDA policy targets in the future. ObjectiveThis study documented the themes pertaining to vaping and ice flavor–related conversations on Twitter. Our goal was to identify key conversation trends and ascertain users’ recent experiences with ice-flavored e-cigarette products. MethodsPosts containing vaping-related (eg, “vape,” “ecig,” “e-juice,” or “e-cigarette”) and ice-related (ie, “Ice,” “Cool,” “Frost,” and “Arctic”) terms were collected from Twitter’s streaming application programming interface from January 1 to July 21, 2021. After removing retweets, a random sample of posts (N=2001) was selected, with 590 posts included in the content analysis. Themes were developed through an inductive approach. Theme co-occurrence was also examined. ResultsMany of the 590 posts were marked as (or consisted of) marketing material (n=306, 51.9%), contained positive personal testimonials (n=180, 30.5%), and mentioned disposable pods (n=117, 19.8%). Other themes had relatively low prevalence in the sample: neutral personal testimonials (n=45, 7.6%), cannabidiol products (n=41, 7%), negative personal testimonials (n=41, 7%), “official” flavor description (n=37, 6.3%), ice-flavored JUUL (n=19, 3.2%), information seeking (n=14, 2.4%), and comparison to combustible tobacco (n=10, 1.7%). The most common co-occurring themes in a single tweet were related to marketing and disposable pods (n=73, 12.4%). ConclusionsOur findings offer insight into the public’s experience with and understanding of ice-flavored e-cigarette products. Ice-flavored e-cigarette products are actively marketed on Twitter, and the messages about them are positive. Public health education campaigns on the harms of flavored e-cigarettes may help to reduce positive social norms about ice-flavored products. Future studies should evaluate the relationship between exposure to personal testimonials of ice-flavored vaping products and curiosity, harm perceptions, and experimentation with these products among priority populations

Association between federal and California state policy violation among vape shops and neighbourhood composition in Southern California.

IntroductionPast studies have documented disparities in regulation compliance among tobacco retailers with respect to ethnic diversity in neighbourhoods. This study investigated the association between compliance with the Food and Drug Administration (FDA) and California state rules and neighbourhood ethnic composition of a vape shop location.MethodsWe recruited 122 vape shops located in 'ethnic enclave' neighbourhoods in Southern California. Trained teams of data collectors visited each of the consented vape shops and coded items in the shops that were visible and on display. Location data for the percentages of ethnic composition for a given city were obtained from the U.S. Census Bureau, American FactFinder. Multilevel logistic regression models examined the relationship between the city-level neighbourhood ethnic composition and vape shop rule violation status: not displaying Ask4ID sign and offering free samples.ResultsVape shops located in neighbourhoods/communities with more white residents were significantly less likely to not display Ask4ID sign (p=0.03) and less likely to offer free sampling (p=0.009), controlling for other neighbourhood ethnic characteristics.DiscussionGreater enforcement for proper signage display is needed for vape shops located in racial/ethnic minority locations to ensure that minors are discouraged from purchasing e-products

Association between federal and California state policy violation among vape shops and neighbourhood composition in Southern California.

IntroductionPast studies have documented disparities in regulation compliance among tobacco retailers with respect to ethnic diversity in neighbourhoods. This study investigated the association between compliance with the Food and Drug Administration (FDA) and California state rules and neighbourhood ethnic composition of a vape shop location.MethodsWe recruited 122 vape shops located in 'ethnic enclave' neighbourhoods in Southern California. Trained teams of data collectors visited each of the consented vape shops and coded items in the shops that were visible and on display. Location data for the percentages of ethnic composition for a given city were obtained from the U.S. Census Bureau, American FactFinder. Multilevel logistic regression models examined the relationship between the city-level neighbourhood ethnic composition and vape shop rule violation status: not displaying Ask4ID sign and offering free samples.ResultsVape shops located in neighbourhoods/communities with more white residents were significantly less likely to not display Ask4ID sign (p=0.03) and less likely to offer free sampling (p=0.009), controlling for other neighbourhood ethnic characteristics.DiscussionGreater enforcement for proper signage display is needed for vape shops located in racial/ethnic minority locations to ensure that minors are discouraged from purchasing e-products

Signs and customer behaviors at vape shops: Multivariate multilevel model analysis.

