Clinical Briefs

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.

Hepatitis C Treatment by Primary Care Clinicians

Source: Arora S, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med 2011;364:2199-2207.

In most communities in the United States, hepatitis C (HEPc) treatment is provided by gastroenterologists. Because HEPc is now the most common cause of end-stage liver disease, and — unless trends reverse — will continue to be so for the foreseeable future, it is important that identification of HEPc infection be continued vigorously in the primary care community, since most at-risk persons see primary care clinicians as their point of initial contact with the health care system.

Treatment of HEPc offers the opportunity for cure of the disease more than 50% of the time, although persons infected with HEPc genotype I have a somewhat lower success rate. Ideally, treatment would be offered to as many infected persons as possible, yet limitations in specialist consultants who traditionally administer the treatment are an obstacle to access for some patients.

The ECHO program (Extension for Community Healthcare Outcomes) is intended to enhance opportunities for provision of health care to underserved populations through, for instance, video-conferencing technology that allows primary care clinicians to receive case-based education with specialist colleagues. Since 2003, ECHO has resulted in 800 HEPc patients being treated by primary care clinicians. The primary outcome of this ECHO-based trial was sustained virologic response, which is defined as undetectable HEPc RNA 6 months beyond the end of treatment. Encouragingly, analysis of outcomes for patients treated on-site at the University of New Mexico HEPc clinic were essentially identical with those of patients treated at distant sites by clinicians guided though case-based video conferencing. Hopefully, enlarging the spectrum of clinicians who can provide state-of-the-art care for HEPc patients will become a goal for other sites that have the capacity for video conferencing.

COPD Exacerbations: The EXACT Tool

Source: Jones PW, et al. Characterizing and quantifying the symptomatic features of COPD exacerbations. Chest 2011;139: 1388-1394.

The impact and consequences of chronic obstructive pulmonary disease exacerbations (COPD-e) are underappreciated. This year, COPD has risen in prominence from the fourth most common cause of death to the third. COPD-e are problematic on multiple levels: as many as 10% of patients admitted for COPD-e die in the hospital, and the mortality within the year of hospitalization is as much as 20%. Additionally, each COPD-e is associated with a further decline in FEV1 that is not restored once the exacerbation is resolved.

Jones et al have performed the first published formal analysis of COPD-e to derive an instrument known as EXACT (Exacerbations of Chronic Pulmonary Disease Tool).

Based on interviews with COPD patients (n = 410), the authors quantified items pertaining to dyspnea, cough, sputum production, chest discomfort, limitations of activity, fatigue, sleep disturbance, and anxiety associated with COPD symptoms.

Ultimately, 14 items were discerned that quantified COPD-e presence and severity. Hopefully, such a tool could be used in daily diaries of COPD patients to help identify exacerbations at the earliest possible stage so that abortive therapy could be instituted without delay. It remains to be determined whether enhanced early detection and intervention for COPD-e will favorably affect symptomatic control, hospitalizations, or mortality.

Are Diabetes Prevention Treatments Truly Disease Modifying?

Source: The DREAM Trial Investigators. Incidence of diabetes following ramipril or rosiglitazone withdrawal. Diabetes Care 2011;34:1265-1269.

Prevention of type 2 diabetes (DM2) is possible by means of several different paths including diet, exercise, metformin, thiazolidinediones, orlistat, acarbose, and valsartan. Although reduced conversion from pre-diabetes to DM2 by as much as 60% has been seen in some DM2 prevention trials, critics point out that it is unclear whether any of the natural history of DM2 — that is, progressive decline in beta cell function — is impacted by currently available interventions. Animal studies have found incretin effects, such as beta cell proliferation and improved beta cell mass, but no persistence of such effects has been confirmed in humans, and most data suggest that none of these favorable effects persist once pharmacotherapy is discontinued. The Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication (DREAM) Trial Investigators published an analysis of glycemic control 2-3 months after cessation of ramipril or rosiglitazone, the agents used in the DREAM trial.

Although the Heart Outcomes Prevention Evaluation trial supported a role for DM2 prevention by ramipril, this was not confirmed in the DREAM Trial, nor was there any beneficial "legacy effect." Although rosiglitazone was effective in DM2 prevention, once stopped, progression to DM2 was similar to placebo. Hence, although prevention of DM2 is achievable with thiazolidinediones, they do not appear to make a sustained impact upon underlying disease pathophysiology since drug cessation is followed by a resumption of declining beta-cell function similar to placebo.