safety and affordabilty: quantifying the impact of real-world evidence

Bernardino Alcázar NavarreteRespiratory Department

H. Alta Resolución de Loja. Granada.

SPAIN

Safety & Affordability: quantifying the ‘IMPACT’ of

real-world evidence Safety & Risk outside the idealised

trial environment

@banavarrete

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• Speaker: • Astra Zéneca/Boehringer-Ingelheim/Chiesi/ Ferrer/ GSK/

Menarini/ Novartis/ Rovi/ Teva/Takeda• Advisory Boards

• Astra Zéneca/Chiesi/ Grifols/Gebro Pharma/GSK/ Menarini/ Novartis

• Research funding• Astra Zéneca/Ferrer/ Forrest/GSK/ Menarini/ Novartis/Takeda

Disclosures

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Today´s agenda

• What RCTs can tell us about risks & safety? • How can Real Life studies help us assessing risks in

pulmonary diseases? • Examples of drug safety in COPD/Asthma. • Examples of risks in daily practice. • Unmet needs in respiratory medicine. • Conclusions

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What can RCTs tell us about risks & safety?

Roche N. Lancet Resp Med 2013; 1 (8): 29-30

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N Engl J Med 2013;369:1491-501.

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N Engl J Med 2016, on line

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Respir Med 2005; 99: 11–19.

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Today´s agenda



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How can Real-Life studies help us?

Arch Intern Med. 2009;169(2):141-149

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Chest 2013; 143(4):1018–1024

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Thorax 2011;66:699-708.

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Today´s agenda



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Examples of drug safety in COPD/ Asthma

Courtesy of A. Chisholm, REG ATS-SASG Meeting

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Courtesy of A. Chisholm, data on file

Cardiovascular risks in smokers treated with nicotine

replacement therapy: A real-life study

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Today´s agenda



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Examples of risks in daily practice

• Design: Two interval, parallel, population-based cohorts (2007 and 2013), with 12 months of follow-up were developed in both countries. The Optimum Patient Care Research Database (OPCRD) and the Permanent Beneficiaries Sample database (EGB) were used in the UK and France, respectively.

• Main outcome measures: Overuse of SABA (defined as >12 units), use of LAB) without ICS, unbalanced (two-fold higher) use of LABA compared to ICS, over the 12-month periods following entry date, in both countries.

• Results: • 39,743 UK and 4,910 French patients were included in the 2007 cohorts and 14,036 UK and 5,657

French patients in the 2013 cohorts.

• UK adults were more frequently exposed to SABA overuse compared to France in both 2007 and 2013.

• In 2013, LABA use without ICS occurred in 0.1% and 1.5% of UK and French adults respectively (0.4% and 2.6% in 2007).

• Unbalanced use of LABA relative to ICS in 2013 occurred in 0.2% and 0.7% of UK and French adults, respectively, in 2013.

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Unmet needs in respiratory medicine

» Safety of LABA/LAMA in patients at risk/with cardiac disease (IHD, HF, Atrial fib).

» Long-term safety of ICs/LABA in patients with COPD.

» Long term safety of macrolides when prescribed for prevention of exacerbations of COPD.

» Safety of ICs/LABA in smokers with asthma.

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Conclusions

» RCTs are not the best option to test whether pharmacological treatments / strategies are safe.

» AEs, specially SAEs, are uncommon and difficult to detect in RCTs with 52 week follow-up periods.

» Real life studies can help detecting safety issues in non-selective populations.

» Examples of safety studies included in the summit posters relating: to CV risk of NRT, beta-blockers in COPD, metabolic consequences of ICs/LABA, inappropriate prescriptions for COPD/Asthma

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Conclusions

» Studies assessing MACEs in patients with COPD on LABA/LAMA therapy, specially in those with cardiovascular diseases, are needed.

» Other issues to be assessed include: safety of ICs/LABA in smoker asthmatics, long- term safety of macrolides for COPD.

safety and affordabilty: quantifying the impact of real-world evidence

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