2015 Gout classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative.

OBJECTIVE: Existing criteria for the classification of gout have suboptimal sensitivity and/or specificity, and were developed at a time when advanced imaging was not available. The current effort was undertaken to develop new classification criteria for gout. METHODS: An international group of investigators, supported by the American College of Rheumatology and the European League Against Rheumatism, conducted a systematic review of the literature on advanced imaging of gout, a diagnostic study in which the presence of monosodium urate monohydrate (MSU) crystals in synovial fluid or tophus was the gold standard, a ranking exercise of paper patient cases, and a multi-criterion decision analysis exercise. These data formed the basis for developing the classification criteria, which were tested in an independent data set. RESULTS: The entry criterion for the new classification criteria requires the occurrence of at least one episode of peripheral joint or bursal swelling, pain, or tenderness. The presence of MSU crystals in a symptomatic joint/bursa (ie, synovial fluid) or in a tophus is a sufficient criterion for classification of the subject as having gout, and does not require further scoring. The domains of the new classification criteria include clinical (pattern of joint/bursa involvement, characteristics and time course of symptomatic episodes), laboratory (serum urate, MSU-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy CT, radiographic gout-related erosion). The sensitivity and specificity of the criteria are high (92% and 89%, respectively). CONCLUSIONS: The new classification criteria, developed using a data-driven and decision-analytic approach, have excellent performance characteristics and incorporate current state-of-the-art evidence regarding gout.

Canceling dental procedures due to elevated blood pressure: Is it appropriate?

BACKGROUND: In 1974, the American Dental Association first considered recommending that dental offices measure blood pressure (BP) routinely, and it has been further encouraged since 2006. Investigators in several dental publications have recommended cancellation of dental procedures based solely on BP greater than 180/110 millimeters of mercury for urgent oral health care and greater than 160/100 mm Hg for elective oral health care, in the absence of prior medical consultation. METHODS: The authors reviewed the evidence for cancellation of any dental or surgical procedures by using an Ovid MEDLINE search for the terms dental, elevated blood pressure, and hypertension. In addition, the authors searched resources at ebd.ada.org using the same criteria. The authors collaborated to develop recommendations in view of 2017 guidelines on this subject. RESULTS: To the authors' knowledge, there are no professionally accepted criteria or study evidence indicating a specific BP elevation at which to prohibit oral health care. Researchers of a 2015 review on management of comorbidities in ambulatory anesthesia failed to find increased morbidity from hypertension in the outpatient setting. CONCLUSIONS: To the authors' knowledge, there are no prospective study investigators that have addressed whether or when to cancel dental procedures due to office-measured elevated BP. The authors recommend using current anesthesiology guidelines based on functional status and past BP measurements to prevent unnecessary cancellations. PRACTICAL IMPLICATIONS: It is seldom necessary to cancel dental procedures on the basis of BP measured before a planned procedure for patients under a physician's care.

Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial.

BACKGROUND: The aim of this study was to assess dual renin system intervention with the maximum recommended doses of aliskiren and valsartan, compared with each drug alone in patients with hypertension. METHODS: In this double-blind study, 1797 patients with hypertension (mean sitting diastolic blood pressure 95-109 mm Hg and 8-h daytime ambulatory diastolic blood pressure > or =90 mm Hg) were randomly assigned to receive once-daily aliskiren 150 mg (n=437), valsartan 160 mg (455), a combination of aliskiren 150 mg and valsartan 160 mg (446), or placebo (459) for 4 weeks, followed by forced titration to double the dose to the maximum recommended dose for another 4 weeks. The primary endpoint was change in mean sitting diastolic blood pressure from baseline to week 8 endpoint. Analyses were done by intention to treat. This trial is registered at ClinicalTrials.gov with the number NCT00219180. FINDINGS: 196 (11%) patients discontinued study treatment before the end of the trial (63 in the placebo group, 53 in the aliskiren group, 43 in the valsartan group, and 37 in the aliskiren/valsartan group), mainly due to lack of therapeutic effect. At week 8 endpoint, the combination of aliskiren 300 mg and valsartan 320 mg lowered mean sitting diastolic blood pressure from baseline by 12.2 mm Hg, significantly more than either monotherapy (aliskiren 300 mg 9.0 mm Hg decrease, p<0.0001; valsartan 320 mg, 9.7 mm Hg decrease, p<0.0001), or with placebo (4.1 mm Hg decrease, p<0.0001). Rates of adverse events and laboratory abnormalities were similar in all groups. INTERPRETATION: The combination of aliskiren and valsartan at maximum recommended doses provides significantly greater reductions in blood pressure than does monotherapy with either agent in patients with hypertension, with a tolerability profile similar to that with aliskiren and valsartan alone.

