Impact on carotid intima-media thickness after laparoscopic sleeve gastrectomy in patients with morbid obesity.

BACKGROUND: We aimed to investigate the impact of laparoscopic sleeve gastrectomy (LSG) on carotid intima-media thickness (CIMT) & left ventricular dysfunction (LVD) which are the independent predictors of subclinical atherosclerosis. METHODS: To assess the change in CIMT & echocardiographic parameters of left ventricular function & correlate with %EWL 6 months and 12 months after LSG, the mean CIMT of bilateral common carotid arteries were measured at 3 different places & 7 parameters were assessed for left ventricular dysfunction after 6 and 12 months of LSG & correlated with the %EWL. RESULTS: A total of 30 patients (27(90%) women & 3(10%) men) with the mean age of 38 ± 7.84 were prospectively enrolled. BMI was significantly reduced from 42.66 ± 3.79 to 37.93 ± 3.60 kg/m2 at six months to 36 ± 3.34 at 12 months after LSG. CIMT values were significantly decreased at 6 months after surgery from 0.50 ± 0.11 mm to 0.46 ± 0.09 mm (p < 0.01) to 0.39 ± 0.07 (p < 0.05) at 12 months. However, no significant change was observed in the right mean CCA values at 6 months after surgery 0.50 ± 0.11 mm vs 0.47 ± 0.09 mm (p = 0.07) as compared to decrease at 12 months after surgery to 0.40 ± 0.08 (p < 0.05). Left mean CCA values at 6 months changed from 0.50 ± 0.11 to 0.45 ± 0.09 (p < 0.01) and at 12 months after surgery to 0.39 ± 007(p < 0.05). On 2D ECHO, ejection fraction increased at 6 months from 60.80 ± 5.89 to 61.93 ± 4.47 (p < 0.5) to after 12 months at 64.30 ± 4.20 (p < 0.05). Wave deceleration time changed at 6 months from 170 ± 36.80 to 150 ± 28.82 (p < 0.05) to 12 months 139.07 ± 17.98 (p < 0.05). Peak early diastolic mitral annular velocity (e) changed at 6 months from 8.12 ± 1.66 to 7.02 ± 1.76 (p < 0.05) to 12 months 6.33 ± 0.76 (p < 0.05). Inter-ventricular septum thickness (IVSD) changed at 6 months from 0.99 ± 0.14 to 0.91 ± 0.14 (p < 0.05) to 12 months 0.82 ± 0.09 (p < 0.05). Intraventricular relaxation time (IVRT) at 6 months changed from 94.33 ± 21.71 to 84.36 ± 14.85 (p < 0.03) to 12 months after surgery 77.40 ± 10.19 (p < 0.05). Left atrial volume index (LAVI) at 6 months decreased from 38.08 ± 11.23 to 30.93 ± 7.16 (p < 0.01) to 12 months after surgery 25.43 ± 3.65 (p < 0.05). Left ventricular diastolic dysfunction [LVIDD] at 6 months changed from 4.32 ± 0.52 to 4.11 ± 0.52 (p < 0.02) to 3.94 ± 0.26 (p < 0.05) to 3.94 ± 0.26 (p < 0.05) at 12 months after surgery. PwD at 6 and 12 months changed from 1.00 ± 0.19 to 0.87 ± 0.10 (p < 0.01) to 0.82 ± 0.08 (p < 0.05) respectively. LV mass changed in 6 months from 148.37 ± 33.09 to 117 ± 29.90 (p < 0.001) to 12 months at 110.64 ± 20.79 (p < 0.05) and left ventricular mass index [LVMI] changed in 6 months from 70 ± 16.89 to 59.626 ± 15.35 (p < 0.001) reaching a value of 57.53 ± 11.18 (p < 0.05) at 12 months. The mean 10-year risk of death due to CVD calculated was significantly reduced from 5.45 ± 6.6 to 2.8 ± 1.7% at 6 months (p < 0.05). This significant decrease in CVD risk has a positive correlation with the decrease in CIMT over 6 months showing a correlation coefficient of 0.018 with statistically significant analysis (p value < 0.05). CONCLUSION: We observed a significant reduction in CIMT & improvement in 2D ECHO parameters at 6 after LSG although no statistically significant change was observed in mean right CIMT & EF at 6 months.

