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NCT04798430
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.
NCT05542719
Background. Atherosclerotic cardiovascular disease (ACVD) comprising coronary disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerosis caused 8.9 million deaths worldwide according to reports submitted by the World Health Organization during 2019, the development and progression of atherosclerosis is favored in the presence of modifiable risk factors such as dyslipidemia. In Mexico, during the period from December 29, 2019, to August 29, 2020, 141,873 deaths from heart disease were reported, even above the 108,658 deaths from SARS COV2 in the same time period. Although it is known that the Mexican mestizo population is susceptible to certain metabolic lipid disorders related to genetic variants, the frequency of dyslipidemia in patients with high cardiovascular risk is unknown to date and may be responsible for this increase. On the other hand, it has been shown that lowering LDL-C levels in this population by means of the pharmacological or dietary treatment stated the current guidelines, decreases chance of death, heart failure, angina, re-infarction or need for coronary revascularization; however, there are still patients not achieving treatment goals. Consequently, it is suggested that through the implementation and correct use of technological tools it is possible to increase efficiency in the medical follow-up of patients, allowing for appropriate lipid levels, like other chronic degenerative diseases such as diabetes and systemic arterial hypertension. Objective. To describe the frequency of dyslipidemias in high-risk and very high-risk patients with atherosclerotic cardiovascular disease, who are IMSS beneficiaries, and to analyze the impact of using an application to achieve dyslipidemia treatment goals at one-year follow-up. Hypothesis For the National Register: Not required since the main objective is to carry out a national register of dyslipidemias. For the use of the application: Null hypothesis: The use of the application does not change the frequency of patients with high and extremely high atherosclerotic cardiovascular risk who achieve the goals of dyslipidemia treatment during one year of follow-up.