|Year : 2021 | Volume
| Issue : 4 | Page : 122-128
To study the prescription patterns and adequacy of use of statins at a tertiary care center of North India
Suraj Khanal DM 1, Shilpa Atwal MD 2, Pinaki Dutta DM 3
1 Department of Cardiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
2 Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
3 Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
|Date of Submission||03-Apr-2021|
|Date of Decision||17-Apr-2021|
|Date of Acceptance||13-May-2021|
|Date of Web Publication||24-Dec-2021|
Dr. Suraj Khanal
Additional Professor, Department of Cardiology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh – 160 012
Source of Support: None, Conflict of Interest: None
Background: The role and benefits of lipid-lowering drugs in active management of dyslipidemia are well established. However, a little is known about whether these drugs are prescribed as per the recent guidelines and the desired effect is achieved or not in routine clinical practice. The aim of this study was to evaluate the prescription patterns and adequacy of use of statins at a tertiary care hospital. Patients and Methods: Patients aged ≥18 years eligible to receive statin therapy for primary or secondary prevention according to the American Heart Association 2018 guidelines were included in the study. Clinical records of all the cases were reviewed for indications of statins, and lipid profile was done at baseline and after 3 months of statin therapy. Results: There were 140 men and 103 women with a mean age of 52.24 ± 12.01 years. 109 (44.9%) patients received statins for primary prevention, whereas 134 (55.1%) patients received statins for secondary prevention. A total of 179 (73.7%) and 64 (26.3%) patients each received atorvastatin and rosuvastatin. 81.9% of the study population received statins according to the guidelines. After 3 months of statin therapy, there was a statistically significant change in the lipid profile in both primary and secondary prevention groups. Conclusions: There are some irrational prescribing practices among physicians affecting the performance of statin therapy in primary and secondary prevention of atherosclerotic cardiovascular disease. A need to rationalize the prescription practices by keeping abreast with the latest recommendations as well as effective patient counseling and education seems warranted.
Keywords: Atherosclerotic cardiovascular disease, atorvastatin, dyslipidemia, rosuvastatin, statins
|How to cite this article:|
Khanal S, Atwal S, Dutta P. To study the prescription patterns and adequacy of use of statins at a tertiary care center of North India. J Clin Prev Cardiol 2021;10:122-8
|How to cite this URL:|
Khanal S, Atwal S, Dutta P. To study the prescription patterns and adequacy of use of statins at a tertiary care center of North India. J Clin Prev Cardiol [serial online] 2021 [cited 2022 May 17];10:122-8. Available from: https://www.jcpconline.org/text.asp?2021/10/4/122/333700
| Introduction|| |
With a significantly high mortality rate of approximately 235/100,000 populations, cardiovascular disease is among the leading causes of deaths worldwide. Serum cholesterol and the various lipoprotein carriers such as low-density lipoprotein (LDL), very LDL (VLDL), and high-density lipoprotein (HDL) are known to be related to atherogenesis. LDL cholesterol (LDL-C) is considered to be the dominant form of atherogenic cholesterol whereas VLDL cholesterol (VLDL-C) is the chief carrier of triglycerides (TG). Non-HDL (combination of LDL-C and VLDL-C) has been proven to be more atherogenic than either of the lipoprotein alone. Apolipoprotein B is the main protein embedded in LDL and VLDL and is a stronger factor of atherogenicity than LDL-C alone.
According to a WHO report, approximately 60% of Indian population is expected to have a cardiovascular disease by 2020. Dyslipidemia is the most important factors implicated in the causation of atherosclerosis, and there is a distinctive profile of dyslipidemia in Indians, characterized by high-level TG, low-level HDL-C, and increased lipoprotein (a). The atherosclerotic cardiovascular disease (ASCVD)-related mortality is substantially greater in the presence of multiple risk factors. Indian Council of Medical Research-India Diabetes conducted a large population-based study to evaluate the prevalence of dyslipidemia in urban and rural India. The study included a total of 16,607 subjects and revealed a very high prevalence of dyslipidemia in India with 79% of the study population having abnormality in one of the lipid parameters. Hydroxymethylglutaryl coenzyme A reductase inhibitor, also called as statins, is one of the commonly prescribed medications for both primary and secondary prevention of ASCVD. A meta-analysis of 27 randomized trials on the LDL-C–lowering effects of statin therapy in people at low risk of vascular disease revealed that reduction of LDL-C with a statin lead to a reduction in the risk of major vascular events as well as all-cause mortality. For adults aged between 40 and 75 years without a history of cardiovascular disease, the US Preventive Services Task Force also recommends the use of low- to moderate-dose statins as an effective primary prevention strategy. The American Heart Association (AHA) and American College of Cardiology (ACC) have revised the guidelines for dyslipidemia management in 2017 and 2018, leading to significant expansion of patients eligible to receive statin therapy. Further, statins also have cholesterol-independent (pleiotropic) effects; hence, they have wide scope of therapeutic use in various disease processes. Since the rational use of drugs is crucial for safe and effective therapy, it is imperative to study the factors associated with a drug use, such as prescription patterns, indications, dosages, patient adherence, and adverse effects. Although the role and benefits of lipid-lowering drugs in active management of dyslipidemia are well established, a very little is known about whether these drugs are prescribed for proper indications according to the recent guidelines and whether the desired effect is achieved or not in routine clinical practice. Therefore, the aim of this study was to evaluate the prescription patterns and adequacy of use of statins at a tertiary care center of North India.
