Hyperlipidemias: Gandhi SK

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.

Harley CR, Gandhi SK, Anoka N, Bullano MF, McKenney JM. · Health Economics and Outcomes, i3 Innovus, 12125 Technology Drive, Minnesota, MN 55244, USA. · Am J Manag Care. · Pubmed #18095778 links to  free full text

Abstract: OBJECTIVE: To understand the practice patterns and National Cholesterol Education Panel (NCEP) Adult Treatment Panel (ATP) III low-density lipoprotein cholesterol (LDL-C) goal attainment rates after switching patients from simvastatin (SMV) to other statins or the combination of SMV and ezetimibe (EZE). METHODS: This retrospective study linked claims and laboratory data from a national health plan. Patients were included if they were taking SMV and were switched to other statins or a fixed-dose combination of SMV and EZE between July 1, 2005, and June 30, 2006. Patients taking dual SMV/EZE before switch were excluded from the study. The NCEP ATP III risk status of patients at switch was assessed based on medical claims, pharmacy claims, and laboratory values in the 12-month preswitch period. Lipid data (available on a patient subset) were used to estimate patients' goal attainment status at and after switch. RESULTS: Of 134 168 patients taking SMV, 11 929 (8.9%) switched to other statins or SMV/EZE. The mean age of switching patients was 54 years (standard deviation, 9 years), 61% were men, 50% were high risk, and 30% were moderate risk. The mean time to switch among new starters of SMV (n = 3379) was 77 days. Forty percent (n = 4772) of the total switches occurred among those taking the lower doses (5, 10, and 20 mg) of SMV. Most patients switched from SMV to SMV/EZE (60.5%), followed by atorvastatin (17.3%), rosuvastatin (10.1%), lovastatin (8.6%), pravastatin (2.9%), and fluvastatin (0.7%). Similarly, most patients switching from higher doses of SMV switched to SMV/EZE (52.5%), followed by atorrestatin (21.1%) and rosuvastatin (10.1%). Overall, 55.6% (758 of 1362) of patients were at ATP III goal at the time of switch from SMV (across all doses; n = 758), and 56.1% (292 of 521) of those taking lower doses were at goal at time of switch. A majority (69.9%) of patients who were at goal and switched from SMV (across all doses) were switched to SMV/EZE, and 61.6% of those at lower doses of SMV switched to the combination drug. Of patients who were not at goal at switch (n = 604), 73.3% attained ATP III LDL-C goal after switch. The mean percent LDL-C reduction that was needed to attain LDL-C goal at switch from SMV (n = 604) was 18.1%. CONCLUSIONS: There is an opportunity to further increase LDL-C goal attainment rates among patients switched from SMV. The clinical, prescription benefit design, and economic implications of the finding that a majority of patients are at goal when switched from SMV and a majority of patients are being switched from SMV to SMV/EZE need to be further examined.

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.

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.

Fox KM, Gandhi SK, Ohsfeldt RL, Blasetto JW, Davidson MH. · Department of Epidemiology & Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. · Int J Clin Pract. · Pubmed #17877650 links to  free full text

Abstract: OBJECTIVE: This study compared effectiveness of rosuvastatin (RSV) with other statins on lowering LDL-C and LDL-C goal attainment among Medicare-eligible patients (age >or= 65 years) and patients with age < 65 years treated in usual clinical practice to provide evidence of real-world effectiveness of statins. METHODS: Retrospective cohort study was conducted in patients, newly prescribed statin therapy during August 2003 to May 2005. Patient inclusion criteria: no prior prescription for dyslipidaemic medication in the preceding 12 months, continuously enrolled for >or= 15 months and >or= 90-day supply of statin. Effectiveness of RSV in reducing LDL-C and attaining LDL-C goal when compared with other statins was evaluated using multivariate regression, adjusting for baseline LDL-C, age, gender, smoking, hypertension, coronary heart disease (CHD), systolic blood pressure and therapy duration. RESULTS: Adjusted per cent LDL-C reduction was significantly greater (p < 0.05) with RSV (24.3% for >or= 65 and 28.5% for < 65) compared with ATV (17.5%, 21.3%), SMV (14.8%, 18.4%), PRV (11.3%, 15.8%), FLV (10.7%, 20.6%) and LOV (13.3%, 14.4%). Among patients in both age groups at high or moderate CHD risk, a greater proportion of RSV patients attained LDL-C goal (76.0% for age group >or= 65 years and 78.4% for age group < 65 years) vs. 50.5-73.0% for >or= 65 and 51.3-71.5% for < 65 years of age on other statins (p < 0.0001). CONCLUSIONS: Rosuvastatin is more effective in lowering LDL-C in Medicare-eligible patients and patients < 65 years of age when compared with other statins in usual clinical practice. Moreover, RSV patients had higher LDL-C goal attainment rates when compared with other statins in high- and moderate-risk patients. The study results have implications for clinicians in selecting the optimal statin to meet individual patient care needs.

