Underuse of lipid-lowering drugs and factors associated with poor adherence: a real practice analysis in Italy

Background Many studies have indicated the adequate use of lipid-lowering drugs (LLDs) as a factor in reducing the risk of cardiovascular disease. However, in clinical practice, a very high percentage of patients are not adequately treated.Objective To analyze the management of hypercholesterolemia in a non-experimental setting and to estimate the factors associated with poor adherence to treatment.Methods A longitudinal study was performed using clinical and demographic data recorded in the General Practitioners database. The sample included all patients, aged 30 years or over, with total blood cholesterol measured between 1 January and 31 December 2000. Utilization of LLDs was defined as the standardized daily dose of the drugs purchased during the 12 months preceding the cholesterol measurement.Results The study included 4764 patients (mean age 59.4±14.1 years, 40.7% males). Of the subjects with a total cholesterol higher than a 6.5 mmol/l, approximately 17% were treated with LLDs. About 39% of the patients with previous atherosclerotic diseases were taking statins. Analysis of patients taking LLDs showed that 40.6% of subjects took less than half of the defined daily dose. Factors associated with poor adherence to treatment were: absence of previous atherosclerotic diseases, absence of concomitant diseases, and smoking. A total cholesterol of less than 5 mmol/l was achieved in 19.9% of patients.Conclusions Analyzing the data contained in the general medicine database made it possible to evaluate the use of LLDs in clinical practice and to establish the need to pay greater attention to achieving the objective set by the treatment.     

Whom are we treating with lipid-lowering drugs? Are we following the guidelines? Evidence from a population-based study: the Tromsø study 2001

Objective: The beneficial effect of lipid-lowering drugs (LLDs) is well documented. Despite increasing sales of LLDs, little is known about what characterizes LLD users. Our objective was to describe LLD users in a general population according to socio-demographic factors, cardiovascular risk factors and coronary heart disease (CHD), and to study the achievement of cholesterol treatment goals according to national guidelines. Methods: The Tromsø study is a population-based study of chronic diseases, risk factors and drug use in the municipality Tromsø, in north Norway. The fifth survey was conducted in 2001 and included 7,973 men and women (attendance rate 78.1%). Self-reported use of LLDs and/or proprietary LLDs was included as LLD use in the analysis. Results: LLD use was reported in 9.6% of all women and 14.0% of all men, of whom 36.5% achieved the nationally recommended lipid goal. Among individuals with CHD, 49.9% of all women and 55.4% of all men were LLD users. The individuals with a risk condition (hypertension and/or diabetes) and total cholesterol level above the target of 5.0 mmol/l and the healthy individuals with total cholesterol level 8.0 mmol/l constituted 47.2% of the study population without CHD. In this group, which was eligible for primary prevention, 8.0% of the women and 7.4% of the men reported LLD use. Conclusions: Only half of all subjects with CHD were taking a LLD. The large discrepancy between national recommendations and actual LLD use in primary prevention should be addressed in future revisions of the guidelines.     

Lipid-lowering drug use in Italian primary care: effects of reimbursement criteria revision

Objective To assess whether the prescribing pattern of lipid-lowering drugs (LLD) changed after reimbursement criteria revision in a general practice in southern Italy. Methods From the Caserta-1 Local Health Service database, 93 general practitioners (GPs) who had consistently sent data about their patients during the years 2003-2005 were recruited. Prevalence of use and incidence of new treatments were calculated for each year, stratified by three drug cohorts: statins, omega-3 fatty acids, and fibrates. Subanalyses by gender, age, and indication of use were performed. Results Overall, 1-year prevalence of LLD use increased from 2003 to 2004. After reimbursement criteria revision (November 2004), a slight decrease was observed for statins, from 41.1 (95% CI: 39.9–42.2) per 1,000 inhabitants in 2004 to 40.3 (39.2–41.5) in 2005, while omega-3 utilization fell markedly: 14.6 (13.9–15.3) vs. 5.4 (5.0–5.8). The use of both statins and omega-3 fatty acids was reduced particularly for primary prevention. On the other hand, utilization of statins increased in diabetic patients and as secondary prevention from 2004 to 2005. Concerning individual molecules, 1-year prevalence of use of any statin declined from 2004 to 2005, except for rosuvastatin. Conclusions Revision of reimbursement criteria led to significant changes in the trend in LLD use in general practice in southern Italy: (1) statin utilization was slightly reduced in 2005, although it increased in certain categories, such as diabetic patients, and (2) omega-3 fatty acid use was strongly reduced even though a higher use in post-infarction cases was reported.     