| Patients and Methods|| |
This prospective, single-arm study was carried out at the Postgraduate Institute of Medical Education Research, Chandigarh, a tertiary care institute in Northern India. Patients of either sex aged ≥18 years eligible to receive statin therapy were screened for the study. Patients were included if they were eligible to receive statin therapy for primary prevention, according to the AHA 2018 guidelines. Patients receiving statins for secondary prevention of ASCVD, who were either not on statins or have been receiving statins for not more than 1 month, were also included. Patients were excluded if they had end-stage kidney disease or have deranged liver enzymes and were not fit for statin therapy. Clinical records of all the cases were reviewed for indications of statins, and lipid profile was done at baseline and after 3 months of statin therapy. The primary outcome measures were indications for the prescription of statin therapy, type of statins used, compliance with the guidelines, and adequacy of prescription in study population, whereas the secondary outcome measures were adherence and response to statin therapy. The study was conducted according to the ethical principles stated in the latest version of Helsinki Declaration and the applicable guidelines for good clinical practice.
Categorical variables were analyzed using Chi-square test and presented in the form of number and percentage. Quantitative data were represented in the form of mean ± standard deviation; mean values across groups were compared using Student's/independent t-test for the normally distributed variables and Mann–Whitney test for nonnormal distributed variables. The width of the resultant confidence intervals for parameters to be estimated was constructed with a significance level of 0.05, i.e. a 95% confidence interval. Statistical analysis was conducted using IBM SPSS statistics (version 22.0, IBM, USA).
| Results|| |
This study was carried out at Post Graduate Institute of Medical Education and Research, Chandigarh, from December 2018 to August 2019. A total of 320 patients from cardiology, endocrinology, and medicine departments were screened, and 268 patients were included in the study. Of the 52 patients who were excluded, 28 did not meet the inclusion criteria whereas 24 refused to participate in the study. Five patients who died of secondary complications and 20 patients who were nonadherent to regular statin therapy and missed few doses were also excluded, and the data of the 243 patients were statistically analyzed.
There were 140 men and 103 women with a mean age of 52.24 ± 12.01 years. The demographic profile and baseline characteristics of the study population are enumerated in [Table 1]. A total of 109 (44.9%) and 134 (55.1%) patients were enrolled in the primary and secondary prevention group, respectively. The most common age group was 41–60 years in 146 (60.1%) patients followed by 31–40 years in 35 (14.4%) patients and 61–70 years in 37 (15.2%) patients. 25 (10.3%) patients were either <30 years of age or above 70 years. Of the 243 patients included in the study, 199 (81.9%), 42 (17.3%), and 2 (0.8%) patients, respectively, were prescribed the adequate dose, under dose, and overdose of statin therapy.
|Table 1: Demographic profile and baseline characteristics of study population (n=243)|
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Indications for prescription of statin therapy
Primary prevention group
A total of 109 patients received prescription of statins for primary prevention. The common indications for prescription of statins in primary prevention group were diabetes mellitus without ASCVD complications in 70 (64.22%) patients, primary dyslipidemia (LDL ≥189 mg/dl) in 18 (16.51%) patients, 40–79 years of age with LDL >70 mg/dl and risk factors for ASCVD in 12 (11%) patients, obesity in 3 (2.7%) patients, and osteoporosis, thyroid disorders, and family history of premature ASCVD in 2 (1.8%) patients each, respectively.
Secondary prevention group
A total of 134 patients received prescription of statins for secondary prevention. The common indications for prescription of statins in the secondary prevention group were acute coronary syndrome in 34 (25.37%) patients, coronary artery disease in 90 (67.15%) patients, ischemic CVA in 4 (2.98%) patients, and peripheral arterial disease in 6 (4.47%) patients.
