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Effectiveness of lipid-lowering therapy among a sample of patients in Colombia. Eficacia del tratamiento hipolipemiante en una muestra de pacientes de Colombia. Send correspondence to Jorge Enrique Machado-Alba, email: machado utp. From a total of 8 patients in 10 cities, a random sample of was stratified according to dyslipidemia.

Information on sociodemographic and anthropometric characteristics, risk factors, and pharmacological and laboratory variables were obtained from medical records.

The patients were being treated with lovastatin In patients with high cardiovascular risk, Among those at moderate risk, On average, there was a 4. Key words: Dyslipidemias; anticholesteremic agents, efficacy; cardiovascular diseases; lovastatin; gemfibrozil; Colombia. Palabras clave: Dislipidemias; anticolesterolemiantes; enfermedades cardiovasculares; lovastatina; gemfibrozilo; Colombia.

When life expectancy and income increase among a population, so does the prevalence of noncommunicable diseases NCDs , such as hypertension, obesity, dyslipidemia, and diabetes. Worldwide, heart disease and stroke represent the two most common causes of death, with dyslipidemia being a primary risk factor 1, 2.

In Colombia, the mortality rate due to cardiovascular disease CVD ranks first among women, and second among men. Under these circumstances, strategies aimed at identifying individuals with dyslipidemia and implementing primary and secondary CVD preventive measures have become health priorities. To provide physicians with tools for dyslipidemia detection, assessment, and treatment, several panels of experts have developed clinical guidelines 7, 8.

The goal of the ATP III is for the Framingham score to quantify each patient's "absolute risk of coronary heart disease over 10 years" during routine medical consultation 7, 9. When these recommendations have been rigorously implemented, the results are fewer cardiovascular events, improved quality of life, and lower dyslipidemia sequelae-related costs Colombia has adopted an essential drugs list into the Plan Obligatorio de Salud Mandatory Health Plan, POS ; initially it included three generic agents for dyslipidemia management: lovastatin, gemfibrozil, and cholestyramine In , atorvastatin was added to the list To access other dyslipidemia control medications, the prescribing physician makes a special request through each Empresa Promotora de Salud health services provider, EPS to the Scientific Technical Committee CTC 11, Patients also have the legal right to request access to a drug not on the list.

The present study evaluated the effectiveness of lipid-lowering therapies in dislipidemic patients affiliated with the SGSSS. Several associated factors were also examined: laboratory reference values; sociodemographic data; clinical background; and lipid-lowering regimens, adherence, and comorbidities. Study design and sample. This was a cross-sectional retrospective study of patients who were: more than 20 years of age, affiliated with the SGSSS, and being treated with lipid-lowering drugs.

These cities were selected for convenience because they had relevant and reliable databases available. Statistical software was used to select subjects in a stratified random sampling, by city, from among the 8 patients receiving lipid-lowering drugs out of a total of 3. The quality of the patient records was reviewed by two physicians. Any incomplete record was replaced by the complete record of another randomized patient from the same city and of the same sex and age group.

Patient information was reviewed systematically by a physician using a designated data collection form to obtain the following study variables from the medical records:. Sociodemographic characteristics: age; sex; educational level, either "low" illiterate or primary school only or "high" completion of secondary school ; and, city of residence.

Anthropometric characteristics: weight, size, body mass index BMI , and abdominal perimeter. Comorbidity medication: a antihypertensive drugs, i. Monitoring: measuring systolic blood pressure SBP and diastolic blood pressure DBP during the most recent medical consultation, counseling on lifestyle changes, and therapy or treatment modifications, if therapeutic goal was difficult to reach. Therapy adherence was determined by the degree to which the patient complied with the recommendations recorded by the doctor in the medical record.

Definition of effectiveness. The effectiveness of lipid-lowering therapies was established based on the following groups, defined according to the ATP III goal set and whether it was achieved or not:. The chi-square test was used to establish associations between variables based on the risk subgroup.

Mean differences were determined by a nonparametric test i. Models of binary logistic regression were applied using the LDL-C and triglyceride levels as the dependent variable, and variables that were significantly-associated with the dependent variable were considered covariables in the bivariate analysis.

The characteristics of the population analyzed are shown in Table 1. Additionally, only 2. The mean doses that were used were: The main comorbidities and co-medications used to manage these and other risk factors are shown in Table 1. In cases Measurements of LDL-C at treatment initiation were found for patients LDL-C measurements taken in the 6 months prior to the study were available for cases Additionally, differences between the initial mean: In the patients comprising risk group 1, Of the 25 patients in risk group 3, Notably, the therapy was changed in Controlled versus uncontrolled dyslipidemic patients.

