Background: Although the treatment of asthma has been addressed in several guidelines, the management of the first acute wheezing episode in infants has not often been evaluated. We surveyed practicing pediatricians in Spain about the treatment they would provide in a simulated case.
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Results: A total of 2347 questionnaires were returned with useful data (78.2%). Most (90.4%) of the pediatricians would use a short-acting beta2 agonist (SABA) via a metered-dose inhaler with a spacer and a face mask or nebulizer. However, only 34.5% chose a SABA alone: 31.3% added an oral steroid and 27.6% added an inhaled corticosteroid (ICS). The factors associated with the use of ICS in the acute attack were: (1) lack of specific training in pediatrics (OR 1.45; 1.12-1.85) and (2) primary care health center setting (OR 1.31; 1.01-1.69) or rural setting (OR 1.28; 1.01-1.66). Forty-four percent did not recommend any follow-up treatment while 20.7% prescribed ICS as maintenance therapy. The factors related to this decision were the same as those described above.
Conclusions: The management of a first wheezing episode seems to meet published guidelines among Spanish pediatricians with formal training in pediatrics and in those who work in a hospital setting or in urban areas.
Claire Danes is an American actress who has a net worth of $35 million. Claire Danes has been in the public eye for years it seems. She began her acting career onstage in New York, appearing in various productions around the city. She then transitioned to television in the early 90s, appearing as a guest star on an episode of "Law and Order", and then on HBO's "Lifestories: Families in Crisis". Just two years after beginning her on-camera careeer, she booked two jobs, back-to-back, that would make her a household name. "My So-Called Life" was a short-lived, but much beloved drama, that only ran for nineteen episodes. Her performance on the show, however, which was completely believable and unaffected, garnered her a Golden Globe, and an Emmy nomination. That same year, she starred opposite Winona Ryder and Susan Sarandon in a well-received adaptation of "Little Women". From there, she began to gain more high-profile roles, including starring in Baz Luhrmann's "Romeo + Juliet", "The Rainmaker", "Les Miserables", "Igby Goes Down", "The Hours", "Terminator 3: Rise of the Machines", and "Stardust", among other projects. She took some time off to attend Yale University, but ultimately decided to focus on her acting career. In 2010, she won an Emmy for her performance in "Temple Grandin", followed by a Golden Globe and a SAG Award for the same performance in 2011. In October of 2011, she began starring on the hit Showtime series, "Homeland", and won another Golden Globe for her work.
Danes booked her first big acting job at 13, on "Dudley," the sitcom pilot from actor Dudley Moore. The show only aired for six episodes on CBS in 1993. She was on an episode of "Law & Order" called "Skin Deep," playing a teenage murderer. In 1994, Danes played Beth March in "Little Women." That same year, she got rave reviews for her role as Angela Chase on "My So-Called Life." That show only aired 19 episodes but has a large cult following to this day. After "My So-Called Life" ended, Danes booked film roles in "Home for the Holidays, the Baz Lurhmann adaptation of "Romeo + Juliet," "The Rainmaker," "The Family Stone," and "Terminator 2: Rise of the Machines," to name just a few.
Beginning in 2011, Claire Danes starred on the hit Showtime series Homeland. In 2014 her salary per episode of Homeland was $250,000. In 2017 her salary per episode was raised to $450,000 which made her one of the highest-paid actors on TV. The series typically films around 12 episodes per season which means she earned around $5.5 million per year from Homeland.
NOCTIVA is available as an oil-in-water emulsion at two dose strengths, 0.83 mcg and 1.66 mcg of desmopressin acetate per spray, for nasal administration. Each spray is 0.1 mL. The dose strengths are expressed as desmopressin acetate and are equivalent to 0.75mcg and 1.5 mcg of desmopressin free base per spray, respectively. Both formulations also contain the following inactive ingredients: cyclopentadecanolide; cottonseed oil; sorbitan monolaurate; polysorbate 20; citric acid, anhydrous; sodium citrate dihydrate; and water for injection.
NOCTIVA (desmopressin acetate) nasal spray is available in a 3.5 mL amber glass bottle (nominal volume) fitted with a nasal actuator, a cartridge pump, and a dip tube, delivering a dose of either 0.83 mcg or 1.66 mcg of desmopressin acetate (equivalent to0.75 mcg or 1.5 mcg of desmopressin) per spray (0.1 mL). Each bottle contains a target amount of 3.8 g formulation with 30 effective doses in addition to the initial priming (5 actuations), equivalent to 30 days of medication when used as one spray once a day.
Two randomized, double-blind, placebo-controlled, multi-center trials conducted in adults 50 years of age and older evaluated the efficacy and safety of NOCTIVA nasal spray compared to placebo. At baseline, 1045 patients treated with NOCTIVA 0.83 mcg or 1.66 mcg, or placebo had nocturia due to nocturnal polyuria, wakening at least 2 times per night to urinate. Nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production. The mean age of the patients studied with nocturia due to nocturnal polyuria was 67 years with 42% between 50 and 64 years of age, and 58% aged 65 years and older. Fifty-seven percent were men and 43% were women. Caucasians comprised 79%, Blacks 12%, Hispanics 6%, and Asians 2% of the trial population.