Correction: Self-reported Morisky Eight-item Medication Adherence Scale for Statins Concords with the Pill Count Method and Correlates with Serum Lipid Profile Parameters and Serum HMGCoA Reductase Levels.

[This corrects the article DOI: 10.7759/cureus.6542.].

Management of diabetic dyslipidemia in Indians: Expert consensus statement from the Lipid Association of India.

In 2021 an estimated 74 million individuals had diabetes in India, almost all type 2 diabetes. More than half of patients with diabetes are estimated to be undiagnosed and more 90% have dyslipidemia that is associated with accelerated development of atherosclerotic cardiovascular disease (ASCVD). Patients of Indian descent with diabetes have multiple features that distinguish them from patients with diabetes in Western populations. These include characteristics such as earlier age of onset, higher frequency of features of the metabolic syndrome, more prevalent risk factors for ASCVD, and more aggressive course of ASCVD complications. In light of the unique features of diabetes and diabetic dyslipidemia in individuals of Indian descent, the Lipid Association of India developed this expert consensus statement to provide guidance for management of diabetic dyslipidemia in this very high risk population. The recommendations contained herein are the outgrowth of a series of 165 webinars conducted by the Lipid Association of India across the country from May 2020 to July 2021, involving 155 experts in endocrinology and cardiology and an additional 2880 physicians.

Association of statin induced reduction in serum coenzyme Q10 level and conduction deficits in motor and sensory nerves: An observational cross-sectional study.

OBJECTIVE: The reduction of Coenzyme Q10 (CoQ10) levels following statin use has been linked to cause peripheral neuropathy. Hence, this study was planned to explore the effect of statin on the serum HMGCR (3-hydroxy-3-methyl-glutaryl-coenzyme A reductase), serum CoQ10 levels and nerve conduction and their correlation. PATIENTS AND METHODS: In an open labelled, cross-sectional, observational study, estimation of serum HMGCR and CoQ10 levels was performed in 50 atorvastatin/rosuvastatin users and 50 normal healthy volunteers (NHV). Statin users were also subjected to nerve conduction studies (NCS). RESULTS: Mean serum HMGCR level in NHV was higher (73.58 ± 7.64 ng/ml; p = 0.003) than that in statin users (49.11 ± 1.98 ng/ml). Similarly, mean serum CoQ10 levels was also lower (30.54 ± 2.03 ng/ml, p < 0.0001) in statin users than in NHV (49.43 ± 3.23 ng/ml). Amongst the 50 statin users, 29 had impaired NCS in sural, tibial and common peroneal nerve with lower mean serum CoQ10 levels (24.05 ± 1.96 ng/ml; p < 0.0001). Significant negative correlation was observed between onset time of action potential (AP) of the sural nerve and serum CoQ10 (r=-0.32) and HMGCR (r=-0.43) levels. There was significant positive correlation of conduction velocity of sural (r = 0.38) and tibial (r = 0.31) nerves with serum CoQ10 level. While conduction velocity in sural (r = 0.37) and common peroneal (r = 0.34) nerves positively correlated with serum HMGCR levels. The amplitude of the AP of the common peroneal nerve positively correlated with both serum CoQ10 (r = 0.52) and HMGCR (r = 0.46) levels. CONCLUSION: Statin users had lower serum CoQ10 and HMGCR levels associated with nerve conduction deficits suggesting a role of CoQ10 in the occurrence of the neurological adverse effects.

Exploring the role of adipsin in statin-induced glucose intolerance: a prospective open label study.