Aliskiren and valsartan in stage 2 hypertension: subgroup analysis of a randomized, double-blind study.

INTRODUCTION: Patients with stage 2 hypertension require large absolute reductions in blood pressure (BP) to achieve recommended BP goals. Combination therapy with the direct renin inhibitor, aliskiren, and the angiotensin receptor blocker, valsartan, has been shown to produce greater BP reductions than either agent alone in a double-blind study in 1797 hypertensive patients. METHODS: This post-hoc analysis evaluated the BP-lowering efficacy of aliskiren in combination with valsartan in a subset of patients (n=581) with stage 2 hypertension (baseline mean sitting systolic BP [msSBP] > or =160 mmHg). Patients were randomized to receive aliskiren/valsartan 150/160 mg, aliskiren 150 mg, valsartan 160 mg, or placebo once daily for 4 weeks followed by 4 weeks at double the initial dose. Mean changes from baseline in msSBP and mean sitting diastolic BP were assessed at week-8 endpoint (intent-to-treat population). RESULTS: Aliskiren/valsartan 300/320 mg reduced BP from baseline by 22.5/11.4 mmHg at week-8 endpoint. BP reductions with combination therapy were significantly greater than with aliskiren 300 mg (17.3/8.9 mmHg, P<0.05), valsartan 320 mg (15.5/8.3 mmHg, P<0.01), or with placebo (7.9/3.7 mmHg, P<0.0001). BP control rates (<140/90 mmHg) were also significantly higher (P<0.05) with aliskiren/valsartan 300/320 mg (29.8%) compared with either aliskiren 300 mg (19.0%) or valsartan 320 mg (13.8%) monotherapy, or placebo (8.9%). All treatments were generally well tolerated. CONCLUSION: Combination therapy with aliskiren and valsartan provided significantly greater BP reductions over aliskiren or valsartan monotherapy and is an appropriate option for management of BP in patients with stage 2 hypertension.

Accuracy of the HoMedics BPA-300, a home blood pressure monitor using the auscultatory method.

PURPOSE: To determine whether the HoMedics Model BPA-300 meets American Association for the Advancement of Medical Instrumentation (AAMI) accuracy standards. METHOD: Simultaneous auscultatory measurements by two observers using a mercury manometer were obtained in participants during measurement with the HoMedics Model BPA-300. Triple measurements were obtained after a minimum of 5 min of rest and 1 min between readings. RESULTS: In total, 132 participants had 396 nurse-measured blood pressures (BP) and 385 successful systolic and 383 diastolic monitor readings. The initial auscultation systolic BP was less than 100 mmHg in 17 participants (12.9%), between 100 and 160 mmHg in 108 participants (81.8%), and greater than 160 mmHg in seven (5.3%) of participants. The average difference between the observers and device was 0.6+/-4.3 mmHg for systolic and 0.5+/-4.3 mmHg for diastolic-measured BPs by AAMI method 1, which met this guideline. The average difference between observers and device by AAMI method 2 was 0.9+/-4.0 mmHg for systolic and 0.5+/-3.9 mmHg for diastolic-measured BP, which met this guideline. CONCLUSION: The HoMedics Model BPA-300 meets AAMI accuracy standards using methods 1 and 2.

2015 Gout Classification Criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative.

OBJECTIVE: Existing criteria for the classification of gout have suboptimal sensitivity and/or specificity, and were developed at a time when advanced imaging was not available. The current effort was undertaken to develop new classification criteria for gout. METHODS: An international group of investigators, supported by the American College of Rheumatology and the European League Against Rheumatism, conducted a systematic review of the literature on advanced imaging of gout, a diagnostic study in which the presence of monosodium urate monohydrate (MSU) crystals in synovial fluid or tophus was the gold standard, a ranking exercise of paper patient cases, and a multicriterion decision analysis exercise. These data formed the basis for developing the classification criteria, which were tested in an independent data set. RESULTS: The entry criterion for the new classification criteria requires the occurrence of at least 1 episode of peripheral joint or bursal swelling, pain, or tenderness. The presence of MSU crystals in a symptomatic joint/bursa (i.e., synovial fluid) or in a tophus is a sufficient criterion for classification of the subject as having gout, and does not require further scoring. The domains of the new classification criteria include clinical (pattern of joint/bursa involvement, characteristics and time course of symptomatic episodes), laboratory (serum urate, MSU-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy computed tomography, radiographic gout-related erosion). The sensitivity and specificity of the criteria are high (92% and 89%, respectively). CONCLUSION: The new classification criteria, developed using a data-driven and decision analytic approach, have excellent performance characteristics and incorporate current state-of-the-art evidence regarding gout.

