Electronic Cigarettes for Smoking Cessation: A Randomised Controlled Trial

Abstract

major bleeds enrolled in five phase III trials comparing dabigatran with warfarin in 27,419 patients treated for 6 to 36 months. There were 627 of 16,755 patients on dabigatran who had major bleeds. These patients were older, had lower creatinine clearances, and more frequently used aspirin or nonsteroid anti-inflammatory agents than those on warfarin with major bleeds (n ¼ 407 of 10,002). Thirty-day mortality after the first major bleed tended to be lower in the dabigatran group (9.1%) than in the warfarin group (13.0%; pooled odds ratio, 0.68; 95% confidence interval, 0.46-1.01; P ¼ .057). With adjustments for sex, age, weight, renal function and concomitant antithrombotic therapy, the pooled odds ratio for 30-day mortality with dabigatran vs warfarin was 0.66 (95% confidence interval, 0.144-1.00; P ¼ .051). In dabigatran patients with major bleeds, the bleeding was more frequently treated with blood transfusions (61%) than bleeds in warfarin patients (42%; P < .001). Patients with major bleeds treated with dabigatran were less frequently treated with plasma compared to warfarin patients with major bleeds (19.8% vs 30.2%; P < .001). Patients with major bleeds had shorter stays in intensive care units if they had previously received dabigatran (mean,1.6 nights) compared with those who had received warfarin (mean, 2.7 nights; P ¼ .01).Comment: There is obviously no ideal anticoagulant agent. Despite the fact there is no reversal agent for dabigatran, outcomes of major bleeding on this drug appear no worse and are perhaps slightly better than outcomes for patients with major bleeding on warfarin. It does not appear overall resources needed to manage major bleeding on dabigatran are greater than to manage such bleeding on warfarin. It also does not appear that the prognosis after major bleeding is worse with dabigatran than with warfarin despite the lack of a reversal agent for dabigatran. Dabigatran is an alternative to warfarin with similar or superior efficacy and overall lower risk of major bleeding. Bleeding episodes can be managed satisfactorily with relatively simple measures such as drug discontinuation and transfusion of red cells. Thus, the overall safety profile of dabigatran compared to warfarin remains favorable. Nevertheless, it is still desirable to develop a specific antidote to dabigatran.

Electronic Nicotine Delivery Systems

“…As of publication date, 1 randomized controlled clinical trial has compared nicotine-containing ENDS, nicotinereplacement therapy (21-mg nicotine patches), and placebo (no nicotine) ENDS. 50 Six-month cessation rates were low overall, and no statistically significant difference was found among the 3 groups. Notable limitations to the study included inadequate behavioral support for all groups and poor participant adherence with study treatments, which was particularly low in the nicotine patch group.…”

Electronic Cigarettes: Vulnerability of Youth

“…The studies also did not find a difference from medicinal nicotine patches, but the patches were often not used by the study participants. 4,[9][10][11] In these studies, almost all individuals, including the controls, reduced combustible cigarette use. Recently quit smokers felt that electronic cigarettes were not associated with success.…”

Positionspapier der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e.V. (DGP) zur elektronischen Zigarette (E-Zigarette)

“…Im Dezember 2014 erschien u. a. ein Cochrane Review zur Frage der Eignung von E-Zigaretten in der Raucherentwöhnung [14]. Die zwei bis dato erschienenen randomisierten, Placebo-kontrollierten Studien [6,7], auf die sich auch die Übersicht von Nowak et al gestützt hatte [16], wurden nach dem GRADE-System als Hinweise geringer bzw. sehr geringer Evidenz für eine solche Eignung bewertet [14].…”