11516 Se Mill Plain Blvd Ste 2C
Vancouver WA 98684
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A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol. - Arthritis & rheumatology (Hoboken, N.J.)
The aim of the Patient/Physician Reported Efficacy Determination In Clinical Practice Trial (PREDICT; ClinicalTrials identifier NCT01255761) was to compare the patient-reported Routine Assessment of Patient Index Data 3 (RAPID-3) instrument with the investigator-based Clinical Disease Activity Index (CDAI) for assessing certolizumab pegol (CZP) treatment response in rheumatoid arthritis patients at 12 weeks and to predict the treatment response at week 52 using the data from week 12 (coprimary end points).Patients received 400 mg of CZP at weeks 0, 2, and 4 (loading dose), followed by 200 mg every 2 weeks thereafter. Patients were randomized 1:1 to assessment with the RAPID-3 or the CDAI. Responder classification was performed at week 12; treatment response was defined as a score of â‰¤6 or a 20% improvement over baseline on the RAPID-3 or a score of â‰¤10 or a 20% improvement over baseline on the CDAI. Long-term treatment success was defined as a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) of â‰¤3.2 at week 52. Comparisons were made for the coprimary end points using noninferiority methods. Patients with improvement of <1 on the CDAI score or with no improvement on the RAPID-3 score at week 12 or patients with high levels of disease activity (CDAI score >22 or RAPID-3 score >12) at 2 consecutive visits were withdrawn from the study.Patients had longstanding disease (mean 8.9 years) and high levels of disease activity (mean scores of 6.3 on the DAS28-ESR, 16.1 on the RAPID-3, and 40.2 on the CDAI). Previous anti-tumor necrosis factor therapy had failed in 55.5% of them. At week 12, a total of 64.7% (by RAPID-3) and 76.4% (by CDAI) of the patients were classified as responders (difference of -11.9% [95% confidence interval -18.4%, -5.3%]). At week 52, a total of 31.5% (by RAPID-3) and 32.3% (by CDAI) of the responders achieved a low level of disease activity on the DAS28-ESR (difference of -1.3% [95% confidence interval -9.3%, 6.6%]).The CDAI classified more patients as CZP responders at week 12 than did the RAPID-3. Although these outcome measures were not statistically comparable, the positive predictive value for low disease activity at week 52 was similar. As these tools cover differing domains of therapy response, further evaluation for clinical disease activity assessments and treatment decisions is needed.Â© 2015 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.
The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial). - The Journal of dermatological treatment
To assess the efficacy and safety of two etanercept dose regimens for psoriasis treatment.Subjects were â‰¥18 years old with stable moderate-to-severe plaque psoriasis. Subjects were randomised to etanercept 50 mg once weekly (QW) or 50 mg twice weekly (BIW) double-blind for 12 weeks, followed by 50 mg QW open label in all subjects through week 24. Only mild topical corticosteroids were permitted on scalp, axillae and groin for first 12 weeks; topical medications (corticosteroids of all potencies, vitamin D analogues and combination products) were allowed as needed for second 12 weeks at physicians' discretion, consistent with "real-world" therapeutic practice. An independent ethics committee reviewed and approved the study protocol.At week 24, 59.9% and 78.2% in the QW/QW and BIW/QW groups achieved PASI 75 improvement. Mean percentage PASI improvement in these groups was 58.5% and 74.1% at week 12 and 70.7% and 81.3% at week 24. Although permitted from weeks 12 to 24, topical agents were used in only 27.7% and 22.6% in the QW/QW and BIW/QW groups by week 24.Both etanercept regimens were efficacious in moderate-to-severe psoriasis, although the BIW/QW regimen consistently provided higher response rates than the QW/QW regimen. More potent topical medications were used electively in <25% of subjects in each group.
