REMAIN study highlights residual dyslipidaemia in acute coronary syndrome Indian patients

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28 February 2017

The REMAIN Study highlights the unmet clinical need for appropriate management of atherogenic dyslipidaemia in high risk Indian patients.

Jaywant SV, Singh AK, Prabhu MS, Ranjan R. Statin therapy/lipid lowering therapy among Indian adults with first acute coronary event: The dyslipidemia Residual and Mixed Abnormalities IN spite of Statin therapy (REMAINS) study. Indian Heart J 2016;68:646-54.

STUDY SUMMARY

Objective

To evaluate the effect of statin therapy/lipid lowering therapy on the lipid profile in Indian adults after a first acute coronary event.

Study design

Multicentre, observational, prospective cohort study in 19 tertiary care centres in India. The planned study duration was 12 weeks from the onset of first acute coronary event (actual average of 13.5 weeks from onset).

Study population

Patients aged ≥35 years with a confirmed diagnosis of first acute coronary event (STEMI [ST elevation myocardial infarction] or NSTEMI [non-ST elevation myocardial infarction]/unstable angina) who were considered for initiation, maintenance or modification of statin therapy before discharge from hospital.

Key endpoints

Lipid parameters (low-density lipoprotein cholesterol [LDL-C]; high-density lipoprotein cholesterol [HDL-C]; triglycerides)
Adequacy of treatment under statin therapy.

Secondary endpoints

Prevalence of mixed dyslipidaemia, especially elevated triglycerides and/or low HDL-C with or without elevated LDL-C on statin treatment

Methods

Lipid abnormalities were defined by the following criteria:

Elevated LDL-C:

≥RF (risk factors) or cardiovascular disease or diabetes mellitus: LDL-C ≥100 mg/dl (2.6 mmol/L).

≥2 RF: LDL-C ≥130 mg/dl (i.e. 3.3 mmol/L)

<2 RF: LDL-C ≥160 mg/dl (i.e. 4.1 mmol/L)

Elevated triglycerides: ≥ 200 mg/dl (i.e. 2.3 mmol/L)

Low HDL-C: <40 mg/dl (1.0 mmol/L) for men and < 50 mg/dl (1.3 mmol/L) for women.

Atherogenic dyslipidaemia was defined as both low HDL-C and elevated triglycerides. Mixed dyslipidemia was defined as the presence of at least 2 lipid abnormalities.

Results

The study included 635 patients, of whom 474 (80% male, mean age 54.2 years, 29% with diabetes mellitus) completed the study and were evaluated. Almost all (96%) patients were not on a statin at baseline. The majority of patients were treated with moderate-high intensity statin therapy (51% on atorvastatin 40 mg, 31% on atorvastatin 80 mg, 3% on rosuvastatin 20 mg and 2% on rosuvastatin 40 mg).

Statin treatment led to a decrease in the proportion of patients with elevated LDL-C (from 25% at baseline to 6% at end of study), but had no effect on the proportions of patients with elevated triglycerides and/or low HDL-C. Despite statin treatment, 13% of patients had atherogenic dyslipidaemia, with or without elevated LDL-C at the end of the study (Table).

Table. Prevalence of lipid abnormalities at baseline and end of study.

Data are given as n (%).

Lipid abnormality	Baseline	End of study
Elevated LDL-C	118 (25)	27 (6)
Low HDL-C	234 (49)	258 (54)
Elevated triglycerides	83 (18)	81 (17)
Atherogenic dyslipidaemia, LDL-C not elevated	36 (8)	55 (12)
Atherogenic dyslipidaemia + elevated LDL-C	21 (4)	5 (1)
Mixed dyslipidaemia	108 (23)	69 (15)

Conclusion

Although statin therapy is effective in lowering LDL-C, there still remains residual dyslipidaemia, which probably should be tackled with therapeutic and non-therapeutic options.

COMMENT

Much of the evidence that atherogenic dyslipidaemia, the combination of elevated triglycerides and low HDL-C levels, is associated with increased cardiovascular risk is available from studies conducted in Europe and North America, predominantly in white North Caucasian individuals.1-5 However, as shown by the INTERHEART study and other reports, atherogenic dyslipidaemia is more often evident amongst other ethnic groups, notably in South Asia, Africa and the Middle East, largely fuelled by adoption of Westernized diet and lifestyle, as well as cultural factors.6-10

The current study adds to this accumulating evidence. In a large cohort of post MI patients in India, 18% of patients had elevated triglycerides, defined as ≥ 200 mg/dl (2.3 mmol/L), almost half had low HDL-C levels and 12% both lipid abnormalities, with or without elevated LDL-C levels, at baseline. While statin treatment was effective in reducing the proportion of patients with elevated LDL-C levels over a 3-month period (from 25% to 6%), it had no effect on the proportions of patients with these non-LDL lipid abnormalities. Clearly, these data highlight the unmet clinical need to identify and appropriately manage the complete lipid profile, including atherogenic dyslipidaemia, an important contributor to lipid-related residual cardiovascular risk, in high risk patients. This need underpins the mission of the Residual Risk Reduction Initiative, which has made repeated calls for action to address this gap in the therapeutic management of high risk patients.2,11

References

1. Nordestgaard BG, Benn M, Schnohr P et al. Non fasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA 2007;298:299–308.

2. Fruchart JC, Sacks F, Hermans MP et al. The residual risk reduction initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol 2008;102:1K–34K.

3. Carey VJ, Bishop L, Laranjo N, et al. Contribution of high plasma triglycerides and low high-density lipoprotein cholesterol to residual risk of coronary heart disease after establishment of low-density lipoprotein cholesterol control. Am J Cardiol 2010;106:757–63.

4. Assmann G, Cullen P, Schulte H. Non-LDL-related dyslipidemia and coronary risk: a case–control study. Diab Vasc Dis Res 2010;7:204–12.

5. Sacks FM, Carey VJ, Fruchart JC. Combination lipid therapy in type 2 diabetes. N Engl J Med 2010;363:692–5.

6. Guptha S, Gupta R, Deedwania P et al. Cholesterol lipoproteins and prevalence of dyslipidemias in urban Asian Indians: a cross sectional study. Indian Heart J 2014;66:280–8.

7. Raal FJ, Blom DJ, Naidoo S et al. Prevalence of dyslipidaemia in statin-treated patients in South Africa: results of the DYSlipidaemia International Study (DYSIS). Cardiovasc J Afr 2013;24:330-8.

8. Karthikeyan G, Teo K.K., Islam S. Lipid profile, plasma apolipoproteins, and risk of a first myocardial infarction among Asians: an analysis from the INTERHEART study. J Am Coll Cardiol 2009;53:244–53.

9. Al Rasadi K, Almahmeed W, AlHabib KF et al. Dyslipidaemia in the Middle East: Current status and a call for action. Atherosclerosis 2016;252:182-7.

10. Al Sifri SN, Almahmeed W, Azar S et al. Results of the Dyslipidemia International Study (DYSIS)-Middle East: clinical perspective on the prevalence and characteristics of lipid abnormalities in the setting of chronic statin treatment. PLoS One 2014;9(1):e84350.

11. Fruchart J-C, Davignon J, Hermans MP et al. Residual macrovascular risk in 2013: what have we learned? Cardiovasc Diabetol 2014;13:26.

Key words

atherogenic dyslipidaemia; elevated triglycerides; residual cardiovascular risk; South Asians; prevalence; high risk patient