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Biomedical subjects

J McMurray

Publications and source records attributed to J McMurray.

At least 37 records · Page 2Linked to original sources
PubMed2000

Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors.

BACKGROUND: Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors. METHODS: Patients with CHF, left ventricular ejection fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d; the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%). RESULTS: The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant; the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16-mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%). CONCLUSIONS: Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.

Aged↗
PubMed2000

Intracavernous alprostadil alfadex is more efficacious, better tolerated, and preferred over intraurethral alprostadil plus optional actis: a comparative, randomized, crossover, multicenter study.

OBJECTIVES: To compare the efficacy, safety, and patient preference of intracavernously administered alprostadil alfadex and intraurethrally administered alprostadil. METHODS: A crossover, randomized, open-label multicenter study of 111 patients with erectile dysfunction of at least 6 months' duration compared the efficacy, safety, and patient preference of intracavernosal alprostadil (EDEX/Viridal) with MUSE plus optional ACTIS. All patients underwent an in-office dose titration with either drug before undertaking an at-home treatment phase. The most frequently used doses during the at-home phase were 40 microg (44.1% of men) and 1000 microg (86.8% of men) for EDEX and MUSE, respectively; the mean doses were 26.1 microg and 922.5 microg for EDEX and MUSE, respectively. RESULTS: More EDEX than MUSE administrations resulted in an erection sufficient for sexual intercourse (82.5% versus 53.0%); significantly more patients using EDEX achieved at least one erection sufficient for sexual intercourse (92.6% versus 61.8%; P <0.0001); and EDEX use resulted in a significantly greater percentage of patients attaining at least 75% of erections sufficient for sexual intercourse (75% versus 36.8%; P <0.0001). Penile pain was the most common side effect for both medications: 20.0% versus 30.5% (in-office) and 33.8% versus 25.0% (at-home) for EDEX and MUSE, respectively. Similar numbers of adverse events were reported with either treatment during the at-home phase. Patient and partner satisfaction was greater with EDEX, and more patients preferred this therapy, choosing to continue it during a patient preference period at the end of the study. CONCLUSIONS: Since intracavernous injection therapy was more efficacious, better tolerated, and preferred by the patients and their partners, it should be offered as the first-choice treatment if oral therapy fails or is contraindicated.

Adult↗
PubMed2000

Intracavernous alprostadil alfadex (EDEX/VIRIDAL) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra).

OBJECTIVES: Sildenafil (Viagra), an oral treatment for erectile dysfunction, has proved popular since its introduction in 1998. However, not all patients respond to this form of therapy. Consequently, this study investigated the efficacy of intracavernous alprostadil alfadex (EDEX/VIRIDAL) treatment in patients not responding to sildenafil. METHODS: In an open-label, multicenter study, patients with erectile dysfunction were treated with sildenafil for 4 weeks. The initial dose was 50 mg, which was increased to 100 mg if no response was achieved. Patients not responding to treatment, measured using the International Index of Erectile Function (IIEF) questionnaire, entered an alprostadil alfadex in-office titration phase, to determine the optimal dose, up to 40 microgram. A 6-week alprostadil alfadex at-home treatment phase followed. RESULTS: In 67 patients who did not respond satisfactorily to sildenafil, the alprostadil alfadex at-home therapy resulted in improvements in questions 3 and 4 of the IIEF in 60 (89.6%) and 57 (85.1%) patients, respectively. The mean improvement in IIEF score for these patients was 2.75 and 2.63 for questions 3 and 4, respectively. The most common side effect was penile pain in 25 (29. 4%) of 85 patients treated with alprostadil alfadex in-office and at home. CONCLUSIONS: Alprostadil alfadex therapy can be used effectively and safely in men who fail initial therapy with sildenafil.

Administration, Oral↗
PubMed2000

Valsartan in acute myocardial infarction trial (VALIANT): rationale and design.

BACKGROUND: Survivors of acute myocardial infarction (MI) complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete pharmacologic mode to inhibit the adverse influence of angiotensin II. METHODS: Valsartan in Acute Myocardial Infarction (VALIANT) is a multicenter, double-blind, randomized, active controlled parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designed with 3 arms, giving equal statistical consideration to survival comparisons of captopril versus the angiotensin II receptor blocker valsartan, as well as the combination of captopril plus valsartan, compared with a proven effective dose of captopril. This 14,500-patient trial is designed with an 86% power to detect a 15% reduction in mortality rate with either use of valsartan compared with captopril. The trial encourages optimal individualization of other proven therapies in acute and chronic infarction, and the international patient body ensures good representation of multiple practice patterns. CONCLUSION: VALIANT is a large international investigative effort that will evaluate the role of valsartan in the management of patients with MI associated with heart failure and/or left ventricular dysfunction. The use of a proven dose of captopril and the comparator arms with valsartan alone or in combination with captopril provides a unique test of whether the angiotensin II receptor blocker can make an additional improvement in clinical outcomes beyond angiotensin-converting enzyme inhibitors.

Angiotensin II↗
PubMed2000

Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study.