Background Evidence from the literature, highlights the increased risk of developing glucose intolerance and type 2 diabetes mellitus (T2DM) with statin therapy. In addition, few animal studies demonstrate that adipsin secreted from adipocytes plays a crucial role in insulin secretion and the development of T2DM. Methods To further explore the role of serum adipsin, in this prospective open label study, 55 newly diagnosed dyslipidemic patients were enrolled. Before starting statin therapy, liver function test (LFT), kidney function test (KFT), lipid profile, glycemic parameters [glycated hemoglobin A (HbA1c), fasting blood sugar (FBS), and postprandial blood sugar (PPBS)], serum insulin, and serum adipsin were estimated. Then these patients were prescribed statin (i.e. atorvastatin, rosuvastatin, or pitavastatin) and after 12 weeks of therapy, all the above investigations were repeated. Results After 12 weeks of statin therapy, the LFT and KFT values remained unchanged and lipid parameters showed significant improvement. But the glycemic parameters deranged significantly (p < 0.001), i.e. FBS, PPBS, and HbA1c increased by 12.49% (102.99 ± 20.76 mg/dL), 24.72% (147.71 ± 47.29 mg/dL), and 21.43% (6.38 ± 1.34%), respectively. On the other hand, the baseline adipsin (2.73 ± 1.99 ng/mL) and insulin (16.13 ± 12.50 mIU/L) levels reduced significantly (p < 0.0001) to 1.43 ±1.13 ng/mL and 6.91 ± 5.93 mIU/L, respectively. The reduction in serum adipsin also showed a positive correlation with reduction in serum insulin (r = 0.85; p < 0.0001). None of the patients experienced any significant adverse effect or reaction leading to discontinuation of therapy. Conclusions There might be an association between reduction in adipsin and development of glucose intolerance by statin therapy.

Proposed low-density lipoprotein cholesterol goals for secondary prevention and familial hypercholesterolemia in India with focus on PCSK9 inhibitor monoclonal antibodies: Expert consensus statement from Lipid Association of India.

BACKGROUND: Rates of atherosclerotic cardiovascular disease (ASCVD) are strikingly high in India compared to Western countries and are increasing. Moreover, ASCVD events occur at a younger age with only modest hypercholesterolemia, most commonly with low levels of high-density lipoprotein cholesterol. The course of ASCVD also appears to be more fulminant with higher mortality. OBJECTIVE: In light of these issues, the Lipid Association of India (LAI) endeavored to develop revised guidelines with more aggressive low-density lipoprotein cholesterol (LDL-C) goals in secondary prevention and for patients with familial hypercholesterolemia compared to guidelines in the United States and other countries. METHODS: Owing to the paucity of clinical outcomes data in India, it was necessary to place major emphasis on expert opinion as a complement to randomized placebo-controlled data generated mostly in non-Indian cohorts. To facilitate this process, the LAI conducted a series of 19 meetings among 162 lipid specialists in 13 cities throughout India over a period of 11 months before formulating this expert consensus statement. RESULTS: The LAI recommends an LDL-C goal <50 mg/dL in all patients in secondary prevention or very high-risk primary prevention but proposes an optional goal ≤30 mg/dL in category A extreme-risk patients (eg, coronary artery disease + familial hypercholesterolemia) and a recommended goal ≤30 mg/dL in category B extreme-risk patients [coronary artery disease + (1) diabetes and polyvascular disease/≥3 major ASCVD risk factors/end organ damage, or (2) recurrent acute coronary syndrome within 12 months despite LDL-C <50 mg/dL, or (3) homozygous familial hypercholesterolemia]. CONCLUSIONS: More aggressive LDL-C goals are needed for prevention of ASCVD in India, as described in this expert consensus statement. Use of statins and ezetimibe needs to increase in India in combination with improved control of other ASCVD risk factors. Proprotein convertase subtilisin kexin type 9 inhibitors can improve LDL-C goal achievement in patients with refractory hypercholesterolemia.

Self-reported Morisky Eight-item Medication Adherence Scale for Statins Concords with the Pill Count Method and Correlates with Serum Lipid Profile Parameters and Serum HMGCoA Reductase Levels.

