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Part I – Clinical Question

Among the 572 patients in the CAPPP (Male and female patients with treated or untreated primary
hypertension, 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. Population
In 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 were
randomized 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 on
diuretics 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 monitored
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 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
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 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 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. Design
The 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 therapy
group. 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 primary
hypertension, aged 25–66 years, were included if their untreated diastolic blood pressure was ≥100
mmHg on two different occasions.

Exclusion Criteria
Patients 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
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 the
first 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 diabetic
subpopulation 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, especially
when 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 out
in 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

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