Cardiac Nursing: Analysis of Intensive Therapy for Type 2 Diabetes CVD

This essay critically evaluates a study on intensive therapy for type 2 diabetes mellitus with microalbuminuria, focusing on its impact on cardiovascular outcomes and overall lifespan. It discusses the methodology of the randomized controlled trial, highlighting its strengths and limitations. The essay analyzes the study's results, which demonstrate the benefits of intensive therapy in reducing cardiovascular events, mortality, and microvascular complications. It also considers the implications for cardiac nursing care, emphasizing the role of nurses in managing type 2 diabetes-related cardiac complications through CVD risk management education. The essay concludes by suggesting areas for future research, particularly focusing on the long-term side effects of intensive therapy.

Running head: CARDIAC NURSING
Cardiac nursing
Name of the Student
Name of the University
Author note

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Background and main theme: Type 2 DM is a complex disorder that gives rise to major
complications in the long duration like hypertension, increased aggregation of platelets,
microvascular damage and reduction in life expectancy (Inzucchi et al. 2015). Risk for
cardiovascular disease (CVD) is greatly increased in patients with type 2 diabetes playing an
important role in beginning of atherosclerosis (Look AHEAD Research Group 2013). Moreover,
diabetic vascular disease is responsible for coronary artery disease (CAD), stroke and risk of
heart failure. Although, many interventions and trial studies were performed earlier to
recommend for multi-factorial treatment of type 2 DM, however, this disease still remains a
major cause for mortality. In a study conducted by Harrison et al. (2014) the efficacy of intensive
therapy was assessed in patients with type 2 DM. The results showed that after 6 year-study,
there was treatment failure with high fasting glucose, systolic blood pressure and lower
sensitivity to inclusion. Until recently, Gæde et al. (2016) conducted an original intervention of
follow-up, randomized control trial of intensive therapy as compared to conventional treatment
in patients with microalbuminuria and type 2 diabetes for 7.8 years. The author was aimed at
studying the potential of long-term, multi-factorial and intensified intervention in addressing the
median differences in patients’ lifespan without or with cardiovascular events, which is
considered a major risk in patients with type 2 diabetes and microalbuminuria. Intensive therapy
(both pharmacological and behavioural approaches) is the main strategy that is discussed in the
paper. The author hypothesized that intensive therapy would help in terms of gained disease free
years of life from the cardiovascular events as major complications in patients with type 2 DM
and microalbuminuria. The term “gained years of life” was emphasized in context to decrease in
life expectancy among patients with type 2 DM and microalbuminuria.

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Methodology: Gæde et al. (2016) adopted randomized controlled trial study design for
their study. Patients were randomized 1:1 that were stratified in blocks by age, sex, urinary
albumin excretion rate and diabetes duration using sealed envelopes (<100 mg/day vs >100
mg/day) in receiving conventional multi-factorial treatment at all times adhered to intensified
treatment or national guidelines that targets co-existing risk factors for later diabetes-related
complications. About eighty patients were assigned to each group with implementation of both
pharmacological and behavioural treatment followed by structural approach. Six study visits
were completed at Steno Diabetes Centre at an average of 1.9, 3.8, 7.8 and 13.3 years, terminated
after 21.2 years. Out of 160 patients, 120 patients completed the interventional study with
follow-up investigations initiated for investigating differences in median time. Three endpoints
were considered for the study. Between the two treatment groups, the difference was studied
after randomization with or without CVD. Secondary endpoint was cardiovascular events rate,
mortality, and diabetic neuropathy events as tertiary endpoints.
Intention-to-treat principle was used for statistical analysis for both groups of patients.
The randomized control trial (RCT) method was advantageous for the study as it aided in
comparing the intensive therapy directly to conventional therapy for establishing superiority.
This methodology is helpful in making causal differences and gives strongest empirical evidence
for study efficacy of a treatment (McCusker and Gunaydin 2015). It greatly minimized selection
bias and considered a gold standard method. In this study, the author allocated European descent,
Danish patients with microalbuminuria and type 2 DM randomly in receiving intensive, multi-
factorial intervention as compared to conventional diabetic treatment. It also helped to seek in
measuring and comparing the intervention outcome after the patients received the treatment.

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However, RCT has certain limitations. The long trial running time may have resulted in loss of
relevance and block randomization used may have resulted in selection bias (Nardi 2018).
Results: 42 and 24 patients in original intensive and original conventional-therapy group
respectively completed the entire period of follow-up and median observation time was
calculated to be 21.2 years after follow-up completion ranging from 20.2-21.9 years. After the
follow-up, the observed mean time for first CVD event or death in conventional-therapy was 8
years as compared to 16.1 years among patients in intensive-therapy group (95% CI 4.0, 12.6
years). After overall adjustment, mortality rate was reduced by 45% and 21% absolute risk
reduction in intensive-therapy group during the entire follow-up period. Moreover, the results
also depicted that death reported from cardiovascular causes reduced by 62% among patients
who received original intensive-therapy. Cardiovascular events were also studied and it was
found that about 35 patients experienced CV event as compared to 51 patients who were in
conventional therapy group. This result corresponds to the fact that there was RR reduction by
51% and absolute risk reduction rate by 20% between the two groups. This result illustrated that
there was reduced mortality due to reduction in CVD risk (Gæde et al. 2016).
Microvascular complications and its progression were also studied by sensitivity analysis
and it was found that retinopathy progression decreased by 33% among patients in intensive-
therapy group. There was reduction in blindness in one eye with 95% CI 0.23, 0.98, p =0.044 or
HR of 0.47. Macroalbuminuria and autonomic neuropathy also reduced by 48% and 41%
respectively in intensive-therapy group.
The results also depicted that there was reduction in mortality rates as there was
decreased CVD incidence rates and related mortality among patients in the original intensive-

