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European Journal of Heart Failure 2004 6(2):219-226; doi:10.1016/j.ejheart.2003.09.009
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© 2003 European Society of Cardiology

Pharmacological treatment in patients with heart failure: patients knowledge and occurrence of polypharmacy, alternative medicine and immunizations

Manuel Martínez-Sellés*, José A. García Robles, Roberto Muñoz, José A. Serrano, Elisa Frades, Marta Domínguez Muñoa and Jesús Almendral

Cardiology Department Hospital Universitario Gregorio Marañón, Dr. Esquerdo, 46, 28007 Madrid, Spain

* Corresponding author. Tel.: +34-91-586-8276; fax: +34-91-586-8276. E-mail address: mmselles{at}navegalia.com


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 Appendix A. English translation...
 References
 
Aims: To evaluate in patients with heart failure (HF) due to systolic dysfunction the occurrence of polypharmacy, alternative medicine, immunization against influenza, and patients’ knowledge about their medication.

Methods and results: Sixty-five patients, 49 men, mean age 60.5±12.0 years answered a confidential questionnaire during 2002. Polypharmacy was frequent, 48 (74%) were taking six or more pills per day and 18 (28%) 11 or more. Fifteen patients (23%) used over-the-counter analgesics. Eight patients (12%) used alternative medicine [five women (31%) vs. three men (6%), P=0.02]. Forty-four patients (68%) received immunization against influenza (18 patients <65 years (54%) vs. 25 patients ≥65 years (79%), P=0.03). Half the patients knew that beta-blockers and vasodilators decreased blood pressure, 31 patients receiving diuretics (88%) knew that this drugs help to eliminate liquids, 12 patients (38%) recognized this effect with low dose spironolactone and 23% or less with other drugs. Only 12 patients (42%) treated with acenocoumarol and 13 of those treated with aspirin (32%) recognized the action of these drugs.

Conclusion: Patients with HF and systolic dysfunction have a poor knowledge about the medication they receive. Polypharmacy, over-the-counter, homeopathic and alternative medicine use is frequent whereas the rate of immunization against influenza is low.

Key Words: Heart failure • Polypharmacy • Influenza • Knowledge

Received February 10, 2003; Revised June 6, 2003; Accepted September 15, 2003


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 Appendix A. English translation...
 References
 
Heart failure (HF) is a common chronic condition that leads to poor quality of life [1] and death. It is the only major cardiovascular condition that has increasing incidence and prevalence [2]. Although the available data suggest that almost half of patients with HF have isolated diastolic dysfunction [3,4], only in patients with left ventricular systolic dysfunction has medical therapy clearly shown an improvement in symptoms and prognosis [5]. However, even in these patients, treatment slows, but does not stop, the progression of the disease. The successful management of HF due to left ventricular systolic dysfunction usually requires use of complex drug regimens to increase survival and prevent episodes of acute decompensation. Since evidence-based treatment of HF with systolic dysfunction implies use of multiple drugs and HF affects mainly elderly patients, polypharmacy could contribute to non-compliance and patient misunderstandings as to use and effects of the prescribed medication [6], particularly if patients are not aware of the benefits of their therapy [7]. Previous studies have shown that patients ranked education related to medication as a priority [8]. Moreover, there are few data about over-the-counter medication and we have found no study addressing homeopathic and alternative medicine use in these patients. However, although the impact of influenza infection on the mortality of HF is well known [9] not all patients with HF are immunized against influenza.

Our aims were: (1) to evaluate the occurrence of polypharmacy, over-the-counter, homeopathic and alternative medicine in patients with HF due to left ventricular systolic dysfunction; (2) to study the rate of immunization against influenza; and (3) to assess the patients’ knowledge about their medication.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 Appendix A. English translation...
 References
 
Seventy-eight consecutive patients with systolic dysfunction followed in our outpatient HF clinic were approached by a nurse, during the spring of 2002, to answer a confidential questionnaire (Appendix A), by themselves or helped by a relative. Sixty-five (83%) agreed to answer the questionnaire at the HF clinic (54 by themselves and 11 helped by a relative). There were 49 men and 16 women, mean age 60.5±12.0, range 24–79 years, 32 patients were ≥65 years (49%). Responders and non-responders did not differ in terms of age or gender.

