The Sage Group

Critical Limb Ischemia Volume I United States Epidemiology, 2010

Prevalence, Market Opportunities and Analysis of the Two Most Common Comorbidities: Diabetes and Chronic Kidney Disease

Research on the epidemiology of critical limb ischemia remains sparse. Population-based research regarding the U.S. prevalence of CLI appears to be nonexistent. To date, the number of U.S. citizens suffering from CLI has been estimated based on fewer than 5 papers published on European populations.

In addition to lack of U.S. data, there appears to be no global data on the number of people suffering from CLI.

CLI Volume I contains a comprehensive analysis of four main topics: the 2010 prevalence of critical limb ischemia in the United States; CLI projections for the 2010-2030 period; the market implications for endovascular and pharmaceutical therapies and the most appropriate methods for estimating the prevalence of CLI in international markets.

Prevalence is defined as the number of new and old cases of critical limb ischemia.

Peer-reviewed research on the incidence and prevalence of critical limb ischemia in geographic areas and populations, as well as in comorbid conditions, is reviewed, analyzed and assessed for applicability to the U.S. population. Because diabetes and chronic kidney disease are both highly prevalent in the critical limb ischemia population, research relating to these two comorbidities is analyzed in great detail.

Over 20 incidence and prevalence calculations are included based on the specific population-based and disease progression methods contained in the reviewed research. Strengths and weaknesses of each method are analyzed.

The most accurate methods to estimate CLI are identified and a range of probable estimates for U.S. prevalence are developed based on the U.S. Census Bureau middle series population projections. To the extent that the necessary data was available, these were “back tested.”

Since detailed critical limb ischemia data by age is unavailable for the U.S. population, the report concludes that the best method to estimate the prevalence of CLI is the diabetes method. This approach begins with segmenting the population age 45 and older by age and glucose status, calculating the prevalence of PAD in each segment and then estimating the prevalence of critical limb ischemia in each.

Market implications are assessed for endovascular devices (stents, angioplasty and atherectomy), pharmaceuticals for risk factor modification, thrombolytics, mechanical thrombectomy devices and adjunct therapies in revascularized patients. In addition there is a substantial opportunity for therapies to treat patients unsuitable for revascularization.

The 2010 revised report presents new, higher estimates for peripheral artery disease and critical limb ischemia based on the increased 2005-2006 NHANES prevalence of diabetes.

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