FDA committee recommends approval for viagra rival.
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Biomedical subjects
Publications and source records attributed to S Gottlieb.
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PURPOSE: To compare the prognosis of patients with a first Q-wave versus non-Q-wave myocardial infarction (MI) in the reperfusion era. METHODS: Patients with a first MI were compared according to type of infarct-Q-wave (n = 1,786) versus non-Q-wave (n = 722)-and by treatment with thrombolysis. RESULTS: Patients with non-Q-wave MI were more likely to be female and to have undergone previous coronary revascularization. Their 30-day mortality rate was 7%, as compared with a rate of 9% among patients with Q-wave infarction (adjusted odds ratio [OR] = 0.6, 95% confidence interval [CI]: 0.4 to 0.9). However, the subsequent 30-day to 1-year mortality rates were similar in patients with Q-wave or non-Q-wave MI. Patients who were not treated with thrombolysis and who had a non-Q-wave MI had a lower 30-day mortality rate (OR = 0.6, 95% CI: 0.3 to 0.9) but a similar 30-day to 1-year mortality rate (hazard ratio [HR] = 1.5, 95% CI: 0.9 to 2.5) as compared with their counterparts who developed Q-wave infarction. Among thrombolysis-treated patients, 30-day (OR = 0.8, 95% CI: 0.4 to 1.5) as well as 30-day to 1-year (HR = 1.2, 95% CI: 0.5 to 3.0) mortality rates were similar between patients who developed either Q-wave or non-Q-wave MI. CONCLUSIONS: Patients who received thrombolysis had similar early and late mortality rates after the index infarction regardless of whether they had a Q-wave or non-Q-wave MI. Conversely, among patients who were not treated with thrombolysis, patients with a non-Q-wave MI had lower early mortality rates but similar long-term mortality rates as those with Q-wave MI.
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CONTEXT: Results from recent studies on the effects of beta1-blockade in patients with heart failure demonstrated a 34% reduction in total mortality. However, the effect of beta1-blockade on the frequency of hospitalizations, symptoms, and quality of life in patients with heart failure has not been fully explored. OBJECTIVE: To examine the effects of the beta1-blocker controlled-release/extended-release metoprolol succinate (metoprolol CR/XL) on mortality, hospitalization, symptoms, and quality of life in patients with heart failure. DESIGN: Randomized, double-blind controlled trial, preceded by a 2-week single-blind placebo run-in period, conducted from February 14, 1997, to October 31, 1998, with a mean follow-up of 1 year. SETTING: Three hundred thirteen sites in 14 countries. PARTICIPANTS: Patients (n = 3991) with chronic heart failure, New York Heart Association (NYHA) functional class II to IV, and ejection fraction of 0.40 or less who were stabilized with optimum standard therapy. INTERVENTIONS: Patients were randomized to metoprolol CR/XL, 25 mg once per day (NYHA class II), or 12.5 mg once per day (NYHA class III or IV), titrated for 6 to 8 weeks up to a target dosage of 200 mg once per day (n = 1990); or matching placebo (n = 2001). MAIN OUTCOME MEASURES: Total mortality or any hospitalization (time to first event), number of hospitalizations for worsening heart failure, and change in NYHA class, by intervention group; quality of life was assessed in a substudy of 741 patients. RESULTS: The incidence of all predefined end points was lower in the metoprolol CR/XL group than in the placebo group, including total mortality or all-cause hospitalizations (the prespecified second primary end point; 641 vs 767 events; risk reduction, 19%; 95% confidence interval [CI], 10%-27%; P<.001); total mortality or hospitalizations due to worsening heart failure (311 vs 439 events; risk reduction, 31%; 95% CI, 20%-40%; P<.001), number of hospitalizations due to worsening heart failure (317 vs 451; P<.001); and number of days in hospital due to worsening heart failure (3401 vs 5303 days; P<.001). NYHA functional class, assessed by physicians, and McMaster Overall Treatment Evaluation score, assessed by patients, both improved in the metoprolol CR/XL group compared with the placebo group (P = .003 and P = .009, respectively). CONCLUSIONS: In this study of patients with symptomatic heartfailure, metoprolol CR/XL improved survival, reduced the need for hospitalizations due to worsening heart failure, improved NYHA functional class, and had beneficial effects on patient well-being.
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AIMS: To assess trends in the management and subsequent outcome in men and women in two cohorts of consecutive patients with acute myocardial infarction hospitalized in coronary care units in Israel, in the pre-reperfusion and the reperfusion eras. METHODS AND RESULTS: We compared trends in the in-hospital management, and 30-day and 1-year mortality in men and women in two cohorts of patients hospitalized with acute myocardial infarction in coronary care units in Israel, in the pre-reperfusion and the reperfusion eras. The first cohort of 5839 consecutive patients (4315 men, 74%) was from the Secondary Prevention Reinfarction Israeli Nifedipine Trial (SPRINT) registry of 1981-1983; the second cohort of 1940 patients (1429 males, 74%) derived from two prospective nationwide surveys conducted in all coronary care units in Israel in January/February 1992 and 1994. The demographic and clinical characteristics of patients with acute myocardial infarction in both periods were comparable. Patients in 1992-94 received aspirin, angiotensin-converting enzyme inhibitors, beta-blockers and nitrates more frequently than in 1981-83. Thrombolysis, coronary angiography, angioplasty and bypass grafting were not used in 1981-83, whereas in 1992-94 these procedures were used in 45%, 28%, 11% and 4% of men, respectively, and in 39%, 20%, 9% and 3% of women, respectively. The 30-day age-adjusted mortality declined, in men, from 17.0% in 1981-83 to 10.8% in 1992-94 (multivariate-adjusted odds ratio [OR]=0. 69; 95% confidence interval [CI] 0.55 to 0.87), and the cumulative 1-year age-adjusted mortality declined from 24.6% to 16.9% (adjusted hazard ratio [HR]=0.70%; 95% CI 0.60 to 0.81). In women, the decline in mortality rates were of similar magnitude, from 24.0% to 15.1% (OR=0.70; 95% CI 0.52 to 0.94), and from 33.6% to 21.0% (HR=0.67; 95% CI 0.55 to 0.81), respectively. In both sexes, the decline in mortality was more marked in patients reperfused by thrombolysis and/or mechanical revascularization, but was also evident in non-reperfused patients. CONCLUSIONS: Despite higher mortality in both periods in women compared to men, the prognosis of men and women with acute myocardial infarction improved considerably during the last decade, with a similar decline in 1-year mortality of approximately 30%. The implementation in daily practice of new therapeutic modalities proven to be effective in clinical trials after acute myocardial infarction, probably played a major role in this favourable outcome in both sexes.
BACKGROUND: When the decision is made to proceed with cardiac transplantation, the risk/benefit ratio for continued medical therapy in that particular patient must be weighed against the risk/benefit ratio associated with cardiac transplantation. This can only be accomplished while the patient is on maximal medical therapy. METHODS: To better define the appropriateness of patients being referred for consideration of transplant, we examined the records of 100 consecutive adult patients referred to a cardiac transplant program. RESULTS: Two of five patients referred for transplantation had at least one contraindication for transplantation. Twenty percent of the patients were not treated with angiotensin-converting enzyme inhibitors and did not have any documented reason for undertreatment. Of those deemed too well for cardiac transplantation, 84% were alive and either class I or II (mean follow-up 21 months). CONCLUSIONS: We found the majority to be undertreated or with an absolute contraindication to transplantation. Of those deemed too well for transplantation after appropriate treatment, 84% were alive and well.