This study population fulfilled the following inclusion criteria: (1) age >16 years; (2) New York Heart Association functional class II–IV; (3) left ventricular ejection fraction <40% assessed by transthoracic echocardiography.

The questionnaire (Appendix A) addressed three issues: (1) general questions about treatment such as: number of pills per day, organization of the medication, and use of over-the-counter drugs and alternative medicine; (2) enquiries concerning recommendation of immunization against influenza and influenza vaccination; (3) questions testing patient's knowledge about the following medications: diuretics, ACE inhibitors, beta-blockers, spironolactone, digoxin, nitrates, other vasodilators, acenocoumarol, aspirin, and statins.

2.1. Statistical analysis
For the comparison of groups, bivariate analyses were performed. The chi-square test (or Fisher exact test, when indicated) was used for categorical variables and the Student t-test for continuous variables, after confirming the assumption of a normal distribution. All tests were two-tailed.

A commercially available microcomputer statistics program (SPSS 10.0 for Windows, Chicago, IL, USA) was used to perform all statistical analysis.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 Appendix A. English translation...
 References
 
Polypharmacy was frequent, with 48 patients (74%) taking six or more pills per day and 18 (28%) 11 or more. Most patients—53 (82%)—organized their own medication while others performed this task in 12 cases (18%) (no relevant differences between men and women). Fifteen patients (23%) used over-the-counter analgesics and only one patient used over-the-counter antibiotics.

Eight patients (12%) used homeopathic and alternative medicine. This use was higher in females—five women (31%) used homeopathic/alternative preparations as compared with three men (6%) (P=0.02)—and decreased with age—patients using homeopathic/alternative preparations were younger 50.5±11.6 vs. 61.7±11.5, P=0.03.

Forty-four patients (68%) had received immunization against influenza. Influenza vaccination was increased with age: only 18 patients <65 years (54%) received vaccination vs. 25 patients ≥65 years (79%), P=0.03. Influenza vaccination recommendation by a physician also increased with age: 16 patients <65 years (48%) received this recommendation as compared with 28 patients ≥65 years (88%), P=0.009.

The answers to the questions testing patient's knowledge of their medication are depicted in Figs. 1–6. Only approximately half of the patients receiving beta-blockers (24 patients: 47%), ACE inhibitors (30 patients: 53%) and other vasodilators (eight patients: 50%) knew that these drugs decreased blood pressure while a significant percentage of patients (9–18%) attributed this action to drugs with no hemodynamic effects such as acenocoumarol (five patients: 18%), statins (five patients: 15%) and aspirin (four patients: 10%) (Fig. 1). Most patients (31–88%) knew that diuretics help to eliminate liquids, 12 patients (39%) also recognized a diuretic action of low dose spironolactone whereas less than 23% attributed this effect to other drugs (Fig. 2). However, in the evaluation of the relation drug–heart function, diuretics were the less appreciated medication, as only 17 patients receiving diuretics (49%) thought these drugs improved heart function (Fig. 3).


Figure 1
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  		Fig. 1 Answers to the question: ‘Do you think this drug decreases blood pressure?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug decreases blood pressure. No: I do not think this drug decreases blood pressure. No answer: does not know or does not answer.

 


Figure 2
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  		Fig. 2 Answers to the question: ‘Do you think this drug helps to eliminate liquids?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug helps to eliminate liquids. No: I do not think this drug helps to eliminate liquids. No answer: does not know or does not answer.

 


Figure 3
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  		Fig. 3 Answers to the question: ‘Do you think this drug makes your heart function better?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug makes my heart function better. No: I do not think this drug makes my heart function better. No answer: does not know or does not answer.

 
Twelve patients (43%) treated with acenocoumarol and 13 (32%) treated with aspirin recognized the action of these drugs (Fig. 4). The ability to cause cough was recognized for ACE inhibitors by six patients (11%) and attributed to other vasodilators (mainly angiotensin receptors antagonists) by four patients (24%); less than 10% attributed this effect to other drugs (Fig. 5). Finally, a potential initial deleterious effect on symptoms was attributed to ACE inhibitors by 10 patients (18%) and to beta-blockers by seven patients (14%) (Fig. 6).


