Hypercholesterolemia: Fox KM

Fox KM, Gandhi SK, Ohsfeldt RL, Blasetto JW, Bays HE. · University of Maryland School of Medicine, Department of Epidemiology & Preventive Medicine, Baltimore, MD, USA. · Curr Med Res Opin. · Pubmed #17655813 No free full text.

Abstract: OBJECTIVE: To compare effectiveness of rosuvastatin (RSV) with other statins on lowering low-density lipoprotein cholesterol (LDL-C) and LDL-C goal attainment among patients with type 1 or type 2 diabetes mellitus. METHODS: A retrospective study using US General Electric Medical Systems (GEMS) database of patients with diabetes mellitus (ICD9 code = 250, prescription for anti-diabetic medication or fasting blood glucose level > or = 126 mg/dL in the 12 months preceding statin therapy) treated across clinical practices in the US, who were newly prescribed statin therapy during August 2003-March 2006, was conducted. Multivariate linear and logistic regression models were used for analyzing prescription data with baseline LDL-C, age, gender, smoking, very high CHD risk, systolic blood pressure, and statin duration as covariates. RESULTS: Of 4754 diabetes mellitus patients, 5% were prescribed RSV, 59% atorvastatin (ATV), 21% simvastatin (SMV), 5% pravastatin (PRV), 2% fluvastatin (FLV), and 7% lovastatin (LOV). RSV patients had significantly higher (p < 0.05) baseline mean LDL-C levels (138 vs. 117-131 mg/dL), lower average starting dose (11.7 vs. 17.0-63.7 mg) and were younger (p < 0.005) than patients on other statins (mean age 61 vs. 63-69 years). Percent LDL-C reduction was significantly greater (p < 0.0001) with RSV (28.4%) compared to ATV (22.5%), SMV (20.1%), PRV (13.7%), FLV (15.8%), and LOV (17.3%). A greater (p < 0.05) proportion of RSV diabetes patients attained LDL-C goal < 100 mg/dL (72.8%) vs. diabetes mellitus patients on other statins (36.8-67.4%). CONCLUSIONS: Rosuvastatin was more effective in lowering LDL-C and achieving LDL-C treatment goals in the diabetes mellitus population as compared to other statins in real-world clinical practice setting. Validating study results in a different diabetes population with dispensed statin prescriptions will help increase generalizability of study findings.

Fox KM, Gandhi SK, Ohsfeldt RL, Davidson MH. · · Am J Manag Care. · Pubmed #18095777 links to  free full text

Abstract: OBJECTIVE: The study compared low-density lipoprotein cholesterol (LDL-C) reduction obtained after switching patients on a statin therapy to rosuvastatin or simvastatin in real-world clinical practice. METHODS: Using information from an electronic medical records database, for patients >or=18 years of age who received newly prescribed statin therapy during August 2003 to March 2006, who were switched to either rosuvastatin or simvastatin, and who had LDL-C values at baseline, switch and postswitch data were included (N = 277). Percent LDL-C reduction between patients switched to rosuvastatin (n = 155) and those switched to simvastatin (n = 122) were compared. Linear regression model was adjusted for percent LDL-C change from preswitch to switch, LDL-C at time of switch, age, sex, smoking, statin aggressiveness, and therapy duration postswitch. Percent LDL-C reduction for patients switched from atorvastatin to rosuvastatin versus atorvastatin to simvastatin was also compared. RESULTS: Patients switched to rosuvastatin or simvastatin were similar in age, sex, and baseline LDL-C (mean, 146 mg/dL). Patients switched to rosuvastatin from any other statin had a significantly greater percent LDL-C reduction (18.4%) postswitch than patients switched to simvastatin (5.8%; P = .0003). After adjusting for baseline covariates, rosuvastatin patients had a significantly greater percent LDL-C reduction postswitch than simvastatin patients (16.0% vs 8.8%, respectively; P = .0002). In the subgroup of patients switched from atorvastatin, patients switched to rosuvastatin (n = 67) had a significantly greater adjusted percent LDL-C reduction (13.6%) postswitch than patients switched to simvastatin (5.5%; n = 75; P = .001). CONCLUSION: Rosuvastatin achieves greater percent LDL-C reduction than simvastatin as a switch therapy in a real-world clinical practice setting. This highlights the need to select the statin to switch to based on additional needed percent LDL-C reduction to meet individual patient targets. Availability of simvastatin (generic statin) and rosuvastatin (branded statin) as treatment options would facilitate efficient and effective management of patients with dyslipidemia.