Cardiovascular drug utilisation and socio-economic inequalities in 20 districts of the Czech Republic

Objective To analyse whether there exists a socio-economic gradient in utilisation of cardiovascular drugs at the district level in the Czech Republic.Methods The aggregated data on drug utilisation during the period 1997–2000, expressed in defined daily doses per 1000 inhabitants per day, were obtained from the General Health Insurance Company. Socio-economic characteristics of the districts in year 2000 (percentage of university-educated inhabitants, percentage of single-member households, number of ambulatory physicians per 10,000 inhabitants, unemployment rate and mean monthly income) were used as single unadjusted predictor variables. Partial correlation controlling for age in districts was used to analyse the relationship of cardiovascular disease (CVD) drug utilisation and several socio-economic variables.Results There were considerable differences in the utilisation of CVD drugs within the districts studied. Significantly higher utilisation of dihydropyridine Ca-channel blockers and statins was found in the districts with a higher percentage of university-educated inhabitants and more ambulatory physicians. CVD drug utilisation (nitrates, fibrates, selective -blockers, verapamil and diltiazem and statins) correlated significantly with the percentage of single-member households. The five socio-economic variables explained more than 60% of the variability in use of dihydropyridine Ca-channel blockers, verapamil and diltiazem, ACE inhibitors and statins.Conclusion There exists a significant gradient in the utilisation of mainly newer CVD drug groups within districts of the Czech Republic that can be, at least partly, explained by social characteristics of the districts.     

Assessment of lipid-lowering treatment in Bulgaria — The CEPHEUS study

This is a multicenter cross-sectional survey of 2,500 Bulgarian adult patients taking lipid-lowering drugs (LLDs) for at least 3 months with no dose change for a minimum of 6 weeks. The primary objective was to establish the proportion of patients who are on LDL-C target, according to the Fourth Joint European Task Force (FJETF) guidelines. The secondary objectives were to define the proportion of patients at target: according to the 2001 National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III and the 2004 NCEP ATP III guidelines. The patients’ demographics, current LLD treatment, cardiovascular medical history were recorded. Next the lipid profile, glucose level and HbA1c were obtained from these patients. The investigators and patients completed questionnaires related to the LLD therapy. Gender, BMI, history of CHD, therapy compliance, risk category, lack of patient’s awareness of LDL-C targets were all studied as determinants of the undertreatment. Despite the satisfactory awareness of guidelines for management of hypercholesterolaemia, their implementation in clinical practice is still poor. Only 43.10% of patients reached the FJETF-recommended LDL-C goal, 45.24% achieved the 2001 NCEP ATP III recommended LDL-C goal, and only 21.51% — reached the 2004 NCEP ATP III recommended target. Males, CHD patients and those who were aware of LDL-C targets had more chance of reaching their desired LDL-C target.     

Statins are less effective in common daily practice among patients with hypercholesterolemia: the REALITY-PHARMO study;

SUMMARY

Background: To study the use and effectiveness of lipid-lowering drugs with respect to lowering of cholesterol levels in routine daily practice.

Methods: 20?392 patients for whom lipid levels records were available between January 1991 and December 2001 were included in this retrospective population based cohort study. From this group of patients 1899 patients started treatment during the study period and had at least one baseline cholesterol measurement during the six months prior to the initiation of lipid lowering drugs and at least one cholesterol measurement after initiation. A patient was defined to be ‘at goal’ if the patient had a total cholesterol less than 5.0?mmol/L.

Results: Our results indicate that only 30.2% of all treated patients achieved goal in the first year of treatment. After the introduction of new guidelines in 1998, recommending more aggressive treatment, the goal attainment percentage rose from 22.4% of those patients treated before 1998 to 42.3% for those in whom treatment was initiated after 1998.

