European Journal of Cardiovascular Medicine

Chronic kidney disease (CKD) is one of today's leading public health problems, with increasing frequency and prevalence. According to the Kidney Disease: Improving Global Outcomes (KDIGO), CKD is defined as kidney damage or glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause [1].

According to the Global Burden of Disease study, CKD was ranked as the 12th leading cause of death globally in 2019, resulting in 1.2 million deaths. The prevalence of CKD is estimated to be around 9-13% worldwide, affecting over 700 million people [2]. While many patients with chronic kidney disease (CKD) may eventually have renal failure, the majority will surrender to cardiovascular disease before the need for dialysis since individuals with CKD face an elevated risk of acquiring cardiovascular disease due to several associated risk factors. These risk factors can be both traditional ones such as age, male gender, diabetes, obesity, hypertension, and dyslipidemia and non-traditional uremia-related risk factors such as anaemia, hyperhomocysteinemia, mineral bone disease-CKD with hyperparathyroidism, oxidative stress, hypoalbuminemia, and chronic inflammation [3]. However, a significant portion of the worldwide renal disease burden and its effects on the outcomes of other illnesses remains unquantified; hence, these figures are likely approximate.

CKD results in profound dysregulation of several key enzymes and metabolic pathways that eventually contribute to disordered high-density lipoprotein (HDL) cholesterol and triglyceride-rich lipoproteins [4]. Many epidemiologic studies have suggested the independent role of dyslipidemia on cardiovascular morbidity and mortality in the general population [5]. It contributes to accelerated atherosclerosis and a higher incidence of coronary artery disease due to elevated LDL-C and reduced HDL-C levels. Dyslipidemia often coexists with metabolic abnormalities like insulin resistance and diabetes, further compounding cardiovascular risk. It may also worsen renal function through mechanisms involving glomerular damage and inflammation. These impacts make dyslipidemia a key factor in shaping treatment strategies for individuals with CRF [6].      

In India, CKD has emerged as a significant public health concern with an increasing prevalence and adverse outcomes. A population-based study conducted in 2019 estimated the prevalence of CKD in India to be approximately 17.2%. The study also highlighted the association of CKD with hypertension, diabetes, and rural-urban disparities in CKD prevalence [7].

The prevalence of CKD and its association with cardiovascular complications pose a significant challenge for healthcare systems worldwide, including India. Understanding the current scenario and addressing CKD risk factors and management strategies are crucial for preventing disease progression, reducing morbidity and mortality, and improving the overall health outcomes for affected individuals.

Study Design: This observational, cross-sectional study aims to estimate the prevalence and pattern of dyslipidaemia among pre-dialysis chronic kidney disease (CKD) patients.

Study Setting: The study was conducted from May 2022 to January 2024 at the Department of General Medicine, GMERS Medical College and Hospital, Valsad, Gujarat, India.

Study Participants: The study included 50 adult patients diagnosed with CKD stages 1–5, defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification. All participants were enrolled during the study period. Adults aged 18 years or older with a confirmed diagnosis of chronic kidney disease (CKD) stages 1 to 5 and who had not yet initiated dialysis were included in the study. Exclusion criteria comprised pregnant women, individuals undergoing dialysis or those who had received a kidney transplant, patients receiving lipid-lowering medications, corticosteroids, or immunosuppressive therapy; participants following a lipid-lowering diet; and individuals who did not provide informed consent.

Exposures: The primary exposure variable in this study was the stage of chronic kidney disease (CKD), classified based on the kidney disease: Improving Global Outcomes (KDIGO) guidelines. CKD stages were defined as follows: Stage 1 with a glomerular filtration rate (GFR) ≥ 90 mL/min/1.73 m² accompanied by evidence of kidney damage; Stage 2 with GFR between 60–89 mL/min/1.73 m² and kidney damage; Stage 3 subdivided into 3a (GFR 45–59 mL/min/1.73 m²) and 3b (GFR 30–44 mL/min/1.73 m²); Stage 4 with GFR ranging from 15–29 mL/min/1.73 m²; and Stage 5 indicating kidney failure, with GFR < 15 mL/min/1.73 m².

