Study identification

EU PAS number

EUPAS1000000622

Study ID

1000000622

Official title and acronym

Cardiovascular events after exacerbations of chronic obstructive pulmonary disease: Results from the EXAcerbations of COPD and their OutcomeS in CardioVascular diseases study in Italy

DARWIN EU® study

No

Study countries

Italy

Study description

Introduction: Exacerbations of chronic obstructive pulmonary disease (COPD) can increase the risk of severe cardiovascular events.
Objective: Assess the crude incidence rates (IR) of cardiovascular events and the impact of exacerbations on the risk of cardiovascular events within different time periods following an exacerbation.
Methods: COPD patients aged ≥45 years between 01/01/2015 and 12/31/2018 were identified from the Fondazione Ricerca e Salute administrative database. IRs of severe non-fatal and fatal cardiovascular events were
obtained for post-exacerbation time periods (1–7, 8–14, 15–30, 31–180, 181–365 days). Time-dependent Cox
proportional hazard models compared cardiovascular risks between periods with and without exacerbations.
Results: Of 216,864 COPD patients, >55 % were male, mean age was 74 years, frequent comorbidities were
cardiovascular, metabolic and psychiatric.
During an average 34-month follow-up, 69,620 (32 %) patients had ≥1 exacerbation and 46,214 (21 %) experienced ≥1 cardiovascular event. During follow-up, 55,470 patients died; 4,661 were in-hospital cardiovascular-related deaths. Among 10,269 patients experiencing cardiovascular events within 365 days post-exacerbation, the IR was 15.8 per 100 person-years (95 %CI 15.5–16.1).
Estimated hazard ratios (HR) for the cardiovascular event risk associated with periods post-exacerbation were highest within 7 days (HR: 34.3, 95 %CI: 33.1–35.6), especially for heart failure (HR 50.6; 95 %CI 48.6–52.7) and remained elevated throughout 365 days (HR 1.1, 95 %CI 1.02–1.13).
Conclusions: COPD patients in Italy are at high risk of severe cardiovascular events following exacerbations, suggesting the need to prevent exacerbations and possible subsequent cardiovascular events through early interventions and treatment optimization.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Letizia Dondi

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This study received unconditional funding from Astra Zeneca SpA.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable