Patients In Real-world Clinical Practice Research Articles

Clinical significance of relative dose intensity during pazopanib treatment to advanced/metastatic soft tissue sarcoma (STS) patients.

e22541Background: The correlation between relative dose intensity (RDI) and clinical outcome of pazopanib therapy to STS patients in real-world clinical practice has not been established. Methods: ...

The prognostic value of long-term visit-to-visit blood pressure variability on stroke in real-world practice: A dynamic cohort study in a large representative sample of Chinese hypertensive population

BackgroundThe prognostic significance of long-term visit-to-visit blood pressure variability (BPV) has not yet been validated in “real world” hypertensive patients. The aim of the current study is to explore the prognostic value of BPV on stroke in hypertensive patients. MethodsThis was a dynamic prospective cohort study based on electronic medical records in Shanghai, China. Hypertensive patients (N=122,636) without history of stroke at baseline, were followed up from 2005 to 2011. The cohort comprised of 4522 stroke patients and 118,114 non-stroke patients during a mean follow-up duration of 48months. BPV was measured by standard deviation (SD) and the coefficient of variation (CV) of blood pressure. ResultsThe visit-to-visit variability of both systolic blood pressure (SBP) and diastolic blood pressure (DBP) was independently associated with the occurrence of stroke [SD: the hazard ratios (95% confidence intervals) of SBP and DBP were 1.042 (1.021 to 1.064) and 1.052 (1.040 to 1.065); CV: the hazard ratios (95% confidence intervals) of SBP and DBP were 1.183 (1.010 to 1.356) and 1.151 (1.005 to 1.317), respectively]. The hazard ratio values increased along with an increase of the BPV levels of SBP and DBP. The increment effect remained significant after controlling the blood pressure control status of subjects. ConclusionsIncreased BPV of both SBP and DBP, independent of the average blood pressure, is a predictor of stroke among community hypertensive patients in real-world clinical practice. The risk of stroke increased along with increased BPV. Stabilizing BPV might be a therapeutic target in hypertension.

Abstract 324: Real World Use of Bivalirudin in ST-Elevation Myocardial Infarction is Associated with Lower In-Hospital Complications, 1-Year Major Adverse Cardiac Events and Mortality

Background: Bivalirudin decreased bleeding and improved mortality in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the HORIZON trial. Currently there is limited data regarding the benefits of bivalirudin in unselected STEMI patients in real-world clinical practice. Methods: We reviewed consecutive STEMI patients at a large regional STEMI referral center from June 2009 to December 2011. All patients received aspirin and P2Y12 inhibitors. In-hospital complications, length of stay (LOS), total variable costs, 1-year cardiovascular readmissions, major adverse cardiac events (MACE) and mortality were compared for: bivalirudin alone, heparin alone and either medication with IIb/IIIa inhibitors. Results: Among 759 STEMI PCI cases, 208 (27.4%) received bivalirudin, 216 (28.5%) heparin and 335 (44.1%) IIb/IIIa, including only 48 cases with bivalirudin. Bivalirudin alone had significantly lower in-hospital complications, bleeding events, mortality and 1-year MACE and mortality (p<0.05 for all) (Figure). There were no significant differences in LOS (median 2.6 vs. 2.8 vs. 2.9 days; p=0.065), total variable costs (median $9,303 vs. $9,242 vs. $9,860; p=0.15) or readmissions within 1 year. Conclusions: In an unselected population of STEMI patients, those treated with bivalirudin had lower in-hospital complications and lower 1-year MACE and mortality rates compared to patients receiving heparin or IIb/IIIa inhibitors. These results provide further support for bivalirudin use in STEMI patients.

The OPTI-MIND study: a prospective, observational study of pacemaker patients according to pacing modality and primary indications

The OPTI-MIND study aims to collect 2-year clinical outcomes of pacemaker patients in real-world clinical practice, overall and according to patient characteristics and pacemaker settings. The present analysis of the OPTI-MIND study describes the programmed device settings after discharge from the pacemaker implant. The objective was to determine whether these settings fit recent guidelines for device-programmed physiological pacing based on the preservation of atrioventricular synchrony, avoiding unnecessary pacing, ensuring rate increase during exercise or preventing neurally mediated symptoms. A total of 1740 patients were enroled at 68 centres worldwide. Baseline patient characteristics and device programming settings are available in 1674 of 1740 patients (96%). Guidelines to ensure physiological pacing were followed in 41% of patients: in patients with sinus node disease (SND), and without atrioventricular block (AVB), device programming could have led to unnecessary right ventricular pacing in 38% of patients. In SND patients with chronotropic incompetence, assisted rate increase during exercise was not programmed in 42% of patients. In 11% of patients with AVB, atrioventricular (AV) synchrony was not pursued; the main drivers being advanced age and history of atrial fibrillation. Patients with both SND and AVB were generally programmed physiologically (87%). The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome.

Effect of calcium acetate/magnesium carbonate in the treatment of hyperphosphataemia in dialysis patients in real clinical practice. One year follow up.