Kamat SA, Gandhi SK, Davidson M. · Health Outcomes Research, HealthCore, Inc., Wilmington, DE 19801, USA. · Curr Med Res Opin. · Pubmed #17519079 No free full text.

Abstract: OBJECTIVES: Statins are increasingly used in the treatment of hypercholesterolemia. Research has shown difficulty in attaining LDL-C goals in routine clinical practice, especially in patients at high risk for coronary events. This study identified risk factors associated with failure to attain LDL-C goals in routine clinical practice and examined the effectiveness of rosuvastatin compared to other statins in patients presenting with these risk factors. METHODS: This retrospective observational study used administrative claims data on patients receiving statins. After stratifying patients into baseline National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) risk categories, logistic regression allowed identification of factors predicting failure to attain LDL-C goal. Separate analyses compared failure rates between rosuvastatin and other statins in patients at an increased risk of goal attainment failure. RESULTS: Of the 4661 patients identified, 50% and 14% had baseline NCEP ATP III high and moderate risk status, respectively. Risk factors associated with goal attainment failure were percentage change required to achieve goal > or = 30%, NCEP high risk status, percentage change required 15-29%, and NCEP moderate risk status. Patients at an increased risk of failure exhibited significantly higher failure rates in all other statin groups compared to rosuvastatin. CONCLUSIONS: This study demonstrates that patients requiring > or = 15% change in LDL-C or NCEP high or moderate risk patients are at a higher risk of goal attainment failure. Rosuvastatin is more effective compared to other statins in patients with these risk factors and given variations in clinical profiles of branded and generic statins, these results may aid in identifying patients most likely to benefit from rosuvastatin compared to other statin therapies. Validating the results of this study in other patient populations would help increase the generalizability of study findings.

Insull W, Ghali JK, Hassman DR, Y As JW, Gandhi SK, Miller E, Anonymous00132. · Baylor College of Medicine and The Methodist Hospital, Houston, TX, 77030-3411, USA. · Mayo Clin Proc. · Pubmed #17493418 links to  free full text

Abstract: OBJECTIVE: To evaluate attainment of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III low-density lipoprotein cholesterol (LDL-C) goal of less than 100 mg/dL with statin treatments in managed care patients at high risk for coronary heart disease. PATIENTS AND METHODS: In a randomized, open-label, multicenter trial (SOLAR [Satisfying Optimal LDL-C ATP III goals with Rosuvastatin]) performed at 145 US clinical centers from June 5, 2002 to July 12, 2004, high-risk men and women in a managed care population received typical starting doses of rosuvastatin (10 mg/d), atorvastatin (10 mg/d), or simvastatin (20 mg/d) for 6 weeks. Those who did not meet the LDL-C target of less than 100 mg/dL at 6 weeks had their dose titrated (doubled), and all patients were followed up for another 6 weeks. RESULTS: A total of 1632 patients were randomized to 1 of the 3 treatment regimens. After 6 weeks, 65% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 41% with atorvastatin and 39% with simvastatin (P<.001 vs rosuvastatin for both). After 12 weeks, 76% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 58% with atorvastatin and 53% with simvastatin (P<.001 vs rosuvastatin for both). Reductions in the LDL-C level, total cholesterol level, non-high-density lipoprotein cholesterol (non-HDL-C) level, and non-HDL-C/HDL-C ratio were significantly greater with rosuvastatin at both 6 and 12 weeks compared with the other statins. Adverse events were similar in type and frequency in all treatment groups, and only 3% of all patients discontinued treatment because of adverse events. No myopathy was observed, no clinically important impact on renal function was attributed to study medications, and clinically important increases in serum transaminases were rare. CONCLUSION: In a managed care population, 10 mg of rosuvastatin treatment resulted in more patients reaching the NCEP ATP III LDL-C goal compared with 10 mg of atorvastatin and 20 mg of simvastatin, potentially reducing the need for titration visits.