333 research outputs found

    Identification of false positive exercise tests with use of electrocardiographic criteria: A possible role for atrial repolarization waves

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    Atrial repolarization waves are opposite in direction to P waves, may have a magnitude of 100 to 200 mu V and may extend into the ST segment and T wave. It was postulated that exaggerated atrial repolarization waves during exercise could produce ST segment depression mimicking myocardial ischemia. The P waves, PR segments and ST segments were studied in leads II, III, aVF and V4 to V6 in 69 patients whose exercise electrocardiogram (ECG) suggested ischemia (100 mu V horizontal or 150 mu V upsloping ST depression 80 ms after the J point). All had a normal ECG at rest. The exercise test in 25 patients (52% male, mean age 53 years) was deemed false positive because of normal coronary arteriograms and left ventricular function (5 patients) or normal stress single photon emission computed tomographic thallium or gated blood pool scans (16 patients), or both (4 patients). Forty-four patients with a similar age and gender distribution, anginal chest pain and at least one coronary stenosis greater than or equal to 80% served as a true positive control group. The false positive group was characterized by (1) markedly downsloping PR segments at peak exercise, (2) longer exercise time and more rapidmore » peak exercise heart rate than those of the true positive group, and (3) absence of exercise-induced chest pain. The false positive group also displayed significantly greater absolute P wave amplitudes at peak exercise and greater augmentation of P wave amplitude by exercise in all six ECG leads than were observed in the true positive group.« les

    Influence of calcium administration on the short-term hemodynamic and anti-ischemic effects of nifedipine

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    This prospective study investigated whether pretreatment with intravenously administered calcium would influence the effect of nifedipine on rest hemodynamics and treadmill performance in patients with ischemic heart disease. Seventeen patients were studied after undergoing a qualifying treadmill exercise test that revealed ST segment depression indicative of ischemic heart disease. Study subjects performed three additional treadmill tests as part of the protocol. One treadmill test was obtained from each patient to provide baseline measurements without a preceding intravenous infusion and in the absence of all antianginal drugs including nifedipine two additional exercise tests were preceded by an infusion and 10 mg of bite-and-swallow nifedipine. The infusions, administered in a randomized, double-blind, crossover fashion, consisted of either 10 ml of 10% calcium chloride (13.6 mEq) in 50 ml of 5% dextrose in water or 5% dextrose in water alone. Rest systolic blood pressure (134 +/- 4.6 mm Hg) was unchanged after placebo infusion (135 +/- 4.6 mm Hg) but decreased to 124 +/- 4.1 mm Hg (p less than 0.01) 25 min after nifedipine administration. Rest systolic blood pressure increased after calcium infusion (from 139 +/- 4.3 to 148 +/- 4.8 mm Hg, p less than 0.01) and then decreased significantly 25 min after nifedipine administration to 135 +/- 4.2 mm Hg (p less than 0.01). Despite a decrease at the time of peak nifedipine effect after either infusion, systolic blood pressure was significantly lower after administration of nifedipine alone than after administration of calcium and nifedipine (124 +/- 4.1 vs. 135 +/- 4.2 mm Hg, p less than 0.01)

    The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials

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    Purpose To understand how improvements in the symptoms of overactive bladder (OAB) seen with the b3-adrenoceptor agonist mirabegron 50 mg, correlate with patient experience as measured by validated and standard patient-reported outcomes (PROs), and to identify whether there is overall directional consistency in the responsiveness of PROs to treatment effect. Methods In a post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled, 12-week Phase III trials of mirabegron 50 mg once daily, responder rates for incontinence frequency (C50 % reduction in incontinence episodes/24 h from baseline to final visit), micturition frequency (B8 micturitions/24 h at final visit), and PROs [minimally important differences in patient perception of bladder condition (PPBC) and subsets of the overactive bladder questionnaire (OAB-q) measuring total health-related quality of life (HRQoL), and symptom bother] were evaluated individually and in combination. Results Mirabegron 50 mg demonstrated greater improvement from baseline to final visit than placebo for each of the responder analyses, whether for individual objective and subjective outcomes or combinations thereof. These improvements versus placebo were statistically significant for all double and triple responder analyses and for all single responder analyses except PPBC. PRO measurements showed directional consistency and significant correlations, and there were also significant correlations between objective and subjective measures of efficacy. Conclusions The improvements in objective measures seen with mirabegron 50 mg translate into a meaningful clinical benefit as evident by the directional consistency seen in HRQoL measures of benefit

    Onset of action of the beta 3-adrenoceptor agonist, mirabegron, in Phase II and III clinical trials in patients with overactive bladder