For risk group 1, the average dose of lovastatin was higher in the controlled patients than in the uncontrolled 74 vs. In risk group 2, the average dose of lovastatin was lower in the controlled patients than in the uncontrolled 62 vs. None of the other three groups showed statistically-significant differences between doses of lovastatin. In risk group 5, the average dose of gemfibrozil was greater in the controlled patients than in the uncontrolled 2 vs.

Table 2 shows the results of the bivariate analysis that compared the subgroup of patients whose total-C was controlled versus the uncontrolled subgroup.

A significant association was found between the rate of total-C control and the following variables: sex, diabetes mellitus, no personal history of stroke, the use of beta-blockers, non-adherence to treatment, lack of behavior modification because of a therapeutic failure, and city of treatment. Table 3 presents the results of the bivariate analysis that compared a subgroup of patients with controlled dyslipidemia with a subgroup of patients with uncontrolled dyslipidemia belonging to risk group 1.

There was no statistical significance with the following variables: city, education level, weight, blood pressure, hypertension, smoking status, family history of MI or stroke, use of beta-blockers, metformin or levothyroxine, or recommended lifestyle changes. Table 4 shows the results of the bivariate analysis comparing the subgroup of patients with controlled dyslipidemia to the uncontrolled subgroup, belonging to risk group 2.

A statistically-significant association was found between the rate of dyslipidemia control and the following variables: sex, age, suffering from high blood pressure, high HDL-C, use of metformin or fibrates, non-adherence to treatment, dose of lovastatin, and city of treatment.

Given that multiple studies have documented that hypercholesterolemia increases the risk of developing CVD, its control has become a goal of physicians 1.

The present study, which showed that This is worrisome because the study sample was from a patient population with easy access to medication. Also of note is that the entire sample of patients received generic drugs. Additionally, the rate of triglyceride control was The frequency of use of different lipid-lowering drugs, e. In this study the controlled patients received doses of lovastatin that were significantly higher than those administered to the uncontrolled patients, but all patients received DDDs lower than the recommended values, as has been reported elsewhere Most patients in the present study had other risk factors that increased the difficulty of dyslipidemia management and control, especially for asymptomatic diseases, such as hypertension, diabetes, and hypothyroidism; and the use of additional medications for each of these problems results in patients with polypharmacy, as reported by another study It was found that the prevalence of aspirin use as a prophylaxis of cardiovascular risk was higher than that reported by other studies It is disconcerting that only In cases where the target LDL-C level was not being met, and if all patients are considered to have complied with the adjustments, then therapy modifications were insufficient 19, It has been shown that quality-of-care improvement programs for patients with metabolic disorders can achieve great changes and reduce complications through effective therapy In this study, however, the proportion of patients who claim to have followed the correct treatment was relatively high, which is in contrast to the low rate of metabolic control This can be correlated with a lack of knowledge on the part of many physicians around what is a desirable goal based on the patient's risk and what drug and dose should be prescribed to reach it Furthermore, the importance of the starting dose to the overall effectiveness of the therapy has been underscored by a study showing that the percentage reduction in LDL-C levels achieved with the initial dose of statins was strongly correlated with the proportion of patients who maintained their goals at 54 weeks; therefore, it is recommended that therapy start at a dose that should achieve the goal, and if insufficient, be increased significantly to achieve it Clinicians should proactively identify patients at high risk of heart disease and treat them aggressively according to the desired lipid level target, first with statins, and then by adding other drugs if necessary There is also evidence that earlier interventions produce more cost-effective results It has even been suggested that a suboptimal statin treatment may increase the risk of coronary events However, despite the guidelines and the evidence of treatment benefits and safety, numerous studies have shown that a small proportion of dyslipidemic patients regularly use lipid-lowering drugs, and an even smaller percentage of people treated have serum cholesterol levels within the range recommended by international protocols A difference was found between the initial and final LDL-C levels despite the statistically-significant reduction percentages, which are lower than those reported for lovastatin by other studies 4.

However, with high doses of this drug, the values are quite close to the results of one study 6. The reasons for this discrepancy may include using a lower dose than recommended, problems with treatment adherence, and a lack of medical management goals 19, 24, The above findings support increasing the dose of the lipid-lowering therapy based on clearly defined objectives 16, Additionally, the presence of comorbidities, such as diabetes mellitus, which contribute to cardiovascular risk, should be evaluated for treatment with the drug of choice and at the appropriate dose The physician must make decisions and modify patient management when achieving the therapeutic goal is difficult 19, Conversely, it is recommended that insurance companies monitor treatment effectiveness, and even adjust the medication in question, or recommend that the clinician do so This research was funded by Audifarma S.

Conflict of interest. One of the authors has a contractual relationship with both funding organizations, but this did not affect the content of the manuscript. Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE STAT 2 trial. Arch Med Sci. Hobbs FD.

Cardiovascular disease and lipids. Issues and evidence for the management of dyslipidaemia in primary care. Eur J Gen Pract. Rev Salud Publica Bogota.


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