Gomma AH, Hirschfield GM, Gallimore JR, Lowe GD, Pepys MB, Fox KM. · Cardiology Department, National Heart and Lung Institute and Royal Brompton Hospital, London, United Kingdom. · Am Heart J. · Pubmed #15199358 No free full text.

Abstract: BACKGROUND: Levels of C-reactive protein (CRP), serum amyloid A protein (SAA), and interleukin-6 (IL-6) can predict coronary restenosis following angioplasty and stent deployment in patients with unstable angina. We investigated whether measurement of periprocedural inflammatory markers predicted the angiographic outcome at 6 months in stable angina patients undergoing coronary stenting. METHODS: We prospectively studied 182 patients; 152 patients underwent elective and successful stenting procedure for de novo lesions in native and nongrafted coronary arteries and 30 individuals in the control group underwent diagnostic angiography alone. CRP, SAA, and IL-6 were determined by high-sensitivity immunoassays. RESULTS: At 6 months, quantitative computer-assisted angiographic analysis in 133 patients with stents showed a binary restenosis rate of 33.8%. Statins were being taken by 80% of the patients. There were no significant differences between the pre- or postprocedure values of CRP, SAA, or IL-6 in patients with or without in-stent restenosis. CONCLUSIONS: Preprocedural inflammatory markers in stable angina subjects undergoing coronary artery stent deployment did not correlate with the development of in-stent restenosis. Differences in pathobiology between stable and unstable coronary syndromes, the widespread use of statins with anti-inflammatory activity in our cohort of patients, along with different mechanisms underlying the early angiographic appearances of restenosis as compared to clinical end points, most likely explain our findings.

Ohsfeldt RL, Gandhi SK, Fox KM. · Texas A&M Health Science Center, College Station, TX, USA. · Curr Med Res Opin. · Pubmed #19422282 No free full text.

Abstract: ABSTRACT Background: This study assessed lipid-monitoring and statin therapy patterns in routine clinical practice for Medicare-eligible patients diagnosed with atherosclerosis. Methods: A retrospective study using a random sample of 1 million patients (>17 years of age) from a US outpatient electronic medical record database was conducted with patients >/=65 years of age having a diagnostic code for atherosclerosis between January 2004 and March 2006. Use of statin therapy at the time of and for 12 months after atherosclerosis diagnosis, in addition to patient demographics, comorbid conditions, baseline and post-diagnosis LDL-C, were recorded. Results: In the million-patient sample, 3303 patients were >/=65 years of age and had a diagnostic code of atherosclerosis. Overall, 63% of these patients were not prescribed statin therapy at the time of or within 12 months after diagnosis. Lipid monitoring within 6 months before diagnosis occurred in 37% of patients. Of those with a recorded baseline LDL-C (n = 1213), 50% had LDL-C >/=100 mg/dL and 87% had LDL-C >/=70 mg/dL. Among patients with baseline LDL-C >/=100 mg/dL, 55% were not prescribed statin therapy at or after their diagnosis compared with 49% of patients with baseline LDL-C <100 mg/dL (p = 0.0001). There were significantly more patients who were prescribed statin therapy with LDL-C <100 mg/dL after diagnosis (67%) than at diagnosis (55%) (p = 0.0008). Limitations: Patients were required to have an ICD-9 diagnosis of atherosclerosis, which may have underestimated those with atherosclerosis that was not coded specifically as atherosclerosis. Because the study included patients treated in physician practice with an electronic medical record system (EMR), they may be different from patients who are treated by physicians not equipped with an EMR. Pharmacy data were the prescription ordered and not the drug claim indicating that the prescription was dispensed. This may overestimate the statin therapy utilization estimates. Conclusions: A substantial gap in the management of diagnosed atherosclerosis was found among Medicare-eligible patients treated in the usual-care setting. There is a need to raise awareness of the importance of lipid monitoring and treatment of hypercholesterolemia in this at-risk population.

