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Page 1: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine
Page 2: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Relativas a esta presentación existen las siguientes relaciones que podrían ser percibidas como potenciales conflictos de intereses:

Declaración de potenciales conflictos de intereses

podrían ser percibidas como potenciales conflictos de intereses:

Dr. Marcos Garcia Rueda ha colaborado con GSK y Pfizer industrias farmacéuticas con interés en el campo del tratamiento del tabaquismo.

Page 3: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 4: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 5: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

SPRAY BUCAL DE SPRAY BUCAL DE NICOTINANICOTINA

Page 6: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

SPRAY BUCAL DE SPRAY BUCAL DE NICOTINANICOTINA

Page 7: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

CHICLE CHICLE 6 6 MGMG

Page 8: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

CHICLE 6 MGCHICLE 6 MG

Page 9: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

INHALADOR MDIINHALADOR MDI

• Double-blind randomized placebo-controlled, parallel group trialcontrolled, parallel group trial

• n:502

• Primary outcome was prolonged 6 month not smoked on 7 consecutive days, analyzed by intention-to-treat

Page 10: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 11: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• “ Nicotine is a toxic compound that should be

Seguridad

• “ Nicotine is a toxic compound that should be handled with care, but the frequent warnings of potential fatalities caused by ingestion of small

amounts of tobacco products or diluted nicotine-

containing solutions are unjustified and need to be revised in light of overwhelming data indicating thatmore than 0.5 g of oral nicotine is required to kill anadult. “

Page 12: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

“ Short-term nicotine use, such as nicotine

Seguridad

“ Short-term nicotine use, such as nicotinemedication to aid smoking cessation, appearsto pose little cardiovascular risk, even to

patients with known CVD. “

Page 13: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

“ human studies, there appears to be

Seguridad

“ human studies, there appears to be inadequate evidence for an associationbetween nicotine exposure and the presenceof or lack of a carcinogenic effect due to thelimited information available. In animal studies,

limited evidence suggests an association

between long-term nicotine exposure and a

lack of a complete carcinogenic effect.”

Page 14: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• The inhaled nicotine exposure mediated oxidative-stress induces autophagy-impairment in the

Seguridad

• The inhaled nicotine exposure mediated oxidative-stress induces autophagy-impairment in themurine lungs as seen by significant (p<0.05, n=4) increase in the expression levels of nitrotyrosineprotein-adduct (oxidative-stress marker, soluble-fraction) and Ub/p62/VCP (impaired-autophagymarker, insoluble-fraction).

“ Overall, our data shows that nicotine, a common component of WPS, e-cigarette vapor and cigarette smoke, induces bronchial epithelial cell apoptosis and senescence via ROS

mediated autophagy-impairment as a potential mechanism for COPD-emphysema

pathogenesis. “

Page 15: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two

• A cotinine value that increased by >50% from baseline was recorded at least one

Seguridad

subjects, of whom 7,120 received NRT and had two cotinine levels measured.

• In the majority of studies, subjects smoked at least 10–15 cigarettes/day at baseline and had smoked for at least 3 years.

• The median increase in cotinine levels among those included in these analyses was >50%–60% (representing levels induced by NRT and any concurrent smoking).

from baseline was recorded at least one visit during treatment in 746 subjects (10.5%); of this group, 69/746 (9.2%) had symptoms.

• Among the total subjects, the incidence of adverse events and high cotinine levels was 69/7,120 (0.97%), and they were mostly categorized as mild or moderate.

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Seguridad

Page 17: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine
Page 18: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Seguridad

Page 19: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 20: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Providing free nicotinereplacement therapy can be a cost-effective strategy for

Adherencia

a cost-effective strategy for increasing quit attempts and cessation rates at a population level.

• After controlling for reverse causation, adherence to 10

weeks of cost-free NRT wasassociated with successfulabstinence at six monthspost-treatment.

Page 21: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Population-based proactive tobacco treatment is effective in increasingengagement in evidence-based tobacco cessation treatments and for increasing long-term population quit rates among hard to reach,

socioeconomically disadvantaged smokers.

Adherencia

Page 22: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 23: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Behavioral and pharmacotherapy interventions

improve rates of smoking cessation among the

general adult population, alone or in combination.

Efectividad

general adult population, alone or in combination. • Data on the effectiveness and safety of electronic

nicotine delivery systems are limited.