Conclusion: The percentage of patients achieving guideline recommended goal is low in real-life even in patients treated with high dose statins.     

Implementation of a Pharmacist-Led Clinic for Hypertensive Patients in Primary Care – A Pilot Study

Objectives:To implement a pharmacist-led Hypertension Management Clinic in one general medical practice. To evaluate the impact of the clinic on blood pressure (BP) control and prevention of coronary heart disease (CHD). Method:A total of 242 patients attended the pharmacist-led hypertension clinic over a 10-month period. Lifestyle and drug therapy alterations were implemented to achieve British Hypertension Society (BHS) target level BP. A sub-group of 160 patients were used to compare BP control in the clinic setting against that with the general practitioner (GP). Assessment was made of 10-year CHD risk in patients with no artherosclerotic disease. Patients with underlying artherosclerotic disease were prescribed statins, and antiplatelet drugs where indicated. Main outcome measures:Changes in numbers of hypertensive patients meeting the BHS target level BP. Changes in prescribing of antiplatelet agents and statins for primary and secondary prevention of artherosclerosis. Results:In 206 patients with established hypertension, the number achieving target level BPs increased from 74 (36%) pre-clinic to 174 (85%) post-clinic; P < 0.001 chi-squared test. After attending the clinic, for 5 months 74 patients (80%) achieved target level BP in the clinic compared with 27 (40%) with standard GP care; P < 0.001 chi-squared test. Of 188 patients assessed for primary prevention therapy, 126 (67%) required treatment with aspirin and 37 (20%) with a statin. Post-clinic 101 (80%) received aspirin compared with 17 (13%) pre-clinic and 34 (92%) received a statin in comparison with 4 (11%) pre-clinic; both P < 0.001 chi-squared test.A total of 52 (96%) of 54 patients received an antiplatelet agent for secondary prevention of artherosclerosis compared with 40 patients (74%) pre-clinic. Thirty six of 54 patients required a statin for secondary prevention. Thirty five patients (97%) received a statin compared with 23 (64%) pre-clinic; both P < 0.01 chi-squared test. Conclusion:Implementation of a pharmacist-led clinic improved blood pressure control and appropriate prescribing of antiplatelet agents and statins for primary prevention of CHD and secondary prevention of artherosclerosis.     

Five-year follow-up of drug utilization for secondary prevention in coronary artery disease

Objective Despite the availability of various prevention guidelines on coronary artery disease, secondary prevention practice utilizing aspirin, beta-blockers, angiotensin converting enzyme inhibitors and statins still can be sub-optimal. In this study, we aimed to assess the guideline adherence of secondary prevention prescribing and the continuity of adherence for a 5-year period in a small cohort of patients angiographically diagnosed to have coronary artery disease. Method In this prospective study, 73 patients who were angiographically diagnosed to have CAD were followed up for 5 years. The baseline demographic and clinical data were collected just before angiography. The baseline drug data were collected at the day of discharge. The fifth year data were taken from the patients via face-to-face consultations or phone interviews. Results The ‘initial prescribing rate’ at discharge was found to be 82% for aspirin, 49% for statins, 44% for ACE inhibitors and 55% for beta-blockers. ‘Continuity of prescribing’ for 5 years was 45% for aspirin, 26% for statins, 17% for ACE inhibitors and 20% for beta-blockers. Conclusions Besides the sub-optimal prescribing of secondary prevention drugs, absence of continuity of prescribing seems to be a challenging issue in pharmaceutical care of coronary artery disease patients.     

The effect of employment status and household composition on health care utilisation in a general practice.

