Clinical Trial Summary
Statins are part of one of the largest groups of drugs prescribed worldwide used in the
treatment of dyslipidemia. Despite the good therapeutic results of statins and their good
tolerance on the part of patients, some adverse effects may occur during treatment. In
skeletal muscle, statins can lead to mitochondrial dysfunction characterized by decreased
adenosine triphosphate production, decreased oxidative phosphorylation capacity, increased
concentration of reactive oxygen species, and decreased mitochondrial biogenesis.
Cardiorespiratory fitness is a physiological indicator that corresponds to the integration of
the cardiovascular, pulmonary, muscular, and cellular (mitochondria) systems in capturing,
transporting and using oxygen, commonly expressed as the maximum oxygen consumption. Several
studies show a strong association of lower cardiorespiratory capacity with an increased risk
of mortality from cardiovascular disease and mortality from all causes.
Combining the use of statins with lifestyle changes has been suggested in many medical
guidelines. Physical exercise plays a fundamental role in improving cardiorespiratory fitness
and controlling dyslipidemia. However, some studies suggest that the association of statin
with physical training can negatively influence the adaptation and improvement of
cardiorespiratory capacity. On the other hand, some studies show that the combination of
statin and physical exercise does not negatively interfere with the maximum oxygen
consumption.
To determine the impact of statins on cardiorespiratory fitness and adaptation to physical
exercise, the investigators will use the database of the Cardiovascular Rehabilitation and
Exercise Physiology Department at Heart Institute (Sao Paulo, Brazil), which currently has
33,804 maximal cardiopulmonary exercise tests. This large database, which is the gold
standard of cardiorespiratory capacity (maximum oxygen consumption), will be used
retrospectively with relevant information and a huge number of participants.
Therefore, the aim of this study will be to explore a large database to assess the effect of
the use of statins and their relationship with cardiorespiratory capacity in physically
active and sedentary individuals (with and without heart failure).
The investigators will use the database of the Cardiovascular Rehabilitation and Exercise
Physiology Department at Heart Institute (Sao Paulo, Brazil) in an exploratory manner. The
investigators will use filters to perform different analyzes and sub-analyses with different
groups of patients. The investigators aimed to compare patients using statins and healthy
controls (not using medications). The analysis strategy will be as following: 1) physically
active and sedentary patients with normal cardiac function using statins and peak oxygen
consumption (peak VO2); 2) physically active and sedentary patients with cardiac dysfunction
(heart failure) using statins and peak VO2; 3) comparison between the hydrophilic and
lipophilic classes of statins; 4) comparison between men and women; 5) retrospective
information on clinical and laboratory variables and 6) test information on cardiorespiratory
capacity and several variables associated with the mortality outcome.
The participants underwent cardiopulmonary exercise testing on a treadmill or bike
(SensorMedics - Vmax Analyzer Assembly, Encore 29S) following a ramp protocol with constant
load increase until exhaustion. Cardiorespiratory capacity will be determined by peak VO2,
assessed at maximum exercise intensity, with a respiratory exchange ratio >1.10.