Outcomes: The primary outcomes assessed in the study included the prevalence of dyslipidemia, which was defined as the presence of any abnormality in the lipid profile, specifically total cholesterol ≥ 200 mg/dL, LDL cholesterol ≥ 100 mg/dL, HDL cholesterol < 40 mg/dL, or triglycerides ≥ 150 mg/dL. In addition, comprehensive lipid profile measurements—including total cholesterol, LDL, HDL, and triglycerides—were obtained for all participants to evaluate lipid abnormalities.

Data Collection: Data were collected using a pre-structured case record form that captured socio-demographic information such as age, gender, occupation, and lifestyle factors; medical history including comorbidities like hypertension and diabetes mellitus; and findings from clinical examination including general physical assessment and vital parameters such as blood pressure, heart rate, and oxygen saturation. Blood samples were obtained following a 12-hour fasting period for lipid profiling, and serum levels of total cholesterol, LDL, HDL, and triglycerides were measured using standard laboratory protocols. Blood was drawn via venepuncture, and serum was separated and stored at -20°C until analysis. All biochemical assays were conducted using automated analysers in the hospital's central laboratory.

Statistical Analysis: The data were analyzed using Epi Info™ CDC version 7. Descriptive statistics were applied to summarise continuous and categorical variables, including mean, standard deviation, and frequency distributions. The association between chronic kidney disease (CKD) stages and lipid abnormalities was evaluated using independent t-tests for continuous variables such as lipid profile parameters, while Chi-square tests were employed for categorical variables, including the prevalence of dyslipidemia. A p-value of less than 0.05 was considered statistically significant.

Ethical Considerations: The Institutional Ethical Committee (IEC) of GMERS Medical College and Hospital, Valsad, approved the study. Written informed consent was obtained from all participants after providing a participant information sheet in their preferred language. Confidentiality of patient information was maintained throughout the study.

This study involved a total of 50 CKD patients. There were 30 male and 20 female participants. Most of the participants, about 50% (n=25), were above 50 years of age, followed by 48% (n=24) in the 31–50 years age group and 2% (n=1) in the 18–30 years group. 56% (n=28) of the patients reported no significant comorbid conditions, whereas 18% (n=9) patients had diabetes mellitus, 16% (n=8) had hypertension, and 10% (n=5) patients had both diabetes and hypertension. On classifying the patients based on KDIGO staging, 24% (n=12) had Stage 4 CKD, and the other 76% (n=38) had Stage 5 CKD. (Table 1)

Table 2 shows the analysis of lipid parameters in pre-dialysis CKD patients. The mean total cholesterol level was 190.18 ± 53.44 mg/dL, with the mean LDL-cholesterol being 95.44 ± 12.68 mg/dL, while the mean HDL-cholesterol level was 41.84 ± 10.10 mg/dL. The mean serum triglyceride level among the study subjects was 113.16 ± 21.88 mg/dL. These findings show that patterns of dyslipidaemia were commonly associated with chronic kidney disease.

Table 1. Characteristics of the Study Subjects

Table 2 Lipid Profile in Pre-Dialysis CKD Patients

Assessing the association between KDIGO staging and lipid parameters among pre-dialysis CKD patients revealed that most patients in Stage 5 CKD had more abnormal lipid profiles than those in Stage 4. The presence of abnormal lipid parameters among patients in Stage 4 versus Stage 5 was elevated total cholesterol (10% vs 90%), elevated LDL-C (5.6% vs 94.4%), elevated triglycerides (9.5% vs. 90.5%) and reduced HDL-C (7.7% vs. 92.3%). The prevalence of abnormal LDL-C and triglyceride levels is significantly associated with advanced CKD stages (p = 0.02 and 0.04, respectively). In contrast, no significant association was observed between advanced CKD stage and abnormal levels of total cholesterol and HDL-C (p = 0.06 and 0.11, respectively). (Table 3)

