American journal of therapeutics
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Sildenafil is widely used as a primary pharmacological treatment of erectile dysfunction in men with and without underlying cardiovascular disease. Although initial reports of adverse cardiac events were reported soon after Food and Drug Administration approval of this agent, a large body of data suggests that sildenafil does not significantly increase the risk of nonfatal myocardial infarction, stroke, or cardiovascular deaths in patients with preexisting ischemic heart disease. ⋯ The patient had presented with chest pain syndrome and borderline elevation of serum troponin I levels 1 week before sildenafil use, and a coronary angiogram had demonstrated normal coronary arteries. This case emphasizes the potential of precipitating coronary thrombosis in patients with unstable plaque after sildenafil use, even in patients with angiographically normal coronary arteries.
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To describe qualitatively recent changes in the Japanese clinical trial environments, we compared the results of the Good Clinical Practice (GCP) audits conducted from April 1997 to March 2000 (FY1997 to FY1999) with those from April 2002 to March 2003 (FY2002). In addition, the audit results were compared between the United States and Japan. The audit findings in the former period were based on the official audits by the Organization for Pharmaceutical Safety and Research (OPSR) that covered 331 hospitals and 775 trials. ⋯ The high prevalence of protocol nonadherence and the relatively few findings of informed consent errors were important characteristics of Japanese trials inferred from the audit result reported by the OPSR in FY2002. In the United States, relatively high proportions of protocol nonadherence and informed consent errors were observed in the audit finding reported in 1997. Although the audit results for clinical trials between the United States and Japan are not strictly comparable, our results suggest that protocol deviations are a compelling issue for quality improvement in the conduct of clinical trials for the 2 regions.
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Chronic pain is among the most common conditions to initiate medical care; 40% of patients victimized by chronic pain are not under the supervision of a physician, and about 70% of patients with severe pain are receiving pain medical care. About dollar 100 billion is an annual estimated cost representing loss of productivity, increased medical costs, and income loss. Major depressive disorder is not infrequently encountered in daily clinical practice often presenting with somatic complaints that include varieties of pain, and these may be so prominent as to direct the treatment to the somatic complaint evaluation to the exclusion of underlying psychopathology. ⋯ A more rapid achievement by venlafaxine of remission and a high-quality pharmacokinetic and pharmacodynamic profile lead to patient compliance and facilitate both fewer relapses and recurrences. Duloxetine is broadly discussed, revealing pharmacokinetic, pharmacodynamic, adverse/side effects, cautions with requisite patient-specific selection, and laboratory monitoring. The management of somatic pain complaints of physical and psychiatric origin is discussed.