OBJECTIVE: This study was undertaken to determine the prevalence of mental disorders among obstetric-gynecologic patients and to assess the validity and utility of the PRIME-MD Patient Health Questionnaire (PHQ) in this population. STUDY DESIGN: A total of 3000 patients were assessed by 63 clinicians at seven obstetrics-gynecology outpatient care sites. The main outcome measures were PRIME-MD PHQ diagnoses, psychosocial stressors, independent diagnoses made by mental health professionals, functional status measures, disability days, health care use, and treatment or referral decisions. RESULTS: Current mental disorders were fairly prevalent, present in 1 in 5 obstetric-gynecologic patients. Patients with PRIME-MD PHQ diagnoses had more functional impairment, disability days, health care use, and psychosocial stressors than did patients without PRIME-MD PHQ diagnoses (P <.005 for all measures). Although most clinicians judged the PRIME-MD PHQ to be useful in management decisions, the questionnaire diagnosis of mental disorder rarely led to therapeutic intervention. CONCLUSION: The PRIME-MD PHQ is a useful instrument for the assessment of mental disorders, functional impairment, and recent psychosocial stressors in the busy obstetrics-gynecology setting.

Adolescent↗
PubMed2000

Why we need new strategies in CHF management.

Despite recent improvements in drug therapy, the prevalence of congestive heart failure (CHF) continues to rise, as a result of the increasing proportion of older people in the population and factors such as greater survival rates after myocardial infarction. More effective management strategies for CHF are therefore needed urgently. The angiotensin II type 1 (AT(1))-receptor blockers might contribute to such strategies, offering placebo-like tolerability and showing promise in early trials of their use in CHF. Large-scale outcome studies, currently underway, will provide further evidence of the value of AT(1)-receptor blockers in CHF. In addition, the involvement of specially trained nurses in patient education and monitoring should enhance compliance with both existing and novel therapies, and thus help to increase the overall efficacy of holistic strategies for CHF management.

Angiotensin Receptor Antagonists↗
PubMed1999

The health economics of the treatment of hyperlipidemia and hypertension.

In the current economic climate it is important to demonstrate that healthcare resources are being used efficiently. As a consequence, pharmacoeconomic analyses are invaluable for assessing the cost-effectiveness of new therapeutic strategies. A condition with recurrent morbid events that are costly to treat provides the greatest potential for cost savings. In contrast, there is less opportunity to redeem original treatment costs when a condition is associated with infrequent and inexpensive morbidity. Consequently, treatment strategies that have a rapid onset and substantial impact on disease progression are likely to be the most highly cost-effective forms of therapy. Elevated blood pressure in the elderly and established coronary heart disease (CHD) are both associated with high rates of costly cardiovascular events (eg, stroke, myocardial infarction, and heart failure). Clinical trials have shown that administration of blood-pressure-lowering agents to elderly hypertensives and the treatment of hypercholesterolemia with statins in the secondary prevention of CHD are highly effective strategies for reducing this morbidity. Pharmacoeconomic analyses of the data from these clinical trials now provide an additional assessment of their cost-effectiveness. The results of these analyses suggest that blood-pressure-lowering therapy for the elderly and the use of statins to control hypercholesterolemia in patients at high risk of CHD are extremely cost-effective, compared with many other routine medical interventions.

Antihypertensive Agents↗
PubMed1999

Candesartan in heart failure--assessment of reduction in mortality and morbidity (CHARM): rationale and design. Charm-Programme Investigators.

BACKGROUND: Chronic heart failure (CHF) is an increasing burden to health care. Pharmacological treatment with angiotensin-converting enzyme (ACE) inhibitors and beta blockers improve survival and reduce hospitalizations in patients with low left ventricular ejection fraction (LVEF). Despite these therapies, morbidity and mortality remains problematic. Furthermore, 30% to 50% of patients with CHF have a preserved LVEF. It is not known if treatments are of benefit in this group. DESIGN: Candesartan in Heart Failure-Assessment of Reduction in Mortality and Morbidity (CHARM) is a program designed to investigate the clinical usefulness of the long-acting angiotensin II type 1 receptor blocker, candesartan cilexetil, in a broad spectrum of patients with symptomatic heart failure. Patients with systolic dysfunction, tolerant or intolerant to an ACE-inhibitor, and patients with preserved systolic function are included. Specifically, the CHARM program consists of 3 independent, parallel, placebo-controlled studies in patients with (1) LVEF less than or equal to 40%, ACE-inhibitor treated (n = 2,300); (2) LVEF less than or equal to 40%, ACE-inhibitor intolerant (n = 1,700); (3) LVEF greater than 40%, not treated with ACE inhibitors (n = 2,500). The 3 studies will be combined to evaluate the effect of candesartan cilexetil on all-cause mortality in the broad spectrum of symptomatic heart failure. The primary objective in each trial is to evaluate the effects on the combined endpoint of cardiovascular mortality or CHF hospitalization. Other endpoints include the effects on myocardial infarction, all-cause hospitalization, and resource utilization. CHARM is intended to randomize 6,500 patients with symptomatic heart failure from 26 countries in Europe, the United States, Canada, South Africa, and Australia. The CHARM program started to enroll patients in March 1999. The follow-up period is a minimum of 2 years. The study is expected to end in the third quarter of 2002.

Adolescent↗