This observational study was conducted to investigate the use and effectiveness of calcium acetate/magnesium carbonate (CaMg) in the treatment of hyperphosphataemia in dialysis patients in real-world clinical practice. 120 adult CKD patients on dialysis who received CaMg alone or in combination with other phosphate binders were followed-up for 3-12 months. Serum phosphorus, calcium, magnesium, parathyroid hormone and albumin concentration was measured at baseline and after 3, 6 and 12 months respectively. In addition, CaMg dosage, use of concurrent phosphate binders, vitamin D and cinacalcet was documented. Patients were evaluated in 2 subgroups – CaMg alone (n=79) vs. CaMg + concurrent phosphate binder (n=41). In both subgroups serum phosphorus levels decreased significantly from baseline at 3, 6 and 12 months of CaMg treatment. The percentage achievement of recommended serum phosphorus targets improved after CaMg initiation. At month 6, a total of 78% were within the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range. Total corrected serum calcium increased during CaMg treatment, but mildly exceeded the upper limit of normal in three patients only. Asymptomatic significant increases in magnesium (p<0.001) were observed in the monotherapy group at 3, 6 and 12 months. A total of 80 patients (67%) experienced episodes of mild hypermagnesaemia (>2.6mg/mL, 1.05mmol/L). This analysis of current clinical practice shows that – consistent with findings from a randomised controlled trial – CaMg treatment leads to marked improvement in serum phosphorus levels, helping patients in trying to achieve K/DOQI and KDIGO (Kidney Disease Improving Global Outcome) targets.

Thresholds in disease activity for switching biologics in rheumatoid arthritis patients: experience from a large U.S. cohort.

To examine the threshold in disease activity associated with switching biologic treatment regimens in rheumatoid arthritis (RA) patients in real-world clinical practice. Using data from a prospective observational North American cohort of RA patients through December 30, 2009, patients who initiated a new anti-tumor necrosis factor α (anti-TNFα) agent with ≥6 months of followup were identified. Patients were classified as switchers or maintainers depending on whether they continued their anti-TNF treatment or switched (including discontinuation) within 12 months. Level of disease activity measured by the Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints (DAS28) at the time of the switch (corresponding followup visit for maintainers) was examined and random-effect multivariable logistic regression was used to adjust for covariates. Mean age and RA duration among 1,549 eligible patients were 56.1 and 9.6 years, respectively, 80% were women, 62% were initiating their first biologic, and 30% were initiating their second biologic. At the time of the switch, the median DAS28 and CDAI score were 3.1 and 8.4 among maintainers and 4.0 and 15.2 among switchers, respectively. Maintainers also experienced a greater amount of reduction in disease activity compared with switchers (CDAI: -7.7 versus -2.3, DAS28: -1.1 versus -0.3). The threshold to switch decreased over calendar time, with the greatest amount of reduction observed among patients with moderate disease activity. On average, physicians and patients were willing to continue biologic treatment for patients who were at or near low disease activity. The threshold to switch decreased over time, especially among partial responders.

PCV106 RE-HOSPITALIZATION RATES OF ACUTE CORONARY SYNDROME PATIENTS IN REAL WORLD CLINICAL PRACTICE: OBSERVATIONS FROM A NATIONAL ADMINISTRATIVE CLAIMS DATA

RE-HOSPITALIZATION RATES OF ACUTE CORONARY SYNDROME PATIENTS IN REAL WORLD CLINICAL PRACTICE: OBSERVATIONS FROM A NATIONAL ADMINISTRATIVE CLAIMS DATA Tunceli O1, Gandhi SK2, Bhandary D2, Stephenson JJ1, Gold A2, Fu AC1, Kern DM1, Singer J1 1HealthCore, Inc., Wilmington, DE, USA, 2AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA OBJECTIVES: Re-hospitalization and mortality rates are increasingly being used as quality of care measures that have significant reimbursement implications. We examine the rates of re-hospitalization and mortality of acute coronary syndrome (ACS) patients in real-world clinical practice. METHODS: Commercially-insured patients (age 18 years) with an inpatient hospitalization for ACS [ICD-9-CM codes for acute myocardial infarction or unstable angina (UA)] between 1/1/2007-5/31/ 2010 were identified from medical claims in the HealthCore Integrated Research Database (HIRD). Patients with ACS events within one year prior to index hospitalization were excluded. All-cause and ACS-related re-hospitalizations and mortality rates within 30 days and 12 months after index event were evaluated. RESULTS: Of 66,772 ACS patients (60% male; mean age 66.6 years), 21% had diagnostic coding for ST elevation myocardial infarction (STEMI), 31% had coding for non-ST elevation myocardial infarction (NSTEMI), 37% had UA, and 11% had not otherwise specified (NOS) ACS. Approximately, 90% and 52% of patients had 30-days and 12 months of continuous eligibility respectively. The 30-day all-cause re-hospitalization rate was 16.3 % (STEMI: 16.4%, NSTEMI: 19.0%, UA: 13.3%, NOS: 20.6%;) and 6.3 % (STEMI: 8.8%, NSTEMI: 6.6%, UA: 5.2%, NOS: 4.5%) for an ACS-related re-hospitalization. The 12-month all cause re-hospitalization rate was 41.3% (STEMI: 39.0%, NSTEMI: 46.4%, UA: 38.2%NOS: 46.6%, )and 16.6% for an ACS-related re-hospitalization. The 30-day post-index mortality rate was 2.4 % (STEMI:1 .8%, NSTEMI:4.3%, UA:0.5%, NOS:5.2%;) and the 12-month rate was 7.0%. For patients with ages 65 years, the 30-day all-cause and ACS-related re-hospitalization rates were 21.2% and 7.0%, respectively. CONCLUSIONS: The re-hospitalization and mortality rate for ACS patients within 30 days and 12-months post-index hospitalization discharge as observed in real-world clinical practice remain high. Use of more effective therapies may provide an opportunity to improve important clinical and economic outcomes in ACS patients.