Figure 4
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  		Fig. 4 Answers to the question: ‘Do you think this drug makes blood coagulation difficult?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug makes blood coagulation difficult. No: I do not think this drug makes blood coagulation difficult. No answer: does not know or does not answer.

 


Figure 5
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  		Fig. 5 Answers to the question: ‘Do you think this drug could cause cough?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug could cause cough. No: I do not think this drug could cause cough. No answer: does not know or does not answer.

 


Figure 6
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  		Fig. 6 Answers to the question: ‘Do you think this drug could have an initial deleterious effect on symptoms?’ The number of patients treated with each drug is shown after the drug. ACE: angiotensin converting enzyme. Yes: I think this drug could have an initial deleterious effect on symptoms. No: I do not think this drug could have an initial deleterious effect on symptoms. No answer: does not know or does not answer.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
Appendix A. English translation...
 References
 
We found that 28% of patients were taking 11 or more pills per day, which could question the feasibility of this kind of treatment. Today, patients with HF and ventricular dysfunction can be expected to receive ACE inhibitors, beta-blockers, and often spironolactone, diuretics, and, in some cases, digoxin. When coronary artery disease is also present, aspirin and statins are often used [5]. In a previous retrospective study of older HF patients (median age 86) [10] 90% were taking four or more different medications. With the development of new, additional treatments, the problem of polypharmacy becomes relevant, as many other drugs are currently being developed as ‘add-on’ therapies alongside current treatments. Thus, although therapy for HF already includes quite a large number of drugs, it is likely to include even more agents in the future. Non-compliance with medical regimen already is the most commonly identified factor related to HF decompensation and accounts for 42% of hospitals admissions for HF [11] and, if the development of new drugs is not accompanied with an increase in patient education, the problem will probably increase in the future. Moreover, HF patients present frequent multiple co-morbidities [12] that imply the additional prescription of drugs to treat other conditions. If we add the use of over-the-counter analgesics (23% in our study) the complexity of treatment can be imagined.

One key finding of our study was the rate of homeopathic and alternative medicine use (12%), particularly high in female patients (almost one-third). Alternative medicine use is also frequent in the general population [13] but had not been previously studied in this setting. The only data we found was the qualitative study by Roger et al. [14] in which one patient of 27 attributed his symptom improvement to an herbal remedy; however, patients in that study were not specifically asked about alternative medicine use. In our opinion, the use of homeopathic and alternative medicine could contribute to further confusion and non-compliance with treatment regimens, as alternative medicine can be used as a substitute to evidence-based medicine.

In our study, patients with HF and systolic dysfunction had a poor knowledge about the medication they were receiving. In agreement with previous findings [14] most patients (88%) knew that diuretics help to eliminate liquids. However, only approximately half of the patients knew that hypotensive drugs decreased blood pressure while a significant percentage of patients attributed this action to drugs with no hemodynamic effect. A surprising finding was that only 42% of patients treated with acenocoumarol and 32% of those treated with aspirin recognized the ability of these drugs to decrease blood coagulability. Although cough was ascribed to ACE inhibitors less frequently than to other vasodilators (mainly angiotensin receptors antagonists), the low use of other vasodilators (16 patients) and the fact that they are frequently prescribed due to cough after ACE inhibitors use, complicates the interpretation of this finding. Unawareness of the potential initial deleterious effect on symptoms of beta-blockers is especially disturbing, since worsening functional class at the beginning of treatment could lead to non-compliance.

Much of our current knowledge of treatment of HF due to ventricular dysfunction is based on patients selected for clinical trials. Such patients do not reflect the spectrum of HF as it presents in the population [15]. Moreover, clinical trials are performed by motivated physicians and patients tend to receive a better follow-up. However, even patients included in clinical trials have a poor knowledge about HF and HF treatment: Yuval et al. found that only 27% of patients participating in HF trials reported complete comprehension of the study [16]. In a survey among new patients visiting a HF clinic, Ni et al. found that 37% said they knew ‘a little or nothing’ about HF [17]. Although a gap between patients receiving and retaining information on HF is known [17] systematic education improves HF patients’ knowledge on essential issues [18].

