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Articles by James M. McKenney
Total Records ( 7 ) for James M. McKenney
  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).

  Kevin Carl Maki , Mary R. Dicklin , Barry C. Lubin , James M. McKenney and Matthew S. Reeves
  not available
  Eileen E. Ming , Michael H. Davidson , Sanjay K. Gandhi , Marcelo Marotti , Carolyn G. Miles , Xiongkan Ke and James M. McKenney
 

Background

Patients may experience increased risk of adverse drug interactions when statins are administered concomitantly with cytochrome P450 3A4 (CYP3A4) inhibitors.

Objective

To determine patient numbers in routine clinical practice with concomitant exposure to CYP3A4-metabolized statins and CYP3A4 inhibitors and highlight potential risk for adverse drug interaction.

Methods

Exposure to prescription medications over 1 year (2005-2006) was evaluated from patient records: US PharMetrics Integrated Patient-Centric administrative claims database and the US General Electric Medical System (GEMS) database. Rates of concomitant prescribing of statins with CYP3A4 inhibitors (listed in United States of America product labels and all identified potential inhibitors) were examined in the cohort overall, in those aged ≥65 years, and in those receiving higher doses of statins.

Results

Overall, 951,166 patient records were included (PharMetrics n = 650,825; GEMS, n = 300,341). Of these, 792,081 (83%) patients used a CYP3A4-metabolized statin as opposed to a non-CYP3A4-metabolized statin (17%). Findings from both databases were consistent. Overall, 25-30% of patients given a CYP3A4-metabolized statin were concomitantly exposed to a CYP3A4 inhibitor, including approximately 9% concomitantly exposed to a labeled inhibitor, findings consistent with those in patients aged ≥65 years, and patients on higher doses of statins.

Conclusions

Clinicians frequently co-prescribe CYP3A4-metabolized statins with CYP3A4 inhibitors. Physician education regarding the impact of these inhibitors on the metabolism of lovastatin, simvastatin, and atrovastatin is needed. Further studies are also needed to determine whether concomitant administration of a non-CYP3A4-metabolized statin (such as fluvastatin, pravastatin, or rosuvastatin) with a CYP3A4 inhibitor, may reduce adverse event rates in routine clinical practice.

  Michael H. Davidson , Kathleen M. Fox , Sanjay K. Gandhi , Robert L. Ohsfeldt and James M. McKenney
 

Objective

We sought to examine the diagnoses and medical management patterns of patients before the incidence of a cardiovascular (CV) event.

Methods

A retrospective study of claims data from a national managed care plan was conducted. Eligible patients had a myocardial infarction, stroke, or revascularization between January 1, 2004 and December 31, 2005, and at least 3 years of continuous enrollment before the CV event. Patients were stratified by whether or not they had a diagnosis of atherosclerosis in the 3 years before the CV event. Diagnostic testing, lipid monitoring, and statin treatment patterns were assessed during the 3-year period before the CV event.

Results

There were 16,543 patients with a CV event, and 65% had no previous diagnosis of atherosclerosis. For all patients, 58% were men, and mean age was 60 years. Angiography or cardiac imaging was performed in <3% of patients, and cardiac stress testing was performed in 13% of patients before the event. Only 19% of patients had ≥1 lipid test in the 12 months and 32% in the 3 years before the event, and their 12-month mean low-density lipoprotein cholesterol was 113 mg/dL. Thirty-four percent of patients were on statin therapy within the 3 years before event. The patient subgroup diagnosed with atherosclerosis had significantly more patients with cardiac testing, lipid monitoring, and statin therapy compared with patients with no previous diagnosis of atherosclerosis.

Conclusion

These results from an actual clinical practice dataset indicate opportunities for improved detection and management of underlying atherosclerotic heart disease to avoid future cardiovascular events.