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    Purpose Long-term persistence with pharmacotherapy for overactive bladder (OAB) requires a drug with an early onset of action and good efficacy and tolerability profile. Although antimuscarinics improve OAB symptoms within 1–2 weeks of initiating treatment, adherence after 3 months is relatively poor due to bothersome side effects (e.g., dry mouth and constipation). Mirabegron, a b3-adrenoceptor agonist, has demonstrated significant improvements in key symptoms of OAB and good tolerability after 12 weeks in Phase III studies. Methods This was a prespecified pooled analysis of three randomized, double-blind, placebo-controlled, 12-week studies, and a Phase II study, to evaluate efficacy and tolerability of mirabegron 25 and 50 mg versus placebo. The main efficacy endpoints were change from baseline to week 1 (Phase II only), week 4, and final visit in mean number of incontinence episodes/24 h, micturitions/24 h, and mean volume voided/micturition (MVV). Results A significant benefit for mirabegron 25 and 50 mg versus placebo was evident at the first assessment point, 4 weeks after initiation of therapy, in Phase III studies for incontinence, micturitions, and MVV. The earliest measured benefit was after 1 week, in the Phase II study. Quality-of-life parameters also significantly improved with mirabegron 25 and 50 mg as early as week 4. Significant benefits continued throughout the studies. Mirabegron was well tolerated. Conclusions The early onset of action and good overall efficacy and tolerability balance that mirabegron offers may lead to high rates of persistence with mirabegron in the long-term treatment of OAB

    Prehospital management of exertional heat stroke at sports competitions for Paralympic athletes

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    Objectives: To adapt key components of exertional heat stroke (EHS) prehospital management proposed by the International Olympic Committee (IOC) Adverse Weather Impact Expert Working Group for the Olympic Games Tokyo 2020 so that it is applicable for the Paralympic athletes.Methods: An expert working group representing members with research, clinical and lived sports experience from a Para sports perspective reviewed and revised the IOC consensus document of current best practice regarding the prehospital management of EHS.Results: Similar to Olympic competitions, Paralympic competitions are also scheduled under high environmental heat stress; thus, policies and procedures for EHS prehospital management should also be established and followed. For Olympic athletes, the basic principles of EHS prehospital care are: early recognition, early diagnosis, rapid, on-site cooling, and advanced clinical care. Although these principles also apply for Paralympic athletes, slight differences related to athlete physiology (e.g., autonomic dysfunction) and mechanisms for hands-on management (e.g., transferring the collapsed athlete or techniques for whole-body cooling) may require adaptation for care of the Paralympic athlete.Conclusions: Prehospital management of EHS in the Paralympic setting employs the same procedures as for Olympic athletes with some important alterations.</div

    Risk of injuries in Paralympic track and field differs by impairment and event discipline A prospective cohort study at the London 2012 Paralympic Games

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    Background: The incidence rates (IRs) and factors associated with injuries in the sport of Paralympic athletics (track and field) have not been comprehensively and prospectively studied. Purpose: To determine injury IRs, characteristics of injuries, and associated factors in the sport of athletics at the London 2012 Paralympic Games. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 977 athletes competing in the sport of athletics were followed over a total 10-day competition period of the Paralympic Games. Daily injury data were obtained via 2 databases: (1) a custom-built, web-based injury and illness surveillance system (WEB-IISS), maintained by team medical personnel; and (2) the organizing committee database, maintained by medical providers in the medical stations operated by the London Organising Committee of the Olympic and Paralympic Games. Athlete impairment and event discipline were obtained via the International Paralympic Committee athlete database. IRs (injuries per 1000 athlete-days) by impairment, event discipline, sex, and age were examined. Results: The overall IR was 22.1 injuries per 1000 athlete-days (95% CI, 19.5-24.7). In track disciplines, ambulant athletes with cerebral palsy experienced a lower incidence of injuries (IR, 10.2; 95% CI, 4.2-16.2) when compared with ambulant athletes from other impairment categories. Athletes in seated throwing experienced a higher incidence of injuries (IR, 23.7; 95% CI, 17.5-30.0) when compared with athletes in wheelchair racing (IR, 10.6; 95% CI, 5.5-15.6). In both track and field disciplines, the majority of injuries did not result in time loss from competition or training. Ambulant athletes experienced the greatest proportion of injuries to the thigh (16.4% of all injuries; IR, 4.0), observed predominantly in track athletes. Wheelchair or seated athletes experienced the greatest proportion of injuries to the shoulder/clavicle (19.3% of all injuries; IR, 3.4), observed predominantly in field athletes. Conclusion: This is the first prospective cohort study examining injury IRs and associated factors in the sport of athletics at the Paralympic Games. Injury patterns were specific to the event discipline and athlete impairment. The majority of injuries occurred to the thigh (ambulant athletes) or shoulder/clavicle (wheelchair or seated athletes) and did not result in time loss. </jats:sec
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