Effect of Two Intensive Statin Regimens on Progression of Coronary Disease
Added on 2023-01-19
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EFFECT OF TWO INTENSIVE
STATIN REGIMENS
ON PROGRESSION OF CORONARY
DISEASE
Presented by
STATIN REGIMENS
ON PROGRESSION OF CORONARY
DISEASE
Presented by
Background information
• Stains results in the reduction of adverse cardiovascular outcomes and also results in slowing down the progression of coronary
atherosclerosis in proportion with the ability of reducing the low density lipoprotein (LDL) ( Stephen J. N, Christie M. B, Philip J. B,
John C, Raimund M. E, Peter L and et.al., 2011)1
• Studies have assesses an ability of intensive statin treatments in order to achieve approaches to administer maximal statin. Satin are the
class of drugs which are normally prescribed by doctors to the patients who are suffering from high level of cholesterol in their blood.
The aim of the study/ The primary hypothesis
To analyse the effect of two intensive statin regimes on progression of coronary disease could decrease the risks of LDL cholesterol leve
in humans.
ÞClinical question of the study : Can Statin treatment help patients in decreasing the cholesterol level in their blood to reduce the hear
attack or stroke and other cardiovascular disease in patients?
The study design
• Randomised, multicentre
• Double-blind trial,
• From January 22, 2008 to June 12, 2009.
• Stains results in the reduction of adverse cardiovascular outcomes and also results in slowing down the progression of coronary
atherosclerosis in proportion with the ability of reducing the low density lipoprotein (LDL) ( Stephen J. N, Christie M. B, Philip J. B,
John C, Raimund M. E, Peter L and et.al., 2011)1
• Studies have assesses an ability of intensive statin treatments in order to achieve approaches to administer maximal statin. Satin are the
class of drugs which are normally prescribed by doctors to the patients who are suffering from high level of cholesterol in their blood.
The aim of the study/ The primary hypothesis
To analyse the effect of two intensive statin regimes on progression of coronary disease could decrease the risks of LDL cholesterol leve
in humans.
ÞClinical question of the study : Can Statin treatment help patients in decreasing the cholesterol level in their blood to reduce the hear
attack or stroke and other cardiovascular disease in patients?
The study design
• Randomised, multicentre
• Double-blind trial,
• From January 22, 2008 to June 12, 2009.
Exclusion/ Inclusion Criteria
Inclusion criteria
• Participants of this research were the patients of 18 to 75 years of age.
• The participants chosen had minimum one vessel with 20 percent of stenosis on clinically indicated coronary angiography. Also, the patients which
were chosen had a target vessel for imaging which was less than 50 percent obstruction.
• Patients which used for the study and who matched to the inclusion criteria have to go under preliminary randomisation through the means of
interactive voice-response system.
• Also, they were randomly assigned within the ratio of 1:1 in order to receive either rosuvastatin at a dose of 20 mg or 40 mg doses of atorvastatin
daily for two weeks in order to ascertain the side effects as well as complaints.
Exclusion criteria
• Some patients which were excluded from the study were the patients which had received very high or intensive lipid lowering therapy and who have
received this therapy for more than three months in a previous year.
• Also, such patients where excluded form the study who had uncontrolled hypertension or had uncontrolled heart failure, or were suffering from renal
infection dysfunction or they were suffering from the liver disease.
• Such were the patients in the study that had been excluded and did not meet the inclusion criteria.
Inclusion criteria
• Participants of this research were the patients of 18 to 75 years of age.
• The participants chosen had minimum one vessel with 20 percent of stenosis on clinically indicated coronary angiography. Also, the patients which
were chosen had a target vessel for imaging which was less than 50 percent obstruction.
• Patients which used for the study and who matched to the inclusion criteria have to go under preliminary randomisation through the means of
interactive voice-response system.
• Also, they were randomly assigned within the ratio of 1:1 in order to receive either rosuvastatin at a dose of 20 mg or 40 mg doses of atorvastatin
daily for two weeks in order to ascertain the side effects as well as complaints.
Exclusion criteria
• Some patients which were excluded from the study were the patients which had received very high or intensive lipid lowering therapy and who have
received this therapy for more than three months in a previous year.
• Also, such patients where excluded form the study who had uncontrolled hypertension or had uncontrolled heart failure, or were suffering from renal
infection dysfunction or they were suffering from the liver disease.
• Such were the patients in the study that had been excluded and did not meet the inclusion criteria.
The additional information for the treatment process
• During the study, patients which had LDL cholesterol level less than 116 mg per decilitre which is almost 3.0 mmol per litre and a triglycerde level of less than 500 mg per decilitre
which is almost 5.6 mmol per litre.
• Such patients again had to undergo through the randomisation with a ratio of 1:1. At this time full time dose treatment of atrovastatin i.e. 80 gm/day or rosuvastatin i.e. 40 gm/per day
was given for 104 weeks.
• The data which was gathered by the academic authors was held and then analysed and after data was analysed effectively decision was made and submitted to manuscript for the
publication.
• All the protocols were followed during the study no confidentiality were breached during the study as coordinating committee and steering committee had confidentiality agreements
with the sponsors.
• A copy of study data base was provided to the coordinating centre and independent analysis was granted also academic authors were given unrestricted for publishing the results that
were gathered from the study.
The sampling method
In order to conduct a research total sample size where n = 1578 patients were selected from 208 centres. Sample size which was selected was randomly assigned for two weeks of
treatment with a half maximal doses of either rosuvastatin or atorvastatin.
Concealed allocation
This procedure was implemented in a randomised control trial in which the individual separating and screening was done is two groups such as atorvastatin and rosuvastatin groups.
This is referred as a kind of consideration which is beyond the blinding the practitioner in order to deliver the care or the patients who are receiving the care during the treatment process.
• During the study, patients which had LDL cholesterol level less than 116 mg per decilitre which is almost 3.0 mmol per litre and a triglycerde level of less than 500 mg per decilitre
which is almost 5.6 mmol per litre.
• Such patients again had to undergo through the randomisation with a ratio of 1:1. At this time full time dose treatment of atrovastatin i.e. 80 gm/day or rosuvastatin i.e. 40 gm/per day
was given for 104 weeks.
• The data which was gathered by the academic authors was held and then analysed and after data was analysed effectively decision was made and submitted to manuscript for the
publication.
• All the protocols were followed during the study no confidentiality were breached during the study as coordinating committee and steering committee had confidentiality agreements
with the sponsors.
• A copy of study data base was provided to the coordinating centre and independent analysis was granted also academic authors were given unrestricted for publishing the results that
were gathered from the study.
The sampling method
In order to conduct a research total sample size where n = 1578 patients were selected from 208 centres. Sample size which was selected was randomly assigned for two weeks of
treatment with a half maximal doses of either rosuvastatin or atorvastatin.
Concealed allocation
This procedure was implemented in a randomised control trial in which the individual separating and screening was done is two groups such as atorvastatin and rosuvastatin groups.
This is referred as a kind of consideration which is beyond the blinding the practitioner in order to deliver the care or the patients who are receiving the care during the treatment process.
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