Patient population

The cardiovascular health care marketplace is highly competitive. This works to the advantage of medical device companies. Hospitals are engaged in intense competition for those who might be candidates for cardiovascular therapies. Therefore, hospitals are anxious to offer the best treatment possible, having the newest devices. Medical specialties are also competing for their share of the same patient population. 

A key element in planning and conducting clinical trials is to ensure that they have scientific validity and objectivity. This is particularly relevant with respect to Phase II and III studies, where it is desired to demonstrate a positive benefit to risk outcome. Responses to a drug among a patient population are rarely homogeneous and clear-cut. Thus, sound statistical principles must be applied in order to be able to distinguish significant effects from random events. 

Efficacy Supplement = submissions for such changes as a new indication or dosage regimen for an approved product, a comparative efficacy claim naming another product, or a significant alteration in the patient population e.g., prescription to Over-The-Counter switch ... 

In general, for smokers with cardiac disease, the benefits of nicotine replacement therapy outweigh the potential risks. In a safety and efficacy study that included veterans with cardiac disease, smoking concurrently with the nicotine patch was not associated with an increase in adverse events (Joseph et al. 1996). Although bupropion SR is generally well tolerated by smokers, it has not been adequately studied in persons with cardiac disease, and definitive conclusions regarding its safety in this patient population cannot currently be made (Society for Research on Nicotine and Tobacco 2003). 

DeVincenzo et al. 2008). Phase n clinical trials in naturally infected RSV patients were initiated in April 2008. ALN-RSVOl is expected to advance into the pediatric patient population by the second half of 2008. 

Moatti JP, Spire B, Kazatchkine M (2004) Drug resistance and adherence to HIV/AIDS antiretroviral treatment against a double standard between the north and the south, AIDS I8 S55-S6I Moore RD, Chaisson RE (1997) Costs to Medicaid of advancing immunosuppression in an urban HIV-infected patient population in Maryland, J Acquir Immune Defic Syndr Hum Retrovirol 16 223-231... 

Changes in perceived physical and mental health status of a schizophrenia patient population following initiation of a conventional or an atypical antipsychotic medication. Poster presented at the American Psychiatric Association Annual Meeting, Toronto, June 1998. 

The efficacy of IV thrombolysis in patients with moderate-to-severe strokes due to proximal arterial occlusions is restricted by several factors, including the relatively short therapeutic window, poor recanalization rates as the clot burden increases, restrictive eligibility criteria, and the risk of intracerebral hemorrhage. Endovascular techniques improve the rates of recanalization in this patient population, and appear to increase the likelihood of a good functional outcome. Intravenous thrombolysis... 

For many years, physicians have been plagued by a paucity of available treatments for patients with acute ischemic stroke. The therapies we had to offer were either potentially quite hazardous, sometimes leading to poor outcomes, or so benign as to seem to offer little benefit. However, with advances in our understanding of stroke mechanisms, different patient populations, timing of therapy, and modern medicines and techniques, we have gained the ability to successfully treat acute ischemic stroke in a manner that has proven beneficial over broad categories of patients. 

Often used to augment blood pressure lowering, CCBAs are most commonly used as add-on therapy for patients who are in need of further blood pressure lowering above and beyond that afforded by diuretics or other antihypertensives. Nonetheless, they have demonstrated their efficacy in select patient populations as very effective blood pressure lowering agents. 

The clinical scenario and the severity of the volume abnormality dictate monitoring parameters during fluid replacement therapy. These may include a subjective sense of thirst, mental status, skin turgor, orthostatic vital signs, pulse rate, weight changes, blood chemistries, fluid input and output, central venous pressure, pulmonary capillary wedge pressure, and cardiac output. Fluid replacement requires particular caution in patient populations at risk of fluid overload, such as those with renal failure, cardiac failure, hepatic failure, or the elderly. Other complications of IV fluid therapy include infiltration, infection, phlebitis, thrombophlebitis, and extravasation. 

Certain patient populations require special considerations due to their altered metabolism, unique volume of distribution, or increased risk for side effects.43 Although many of these patients are excluded from clinical trials in SE, the standard algorithm for SE still applies for these patients in terms of immediate care, assessment, and drugs (see Table 28-2). 

Poor sleep architecture and fragmented sleep secondary to OSA can cause excessive daytime sleepiness (EDS) and neu-rocognitive deficits. These sequelae can affect quality of life and work performance and may be linked to occupational and motor vehicle accidents. OSA is also associated with systemic disease such as hypertension, heart failure, and stroke.21-23 OSA is likely an independent risk factor for the development of hypertension.24 Further, when hypertension is present, it is often resistant to antihypertensive therapy. Fatal and non-fatal cardiovascular events are two- to threefold higher in male patients with severe OSA.25 OSA is associated with or aggravates biomarkers for cardiovascular disease, including C-reactive protein and leptin.26,27 Patients with sleep apnea often are obese and maybe predisposed to weight gain. Hence, obesity may further contribute to cardiovascular disease in this patient population. 

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