Davidson MH, Gandhi SK, Ohsfeldt RL, Fox KM. · Pritzker School of Medicine, University of Chicago, Chicago, Illinois 60610, USA. · Am J Med. · Pubmed #19110088 No free full text.

Abstract: Little is known about the lipid profiles and associated treatment patterns of patients in whom atherosclerosis is diagnosed. This investigation assessed and described the low-density lipoprotein (LDL) cholesterol levels and treatment patterns for hypercholesterolemia in patients with atherosclerosis who were treated in routine clinical practice. This retrospective database study used a random sample (1 million patients) from a national outpatient electronic medical record database (GE Medical Systems, Milwaukee, WI) and included patients with a diagnostic code for atherosclerosis (International Classification of Diseases [ICD]-9 code of 440.xx or 414.x or 437.x) between January 2004 and March 2006. Use of hypercholesterolemia medications at the time ICD codes for atherosclerosis were recorded and thereafter was documented. Patient demographics, comorbid conditions, baseline LDL cholesterol (closest value within 6 months of the diagnosis date), and follow-up LDL cholesterol (after diagnosis) were also documented. A total of 10,637 eligible patients had an ICD diagnostic code for atherosclerosis. Most patients (61.3%) were not taking any dyslipidemia medication at the time of and after atherosclerosis diagnosis. A total of 3% were prescribed therapy with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) before the time of atherosclerosis diagnosis, and 25% were prescribed a statin after diagnosis. Approximately 62% of patients with atherosclerosis did not have a baseline LDL cholesterol estimate. Of patients with LDL cholesterol recorded at diagnosis (n = 4,067), 24% had LDL cholesterol > or = 130 mg/dL (1 mg/dL = 0.02586 mmol/L), 53% had LDL cholesterol > or = 100 mg/dL, and 87% had LDL cholesterol > or = 70 mg/dL. Among patients with LDL cholesterol > or = 100 mg/dL at diagnosis, 57% were not prescribed statin treatment after diagnosis. Of those with baseline and postdiagnosis LDL cholesterol values (n = 1,395), 49% had baseline LDL cholesterol > or = 100 mg/dL. Among patients on statin or any other hypercholesterolemia therapy after diagnosis who had baseline and follow-up LDL cholesterol values (n = 682), 87% had baseline LDL cholesterol > or = 70 mg/dL and 51% had baseline LDL cholesterol > or = 100 mg/dL, whereas 82% had postdiagnosis LDL cholesterol > or = 70 mg/dL and 43% had postdiagnosis LDL cholesterol > or = 100 mg/dL. The results from this study, which was conducted in a routine clinical practice setting, indicate the opportunities and the need for better monitoring and management of lipid levels in patients with atherosclerosis.

Fox KM, Gandhi SK, Ohsfeldt RL, Blasetto JW, Davidson MH. · Department of Epidemiology & Preventive Medicine, School of Medicine, University of Maryland, Baltimore, MD, USA. · Clin Ther. · Pubmed #18158079 No free full text.