During these trials, serious adverse reactions were reported in 2%, 2%, and 3% of patients with nocturia due to nocturnal polyuria treated with NOCTIVA 0.83 mcg, NOCTIVA 1.66 mcg, and placebo, respectively. There was one case of hyponatremia in the 1.66 mcg group and one case in the placebo group classified as serious adverse reactions.
Among patients with nocturia due to nocturnal polyuria, the discontinuation rate due to adverse reactions was 4.0% with NOCTIVA0.83 mcg, 4.4% with NOCTIVA 1.66 mcg, and 2.3% with placebo. Table 1 displays the most common adverse reactions leading to discontinuation in patients with nocturia due to nocturnal polyuria.
Table 2 summarizes the most common adverse reactions reported by patients with nocturia due to nocturnal polyuria. This table shows adverse reactions reported in at least 2% of patients treated with NOCTIVA and at a higher incidence with the 1.66 mcg dose than with placebo.
Following nasal spray administration of NOCTIVA, the median time to peak plasma concentrations (Tmax) was 0.25 hour for the 0.83 mcg dose and 0.75 hour for the 1.66 mcg dose. The mean ( S.D.) peak plasma concentration (Cmax) was 4.00 ( 3.85) pg/mL for the0.83 mcg dose and 9.11 ( 6.90) pg/mL for the 1.66 mcg dose. Plasma NOCTIVA concentrations generally declined below 2 pg/mL (lower limit of quantitation) between four to six hours post-dose.
Following an intranasal dose of 1.66 mcg of NOCTIVA, the median apparent terminal half-life (T1/2) was 2.8 hours. The distribution of T1/2 in patients with an eGFR above 50 mL/min/1.73 m2 ranged from 1.4-3.8 hours.
The efficacy of NOCTIVA in patients with nocturia due to nocturnal polyuria was established in two 12-week randomized, double-blind, placebo-controlled, multi-center trials in adults at least 50 years of age. At baseline, patients were required to have a six-month history of at least two nocturic episodes per night, on average, and at least 13 documented nocturia episodes over 6 nights during screening. The majority of patients in these trials were Caucasian (79%). The mean age was 67 years (range 50-90 years), 57% were men and 43% were women.
In Trial 1, a total of 612 patients with nocturia due to nocturnal polyuria were randomized to receive either NOCTIVA 1.66 mcg (n=199), NOCTIVA 0.83 mcg (n=209) or placebo (n=204). In Trial 2, a total of 433 patients were randomized to receive NOCTIVA1.66 mcg (n=143), 0.83 mcg (n=145) or placebo (n=145). In both trials, nocturnal polyuria was defined as a night-time urineproduction exceeding one-third of the 24-hour urine production confirmed with a 24-hour urine frequency/volume chart.
Each trial had two co-primary efficacy endpoints: (1) The change in mean number of nocturic episodes per night from baseline during the 12-week treatment period, and (2) The percentage of patients who achieved at least a 50% reduction from baseline in the mean number of nocturia episodes per night during the 12-week treatment period.
Figure 1 shows the percentage of patients in each treatment arm who achieved various reductions from baseline in the mean number of nightly nocturic episodes. In both trials, there was consistent separation between the NOCTIVA 1.66 mcg and placebo curves.
BACKGROUND: Streptococcus pneumoniae is a leading and serious coinfection in adults with human immunodeficiency virus (HIV) infection, particularly in Africa. Prevention of this disease by vaccination with the current 23-valent polysaccharide vaccine is suboptimal. Protein conjugate vaccines offer a further option for protection, but data on their clinical efficacy in adults are needed. METHODS: In this double-blind, randomized, placebo-controlled clinical efficacy trial, we studied the efficacy of a 7-valent conjugate pneumococcal vaccine in predominantly HIV-infected Malawian adolescents and adults who had recovered from documented invasive pneumococcal disease. Two doses of vaccine were given 4 weeks apart. The primary end point was a further episode of pneumococcal infection caused by vaccine serotypes or serotype 6A. RESULTS: From February 2003 through October 2007, we followed 496 patients (of whom 44% were male and 88% were HIV-seropositive) for 798 person-years of observation. There were 67 episodes of pneumococcal disease in 52 patients, all in the HIV-infected subgroup. In 24 patients, there were 19 episodes that were caused by vaccine serotypes and 5 episodes that were caused by the 6A serotype. Of these episodes, 5 occurred in the vaccine group and 19 in the placebo group, for a vaccine efficacy of 74% (95% confidence interval [CI], 30 to 90). There were 73 deaths from any cause in the vaccine group and 63 in the placebo group (hazard ratio in the vaccine group, 1.18; 95% CI, 0.84 to 1.66). The number of serious adverse events within 14 days after vaccination was significantly lower in the vaccine group than in the placebo group (3 vs. 17, P=0.002), and the number of minor adverse events was significantly higher in the vaccine group (41 vs. 13, P=0.003). CONCLUSIONS: The 7-valent pneumococcal conjugate vaccine protected HIV-infected adults from recurrent pneumococcal infection caused by vaccine serotypes or serotype 6A. (Current Controlled Trials number, ISRCTN54494731.) 2ff7e9595c
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