  Michael H. Davidson , Christie M. Ballantyne , Terry A. Jacobson , Vera A. Bittner , Lynne T. Braun , Alan S. Brown , W. Virgil Brown , William C. Cromwell , Ronald B. Goldberg , James M. McKenney , Alan T. Remaley , Allan D. Sniderman , Peter P. Toth , Sotirios Tsimikas , Paul E. Ziajka , Kevin C. Maki and Mary R. Dicklin
  The National Cholesterol Education Program Adult Treatment Panel guidelines have established low-density lipoprotein cholesterol (LDL-C) treatment goals, and secondary non-high-density lipoprotein (HDL)-C treatment goals for persons with hypertriglyceridemia. The use of lipid-lowering therapies, particularly statins, to achieve these goals has reduced cardiovascular disease (CVD) morbidity and mortality; however, significant residual risk for events remains. This, combined with the rising prevalence of obesity, which has shifted the risk profile of the population toward patients in whom LDL-C is less predictive of CVD events (metabolic syndrome, low HDL-C, elevated triglycerides), has increased interest in the clinical use of inflammatory and lipid biomarker assessments. Furthermore, the cost effectiveness of pharmacological intervention for both the initiation of therapy and the intensification of therapy has been enhanced by the availability of a variety of generic statins. This report describes the consensus view of an expert panel convened by the National Lipid Association to evaluate the use of selected biomarkers [C-reactive protein, lipoprotein-associated phospholipase A2, apolipoprotein B, LDL particle concentration, lipoprotein(a), and LDL and HDL subfractions] to improve risk assessment, or to adjust therapy. These panel recommendations are intended to provide practical advice to clinicians who wrestle with the challenges of identifying the patients who are most likely to benefit from therapy, or intensification of therapy, to provide the optimum protection from CV risk.
  Mark J. Cziraky , Vincent J. Willey , James M. McKenney , Siddhesh A. Kamat , Maxine D. Fisher , John R. Guyton , Terry A. Jacobson and Michael H. Davidson
 

Background

The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs (LLDs) in randomized clinical trials may be elucidated with population-based studies.

Objective

To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy.

Methods

This observational study used claims data from 9 million members of five United States health plans to identify patients (≥18 years) who received >2 statin and nonstatin LLDs during July 2000 to December 2004. Inpatient International Classification of Diseases, Ninth Revision, Clinical Modification, codes for rhabdomyolysis (791.3, 728.89, and 728.88) were observed during the follow-up period; cases were confirmed with patients' medical records. Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure; multivariate analysis was conducted.

Results

The study cohort (N = 473,343) received 490,988 and 11,624 person-years of LLD, and combination therapy, respectively. Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims; 42 cases were confirmed. With atorvastatin as reference, rhabdomyolysis rates (95% confidence interval) were greatest for cerivastatin, 8.4 (2.3-21.7); no difference among available statins was observed. Rates for other LLD monotherapies were: niacin, 2.1 (0.3−7.7), ezetimibe, 2.1 (0.3−7.8), fenofibrate, 0 (0−1.7), and gemfibrozil, 2.0 (0.5−5.2). Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis (odds ratio 4.74, 95% confidence interval 1.1-21.2, P = .041) versus atorvastatin among the statins. Combination therapies had increased rhabdomyolysis risk (OR 7.1, 1.6-31.6, P = .010) versus LLDs alone.

Conclusion

The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.

  Terry A. Jacobson , Matthew K. Ito , Kevin C. Maki , Carl E. Orringer , Harold E. Bays , Peter H. Jones , James M. McKenney , Scott M. Grundy , Edward A. Gill , Robert A. Wild , Don P. Wilson and W. Virgil Brown
  Various organizations and agencies have issued recommendations for the management of dyslipidemia. Although many commonalities exist among them, material differences are present as well. The leadership of the National Lipid Association (NLA) convened an Expert Panel to develop a consensus set of recommendations for patient-centered management of dyslipidemia in clinical medicine. The current Executive Summary highlights the major conclusions in Part 1 of the recommendations report of the NLA Expert Panel and includes: (1) background and conceptual framework for formulation of the NLA Expert Panel recommendations; (2) screening and classification of lipoprotein lipid levels in adults; (3) targets for intervention in dyslipidemia management; (4) atherosclerotic cardiovascular disease risk assessment and treatment goals based on risk category; (5) atherogenic cholesterol-non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol-as the primary targets of therapy; and (6) lifestyle and drug therapies intended to reduce morbidity and mortality associated with dyslipidemia.
 
 
 
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