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therapy group. For all endpoints, RR reductions and absolute risk were in line that corresponded
with previous findings confirming the fact that original intensive-therapy for type 2 DM and
microalbuminuria was durable, multi-factorial, and intensified. Moreover, in the Steno-2 study,
although, there were high progression rates for microvascular complications, yet there was
significant and relevant risk reduction for neuropathy, retinopathy and nephropathy, blindness
with reduction in risk for renal disease at end stage. The author accepted the initial hypothesis
that CVD events and related risk could be reduced with intensive-therapy in patients with type 2
DM and microalbuminuria as compared to single-risk-factor interventions trials that were
performed earlier (Gæde et al. 2016).
Conclusions/Recommendations: From the results, the author concluded that multi-
factorial, intensified treatment of type 2 DM with microalbuminuria was found to be 7.8 years as
compared to patients who received conventional treatment. There was increase in length of
median life by 7.9 years, 21.2 years of entire follow-up and there was increase in matching of
gained years and free from cardiovascular complications in patients with microalbuminuria and
type 2 DM. Moreover, this approach of original intensive-therapy was of great significance in
controlling risk factors and complications of type 2 DM. This therapy was broadly implemented
as per clinical guidelines and the findings led to more focus on the preventative effects of the
disease (Nathan 2015).
The early intervention concept in patients at low risk has proven to be quite beneficial for
the combined blood pressure and lipid treatment at intermediate risk, without the CVD risk. The
Steno-2 study in the study is robust as the endpoints data were considered complete as the
relevant data were of high quality. Moreover, the concomitant treating of multiple risk factors
was found to be of profound importance that was supported by previous findings in the paper.

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The study design that was employed for the study resembled real life situation and researchers
had no direct influences on lifestyle or medicine compliance of the participants.
In trials that involves beneficial and long-term effects are termed as “legacy effect” or
“metabolic memory” and in such studies, at the end of trial, protocol was stopped and subsequent
risk factor control was not reported or relaxed. However, in this Steno-2 study, the patients
continued with the original intensive-therapy and treatment goals and patients in group of
conventional therapy started with the same treatment goals of intensified therapy during the
follow-up period. The study also interpreted that continuous benefits that was witnessed in the
trial was a direct consequence of intensification during the early intervention in low absolute risk
patients for diabetic complications. This is compared to a situation where increase in vascular
damage is already established with intensification in later stages of disorder (Gæde et al. 2016).
Cardiac nursing care: Within the clinical context, original intensive therapy is
significant to cardiac nursing care as it is beneficial in reducing the risk of neurologic and
microvascular complications of type 1 DM and microalbuminuria. This therapy is significant as
compared to conventional therapy for reducing the risk of long-term incidence of CVD events
associated with type 2 DM. This therapy can be helpful for cardiac nurses to reduce conditions of
CVD that are associated with long-term complications in type 2 DM through CVD risk
management education. The cardiac nurse can play a vital role in better management of type 2
DM cardiac complications and in reducing the risk of CVD events in patients through original
intensified therapy (Gæde et al. 2016).
Future studies: Until recently, there are side effects that are reported in long-term use of
intensive therapy in patients with type 2 DM. There is also prevalence of severe hypoglycaemic

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conditions in patients with targeted treatment for HbA1c (García-Pérez et al. 2013). There is need
for future studies to study the side effects of long-term use of this therapy to decrease mortality
and severe CVD events. Still, patients with type 2 DM undergoing intensive therapy have
increased risk for mortality. Therefore, there is a need for further studies to understand the
efficacy of this therapy in reducing cardiac related complications in patients associated with type
2 DM.

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References
Gæde, P., Oellgaard, J., Carstensen, B., Rossing, P., Lund-Andersen, H., Parving, H.H. and
Pedersen, O., 2016. Years of life gained by multifactorial intervention in patients with type 2
diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised
trial. Diabetologia, 59(11), pp.2298-2307.
García-Pérez, L.E., Álvarez, M., Dilla, T., Gil-Guillén, V. and Orozco-Beltrán, D., 2013.
Adherence to therapies in patients with type 2 diabetes. Diabetes Therapy, 4(2), pp.175-194.
Harrison, L.B., Adams-Huet, B., Li, X., Raskin, P. and Lingvay, I., 2014. Intensive therapy in
newly diagnosed type 2 diabetes: results of a 6-year randomized trial. Journal of Investigative
Medicine, 62(4), pp.676-686.
Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., Diamant, M., Ferrannini, E., Nauck, M., Peters,
A.L., Tsapas, A., Wender, R. and Matthews, D.R., 2015. Management of hyperglycemia in type
2 diabetes, 2015: a patient-centered approach: update to a position statement of the American
Diabetes Association and the European Association for the Study of Diabetes. Diabetes
care, 38(1), pp.140-149.
Look AHEAD Research Group, 2013. Cardiovascular effects of intensive lifestyle intervention
in type 2 diabetes. New England journal of medicine, 369(2), pp.145-154.
McCusker, K. and Gunaydin, S., 2015. Research using qualitative, quantitative or mixed
methods and choice based on the research. Perfusion, 30(7), pp.537-542.
Nardi, P.M., 2018. Doing survey research: A guide to quantitative methods. Routledge.

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Nathan, D.M., 2015. Diabetes: advances in diagnosis and treatment. Jama, 314(10), pp.1052-
1062.