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Articles by James McKenney
Total Records ( 3 ) for James McKenney
  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
  James McKenney , Sanjay K. Gandhi , Kathleen M. Fox and Robert L. Ohsfeldt
 

Background

Clinical guidelines have recommended a LDL-C goal of <100 mg/dL for high-risk individuals and lipid-modifying therapy for patients not reaching this goal.

Objective

This investigation assessed low-density lipoprotein cholesterol (LDL-C) levels and treatment patterns among patients diagnosed with atherosclerosis with or without a previous cardiovascular disease (CVD) event.

Methods

We conducted a retrospective study by using claims data from a national health plan that included patients with ≥ 1 medical claim for atherosclerosis (ICD-9 of 440.xx, 414.x, 437.0, 437.1, or 437.3) between January 2004 and March 2006. Use of lipid-modifying medications at the time of diagnosis and thereafter, patient demographics, comorbid conditions, baseline, and postdiagnosis LDL-C were assessed.

Results

There were 311,567 patients who had an atherosclerosis ICD-9 code, 46% of whom had a previous CVD event. Among patients with an atherosclerosis diagnosis and CVD event, lipid-modifying therapy was received by 50% before diagnosis and 57% after diagnosis, compared with 37% before and 48% after diagnosis for patients with an atherosclerosis diagnosis and no previous CVD event. Of the patients with baseline LDL-C (15%, n=46,923), 44% had an LDL-C <100 mg/dL at diagnosis; of those with LDL-C ≥ 100 mg/dL, only 54% received lipid-modifying therapy and only 64% achieved an LDL-C <100 mg/dL in the 12 succeeding months. Among patients with baseline and postdiagnosis LDL-C values (n=24,724), 55% had a baseline LDL-C ≥ 100 mg/dL and 46% had a baseline non-HDL-C ≥ 130 mg/dL.

Conclusions

In conclusion, many patients in a managed care plan diagnosed with atherosclerosis with or without a previous CVD event present opportunities for better lipid management. Healthcare providers should evaluate more aggressive lipid management interventions for these patients for potential downstream cardiovascular benefits.

  James McKenney , Harold Bays , Michael Koren , Christie M. Ballantyne , John F. Paolini , Yale Mitchel , Abigaile Betteridge , Olga Kuznetsova , Aditi Sapre , Christine McCrary Sisk and Darbie Maccubbin
 

Objective

To evaluate the safety profile of extended-release niacin/laropiprant (ERN/LRPT), pooling data from studies in the clinical development program.

Methods

Data were pooled from three active- or placebo-controlled phase 3 studies and three 1-year extensions of phase 2 studies that ranged from 12 to 52 weeks (N = 4747): ERN/LRPT = 2548; ERN or Niaspan® (ERN-NSP = 1268); or simvastatin or placebo (SIMVA-PBO = 931).

Results

The safety and tolerability profile for ERN/LRPT was similar to that of ERN-NSP, except for fewer flushing-related adverse experiences and discontinuations with ERN/LRPT than ERN-NSP. The incidence of consecutive ≥3x the upper limit of normal increases in alanine aminotransferase and/or aspartate aminotransferase was numerically (but not statistically) greater with ERN/LRPT (1.0%) than ERN-NSP (0.5%) and similar to SIMVA-PBO (0.9%). Elevations were reversible with therapy discontinuation and not associated with clinical hepatotoxicity. There was no evidence that ERN/LRPT administered alone or concurrently with a statin had adverse effects on muscle. ERN/LRPT and ERN-NSP produced small median increases in fasting blood glucose levels (∼4 mg/dL) after 24 weeks of treatment, consistent with known effects of niacin.

Conclusion

The favorable safety and tolerability profile of ERN/LRPT for up to 1 year supports the use of LRPT to achieve improved therapeutic dosing of niacin, an agent with comprehensive lipid-modifying efficacy and shown to reduce cardiovascular risk.

 
 
 
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