Abstract: BACKGROUND: Lipid management in clinical practice has been suboptimal with a significant proportion of patients not achieving recommended cholesterol levels. A reason for low goal attainment may be the limited use of upward dose titration. OBJECTIVE: The aim of this study was to determine if, in routine clinical practice, a lower rate of titration is observed among rosuvastatin patients who achieved the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) target low-density lipoprotein cholesterol (LDL-C) goals as compared with patients achieving the target LDL-C goals on other statins. METHODS: This retrospective database study included the patients, aged > or =18 years, of approximately 3000 physicians across the United States, who were newly prescribed statin treatment from August 2003 to May 2005. Patients were excluded if they started on a maximum dose of statin, were at LDL-C goal at baseline (no clinical reason for titrating), or on fluvastatin (<70 patients). Titration rate with rosuvastatin was compared with other statins. Multivariate logistic regression models adjusted for baseline LDL-C, coronary heart disease risk, treatment duration, and target LDL-C goal attainment. RESULTS: This study assessed 12,041 patients for upward titration. Of the 5955 eligible patients (mean age, 63 years; male, 47%), 7.2% were prescribed rosuvastatin, 63.5% atorvastatin, 15.3% simvastatin, 7.2% pravastatin, and 6.9% lovastatin. Overall, 4337 patients (72.8%) attained the NCEP ATP III target LDL-C goal. Mean duration of statin treatment was 188 days for rosuvastatin compared with 238 to 260 days for the other statins (all, P < 0.05). Among patients attaining the target LDL-C goal, significantly fewer rosuvastatin patients (8.3%) had titration compared with atorvastatin (17.0%), simvastatin (20.0%), pravastatin (20.7%), and lovastatin (23.5%) (all, P < 0.05). After adjusting for baseline characteristics, patients attaining the target LDL-C goal on other statins were significantly more likely to be titrated as compared with rosuvastatin (odds ratios, 2.0-3.3; P < 0.05). Lower titration rates for rosuvastatin patients were also observed in the total population (P < 0.05). CONCLUSION: Our study found that rosuvastatin patients who attained the NCEP ATP III target LDL-C goal had significantly lower titration rates than patients receiving other statins.

Chua TP, Saia F, Bhardwaj V, Wright C, Clarke D, Hennessy M, Fox KM. · Department of Cardiology, Royal Brompton and Harefield Hospital Trust, London, UK. · Int J Cardiol. · Pubmed #10716139 No free full text.

Abstract: BACKGROUND: There are limited studies on gender differences in patients with unstable angina. We investigated the influence of gender in these patients in a tertiary referral centre. METHODS AND RESULTS: Three hundred and thirteen consecutive patients (210 men and 103 women) with unstable angina were studied over a 42-month period. Patient characteristics, cardiovascular risk factors and subsequent management including coronary artery bypass graft (CABG) operation and percutaneous transluminal coronary angioplasty (PTCA) were investigated. There was no difference in age [61.6 (11.0) (S.D.) years for men vs. 63.5 (10.5) years for women]. Diabetes mellitus and hypertension were more common in women (diabetes, 11% vs. 23%, P = 0.007; hypertension, 32% vs. 52%; P = 0.001). The number of smokers was greater in men (73% vs. 46%, P = 0.00001). There was no difference in the prevalence of hypercholesterolaemia or in the incidence of previous myocardial infarction, previous history of angina and family history of ischaemic heart disease. The duration of unstable angina before presentation to the referring hospital was similar in both sexes. The use of aspirin, intravenous heparin and antianginal drugs was also comparable in the two genders. The number of coronary arteries involved in men and women appeared similar (one vessel, 22% vs. 27%; two vessels, 26% vs. 21%; three vessels, 52% vs. 52% in men and women, respectively). The proportion of men and women who underwent subsequent revascularisation was also similar (CABG, 31% vs. 33%; PTCA, 42% vs. 40%). The overall in-hospital mortality was higher in women (6.8% vs. 2.8%), but was not statistically significant (P = 0.18). CONCLUSIONS: Gender differences in unstable angina manifest in the preponderance of selected risk factors including diabetes mellitus and hypertension in women and smoking in men. There is no difference in age, the degree of coronary artery involvement and the subsequent management in a tertiary referral centre.