IntroductionThis study examined vape shop customers' behaviors in relation to shop display practices. We hypothesized that display of signs conveying supportive attitude toward vaping at vape shops would be positively associated with customer purchasing and in-shop vaping behaviors.MethodsWe recruited vape shops throughout Southern California (N = 122). Trained teams of data collectors visited each of the consented vape shops, observed customers' characteristics and behaviors (N = 254) and coded items in the shops that were visible and on display. We conducted a multivariate multilevel analysis to account for the data structure where customers were nested within vape shops.ResultsMale customers were more likely to purchase e-liquid at the shop than female customers (p < .001). There were no sex differences vaping at the shop (p = .353). We observed more customers vaping at shops with e-cigarette safety displays (p = .024) and more customers purchasing e-liquid at shops with quit smoking signage (p = .004). Point-of-sale displays were not associated with either customer vaping or purchasing behaviors observed at the shop. Displays of state-regulated and nonregulated (i.e., tobacco industry) age-of-sale compliance signs, Ask4ID and WeCard, were not significantly associated with customer vaping or purchase behaviors.ConclusionCertain display signs present at vape shops might communicate to customers that engaging in certain behaviors (e.g., vaping inside the shops) may be safe or acceptable

Signs and customer behaviors at vape shops: Multivariate multilevel model analysis.

IntroductionThis study examined vape shop customers' behaviors in relation to shop display practices. We hypothesized that display of signs conveying supportive attitude toward vaping at vape shops would be positively associated with customer purchasing and in-shop vaping behaviors.MethodsWe recruited vape shops throughout Southern California (N = 122). Trained teams of data collectors visited each of the consented vape shops, observed customers' characteristics and behaviors (N = 254) and coded items in the shops that were visible and on display. We conducted a multivariate multilevel analysis to account for the data structure where customers were nested within vape shops.ResultsMale customers were more likely to purchase e-liquid at the shop than female customers (p < .001). There were no sex differences vaping at the shop (p = .353). We observed more customers vaping at shops with e-cigarette safety displays (p = .024) and more customers purchasing e-liquid at shops with quit smoking signage (p = .004). Point-of-sale displays were not associated with either customer vaping or purchasing behaviors observed at the shop. Displays of state-regulated and nonregulated (i.e., tobacco industry) age-of-sale compliance signs, Ask4ID and WeCard, were not significantly associated with customer vaping or purchase behaviors.ConclusionCertain display signs present at vape shops might communicate to customers that engaging in certain behaviors (e.g., vaping inside the shops) may be safe or acceptable

Predictors of Vape Shops Going out of Business in Southern California.

ObjectivesVape shops have proliferated in the United States (US) in recent years. As of May 2016, the US Food and Drug Administration (FDA) asserted its authority to regulate electronic nicotine delivery systems. It is critical to understand how these polices have affected the vape shop industry, as the rise and fall of vape shop proliferation has the potential for influencing public health.MethodsIn this longitudinal study, we examined factors associated with vape shop (N = 77) closure over a 2-1/2-year period in southern California. We assessed predictors of vape shops going out of business using a multivariate logistic regression model.ResultsAmong 77 vape shops assessed at baseline, 44.2% closed over a 2-1/2-year period. The absence of a "bar type" physical environment (OR = 2.64, 95% CI = 1.12-6.20), poorer shop accessibility (OR = 7.11, 95% CI = 1.17-43.24), fewer reports of qualified personnel (OR = 2.28, 95% CI = 1.12-4.64), less average time spent in shop by customers (OR = 4.8, 95% CI = 1.18-19.60), a narrower e-liquid flavor selection (OR = 6.55, 95% CI = 1.56-27.49), and less vape device diversity (OR = 2.36, 95% C = 1.13-4.91) predicted vape shop closure.ConclusionsThe rise and subsequent decline in vape shops could potentially affect public health. However, there needs to be more research on their association with public health.