Table 3: Relation of KDIGO Staging with Lipid Parameters

*p-value calculated using chi-square test

The mean values of Glomerular filtration rate (GFR) and serum creatinine according to stages of CKD are 25.65 ± 8.32 mL/min/1.73m² and 3.43 ± 1.73 mg/dL in Stage 4 and 7.05 ± 2.88 mL/min/1.73m² and 8.58 ± 3.11 mg/dL in Stage 5, respectively. Among the lipid parameters, the prevalence of elevated total cholesterol, elevated LDL-cholesterol and elevated TG was significant with advanced CKD stage (p-value= 0.03, 0.04, 0.04; respectively). Levels of HDL-cholesterol were lower in Stage 5 than Stage 4 but were not statistically significant (p= 0.21). These findings suggest a worsening of lipid profile parameters as CKD progresses.

Table 4 Mean RFT and Lipid Profile parameters with KDIGO Staging

*p-value calculated using chi-square test

Of the 50 CKD subjects, 48% (n=24) had dyslipidaemia. The prevalence of dyslipidaemia was 40% (n=8) in female CKD patients and 53% (n=16) in male CKD patients, but the difference was not statistically significant (p=0.53). Dyslipidaemia was commoner in CKD patients who were of age more than 50 years (64%). There were 33% (n=8) patients in the age group 31-50 years with dyslipidaemia. The association between age group and dyslipidaemia showed statistical significance (p = 0.06), indicating a trend toward increased prevalence of dyslipidaemia with advancing age.

Table 5. Association between dyslipidaemia, gender and age among CKD subjects

*p-value calculated using chi-square test.

The incidence of clinical coronary heart disease among CKD patients is 40%, with cardiovascular disease (CVD) mortality rates being 10 to 30 times higher than those of the general population across similar demographics [8]. CKD patients often present early signs of atherosclerosis, with dyslipidemia identified as a major risk factor for CVD. Significant deviations in lipoprotein metabolism are observed in these patients, potentially leading to severe dyslipidaemia in the disease's later stages. CKD, characterized by the gradual loss of kidney function due to underlying health issues, is a leading cause of death from cardiovascular causes among those with mild-to-moderate stages of the disease as well as end-stage renal disease (ESRD). Projections made by the global health burden of disease epidemiologists forecast that in 2040, CKD will be the 5th disease in rank responsible for death globally [9]. 

The present study aimed to determine the prevalence and pattern of dyslipidemia in pre-dialysis chronic kidney disease (CKD) patients, specifically those in Stages 4 and 5, in a tertiary care hospital in South Gujarat. The motivation behind this investigation lies in the well-established link between CKD and cardiovascular morbidity, with dyslipidemia recognized as a key contributor to this elevated risk.

The study used the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria[10] to define lipid abnormalities. Specific lipid abnormalities included elevated total cholesterol (TC) in 40%, elevated LDL-cholesterol (LDL-C) in 36%, elevated triglycerides (TG) in 42%, and low HDL-cholesterol (HDL-C) in 26% of participants. Notably, the severity and pattern of dyslipidemia showed a clear correlation with the CKD stage. Patients in Stage 5 had significantly higher mean total cholesterol, triglycerides, and LDL-C levels than those in Stage 4. Moreover, the prevalence of overall dyslipidemia, abnormal LDL-C, and elevated triglycerides was significantly greater in Stage 5, indicating a progressive worsening of lipid derangements with declining renal function. These findings support the premise that dyslipidemia intensifies with CKD progression, reinforcing the need for early and aggressive lipid monitoring and management in pre-dialysis patients to reduce cardiovascular complications.

