Inadequate pain relief among patients with primary knee osteoarthritis.

BACKGROUND: Despite the widespread treatments for osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. OBJECTIVES: To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. METHODS: Patients ≥50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate pain relief (IPR) was defined as a score >4/10 on item 5 of the BPI. RESULTS: Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p<0.001) and in all eight domains and summary components of SF-12 (p<0.001). CONCLUSIONS: Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life.

Inadequate pain relief among patients with primary knee osteoarthritis / Alívio inadequado da dor em pacientes com osteoartrite de joelho primária

ABSTRACT Background: Despite the widespread treatments for osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. Objectives: To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. Methods: Patients ≥50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate pain relief (IPR) was defined as a score >4/10 on item 5 of the BPI. Results: Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p < 0.001) and in all eight domains and summary components of SF-12 (p < 0.001). Conclusions: Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life.

RESUMO Antecedentes: Apesar dos tratamentos muito difundidos para a osteoartrite (OA), dados sobre os padrões de tratamento, a adequação do alívio da dor e a qualidade de vida são limitados. O estudo multinacional prospectivo Survey of Osteoarthritis Real World Therapies (SORT) foi projetado para investigar esses aspectos. Objetivos: Analisar as características e os desfechos relatados pelo paciente do conjunto de dados português do Sort no início da observação. Métodos: Consideraram-se elegíveis os pacientes com 50 anos ou mais com OA de joelho primária que recebiam analgésicos orais ou tópicos. Os pacientes foram recrutados de sete centros de saúde de Portugal entre janeiro e dezembro de 2011. A dor e a função foram avaliadas pelo Brief Pain Inventory (BPI) e pelo WOMAC. A qualidade de vida foi avaliada com o 12-item Short Form Health Survey (SF-12). O alívio inadequado da dor (AID) foi definido como uma pontuação > 4/10 no item 5 do BPI. Resultados: Foram analisados 197 pacientes. A idade média foi de 67 anos e 78,2% eram do sexo feminino. A duração média da OA de joelho foi de 6,2 anos. O AID foi relatado por 51,3% dos pacientes. O sexo feminino (odds ratio ajustado - OR 2,15 [IC 95% 1,1-4,5]), o diabetes (OR = 3,1 [IC 95% 1,3-7,7]) e a depressão (OR 2,24 [IC 95% 1,2-4,3]) estiveram associados a um maior risco de AID. Os pacientes com AID relataram piores desfechos em todas as dimensões do Womac (p < 0,001) e em todos os oito domínios e nos dois componentes sumários do SF-12 (p < 0,001). Conclusões: Os resultados do presente estudo indicam que é necessário melhorar o manejo da dor na OA de joelho a fim de alcançar melhores desfechos em termos de alívio da dor, função e qualidade de vida.

Inadequate pain relief among patients with primary knee osteoarthritis. / Alívio inadequado da dor em pacientes com osteoartrite de joelho primária.

BACKGROUND: Despite the widespread treatments for Osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. OBJECTIVES: To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. METHODS: Patients ≥ 50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate Pain Relief (IPR) was defined as a score>4/10 on item 5 of the BPI. RESULTS: Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p<0.001) and in all eight domains and summary components of SF-12 (p<0.001). CONCLUSIONS: Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life.

Acute kidney injury and death associated with renin angiotensin system blockade in cardiothoracic surgery: a meta-analysis of observational studies.

BACKGROUND: Acute kidney injury (AKI) is a common complication after cardiovascular surgery. The use of renin angiotensin system (RAS) blockers preoperatively is controversial due to conflicting results of their effect on the incidence of postoperative AKI and mortality. STUDY DESIGN: Meta-analysis of prospective or retrospective observational studies (1950 to January 2013) using MEDLINE, EMBASE, the Cochrane Library, conferences, and ClinicalTrials.gov, without language restriction. SETTING & POPULATION: Patients undergoing cardiovascular surgery. SELECTION CRITERIA FOR STUDIES: Retrospective or prospective studies evaluating the effect of preoperative use of RAS blockers in the development of postoperative AKI and/or mortality in adult patients. INTERVENTION: Preoperative use of RAS blockers. RAS-blocker use was defined as long-term use of either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers until the day of surgery. OUTCOMES: The primary outcome was the development of postoperative AKI; the secondary outcome was mortality. AKI was defined by different authors using different criteria. Death was ascertained in the hospital, at 30 days, or at 90 days in different studies. RESULTS: 29 studies were included (4 prospective and 25 retrospective); 23 of these involving 69,027 patients examined AKI, and 18 involving 54,418 patients studied mortality. Heterogeneity was found across studies regarding AKI (I2 = 82.5%), whereas studies were homogeneous regarding mortality (I2 = 20.5%). Preoperative RAS-blocker use was associated with increased odds for both postoperative AKI (OR, 1.17; 95% CI, 1.01-1.36; P = 0.04) and mortality (OR, 1.20; 95% CI, 1.06-1.35; P = 0.005). LIMITATIONS: Lack of randomized controlled trials, different definitions of AKI, different durations of follow-up used to analyze death outcome, and inability to exclude outcome reporting bias. CONCLUSIONS: In retrospective studies, preoperative use of RAS blockers was associated with increased odds of postoperative AKI and mortality in patients undergoing cardiovascular surgery. A large, multicenter, randomized, controlled trial should be performed to confirm these findings.