OBJECTIVE: to investigate the effect of employment status and family composition on general practice and secondary health care utilisation rates of a New Zealand general practice population. METHODS: the study practice's health care records were electronically interrogated and pooled data on utilisation rates was obtained for a 12 month period. Individual records were grouped according to the number of people in the family and families were further categorised according to the employment status of the adults in the family. Comparisons were made between family groups in rates of general practice and secondary care activities. Costs were attributed to each activity and a cost analysis undertaken. RESULTS: families of four or more people depending on government benefits had a lower primary care cost per person than equivalent families where an adult was in paid employment, but higher costs in secondary care resulted in a higher total health care cost. Overall, for the year reviewed, the mean cost per person for public health care was $365 for people in families where at least one person was in the paid workforce, $568 for those in families depending on government support, and $1438 for people over 60 years of age. CONCLUSION: in this practice the increased use of secondary care facilities by those who have lower rates of general practice activity resulted in a higher overall cost of health care to those patients. This study indicates the need for further analyses of activities by differing patient groupings to facilitate rational and equitable health care planning.     

Bronchospasm and cough as adverse reactions to the ACE inhibitors captopril, enalapril and lisinopril. A controlled retrospective cohort study.

1. We report a controlled retrospective cohort study of respiratory adverse reactions to ACE inhibitors. Bronchospasm and cough occurred at a higher rate in patients treated with ACE inhibitors, no links with sex, past history of bronchospasm, drug type or dose were found. 2. Cohorts of 1013 patients on angiotensin converting enzyme (ACE) inhibitors and 1017 patients on lipid lowering drugs (LLDs) were compared for the occurrence of new bronchospasm, relapse of previous bronchospasm, increase of current bronchospasm, and cough. 3. The prevalence of bronchospasm was 5.5% for patients on ACE inhibitors and 2.3% for patients on LLDs, P < 0.001. The relative risk of a bronchospasm adverse reaction for a patient on an ACE inhibitor compared with a patient on a LLD was 2.39, 95% confidence interval 1.47 to 3.90. 4. No ACE inhibitor specificity, or significant sex differences were found in the prevalence of bronchospasm or cough after correcting for bias implicit in the original cohorts. The bronchospastic reactions were not dose dependent. 5. The prevalence of a past history of bronchospasm in patients reporting ACE inhibitor-induced bronchospasm (16%) was not significantly different from the prevalence in patients on ACE inhibitors without an adverse reaction (13%), P = 0.447. 6. The prevalence of ACE inhibitor cohort cough was 12.3% and 2.7% in the patients on LLDs, P < 0.0001. Cough did not occur more commonly in patients on ACE inhibitors who had experienced any bronchospasm (28%) than in patients on LLDs with bronchospasm (27%).     

Lipid-lowering treatment in coronary artery disease: a survey in an ambulatory outpatient clinic.

OBJECTIVES: In controlled trials, HMG-CoA reductase inhibitors (statins) effectively reduced cardiovascular events in patients with coronary artery disease (CAD). However, recent pharmacoepidemiological studies indicate an underuse of statins in the target population. The objective of this study was to examine the extent to which CAD patients in Germany actually received statins under field conditions. METHODS: We evaluated the medical records of 296 patients referred to the cardiology outpatient clinic of the Frankfurt University Hospital by their general practitioner (GP) in the period 1995 to 1998. All patients had symptomatic, angiographically proven CAD, 142 had previous myocardial infarction. A diagnosis of dyslipidemia was taken from the records. Most patients were visited on more than 1 occasion. In all, we were able to access 296 records for a 1st visit, 76 records for a 2nd visit and 29 records for a 3rd visit and 16 records for > 3 visits. RESULTS: According to the entry criteria of the 4S Trial (total cholesterol 5.5-8.0 mmol/l or 212-311 mg/dl), 108 patients were deemed as eligible for lipid-lowering treatment, criteria of the LIPID Trial (4.0-7.0 mmol/l or 154-270 mg/dl) gave a yield of 190 patients. The actual treatment rate with a statin at the 1st visit was 34% (LIPID Group) and 40% (4S Group). At later visits, the treatment rates with statins increased to 63% (LIPID Group) and 79% (4S Group), due to advice given to the GP by the outpatient clinic. When the observation period was devided into 2 periods (04/95 - 01/97; 02/97 - 09/98), actual treatment rates (all visits) for the 4S Group were 43% and 38%, respectively, indicating no further "penetration" of the 4S Study in the therapy decision-making of the GPs. CONCLUSIONS: The data indicate that necessary treatment with a HMG-CoA reductase inhibitor is often withheld in the ambulatory setting.