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Page 25: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Interventions that combine pharmacotherapy and

behavioural support increase smoking cessation success

compared to a minimal intervention or usual care.

• Updating this review with an additional 12 studies (5,000 participants) did not materially change the effectestimate.

Efectividad

estimate.

Page 26: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine
Page 27: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Authors’ conclusions

Efectividad

• All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) can help people whomake a quit attempt to increase their chances of successfully stoppingsmoking.

• NRTs increase the rate of quitting by 50 to 70%, regardless of setting. • The effectiveness of NRT appears to be largely independent of the intensity of

additional support provided to the individual. • Provision of more intense levels of support, although beneficial in facilitating

the likelihood of quitting, is not essential to the success of NRT.

Page 28: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine
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“ After more than 100 randomized clinical trials

Efectividad

“ After more than 100 randomized clinical trialshave been conducted, the overall effectivenessof NRT is in doubt. “

Simple, well-established meta-regressionmethods can test, accommodate, and correctmultiple sources biases, often mentioned butdismissed by conventional systematic reviews.

Page 30: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 31: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Comparaciones

Page 32: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Among adults motivated to quit smoking,12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRTproduced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks

Comparaciones

Page 33: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Comparaciones

• Flexible and combination NRT and varenicline enhance success in the early phases of quitting.

• Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.

Page 34: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

“ Snus performed similarly to nicotine gum in cigarette

Comparaciones

“ Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction

and greater toxicant exposure than nicotine gum. “

Page 35: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Comparaciones

“E-cigarette use was negatively associated with successful quitting in this large community sample of smokers accessing standard evidence-based smoking cessation treatment through primary care clinics, even after adjusting for covariates such as severity of tobacco dependence, gender, and age. The findings suggest that concurrent use of e-cigarettes with NRT may harm cessation attempts. “

Page 36: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 37: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Qualitative analyses might be better suited at this stage to determine what is

Poblaciones especiales

• Qualitative analyses might be better suited at this stage to determine what is acceptable to adolescents; patches might be more welcoming with other patch products on the market utilized by this population such as birth control; gum might be limited as students are typically restricted from chewing gum within the school setting.

• Considering these factors and finding a more acceptable method may allow youth to attain the benefits of NRT in a form they will actually use.

• While effectiveness evidence thus far is lacking, methodological improvements are warranted for future trials.

Page 38: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Poblaciones especiales

“ The great demand for NRT and the association between NRT use with quit attempts and abstinence at 1-week posthospitalisationsupports adoption of tobacco treatment in acute psychiatric settings. “

Page 39: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Randomised placebo-controlled trial of nicotine replacement therapy in pregnancy – clinical effectiveness and safety until 2 years after delivery, with economic evaluation.

Poblaciones especiales

• At 12–24 weeks’ gestation, supplementing behavioural support with a 15 mg per 16 hours nicotine patch was no more effective than placebo in promoting sustained smoking cessation throughout pregnancy.

• Despite significantly higher cessation rates occurring at 1 month in significantly, higher in the NRT group at delivery and this (still non-significant) difference remained at 6, 12 and 24 months.

Page 40: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

A postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge.

Poblaciones especiales

Page 41: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

•• Formas de TSNFormas de TSN

•• SeguridadSeguridad

•• AdherenciaAdherencia

INDICE DE LA PRESENTACIÓN

•• AdherenciaAdherencia

•• EfectividadEfectividad

•• ComparacionComparacion otros otros ttosttos

•• Poblaciones especialesPoblaciones especiales

•• OtrosOtros

Page 42: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• The CLIQ system has favorable cost-effectiveness comparedto other smoking cessation interventions.

• Cost-effectiveness will be greatest for health systems with highnumbers of smokers and with the high smoker participation

Coste-efectividad

numbers of smokers and with the high smoker participationrates.

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• Modelo adecuado y reproducible.• Resultados incontestables.• Rentabilidad desde el 4º año hasta el infinito.

Coste-efectividad

Page 44: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

• Distintos escenarios• Resultados por Comunidades Autónomas

Coste-efectividad

Page 45: podrían ser percibidas como potenciales conflictos de ...€¦ · • The 28 studies included a total of 12,758 evaluable subjects, of whom 7,120 received NRT and had two • A cotinine

Marcos Garcia Rueda

[email protected]

[email protected]

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