Archive for the ‘Blood Pressure’ Category

Pharmaceutical Approval Update: Sodium Oxybate Oral Solution (Xyrem)

Sodium Oxybate Oral SolutionSodium Oxybate Oral Solution (Xyrem)

Manufacturer: Jazz Pharmaceuticals, Palo Alto, CA Indication: Sodium oxybate is indicated for the treatment of excessive daytime sleepiness in patients with narcolepsy. The drug was originally approved as the first and only treatment for cataplexy in patients with narcolepsy. (Cataplectic patients experience a sudden loss of muscle tone and fall to the floor.)

Biological Class: Sodium oxybate is a sodium salt of gamma-hydroxybutyrate (GHB). GHB is a substance that is frequently abused when acquired illicitly and used illegally.

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patient expectations

We elicited expectations of treatment in 93 hypertensive African-American patients followed in a primary care practice. This is the only study, to our knowledge, that explored expectations of in this patient population. Our findings indicate that patients had multiple, varied expectations of their blood pressure treatment that were grouped into three major categories and the theme underlying these categories was role identification, such that patients attributed specific roles or functions in the course of treatment to themselves (patient’s role), to their physicians (physician’s role), and to their medications (medication effects). Contrary to previous beliefs, the majority of patients actually expected to follow their physi­dans’ recommendations, such as taking their medications, being proactive in their care, and seeking prognostic information. They expected their physicians to serve as sources of information; they wanted their physicians to educate them about the side effects of their medications as well as their mechanism of action; and they expected appropriate physiologic response from medications, such as blood pressure lowering and prevention of complications.

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Table 1 outlines the demographic characteristics of the study sample. The median duration of hypertension was eight years with median hypertension treatment duration of six years. Blood pressure data were available on 81 patients, of whom 60% had uncontrolled hypertension [defined as systolic blood pressure of 140 mm hg or diastolic blood pressure of 90 mm hg]. Regarding comorbidity, most patients had no comorbid illness, 26% had diabetes, while fewer than 6% had heart disease, cerebrovascular disease, peripheral vascular disease, or renal failure.

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Several methods have been proposed for eliciting patients’ expectations, including use of self-administered questionnaires, semistructured interviews, and focus groups. We conducted a qualitative study using in-depth, open-ended individual interviews to elicit expectations of blood pressure treatment in a group of hypertensive African-American patients.

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African Americans have the highest prevalence of hypertension in the United States, and they experience higher rates of hypertension-related adverse outcomes, such as stroke and renal disease, compared to European Americans. Such high rates of hypertension-related adverse outcomes may be explained, in part, by the higher rates of uncontrolled hypertension noted in African Americans compared to European Americans. While some investigators have suggested that these racial disparities in adverse outcomes may be due to poorer medication adherence noted in African Americans compared to European Americans, others have attributed them to the lay beliefs about the meaning, causes, and treatment of hypertension in this population. The beliefs patients have may underlie how they construct their own models or understanding of their illness with such models often differing from traditional biomedical beliefs held by physicians. Such discordance may, in turn, lead to poor clinical outcomes. For example, in a clinic-based study of older hypertensive African-American women in Louisiana, Heurtin-Roberts and colleagues identified two models of hypertension—a traditional biomedical model where hypertension was perceived to be a chronic disease that requires lifelong treatment and a nonbiomedical model where hypertension was perceived to be an acute, hyperactive, nervous disease that occurs in exacerbations and frequently leads to increased pressure in the blood. The authors further demonstrated that patients with nonbiomedical models of hypertension had poorer compliance and blood pressure control compared to those with biomedical models.

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So Many Advances in Medicine, So Many Yet to Come