The MDRD equation underestimates the prevalence of CKD among blacks and overestimates the prevalence of CKD among whites compared to the CKD-EPI equation: a retrospective cohort study.

BACKGROUND: Black individuals are far more likely than white individuals to develop end stage renal disease (ESRD). However, earlier stages of chronic kidney disease (CKD) have been reported to be less prevalent among blacks. This disparity remains poorly understood. The objective of this study was to evaluate whether the lower prevalence of CKD among blacks in early stages of CKD might be due in part to an inability of the MDRD equation to accurately determine early stages of CKD in both the black and white population. METHODS: We conducted a retrospective cohort study of 97, 451 patients seen in primary care clinic in Veterans Integrated Service Network 2 (VISN 2) over a 7 year period to determine the prevalence of CKD using both the Modification of Diet in Renal Disease (MDRD) Study equation and the more recently developed CKD Epidemiology Collaboration (CKD-EPI) equation. Demographic data, comorbid conditions, prescription of medications, and laboratory data were recorded. Logistic regression and quantile regression models were used to compare the prevalence of estimated glomerular filtration rate (eGFR) categories between black and white individuals. RESULTS: The overall prevalence of CKD was lower when the CKD-EPI equation was used. Prevalence of CKD in whites was 53.2% by MDRD and 48.4% by CKD-EPI, versus 34.1% by MDRD and 34.5% by CKD-EPI in blacks. The cumulative logistic regression and quantile regression showed that when eGFR was calculated by the EPI method, blacks were as likely to present with an eGFR value less than 60 mL/min/1.73 m2 as whites. Using the CKD-EPI equation, blacks were more likely than white individuals to have stage 3b, 4 and 5 CKD. Using the MDRD method, the prevalence in blacks was only higher than in whites for stage 4 and 5 CKD. Similar results were obtained when the analysis was confined to patients over 65 years of age. CONCLUSIONS: The MDRD equation overestimates the prevalence of CKD among whites and underestimates the prevalence of CKD in blacks compared to the CKD-EPI equation.

Triptan persistency among newly initiated users in a pharmacy claims database.

OBJECTIVE: Our study was conducted to describe prescription refill patterns among patients newly treated with triptans. BACKGROUND: Although triptans are efficacious in treating migraine headache, the persistency of triptan use among newly initiated users has not been well described. METHODS: From a US pharmacy claims database, we identified patients receiving new triptan monotherapy prescriptions from 2001 to 2005. Prescription refill information was gathered for two years for each patient. Persistency was defined as sustained refills of the index triptan prescription, regardless of duration between refills. RESULTS: Of 40,892 patients receiving a new triptan prescription, 53.8% (N = 22031) did not persistently refill their index triptan. Of these, 25.5% discontinued prescription migraine therapy, 7.4% switched to a different triptan, and 67.1% switched to a non-triptan migraine medication at the time of their first refill. Only 46.2% of patients received at least one persistent refill. CONCLUSIONS: Migraine patients were more likely to discontinue their triptan after their index prescription than at any other time in their prescription refill history. The majority of patients did not persistently refill triptans, but filled prescriptions for non-specific migraine therapies such as opioids and non-steroidal anti-inflammatory drugs. Reasons for triptan discontinuation warrant further investigation.

Differences in baseline characteristics between patients prescribed sitagliptin versus exenatide based on a US electronic medical record database.