Background It is imperative that non-compliance with statins be identified and addressed to maximize their clinical benefits. Patient self-reporting methods are convenient to apply in clinical practice but need to be validated. Objective We studied the concordance of a patient self-report method, Morisky eight-item medication adherence scale (MMAS)), with the pill count method in measuring adherence with statins and their correlation with extended lipid profile parameters and serum hydroxyl-methylglutaryl coenzyme A reductase (HMGCoA-R) enzyme levels. Methods MMAS and the pill count method were used to measure the adherence with statins in patients on statins for any duration. Patients were subjected to an estimation of extended lipid profile and serum HMGCoA-R levels at the end of three months follow-up. Results Out of a total of 200 patients included in the study, 117 patients had a low adherence (score less than 6 on MMAS) whereas 65 and 18 patients had medium (score 6 or 7) and high adherence (score of 8), respectively. The majority of patients who had low adherence to statins by MMAS were nonadherent by the pill count method yielding a concordance of 96.5%. Medium or high adherence to statins by the MMAS method had a concordance of 89.1% with the pill count method. The levels of total cholesterol, low-density lipoprotein-cholesterol, apolipoprotein B, and HMGCoA-R were negatively correlated with compliance measured by pill count and MMAS in a statistically significant way and with similar correlation coefficients. HMGCoA-R levels demonstrated a plateau phenomenon, with levels being 9-10 ng/ml when compliance with statin therapy was greater than 60% by pill count and greater than 6 on the Morisky scale. Conclusion In conclusion, MMAS and the pill count method showed concordance in measuring adherence to statins. These methods need to be explored further for their interchangeability as surrogates for biomarker levels.

Randomized controlled trial comparing the efficacy of daily and every other day atorvastatin therapy and its correlation with serum hydroxymethylglutaryl-CoA reductase enzyme levels in naïve dyslipidemic patients.

OBJECTIVE: Data regarding efficacy comparison of daily regimen (DR) versus every other day regimen (EODR) atorvastatin therapy is not validated by estimation of serum hydroxymethylglutaryl-CoA reductase (HMGCR) levels and HMGCR correlation with lipid indices. METHODS: In this randomized controlled trial, we compared the efficacy of DR versus EODR by measuring lipid indices and serum HMGCR levels at baseline and after 12 weeks of 10 mg atorvastatin therapy. Primary endpoint was comparison of mean change in serum HMGCR levels and lipid indices of both groups and their correlation with each other. Secondary endpoints were assessed by estimating serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatine kinase MM (CK-MM) levels and adverse drug reactions (ADRs). RESULTS: A total of 61 patients were enrolled of which 46 completed the study (24 in DR vs 22 in EODR group). The mean reduction in total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C) and non-high density lipoprotein-cholesterol (HDL-C) was significantly higher in DR group, whereas mean reduction in triglycerides (TG) and increase in HDL-C was similar in both the groups. Reduction in serum HMGCR levels was comparable in both the groups (31.17% vs 28.19%). Change in serum HMGCR levels correlated more with change in lipid indices of DR group. Also, safety parameters were similar between the two groups. CONCLUSION: Both the regimens achieved therapeutic goals, however DR was found to be superior as it achieved greater reduction in TC and LDL-C. Further, these findings are substantiated by correlation of lipid indices with serum HMGCR levels.

Correlation of compliance to statin therapy with lipid profile and serum HMGCoA reductase levels in dyslipidemic patients.

BACKGROUND: The efficacy of statin therapy may be lost or vary with reduction in compliance and intensity of statin therapy. OBJECTIVE: To study and correlate the quantitative effect of compliance on lipid profile and 3-hydroxyl-3-methylglutaryl coenzyme A reductase (HMGCoA-R) levels in dyslipidemic patients. METHODS: Compliance to different intensity of statin therapy assessed by pill count was correlated with serum levels of total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (TG), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and HMGCoA-R. RESULTS: Out of 200 patients, 160 received moderate intensity statin therapy whereas 40 were on high intensity statin therapy. The overall mean compliance of patients was 56.7%. The compliance of patients on moderate intensity statin therapy was higher (56.8%) than those on high intensity (56.4%) (p=0.92). There was significant inverse correlation (p<0.05) between compliance and TC, TG, LDL-C and HMGCoA-R levels and positive correlation (p<0.05) with HDL-C levels. The mean serum HMGCoA-R levels did not fall below 9-10ng/mL when compliance to either moderate or high intensity statin therapy was increased above 60%. CONCLUSIONS: It is appropriate to improve the compliance to existing statin therapy than switching over to higher intensity statin therapy. Estimation of HMGCoA-R levels may be explored as a surrogate marker to monitor and assess the compliance of patients to statin therapy.