Our study identified a 48% prevalence of dyslipidemia in pre-dialysis CKD patients, which is lower than that reported in various Indian and global studies. Choudhary et al. [11] indicated an 82.6% prevalence, whereas Khade et al. [12] discovered 73.1% among CKD patients. Similarly, Adejumo et al. reported a 60% prevalence in a Nigerian CKD group [13]. However, our findings are still significantly higher than those observed in non-CKD control groups, such as Adejumo's study, which found a 39% prevalence in the control group [13]. This demonstrates that dyslipidemia remains a considerable burden in pre-dialysis CKD, even if prevalence varies by geography. Variations in diagnostic criteria, CKD etiologies, population demographics, dietary trends, and genetic origins might all contribute to these disparities.

Participants in our study had a mean age of 50.02 ± 14.77 years, which indicates that our subject cohort was predominantly within the economically productive age group. This is similar to the average age reported by Rizwan et al. [14]. and slightly lower than that reported by Adejumo et al. [13]. (~47 years). The male predominance (60%) in our cohort is similar to that reported by Verma et al. [15]. (59%) but is less marked than in studies such as Rizwan et al. [14]. (66.9%), indicating some variability in gender distribution across CKD populations. Our population is characterised by significant renal impairment, with a mean GFR of 11.51 ml/min/1.73 m², and a majority of the study participants having Stage 5 CKD (76%). This implies that our results mainly reflect changes in lipid profile in the late stages of pre-dialysis CKD—conversely, studies like those by Adejumo et al. [13]. Stage 3 also had the highest concentration of patients, which might also have affected the described lipid trends and overall prevalence of dyslipidemia.

Serum Total Cholesterol (TC)

In the present study, elevated total cholesterol (TC ≥200 mg/dL) was observed in 40% of participants, with a mean TC of 190.18 ± 53.44 mg/dL. A statistically significant increase was noted between CKD stages, rising from 171.25 mg/dL in Stage 4 to 210.19 mg/dL in Stage 5 (p = 0.03). This prevalence is comparable to Akpan et al. (44%)[16] but lower than the figures reported by Choudhary et al.  [11]. (50.4%). The mean TC in our study aligns closely with the value reported by Bhushan et al. [17]. (195 mg/dL), yet exceeds that of Verma et al. [15]. (137 mg/dL). The moderate prevalence of hypercholesterolemia in our cohort may reflect competing influences such as malnutrition and inflammation, which are common in advanced CKD and can depress serum cholesterol. However, the significant upward trend from Stage 4 to 5 underscores the progressive dysregulation of lipid metabolism as renal function deteriorates.

Serum LDL-Cholesterol (LDL-C)

Elevated LDL-C (≥100 mg/dL) was identified in 36% of the cohort, with a mean LDL-C of 95.44 ± 12.68 mg/dL. A significant rise was observed from 90.88 mg/dL in Stage 4 to 98.92 mg/dL in Stage 5 (p = 0.04), and the prevalence of abnormal LDL-C was significantly higher in Stage 5 (p = 0.02). While this prevalence is lower than that reported by Khade et al. [12]. (59.6%) and Akpan et al. [16]. (48%), it still denotes a significant atherogenic trend. Our mean LDL-C is also lower than the values reported by Bhushan et al. (153 mg/dL). The relatively lower LDL-C levels in our predominantly Stage 5 population could reflect altered hepatic synthesis or increased catabolism due to chronic inflammation. Nonetheless, the statistically significant elevation between CKD stages supports the notion that LDL-C accumulation remains a significant metabolic derangement in end-stage renal disease.

Serum HDL-Cholesterol (HDL-C)

Low HDL-C (<40 mg/dL) was found in 26% of participants, with a mean level of 41.84 ± 10.10 mg/dL. No significant difference was observed in HDL-C between Stage 4 (44.63 mg/dL) and Stage 5 (40.34 mg/dL) (p = 0.21), nor in the prevalence of low HDL-C across stages (p = 0.11). This prevalence is substantially lower than those reported by Choudhary et al. (73.9%)[11] but is comparable to Khade et al. [12]. (34.6%). Our mean HDL-C is marginally higher than the values reported by Bhushan et al. [17]. (38 mg/dL) and similar to those observed by Rizwan et al. [14]. Several studies have noted markedly lower HDL-C levels in dialysis patients, indicating worsening HDL metabolism with advanced disease or dialysis initiation. Despite the relatively modest prevalence of low HDL-C in our cohort, this parameter remains clinically relevant due to its central role in reverse cholesterol transport. The lack of significant decline from Stage 4 to 5 may be due to a limited Stage 4 sample size or other confounding influences. However, qualitative dysfunction of HDL is likely present regardless of concentration, driven by reduced ApoA-I/A-II, impaired LCAT activity, and increased CETP-mediated exchange.

