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Part I – Clinical Question Among the 572 patients in the CAPPP (Male and female patients with treated or untreated primary hyper tension, aged 25–66 years) is Captopril superi or to a diure tic/ß -blocker antih ypert ensive treatment regimen in preventing cardiovascular events in hypertensive diabetic patients, especially in those with metabolic decompensation? Part II – Title of the article Reduced Cardiovascular Morbidity and Mortality in Hypertensive Diabetic Patients on First-line Therapy With an ACE Inhibitor Compared With a Diuretic/Beta-blocker-based Treatment Regimen: A Subanalysis of the Captopril Prevention Project. Leo Niskane n, MD, Thomas Hedner, MD, Lenn art Hansson , MD, Jan Lank e, MD, Ander s Nikl ason, MB and for the CAPPP study group, Department of Medicine, University of Kuopio, Kuopio, Finland Part III - Study Characteristics A. Popula ti on In the CAPPP, 572 (4.9% of 10,985 hypertensive patients) had diabetes at baseline and were studi ed accord ing to a prosp ectiv e, randomized, open, blinde d, end point trial design.Pat ients were treated and followed for an average of 6.1 years. Male and female patients with treated or untreated  primary hypertension, aged 25–66 years, were included if their untreated diastolic blood pressure was 100 mmHg on two different occasions. Patients with secondary hypertension, serum creatinine >150 µmol/l, and indic ations requiri ng ß-blo ckade treatment were exclud ed. Eligi ble patients were randomized to recei ve eithe r a captopril-based regimen or convent ional antihyper tensi ve treat ment (diuretics and/or ß-blockers). B. Int ervent ion compar ed ACE inhibitor –based therapy with convent ional antihype rtens ive thera py that was based on diure tics and/or ß-bloc kers. Comparis on by inter venti on group of diabet ic and nondiabetic patients who remained free from primary end point (fatal or nonfatal stroke, myocardial infarction, or other fatal cardiovascular events) in the CAPPP cohort. Analyses of secondary events showed that total mortality was lower in the captopril than in the conv ent ion al the rapy group all car dia c eve nts (fa tal and nonfat al myo car dia l inf arc tio n, other cardiovascular deaths, and sudden deaths as well as IHD, CHF, and atrial fibrillation) were lower in the captopril than in the conventional therapy. C. Out come moni tore d These 572 patients provided 3,445 patient-years, and only one of them was lost to follow-up. Blood pressure at baseline was similar in the captopril compared with the conventional therapy group. The baseline characteristics were comparable between the two study groups. Blood pressure levels during the study are shown in Fig. 1. If the in-study blood pressure for every diabetic patient is defined as the average of all blood pressure recordings from 12 months onwards, then these in-study  blood pressures were somewhat higher in the captopril than in the conventional group. D. Does the st udy focus on a sign ific ant probl em in clini cal pract ice? Yes indeed, the problem presented by the study focus on how the treatment regimens can affect the conditions of the people included in the study and further to the people who would benefit from

Transcript of ebn_ABC

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Part I – Clinical Question

Among the 572 patients in the CAPPP (Male and female patients with treated or untreated primaryhypertension, aged 25–66 years) is Captopril superior to a diuretic/ß-blocker antihypertensive

treatment regimen in preventing cardiovascular events in hypertensive diabetic patients, especially in

those with metabolic decompensation?

Part II – Title of the article

Reduced Cardiovascular Morbidity and Mortality in Hypertensive Diabetic Patients on First-line

Therapy With an ACE Inhibitor Compared With a Diuretic/Beta-blocker-based Treatment Regimen:A Subanalysis of the Captopril Prevention Project.Leo Niskanen, MD, Thomas Hedner, MD, Lennart Hansson, MD, Jan Lanke, MD, Anders Niklason, MB and for the

CAPPP study group, Department of Medicine, University of Kuopio, Kuopio, Finland

Part III - Study Characteristics

A. PopulationIn the CAPPP, 572 (4.9% of 10,985 hypertensive patients) had diabetes at baseline and were

studied according to a prospective, randomized, open, blinded, end point trial design.Patients were

treated and followed for an average of 6.1 years. Male and female patients with treated or untreated primary hypertension, aged 25–66 years, were included if their untreated diastolic blood pressure

was ≥100 mmHg on two different occasions. Patients with secondary hypertension, serum creatinine

>150 µmol/l, and indications requiring ß-blockade treatment were excluded. Eligible patients wererandomized to receive either a captopril-based regimen or conventional antihypertensive treatment

(diuretics and/or ß-blockers).

B. Intervention compared

ACE inhibitor–based therapy with conventional antihypertensive therapy that was based ondiuretics and/or ß-blockers. Comparison by intervention group of diabetic and nondiabetic patients

who remained free from primary end point (fatal or nonfatal stroke, myocardial infarction, or other fatal cardiovascular events) in the CAPPP cohort.

Analyses of secondary events showed that total mortality was lower in the captopril than in the

conventional therapy group all cardiac events (fatal and nonfatal myocardial infarction, other cardiovascular deaths, and sudden deaths as well as IHD, CHF, and atrial fibrillation) were lower in

the captopril than in the conventional therapy.