INTRODUCTION: Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, and exenatide, an injectable glucagon-like peptide-1 receptor agonist, are incretin-based therapies for the treatment of type 2 diabetes. This study examined differences in baseline characteristics between patients with type 2 diabetes initiating sitagliptin vs. exenatide treatment in clinical practice settings in the US. METHODS: The General Electric Healthcare's Clinical Data Services electronic medical records database, covering 12 million US patients of all ages from 49 states, was used to identify patients with type 2 diabetes, aged > or =30 years, who received their first sitagliptin or exenatide prescription between October 1, 2006 and June 30, 2008 (index period). Patient's medical records, including demographics, diagnoses, procedures, prescriptions, and laboratory results were extracted for the 12-month period (baseline) prior to the date of the first prescription of sitagliptin or exenatide (ie, the index date). Patient baseline profiles were stratified by mono-, dual, or triple therapy and compared between regimens with sitagliptin or exenatide. RESULTS: A total of 9543 patients initiated therapy with sitagliptin (n=5589) or exenatide (n=3954) during the index period. For those initiating monotherapy, 876 patients initiated sitagliptin and 476 initiated exenatide. Compared with patients initiating exenatide at baseline, patients on sitagliptin were older (64 vs. 55 years), more likely to be men (45% vs. 35%), and less likely to be obese (60% vs. 87%), and had higher hemoglobin A(1c) (HbA(1c); 7.1% vs. 6.9%), a higher serum creatinine (1.2 mg/dL vs. 1.0 mg/dL), and a higher prevalence of pre-existing cardiovascular complications or microvascular conditions (all P<0.01 for sitagliptin vs. exenatide). For dual therapy, 1885 were prescribed sitagliptin and 1392 were prescribed exenatide. For triple therapy, 2828 were prescribed sitagliptin and 2086 were prescribed exenatide. The observed patient profile differences with dual and triple therapy were generally consistent with those observed with monotherapy. CONCLUSION: In a clinical practice setting, there are differences in the baseline characteristics of patients with type 2 diabetes who are prescribed sitagliptin relative to those prescribed exenatide. These findings have important implications for conclusions drawn from observational studies using medical record or claim databases, as estimated clinical and health outcomes measures may be biased due to channeling of patients to different therapies based on different baseline characteristics.

Baseline characteristic differences between patients prescribed sitagliptin vs. other oral antihyperglycemic agents: analysis of a US electronic medical record database.

AIMS: This study examined the relationship of baseline characteristics and medication use in patients with type 2 diabetes who were prescribed sitagliptin versus other oral antihyperglycemic agents in clinical practice settings in the United States. METHODS: The General Electric Healthcare's Clinical Data Services electronic medical record (EMR) database, covering 12 million US patients of all ages from 49 states, was used to identify patients with type 2 diabetes, aged >or=30 years, who received their first sitagliptin, metformin, sulfonylurea, or thiazolidinedione prescription between October 2006 and June 2008 (index period) as part of new mono-, dual, or triple therapy regimens. Patient demographics, diagnoses, prescriptions, and laboratory results were extracted for the 12-month period (baseline) prior to the index date (i.e., date of first prescription). Data were stratified by mono-, dual, or triple therapy and compared between sitagliptin regimens and non-sitagliptin regimens with other oral agents (metformin, sulfonylureas, or thiazolidinediones). Adjusted logistic regression analyses were used to estimate odds ratios (OR) associated with prescribing sitagliptin versus other oral monotherapy in relation to patient baseline characteristics. RESULTS: Among 41,836 patients new to oral monotherapy, 876 (2.1%) received sitagliptin. Compared to patients initiating non-sitagliptin monotherapy, patients on sitagliptin monotherapy were older (64 vs. 60 years) and had lower body mass index (33 kg/m(2) vs. 34 kg/m(2)), higher serum creatinine (1.2 vs. 1.0 mg/dL), higher prevalence of chronic renal disease (7.2% vs. 1.9%), greater use of lipid-lowering agents (42% vs. 38%), and higher prevalence of cardiovascular conditions (CVD: 12.7% vs. 8.3%) and microvascular complications (MVD: 13.4% vs. 5.8%) (all p < 0.05). Of 22,683 patients new to dual therapy, 1885 (8.3%) were on sitagliptin regimens. Relative to patients on non-sitagliptin dual therapy regimens, patients prescribed sitagliptin as part of dual therapy regimens were older and had higher serum creatinine, higher prevalence of CVD, MVD, or chronic renal disease, and greater use of lipid-lowering and antihypertensive agents (all p < 0.05). Among 9967 patients new to triple therapy, 2828 (28.4%) were on triple therapy regimens with sitagliptin. Relative to patients on non-sitagliptin triple therapy regimens, patients on sitagliptin as part of triple therapy regimens were older, and had higher serum creatinine and greater use of antihypertensive or lipid-lowering agents (all p < 0.05). Adjusted logistic regression showed that significant predictors of being prescribed sitagliptin monotherapy were older age (OR 1.01, 95% CI 1.00, 1.02), higher HbA(1c) level (OR 1.10, 95% CI 1.04, 1.17), higher serum creatinine level (OR 1.22, 95% CI 1.08, 1.39), presence of MVD (OR 1.50, 95% CI 1.08, 2.09), and presence of chronic renal disease (OR 2.22, 95% CI 1.41, 3.49). LIMITATIONS: Diabetes care delivered by non-participating physicians is not captured in the GE CDS EMR database and, therefore, the prevalence of the diseases identified based on ICD-9 diagnosis/procedure and CPT codes provided in the Appendix may be underestimated. Duration of diabetes was not consistently recorded and some measures were not available. CONCLUSION: Patients with type 2 diabetes who were prescribed sitagliptin regimens in clinical practice were older and more likely to have pre-existing co-morbid conditions compared to patients receiving non-sitagliptin regimens with other common oral antihyperglycemic agents. These findings have important implications for observational studies in that estimated clinical and health outcome measures may be biased due to channeling of patients to different therapies based on different baseline characteristics.