24 research outputs found

    Baseline characteristics and enrichment results from the SONAR trial

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    Aim: The SONAR trial uses an enrichment design based on the individual response to the selective endothelin receptor antagonist atrasentan on efficacy (the degree of the individual response in the urinary albumin‐to‐creatinine ratio [UACR]) and safety/tolerability (signs of sodium retention and acute increases in serum creatinine) to assess the effects of this agent on major renal outcomes. The patient population and enrichment results are described here. Methods: Patients with type 2 diabetes with an estimated glomerular filtration rate (eGFR) within 25 to 75 mL/min/1.73 m2 and UACR between 300 and 5000 mg/g were enrolled. After a run‐in period, eligible patients received 0.75 mg/d of atrasentan for 6 weeks. A total of 2648 responder patients in whom UACR decreased by ≄30% compared to baseline were enrolled, as were 1020 non‐responders with a UACR decrease of <30%. Patients who experienced a weight gain of >3 kg and in whom brain natriuretic peptide exceeded ≄300 pg/mL, or who experienced an increase in serum creatinine >20% (0.5 mg/dL), were not randomized. Results: Baseline characteristics were similar for atrasentan responders and non‐responders. Upon entry to the study, median UACR was 802 mg/g in responders and 920 mg/g in non‐responders. After 6 weeks of treatment with atrasentan, the UACR change in responders was −48.8% (95% CI, −49.8% to −47.9%) and in non‐responders was −1.2% (95% CI, −6.4% to 3.9%). Changes in other renal risk markers were similar between responders and non‐responders except for a marginally greater reduction in systolic blood pressure and eGFR in responders. Conclusions: The enrichment period has successfully identified a population with a profound UACR reduction without clinical signs of sodium retention in whom a large atrasentan effect on clinically important renal outcomes is possible. The SONAR trial aims to establish whether atrasentan confers renal protection

    The Physics of the B Factories

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    EFEITO ANALGÉSICO DO BUTORFANOL NA DOR SOMÁTICA EM GATOS ANESTESIADOS COM PROPOFOL ANALGESIC EFFECT OF BUTORPHANOL ON SOMATIC PAIN IN CATS ANESTHETIZED WITH PROPOFOL

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    O propofol Ă© um agente anestĂ©sico intravenoso usado para indução e manutenção da anestesia, mas produz analgesia limitada, havendo a necessidade do uso concomitante de analgĂ©sicos. Avaliou-se o efeito analgĂ©sico do butorfanol na dor somĂĄtica em gatos anestesiados com doses fracionadas de propofol. Foram utilizados 16 animais, distribuĂ­dos aleatoriamente em dois grupos. Os animais do grupo controle foram prĂ©-tratados com 0,2mg/kg de acepromazina por via IM e, apĂłs 15 minutos, receberam 6mg/kg de propofol por via IV. Os animais do grupo tratamento foram prĂ©-medicados com uma combinação de acepromazina (0,2mg/kg) e butorfanol (0,8mg/kg), administrados na mesma seringa por via IM, e, apĂłs 15 minutos, receberam 6mg/kg de propofol por via IV. Em ambos os grupos, a manutenção da anestesia foi feita com administraçÔes de propofol, na dose de 3mg/kg, por via IV, sempre que necessĂĄrio, durante 60 minutos. A necessidade de readministração de propofol foi verificada pela resposta apresentada ao pinçamento cutĂąneo, atravĂ©s de uma pinça de Kocher. Avaliaram-se tambĂ©m as freqĂŒĂȘncias cardĂ­aca e respiratĂłria, pressĂŁo arterial mĂ©dia, saturação de oxiemoglobina e temperatura retal. A administração de butorfanol causou apenas redução nas freqĂŒĂȘncias cardĂ­aca e respiratĂłria e na saturação de oxiemoglobina, em comparação com o grupo controle,sem exercer influĂȘncia significativa sobre o perĂ­odo hĂĄbil, a dose total administrada e o perĂ­odo de recuperação do propofol. Concluiu-se que a adição de butorfanol nĂŁo produziu analgesia somĂĄtica em gatos anestesiados com doses fracionadas de propofol.<br>Propofol is an intravenous anesthetic agent used for induction and maintenance of anesthesia but produces limited analgesia, and concomitant use of analgesics is necessary. The analgesic effect of butorphanol in somatic pain in cats anesthetized with intermittent doses of propofol was evaluated. Sixteen animals were randomly assigned to 2 groups. Control group animals were premedicated with IM acepromazine (0,2mg/kg) and after 15 minutes IV propofol (6mg/kg) was administered. Treatment group animals were premedicated with IM acepromazine (0,2mg/kg) and butorphanol (0,8mg/kg), mixed in the same syringe and after 15 minutes IV propofol (6mg/kg) was administered. In both groups anesthesia was maintained with repeated injections of propofol (3mg/kg) as needed, during 60 minutes. The need to complement propofol doses was determined by reactions to a skin pinch with a Kocher hemostatic forceps.Heart rate, respiratory rate, mean blood pressure, rectal body temperature and oxyhemoglobin saturation were also recorded. Administration of butorphanol caused minimal changes in cardiopulmonary variables compared to control group and did not affect duration of anesthesia and total dose of propofol or recovery period. We concluded that addition of butorphanol did not produce somatic analgesia during anesthesia maintained with repeated injections of propofol in cats

    Acute Aluminum Intoxication

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    Observation of CP violation in the B0 meson system

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    We present an updated measurement of time-dependent CP-violating asymmetries in neutral B decays with the BABAR detector at the PEP-II asymmetric B Factory at SLAC. This result uses an additional sample of Upsilon(4S) decays collected in 2001, bringing the data available to 32 million B-anti-B pairs. We select events in which one neutral B meson is fully reconstructed in a final state containing charmonium and the flavor of the other neutral B meson is determined from its decay products. The amplitude of the CP-violating asymmetry, which in the Standard Model is proportional to sin2beta, is derived from the decay time distributions in such events. The result sin2beta = 0.59 +/- 0.14 (stat) +/- 0.05 (syst) establishes CP violation in the B^0 meson system. We also determine |lambda| = 0.93 +/- 0.09 {stat} +/- 0.03 {syst}, consistent with no direct CP violation.Comment: 8 pages, 2 figures, submitted to Physical Review Letter

    The first year of the BABAR experiment at PEP-II

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    The BABAR detector, situated at the SLAC PEP-II asymmetric e^+e^- collider, has been recording data at energies on and around the Upsilon(4S) resonance since May 1999. In this paper, we briefly describe the PEP-II B Factory and the BABAR detector. The performance presently achieved by the experiment in the areas of tracking, vertexing, calorimetry and particle identification is reviewed. Analysis concepts that are used in the various papers submitted to this conference are also discussed
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