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Articles by Richard H. Karas
Total Records ( 7 ) for Richard H. Karas
  Richard H. Karas , Daiva R. Bajorunas , Christie M. Ballantyne , Michael H. Davidson , Laurence H. Keller , James McKenney , Robert J. Padley and Roopal B. Thakkar
  not available
  Richard H. Karas , Daiva R. Bajorunas , Michael H. Davidson , Moti Kashyap , Laurence H. Keller , Robert H. Knopp , Robert J. Padley and Roopal B. Thakkar
  not available
  Scott L. Charland , Mark J. Cziraky , Ralph Quimbo , Richard H. Karas , William Insull , Michael Davidson and Eric J. Stanek
 

Background

Cardiovascular (CV) event risk is significantly lower in patients with combined low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) at desired levels versus those without lower levels. However, this has not been investigated relative to specific patterns of baseline lipid abnormalities.

Objective

To evaluate the association between desired combined lipid value achievement and risk of CV events in patients with different baseline lipid profiles.

Methods

A retrospective managed care database analysis among treatment-naive adults with elevated CV event risk, ≥12 months follow-up, and full lipid panel from January 1, 2001 to December 31, 2001 plus ≥1 panel before a CV event or study end. Patients were stratified into three baseline cohorts: isolated high LDL-C (Cohort 1), high LDL-C + low HDL-C or high TG (Cohort 2), and high LDL-C, low HDL-C, and high TG (Cohort 3). CV event risk stratified by combined desired lipid value achievement was assessed in each cohort.

Results

Achievement of combined desired lipid values/median days to achievement was 29% in 385 days (Cohort 1), 11% in 413 days (Cohort 2), and 7% in 505 days (Cohort 3). Achievement of combined desired lipid values was associated with an adjusted 25%-46% lower CV event risk in Cohort 1 (hazards ratio, 0.75; 95% confidence interval 0.65-0.87), Cohort 2 (hazards ratio, 0.54; 95% confidence interval 0.43-0.67), and Cohort 3 (hazard ratio, 0.54; 95% confidence interval 0.37-0.78).

Conclusion

Patients with combined desired lipid values had lower risk of CV events versus those without such values. The risk reduction was greatest among patients with multiple lipid abnormalities, suggesting a potential benefit of interventions targeting low HDL-C and/or high TG in addition to high LDL-C.

  Christie M. Ballantyne , Michael H. Davidson , James M. McKenney , Laurence H. Keller , Daiva R. Bajorunas and Richard H. Karas
 

Background

The number of patients with multiple lipid abnormalities is increasing. Lipid treatment guidelines are established for low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). The importance of treating HDL-C and triglycerides is gaining recognition.

Objective

To determine, in patients who had been treated previously with simvastatin 40 mg/day, the efficacy, safety, and tolerability of two regimens of a combination of proprietary niacin, extended-release core, coated with 40 mg/day simvastatin (NER/S), compared to 80 mg/day simvastatin monotherapy (S80).

Methods

High-risk patients (n = 343) with dyslipidemia were treated for 24 weeks with NER/S (1000/40 mg/day or 2000/40 mg/day) or S80.

Results

Median percentage change from baseline to week 24 in non-HDL-C in either NER/S group was noninferior to S80 (−11.3%, −17.1%, and −10.1%, respectively). Changes in LDL-C were comparable (−8.6%, −11.6%, and −12.7%, respectively). Doubling the dose of simvastatin (S80) did not alter HDL-C, triglycerides, or lipoprotein(a); however, both NER/S doses resulted in significant improvements in all three parameters (+21.9%, −31.8%, and −21.0%, respectively, for NER/S 2000/40 mg/day). The safety of NER/S was consistent with the safety profile of each individual component. Treatment with both doses of NER/S was well tolerated; 59% of patients experienced flushing, 78% of flushing was mild or moderate in intensity, 49% of those who flushed during dose titration did not flush during weeks 13 to 24, and only 4.6% of patients discontinued because of flushing.

Conclusion

NER/S provides similar reductions in non-HDL-C and LDL-C compared to doubling the simvastatin dose to 80 mg; however, only NER/S resulted in improvements in HDL-C, triglycerides, and lipoprotein(a).

  Haseeb Jafri , Alawi A. Alsheikh-Ali , Paula Mooney , Carey D. Kimmelstiel , Richard H. Karas and Jeffrey T. Kuvin
 

Background

The importance of the number of circulating low-density lipoprotein (LDL) cholesterol particles, in addition to total LDL level, has been increasingly recognized. The effects of extended-release niacin (ERN) on LDL particle numbers have not been studied.