Comparison of the Omron HEM-637 wrist monitor to the auscultation method with the wrist position sensor on or disabled.

BACKGROUND: To determine whether the Omron HEM637 wrist model with the wrist positioning sensor turned on (Son) is more accurate relative to upper arm auscultation by trained professionals than when the sensor was manually turned off (Soff). METHODS: Forty-four subjects, at least 30 years old, had repeated, sequential dual-observer upper arm auscultatory measurements (5 to 6 each) and oscillometric Omron HEM637 wrist measurements (4 each). Nineteen subjects were assigned to the wrist sensor On group and 25 were assigned to the wrist sensor Off group. A total of 425 auscultatory and 164 wrist measurements were analyzed. RESULTS: The Omron HEM-637 measured the blood pressure (BP) with equal accuracy to the observers using the auscultatory technique (difference -1.37 +/- 8.51/3.47 +/- 8.07 mm Hg, P =.71/.14). The wrist sensor did improve the accuracy of the measurements compared to the subjects that had the sensor deactivated. The sensor On group (Son) measured the systolic BP (0.82 +/- 9.83 mm Hg) and diastolic BP (-0.72 +/- 9.07 mm Hg) statistically the same as by auscultation (P =.86 for systolic BP and P =.83 for diastolic BP). The sensor Off (Soff) group measured the SBP (-3.03 +/- 7.12 mm Hg) and diastolic BP (-5.56 +/- 6.68 mm Hg) statistically different than auscultation (P =.46 for systolic BP and P =.02 for diastolic BP). The higher (negative) measurement for both the systolic BP and diastolic BP suggests that the average position of the wrist was 1.75 inches (4.4 cm) below the heart level in this group with the sensor off. CONCLUSIONS: This study demonstrated that the Omron HEM-637 monitor with a wrist sensor more accurately measured BP compared to the same model with the sensor turned off.

Accuracy of the HoMedics Walgreens Deluxe Arm Blood Pressure device (WGNBPA-540) compared with auscultation in 85 individuals.

PURPOSE: To determine whether the HoMedics Walgreens Deluxe Arm Blood Pressure device (WGNBPA-540) meets the Association for the Advancement of Medical Instrumentation and the Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol accuracy requirements. MATERIALS AND METHODS: Simultaneous auscultatory measurements by two observers were obtained in individuals during measurement with the HoMedics WGNBPA-540. Each individual had three measurements after a minimum of 10 min of rest and 1 min between readings. RESULTS: Two hundred and fifty-five triplicate measurements were made in 85 individuals. The observer minus the WGNBPA-540 mean systolic blood pressure/diastolic blood pressure differences were 0.92/-0.22 mmHg (± 0.4.51/4.42 mmHg standard deviation). The observer minus WGNBPA-540 device within 5 mmHg for the systolic blood pressure/diastolic blood pressure was 86.27/92.16%, within 10 mmHg was 99.61/97.65%, and within 15 mmHg was 100/98.82%. CONCLUSION: The HoMedics model, WGNBPA-540, meets the Advancement of Medical Instrumentation (methods 1 and 2) and the International Protocol accuracy standard requirement.

Aliskiren/valsartan combination for the treatment of cardiovascular and renal diseases.

Chronic activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in the development of hypertension, and cardiac and renal diseases. RAAS inhibitors, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), improve cardiovascular and renal outcomes. However, studies have shown that residual morbidity and mortality remains high, despite current optimal treatment. More comprehensive control of the RAAS might provide additional reductions in morbidity and mortality. Direct renin inhibitors offer the potential for enhanced RAAS control as they target the system at the point of activation, thereby reducing plasma renin activity (PRA); by contrast, ARBs and ACE inhibitors increase PRA. Elevated PRA is independently associated with cardiovascular morbidity and mortality. A single-pill combination of the direct renin inhibitor, aliskiren, and the ARB, valsartan, at once-daily doses of 150/160 mg and 300/320 mg, has recently been approved by the US FDA for the treatment of hypertension in patients not adequately controlled on aliskiren or ARB monotherapy, and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. This article examines the efficacy, safety and tolerability of aliskiren/valsartan combination therapy, and considers the evidence for the potential organ-protection benefits of this treatment.