Author's reply

We appreciate Dr Zhang's interest in our study [[1]Nakamura M. Yamashita T. Yajima J. Oikawa Y. Ogasawara K. Sagara K. Koike A. Kirigaya H. Nagashima K. Otsuka T. Uejima T. Funada R. Matsuno S. Suzuki S. Sawada H. et al.Impact of early statin initiation on secondary prevention in Japanese patients with coronary artery disease.J Cardiol. 2011; 57: 172-180Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar] and the opportunity to discuss some issues. We also congratulate Dr Zhang and coworkers for their studies of the US National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry, which showed the effect of statins on reduction in mortality after percutaneous coronary intervention (PCI), consistent with our results, and the meta-analysis, which showed that statins were significantly associated with reduced repeat revascularization, but are unfortunately not associated with reduced mortality rate in patients undergoing PCI. As stated in our article, the relatively small size of the study population is one of the limitations. Propensity score analysis may be helpful for adjusting confounding factors efficiently. Moreover, the small number of events could lead to overestimation of the drug effects. We agree on these points with his comment. Therefore, a study with a larger population is now in progress and should allay his concerns. However, several previous studies using propensity score analysis have shown that the effect of early-initiated statins against death provided a similar level of risk reduction to our results in coronary artery disease (CAD) patients with or without PCI [2Lenderink T. Boersma E. Gitt A.K. Zeymer U. Wallentin L. Van de Werf F. Hasdai D. Behar S. Simoons M.L. Patients using statin treatment within 24 h after admission for ST-elevation acute coronary syndromes had lower mortality than non-users: a report from the first Euro Heart Survey on acute coronary syndromes.Eur Heart J. 2006; 27: 1799-1804Crossref PubMed Scopus (61) Google Scholar, 3Garot P. Bendaoud N. Lefèvre T. Morice M.C. Favourable effect of statin therapy on early survival benefit at the time of percutaneous coronary intervention for ST-elevation myocardial infarction and shock.EuroIntervention. 2010; 6: 350-355Crossref PubMed Scopus (13) Google Scholar]. We think the main topic in Dr Zhang's letter is, at least from the clinical perspective, whether statins, especially early-initiated statins, can reduce the repeat revascularization rate. Our study cannot reveal the effect of early statin initiation on reduction in target lesion revascularization (TLR). Here, we need to underscore the necessity to distinguish precisely between TLR and target vessel revascularization or non-target vessel revascularization (and combined repeat revascularization) when discussing the endpoint about repeat revascularization. It has not been clearly established whether statins can provide a benefit in reducing the incidence of restenosis after stent implantation. In fact, both the NHLBI Dynamic Registry and the meta-analysis performed by Dr Zhang et al. showed no effect against TLR, consistent with our result. In addition, when we consider these revascularization rates, especially TLR, the procedures during stent deployment, such as with or without intravascular ultrasound guidance, have been reported to be an indispensable factor [4Mintz G.S. Weissman N.J. Intravascular ultrasound in the drug-eluting stent era.J Am Coll Cardiol. 2006; 48: 421-429Abstract Full Text Full Text PDF PubMed Scopus (137) Google Scholar, 5Romagnoli E. Sangiorgi G.M. Cosgrave J. Guillet E. Colombo A. Drug-eluting stenting: the case for post-dilation.JACC Cardiovasc Interv. 2008; 1: 22-31Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar]. Revascularization rate could be also influenced by the follow-up method because routine angiographic follow-up increases the detection rate in restenosis and de novo stenosis. For these reasons, the conclusions drawn from Dr Zhang and coworkers’ reports of their studies may not apply to our study populations with CAD who underwent PCI because of the differences in endpoint, patient backgrounds, and follow-up method. As mentioned in our article, there are some possible explanations for the discrepancy between the effects of early initiation of statins on mortality and TLR. Although we do not have the clear answer for this discrepancy, we believe from our results and previously published reports that early-initiated statins can produce a beneficial risk reduction in mortality for Japanese CAD patients in real-world clinical practice.