Objective

To evaluate ERN's effects on LDL particle numbers.

Methods

Fifty-four patients with stable coronary artery disease (CAD) and well-controlled LDL levels were randomly assigned to 3 months of ERN (1 g/day) or placebo in addition to their baseline medications. Lipoprotein particle number was analyzed by proton nuclear magnetic resonance spectroscopy at baseline and after 3 months.

Results

Compared to baseline, the addition of ERN had no significant effect on total LDL cholesterol levels; however, ERN decreased the number of medium and small LDL particles (P < .005). After 3 months, ERN decreased the number of medium and small LDL particles compared to placebo-treated patients (P < .05). ERN raised HDL cholesterol levels by 2.7%, significantly increased the number of large HDL particles (P < .001), and decreased the number of small HDL particles (P = .027) compared to placebo. There were no significant changes in lipid values or particle numbers in the placebo-treated patients. In patients with stable coronary artery disease and well-controlled LDL cholesterol levels, ERN reduced the number of circulating particles of the more atherogenic subtypes of LDL, despite having no effect on total LDL cholesterol levels. ERN also favorably altered the number of HDL particles.

Conclusion

ERN-induced alterations in lipoprotein particle numbers may contribute to its anti-atherosclerotic effects, and these effects may not be evident from the standard lipid profile.

  Alawi A. Alsheikh-Ali and Richard H. Karas
 

Background

In the recently reported Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, the combination of ezetimibe/simvastatin (E/S) was associated with a significantly increased risk of cancer compared to placebo, causing widespread public concern.

Objective

We examined the rates of cancer adverse event reports filed with the US Food and Drug Administration (FDA) of patients on ezetimibe or E/S, and compared these to reports with other potent cholesterol-lowering drugs.

Methods

We tabulated all adverse event reports listing “cancer” or “malignancy” filed with the FDA (July 2004 to March 2008) of patients taking ezetimibe or E/S, and compared those to reports of patients taking simvastatin, atorvastatin, or rosuvastatin. We calculated rates for such reports per million prescriptions. A secondary analysis examined cancer reports as a proportion of all reported adverse events for each medication.

Results

Prescriptions for all drugs totaled 559 million (approximately 52 and 55 million prescriptions of ezetimibe and E/S, respectively), and cancer adverse event reports totaled 2334. There were 2.9 and 1.3 cancer-associated adverse event reports per million ezetimibe or E/S prescriptions, respectively, compared to a range of 3.1 to 5.1 per million prescriptions for the other drugs. Findings were similar when only reports listing the drug as “suspect” were considered. The proportions of reports listing cancer relative to all adverse event reports were 2.0% and 1.9% for ezetimibe and E/S, respectively, compared to a range of 1.3% to 3.9% for the other drugs.

Conclusions

This large-scale post-marketing analysis of reported adverse events does not support that ezetimibe or E/S increase the risk of cancer.

  Erika M. Felix-Getzik , Jeffrey T. Kuvin and Richard H. Karas
 

Background

Low levels of high-density lipoprotein cholesterol (HDL-C) are an independent risk factor for coronary artery disease. For this study, nonoptimal HDL-C is defined as less than 40 mg/dL for male patients and less than 50 mg/dL for female patients. Even when low-density lipoprotein cholesterol (LDL-C) and non-HDL-C goals are met, significant risk for subsequent cardiovascular events remains in patients with acute coronary syndrome (ACS).

Objective

This study is a prospective, observational study to determine the prevalence of low HDL-C levels in 250 consecutive patients presenting with ACS who have well-controlled LDL-C levels.

Methods

This was an institutional review board-approved, prospective, observational study in which we evaluated consecutive patients admitted to the adult general cardiology service with a diagnosis of ACS.

Results

One hundred nine (44%) patients had LDL-C levels less than 100 mg/dL on admission. Of those patients, 90 (83%) had a nonoptimal HDL-C. Interestingly, a majority of patients, 94 (86%), had non-HDL-C levels at target. At discharge, approximately one half of eligible patients were started on therapy to increase their HDL-C levels.

Conclusion

In conclusion, nonoptimal HDL-C levels are highly prevalent in patients presenting with ACS and reasonably controlled LDL-C and non-HDL-C levels.

 
 
 
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