Serum Triglycerides (TG)

Elevated triglycerides (TG ≥150 mg/dL) were observed in 42% of patients, with a mean TG of 113.16 ± 21.88 mg/dL. Mean TG significantly increased from 106.13 mg/dL in Stage 4 to 119.84 mg/dL in Stage 5 (p = 0.04), with a considerably higher prevalence of hypertriglyceridemia in Stage 5 (p = 0.04). This prevalence is lower than reported by Choudhary et al. (67%) yet comparable to Khade et al. (36.5%)[12] and notably higher than Akpan et al. (26%)[16]. Our mean TG level is markedly lower than those reported by Bhushan et al. (206 mg/dL)[17] and Verma et al. (161 mg/dL)[15]. Our cohort's relatively modest TG levels could reflect regional dietary habits, genetic influences, or reduced hepatic production in some patients with malnutrition or chronic inflammation. Nonetheless, the significant increase in TG from Stage 4 to Stage 5 supports its role as a progressively worsening atherogenic marker in CKD. Prior studies, including Zhang et al. [19]., have identified TG as a key predictor of CKD risk and shown a negative correlation with eGFR, reinforcing the biological plausibility of our findings. Elevated TG in CKD is attributed mainly to reduced LPL activity and impaired catabolism of VLDL, particularly under the influence of uremic toxins and insulin resistance [6][18].

STRENGTHS AND LIMITATIONS

We provide this region-specific, globally unique data on the prevalence of dyslipidemia, comparing Stage 4 and Stage 5 CKD cases in South Gujarat advanced pre-dialysis CKD patients. KDIGO classification and laboratory techniques were conventional. However, there are significant limitations to recognize. The study's cross-sectional nature limits the determination of causation or the monitoring of lipid evolution over time. The total sample (N=50) is small, and the limited number of subjects in Stage 4 (n=12) restricts the power and generalizability of the stage comparison. Thus, the overwhelming dominance of Stage 5 patients (76%) in our cohort means our findings predominantly describe very advanced CKD and cannot be easily generalized to earlier stages or truly reflect the population prevalence of the overall CKD population. The fact that this is a single-centre study with purposive sampling also limits representativeness. We also did not measure advanced lipid markers such as ApoB, ApoA-I, or Lp(a), which may allow further risk stratification.

CLINICAL IMPLICATIONS AND FUTURE DIRECTIONS

Our study emphasizes the need for early identification and control of dyslipidemia in CKD, even in the pre-dialysis phase. The debate about the utility of statins in end-stage renal disease endpoint continues. However, abundant data supports the beneficial effect of statin therapy on CKD as a whole, especially at earlier stages (i.e., Stages 3–4), particularly in the setting of additional CV risk factors. Our findings indicate that lipids should be routinely monitored and managed in patients with CKD, targeting specifically triglycerides and HDL-C rather than LDL-C alone. As shown, these abnormalities are atherogenic, so early interventions focused on lifestyle modification, glycemic control, and pharmacologic therapy should be started.

In conclusion, this study reveals that dyslipidemia is highly prevalent (48%) among pre-dialysis CKD patients, predominantly in Stage 5, within a tertiary care hospital in South Gujarat. The lipid profile, particularly TC, LDL-C, and TG, significantly deteriorates as CKD progresses from Stage 4 to Stage 5. These findings highlight the substantial cardiovascular risk burden in advanced CKD and emphasize the necessity for diligent lipid profile monitoring and management to mitigate cardiovascular complications in this vulnerable population.

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