C. Outcome monitoredThese 572 patients provided 3,445 patient-years, and only one of them was lost to follow-up.

Blood pressure at baseline was similar in the captopril compared with the conventional therapy

group. The baseline characteristics were comparable between the two study groups. Blood pressurelevels during the study are shown in Fig. 1. If the in-study blood pressure for every diabetic patient isdefined as the average of all blood pressure recordings from 12 months onwards, then these in-study

 blood pressures were somewhat higher in the captopril than in the conventional group.

D. Does the study focus on a significant problem in clinical practice?Yes indeed, the problem presented by the study focus on how the treatment regimens can affect

the conditions of the people included in the study and further to the people who would benefit from

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the study/research itself. It focuses more on the medications given to the subject and how it changes

the conditions of the subject in terms of their blood pressure levels and concerns about diabetes.

Part IV – Methodology/Design

A. Methodology used

Patients were treated and followed for an average of 6.1 years[23]

. Male and female patients withtreated or untreated primary hypertension, aged 25–66 years, were included if their untreated

diastolic blood pressure was ≥100 mmHg on two different occasions. Patients with secondary

hypertension, serum creatinine >150 µmol/l, and indications requiring ß-blockade treatment wereexcluded. Eligible patients were randomized to receive either a captopril-based regimen or 

conventional antihypertensive treatment (diuretics and/or ß-blockers).

The treatment goal was a supine diastolic blood pressure ≤90 mmHg. To reach this goal, the dose

could be increased to 100 mg daily (once or twice daily) in the captopril-treated group; if necessary,a diuretic could be added. In the conventionally treated group, an optimal dose of a ß-blocker or a

diuretic was used. The investigators were free to choose the agents, and in a second step, the diuretic

and the ß-blocker could be combined. As a last step, a calcium-channel blocker could be added in

 both treatment groups.

B. DesignThe CAPPP was conducted at 536 health centers in Sweden and Finland using the PROBE

(Prospective Randomized Open Blinded Endpoint) study design, which has great similarity to

routine clinical practice. Setting

C. Data Sources

Patients were treated and followed for an average of 6.1 years. 10,985 patients in the CAPPP,

there were 309 patients with diabetes in the captopril group and 263 in the conventional therapygroup. These 572 patients provided 3,445 patient-years, and only one of them was lost to follow-

up.

Inclusion Criteria

The inclusion criteria were Male and female patients with treated or untreated primaryhypertension, aged 25–66 years, were included if their untreated diastolic blood pressure was ≥100

mmHg on two different occasions.

Exclusion CriteriaPatients with secondary hypertension, serum creatinine >150 µmol/l, and indications requiring

ß-blockade treatment were excluded.

D. Has the original studies been replicated? No, there is no detail in the article stated that the research has been replicated. There is also no

declared competing interest regarding this study.

Part V – Result of the Study

In diabetic patients, the incidence of the primary end point, fatal and nonfatal myocardial

infarction and stroke as well as other cardiovascular deaths, was significantly lower in the captopril

than in the conventional therapy group (relative risk [RR] = 0.59;  P  = 0.018) (Tables 2 and 3 and

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Fig. 2). When the events comprising the primary end point were analyzed separately, the following

results were obtained: 1) cardiovascular mortality, defined as fatal stroke and myocardial infarction,

sudden death, and other cardiovascular death, tended to be lower in the captopril group (RR = 0.48; P  = 0.084) (Table 2); 2) fatal and nonfatal strokes did not differ between the study groups (RR =

1.02;  P  = 0.959) (Table 2); and 3) fatal and nonfatal myocardial infarctions were markedly less

frequent in the captopril than in the conventional therapy group (RR = 0.34; P 

= 0.002) (Table 2).

Part VI – Author’s conclusion and recommendations

In regard to the effects on cardiovascular morbidity and mortality, the CAPPP study was thefirst intervention trial in hypertensive patients to compare an ACE inhibitor–based therapy with

conventional antihypertensive therapy that was based on diuretics and/or ß-blockers. For the entire

study population, diabetic and nondiabetic subjects combined, both regimens were equally effective

in preventing the primary end point. However, the effects of the two regimens in the diabeticsubpopulation showed a clear difference in the risk of developing a primary end point in favor of a

captopril-based regimen. Importantly, captopril treatment in the diabetic subpopulation reduced fatal

cardiovascular events by about one-half. However, as a subgroup analysis, the data should be

interpreted with caution.In conclusion, analysis of the outcome of the diabetic patient group in the CAPPP showed that the

ACE inhibitor is an obvious first-choice drug for hypertensive patients with diabetes, especiallywhen there is metabolic decompensation. However, because elevated blood pressure levels should be

aggressively treated in diabetic patients, a multiple drug regimen is commonly required to achieve

optimal treatment targets.

Part VII – Applicability

A. Does the study provide a direct enough answer to clinical question in terms of type of patients,intervention and outcome?

• The study has provided a direct enough answer to the clinical question which is that

the captopril treatment in the diabetic subpopulation reduced fatal cardiovascular events

 by about one-half.

B. Is it feasible to carry out the nursing action in the real world?

• The nursing action is not just applicable but also and most likely feasible to carry outin the real world in a way that nurses are always cautious in every medication that they

would give it’s adverse and side effects on the patient.

Part VIII – Reviewer’s conclusions and recommendations

I reviewer, concluded that this research study has answered directly the clinical question. All

the necessary information to prove was provided which are the medications used in the diabetic patients with hypertension. By this knowledge we can implement our interventions effectively

and that we can apply decision making regarding patient rehabilitation progression and

ultimate discharge planning