Comparison of Effect of Enalapril and Losartan Monotherapy on Quality of Life and Safety of Stage 1 Hypertensive Patients.

An open label randomized controlled study was conducted to compare the quality of life (QoL) and safety of newly diagnosed stage I hypertensive patients randomized into two groups of 30 receiving either enalapril 5 mg or losartan 50 mg per-oral once daily for three months. QoL was assessed at the baseline and at the end of study using SF-36v2 health care questionnaire. Adverse drug reactions (ADRs) were monitored. Investigations at baseline were compared with those after intervention. Pre & post-intervention QoL transformed scores within each group and change in the same between two groups were analyzed using paired and unpaired t-test respectively. Transformed scores of role limitation due to energy/fatigue, emotional well being and general health domains improved significantly in both treatment groups. Scores of bodily pain improved significantly (p=0.0008) in losartan group only. Results were not significantly different between two groups (except for bodily pain). No serious ADR was reported.

Safety and efficacy of Qurse-e-istisqua in chronic hepatitis C infection: an exploratory study.

BACKGROUND: Qurse-e-istisqua (Q-e-I), an Unani medicine commonly prescribed to treat liver disorders. OBJECTIVES: To study efficacy and safety of Q-e-I in hepatitis C virus (HCV) infection. METHODS: In this randomized double-blind exploratory study, 60 naive patients of HCV infection were assigned to receive either interferonα2a (IFNα2a) (3 mIU, subcutaneous, thrice weekly), ribavirin (RBV) (1000 mg, orally, twice daily in divided doses) and placebo (n = 30) or IFNα2a, RBV and Q-e-I (5 g, orally, thrice daily in divided doses) (n = 30). HCV RNA levels, serum hyaluronic acid (SHA), ultrasound image scoring for fibrosis, liver and renal function test, prothrombin time, were done at the baseline and thereafter periodically. RESULTS: Early virologic response (EVR), end of treatment response (ETR) and sustained virologic response (SVR) were 90%, 96.6% and 90% in the control group and 86.6%, 90.0% and 83.3% in the treatment group. SHA level was lower in the treatment group at the end of the treatment as compared to the control group. Mean end of follow-up ultrasound image scoring for fibrosis in the control and the treatment group was 1.37 ± 0.07 and 1.22 ± 0.06 respectively. Aspartate aminotransferase (AST) levels were significantly lower in the treatment group than the control group at 1-month. Commonly observed adverse drug reactions included fever, hair fall, fatigue, anemia, and diarrhea. CONCLUSION: Q-e-I was well tolerated and showed anti-fibrotic activity. EVR, ETR and SVR suggested that Q-e-I do not have any anti-HCV activity. Early recovery in AST and inhibition of progress of fibrosis in Q-e-I group was probably due to the anti-inflammatory and antioxidant activity of its ingredients.

Supervised conventional interferon α2a in combination with ribavirin therapy is the preferred alternative for treatment of chronic hepatitis C.

OBJECTIVE: To document the significant sustained virological response with supervised conventional interferon α and ribavirin therapy in hepatitis C virus (HCV)-infected patients, this study was planned. MATERIALS AND METHODS: Sixty chronic hepatitis C naive patients were included in this study. Complete blood counts, prothrombin time, ALT, AST, and qualitative HCV RNA were done. Conventional interferon (INF) α2a, 3MIU, S.C and ribavirin 1000 mg PO was given as supervised therapy for 24 weeks in genotype 3 and 48 weeks in genotype 1 and 4 HCV patients. Qualitative HCV RNA was repeated at 12 weeks, 24 weeks for HCV infections with genotype 1, 2, 3 and 4, at 48 weeks for genotype 1 and 4, and thereafter 6 months after completion of treatment. End virological and sustained virological responses were observed. RESULTS: Out of 60 patients, 55 completed the study. Five patients were lost to follow-up. Overall SVR was seen in 47 patients (85.4%) and 4 patients had relapses. CONCLUSION: Significant sustained virological response rates were seen in patients with supervised conventional INF α2a and ribavirin therapy.