Drugs known to be extremely effective in HF are considerably underused [19], in part due to the presence of side effects. The likelihood of side effects, such as hypotension, bradycardia and cough could probably be reduced with a better patient's knowledge of the medication, which would result in better compliance. Moreover, patient education and support interventions have been shown to be a key component in comprehensive HF management improving the outcome and quality of life among patients with HF and reducing costs [20–22].

Finally, the low rate of immunization against influenza (68%) is also particularly disappointing, specially the low rate of vaccination recommendation in younger patients (48% in patients <65 years). Influenza infections commonly trigger exacerbations of congestive HF [23] and the impact of influenza infection on the mortality of HF is well known [9], probably contributing importantly to the winter peak in HF deaths and hospitalizations [12,24,25]. Increasing the rate of immunization against influenza could decrease this winter peak as vaccination is associated with a 27% decrease in hospitalizations for congestive HF [26] and all individuals with chronic HF could benefit from immunization with this vaccine. Previous reports [27] have shown that the uptake of influenza vaccination in the elderly, despite its effectiveness, is low. The evidence that vaccination reduces morbidity and mortality and does not cause colds needs to be stressed in patients with chronic HF.

4.1. Limitations and strengths
Our study has several limitations. First, the obvious drawbacks of the descriptive design. Second, the small number of patients included and their clinical profile, as patients followed in our HF clinic are younger and present less non-cardiac illnesses than typical HF patients. However, it is conceivable that polypharmacy and poor medication knowledge are even more important in older patients with more comorbidity. Third, as the questionnaire was confidential we did dot have information on potentially important factors such as civil status, level of education, profession, etiology and duration of HF. Finally, the overall difficulties of measuring knowledge are increased when using a non-previously validated questionnaire.

Nevertheless, our study has several important strengths. First, this is the first description of homeopathic and alternative medicine use in HF. Second, our work alerts to the fact that, in patients with HF, polypharmacy could be related to a very poor knowledge about their medication. Therefore our study points out that the advances in HF with systolic dysfunction have not been accompanied with educational initiatives that are essential to implement the new drugs in every-day clinical practice.

In conclusion, patients with HF and systolic dysfunction have a poor knowledge about the medication they receive. Polypharmacy, over-the-counter drugs, homeopathic and alternative medicine use is frequent while the rate of immunization against influenza is low. More efforts by both physicians and nurses in explaining the condition, treatment, and benefits of immunization to patients and their families would possibly strengthen the compliance.


   Appendix A. English translation of the questionnaire (original in Spanish)
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 Appendix A. English translation...
References
 
This is a confidential questionnaire about the treatment you are receiving. You can answer it yourself or helped by a relative. In case you have any doubt please contact us.
Age: ...... Sex: {square} Male Number of pills you take each day
{square} Female {square} 1 to 5 {square} 6 to 10 {square} more than 10
(1) Do you usually receive immunization against influenza?
{square} Yes
{square} No
(2) Has influenza vaccination been recommended to you by a physician?
{square} Yes
{square} No
(3) Do you use homeopathic and alternative medicine preparations?
{square} Yes. Preparation name: ......
{square} No
(4) Do you use over-the-counter drugs?
{square} Yes, antibiotics. Names ......
{square} Yes, analgesics. Names ......
{square} Yes, other. Names ......
{square} No.
(5) Do you organize your medication yourself or do others perform this task?
{square} Patient
{square} Relatives
{square} Others: ......
(6) This questionnaire is been answered by ......
{square} The patient
{square} The patient helped by a relative
Are you taking any of these drugs?
A list of all the drugs available in Spain belonging to one of the following groups was presented
(one page for each group):
Diuretics. ACE inhibitors. Beta-blockers. Spironolactone. Digoxin. Nitrates. Other vasodilators.
Acenocoumarol. Aspirin. Statins.
{square} No: Go to the next page.
{square} Yes: Do you think this drug ......
Yes No Don't know
... decreases blood pressure?
 {square} {square} {square}
... helps to eliminate liquids?
 {square} {square} {square}
... makes your heart function better?
 {square} {square} {square}
... makes blood coagulation difficult?
 {square} {square} {square}
... could cause cough
 {square} {square} {square}
... could have an initial deleterious effect on symptoms?
 {square} {square} {square}


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 Appendix A. English translation...
 References
 

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