Improvements in patient-reported outcomes, symptoms of depression and anxiety, and their association with clinical remission among patients with moderate-to-severe active early rheumatoid arthritis. - Rheumatology (Oxford, England)
To assess the association between clinical remission in RA and patient-reported outcomes (PROs), including depression/anxiety symptoms, in adults with moderate-to-severe active early RA.Patients from the COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis (COMET) trial (104 weeks) with measures on the Hospital Anxiety and Depression Scale at baseline and subsequent visits (nâ€‰=â€‰389) were included. PROs investigated were the HAQ disability index, pain and fatigue visual analogue scales (VASs), EuroQoL health status VAS and the Medical Outcomes Short Form-36 physical and mental component summaries. The impact of clinical remission as measured by 28-joint DAS (DAS-28) on depression/anxiety symptoms at Week 104 was assessed using logistic regression. Least square means for PRO improvements from baseline were estimated by analysis of covariance. Missing data were imputed using the last observation carried forward method.When depression/anxiety symptoms were absent at baseline, significantly more patients achieved clinical remission, low disease activity and normal functioning at Week 104. Reciprocally, patients who achieved clinical remission were less likely to maintain symptoms of depression or anxiety compared with non-remitters [depression odds ratio (OR): 0.35, Pâ€‰=â€‰0.0233; anxiety OR: 0.48, Pâ€‰=â€‰0.0371]. Fatigue and pain had a significant impact on changes in depression status, but did not influence anxiety status. Finally, clinical remission was significantly associated with improvements in all PRO measures (Pâ€‰<â€‰0.001); conversely, depression/anxiety symptoms reduced PRO improvements.Among moderate-to-severe active early RA patients, clinical remission reduces symptoms of depression/anxiety, and independently improves PROs, thereby suppressing the negative impact of depression/anxiety on these measures.
Hidden cost of rheumatoid arthritis (RA): estimating cost of comorbid cardiovascular disease and depression among patients with RA. - The Journal of rheumatology
To examine resource utilization and direct healthcare cost associated with comorbid cardiovascular disease (CVD) and depression among patients with prevalent rheumatoid arthritis (RA) based on analyses of retrospective healthcare claims data.The index date was set as the first observed claim with an RA diagnosis. Patients were required to be >or=18 years of age, to have received RA-related treatment during the pre-index period, and to have 12-month pre- and post-index data. Based on pre-index utilization, patients were classified into 4 diagnosis groups: RA alone, RA+CVD, RA+depression, and RA+CVD+depression. Analyses focused on annual differences in costs between patients with RA alone and those with CVD and/or depression. A generalized linear model was applied to control for demographic and clinical characteristics and to estimate cohort-specific adjusted mean annual healthcare cost.Of 10,298 patients, 8,916 had RA alone (86.6%), 608 had RA+CVD (5.9%), 716 had RA+depression (7.0%), and 58 had RA+CVD+depression (0.5%). All patients with CVD and/or depression incurred significantly higher followup costs compared with patients with RA alone. Adjusted annual mean healthcare costs were highest for RA+CVD (US$14,145), followed by RA+CVD+depression ($13,513), RA+depression ($12,225), and RA alone ($11,404). Although patients with CVD and/or depression had a greater rate of RA-related hospitalization, adjusted RA-related healthcare costs did not reflect any statistically significant differences as compared to the RA-alone cohort.A significant proportion (13.4%) of patients with prevalent RA have comorbid CVD and/or depression. The presence of these conditions significantly affects annual healthcare costs as well as specific RA-related utilization patterns.
Assessing the true learning needs of health care professionals in epilepsy care. - Epilepsy & behavior : E&B
This needs assessment, initiated by the American Epilepsy Society (AES) in cooperation with AXDEV Group Inc. (AXDEV), used a mixed-method approach to explore the educational and clinical practice needs of health care professionals in epilepsy care and to identify significant barriers to caring for people with epilepsy. The multiphase assessment began with key informant interviews with AES educational leaders. In Phase II, 26 stakeholders, including epileptologists, neurologists, professionals in epilepsy care, and people with epilepsy, shared their experiences in epilepsy care during four focus groups at the AES annual meeting. In Phase III, a quantitative online survey based on Phase II results was distributed to 228 respondents, including epileptologists (n=84), neurologists (n=55), professionals in epilepsy care (n=69), and others (n=20). Results of the comprehensive analysis of Phase III quantitative data are presented here. They reveal the unmet needs of health care professionals in this therapeutic domain and are discussed in terms of their implications for epilepsy care.
Potential impact on cardiovascular public health of over-the-counter statin availability. - The American journal of cardiology
Over-the-counter (OTC) statin availability has been hypothesized to represent a strategy for treating consumers at moderate risk of coronary heart disease (CHD) who are currently not receiving drug therapy. The viability of this strategy has been questioned, particularly with respect to the public health benefit that can be obtained in an unsupervised treatment environment. The previously reported Consumer Use Study of Over-the-Counter Lovastatin (CUSTOM) examined consumer behavior in a simulated OTC setting in which 20 mg lovastatin could be purchased. Framingham CHD risk scores were calculated for 981 self-selected consumers who used OTC lovastatin in CUSTOM. Overall, this group had a median 10-year CHD risk of 10%, but with significant numbers of consumers with estimated risks of <5% and >20%. According to the risk profile of CUSTOM consumers, the use of 20 mg lovastatin for 10 years would be expected to prevent approximately 33,100 CHD events per 1 million users. This represents a 10-year number needed to treat of 30 consumers. This optimal benefit may be reduced because some higher risk consumers in CUSTOM used lovastatin rather than appropriate, more aggressive supervised care. On the basis of the frequencies of diversion from optimal care observed in CUSTOM, the number of events prevented might be reduced to 23,000 (number needed to treat 43 consumers). Sensitivity analyses have demonstrated that these estimates are robust and that the predicted public health benefit likely falls in the range of 23,000 to 33,000 CHD events prevented per 1 million treated for 10 years. In conclusion, on a population basis, OTC statin availability is likely to result in clinically meaningful reductions in CHD morbidity and mortality. The analyses also identified opportunities for optimizing the use of OTC statins in the marketplace.
Frequency of myopathy in patients receiving lovastatin. - The American journal of cardiology
Lovastatin (Mevacor) 20 mg is being considered for nonprescription availability. Because the most severe untoward consequence of therapy with any statin is rhabdomyolysis, the clinical data for lovastatin pertaining to this adverse event were reviewed. Evidence to date, based on almost 2 decades of experience, points to an extremely low risk for myopathy and rhabdomyolysis associated with lovastatin.
Estimating cholesterol treatment rates among individuals with multiple risk factors and without coronary heart disease. - The American journal of cardiology
This retrospective study examined lipid-lowering therapy treatment rates from 2000 to 2001 using the Ingenix LabRx Database. Patients with multiple risk factors without coronary heart disease were identified based on the presence of >/=2 of the following: men >/=45 years, women >/=55 years, hypertension, high-density lipoprotein cholesterol <40 mg/dl, total cholesterol >/=200 mg/dl, or obesity. Lipid treatment rates were estimated among those needing therapy (defined as low-density lipoprotein cholesterol >/=130 mg/dl or currently receiving lipid-lowering therapy). The overall lipid-lowering therapy treatment rate was 38% and the estimated lipid treatment gap (percent needing treatment who were not receiving it) was 62%.
A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). - The American journal of cardiology
The Consumer Use Study of OTC Mevacor evaluated the ability of subjects to self-manage high levels of low-density lipoprotein (LDL) cholesterol by using a multifaceted cholesterol self-management program (the Mevacor Over-the-Counter Self-Management System; MOTC-SMS). This 26-week all-comers multicenter observational study was conducted in naturalistic storefront settings that used the fully functional MOTC-SMS to guide subjects' behavior. Of 3,316 subjects who evaluated the product (evaluators), 1,061 took >or=1 20-mg tablet of Mevacor OTC (users). Eighty-four percent of evaluators made appropriate initial use decisions. Most users demonstrated acceptable ongoing use behavior regarding treatment to goal, compliance/persistence, changes in health status, dietary patterns, and exercise habits. Throughout the study, 23 users (2%) demonstrated behavior that created the potential for suboptimal safety. After 26 weeks, median levels of LDL cholesterol were reduced by 25% among users who fasted. Of the 878 users who completed the study lipid test, 548 (62%) achieved the LDL cholesterol target goal (<130 mg/dl). Physician interactions were common. Mevacor OTC was well tolerated, with no observable adverse experiences from drug interactions or reports of myopathy. This actual use study demonstrates that the MOTC-SMS can effectively guide consumers to interact with health care professionals and to make appropriate initial and ongoing use decisions to manage their elevated levels of LDL cholesterol, with minimal potential or actual safety risk.
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