Type of statins prescribed and compliance with the guidelines
A total of 179 (73.7%) patients received atorvastatin; 75 (68.8%) in the primary prevention group and 104 (77.6%) in the secondary prevention group. 64 (26.3%) patients received rosuvastatin; 34 (31.2%) in the primary prevention group and 30 (22.4%) in the secondary prevention group. In our study, 81.9% of the study population received statins according to guidelines, whereas 18.1% of patients did not received statins as per the guidelines. The distribution of patients who received statin therapy as per guidelines in the primary and secondary prevention groups was 91 (83.5%) and 108 (80.6%), respectively. The distribution of patients who did not received statin therapy as per the guidelines in the primary and secondary prevention groups was 18 (16.5%) and 26 (19.4%), respectively.
Primary prevention group
Of the 109 prescription in the primary prevention group, 91 (83.5%) prescriptions were according to the guidelines whereas 18 (16.5%) were not according to the guidelines. In this group, there were 70 patients with diabetes mellitus without ASCVD complications and 39 non diabetics with moderate-to-high risk of ASCVD. Of the 70 patients with diabetes mellitus, 50 had no additional risk factor and received moderate-intensity statin as per the guidelines without any need of risk score calculation. 20 patients had (≥1 additional risk factor) of which only 10 received high-intensity statin, and the remaining 10 received either moderate- or low-intensity statin which was not according to the guideline. Among the 39 nondiabetic patients, 31 prescriptions were found in compliance with the guidelines, whereas remaining 8 were prescribed statin without any mention of 10-year ASCVD risk score estimation on prescription slip. Framingham Risk Score was used in our study for risk estimation in patients <40 or >0 years of age, receiving statins for primary prevention as it is more sensitive for Indian population as compared to other scores. Of the 39 patients, 8, 21, and 10 patients, respectively, were in the low-, intermediate-, and high-risk ASCVD category. In the low-risk ASCVD category, 2 patients were receiving moderate-intensity statins, without additional risk factors assessment and discussion with patient which is not in accordance with the current guidelines. Similarly, in the intermediate- and high-risk ASCVD category, 2 and 4 patients, respectively, were receiving low-intensity statins which is not as per the guidelines.
Secondary prevention group
Of the 134 prescription in the secondary prevention group, 108 (80.6%) prescriptions were according to the guidelines, whereas 26 (19.4%) were not according to the guidelines. Of the 26 patients, 20 patients with coronary artery disease were receiving moderate-intensity statin against the recommended high-intensity statin and 6 patients with peripheral arterial disease were receiving low-intensity statin, whereas high intensity is indicated as per the guidelines.
Adequacy of prescriptions in the study population
Primary prevention group
Of the 91 patients in this group who received statins as per the guidelines, 16, 69, and 6 patients, respectively, were in high-risk, intermediate-risk, and low-risk group. Among the high-risk group, 15 (93.7%) patients achieved LDL reduction of >50%, which was considered adequate as per the guidelines. 49 (71%) patients in the intermediate-risk group achieved LDL reduction of 30%–50%, whereas all 6 patients in the low-risk group achieved LDL reduction of <30% which was considered adequate as per the guidelines.
Secondary prevention group
Of the 108 patients in this group who received statins as per the guidelines, 34 (31.48%) patients achieved LDL reduction of >50%, which was considered adequate as per the guidelines.
Adherence to statin therapy
During the course of this study, all 243 patients were adherent to the statin therapy.
Effect on lipid profile after 3 months of statin treatment
Lipid profile at baseline and after 3 months of statin therapy for primary and secondary prevention group is enumerated in [Table 2].
Primary prevention group
The mean decrease in total cholesterol, TG, LDL, and VLDL levels in this group after 3 months of statin treatment was 17.24%, 21.24%, 33.19%, and 22.83%, respectively, whereas the increase in mean HDL level was 9.55%.
Secondary prevention group
The mean decrease in total cholesterol, TG, LDL, and VLDL levels in this group after 3 months of statin treatment was 14.35% 15.80%, 36.92%, and 16.17%, respectively, whereas the increase in mean HDL level was 8.77%. Hence, there was statistically significant change in lipid profile from baseline in both primary and secondary prevention groups after 3 months of statin treatment.
Effect of atorvastatin and rosuvastatin on lipid profile
Effect of atorvastatin and rosuvastatin therapy on lipid profile in the primary and secondary prevention group is enumerated in [Table 3] and [Table 4].
|Table 3: Effect of atorvastatin on lipid profile in primary and secondary prevention group|
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|Table 4: Effect of rosuvastatin on lipid profile in primary and secondary prevention group|
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Both atorvastatin and rosuvastatin were associated with significant change in the lipid profile after 3 months of treatment in primary as well as secondary prevention group. In both the primary and secondary prevention groups, the mean percent decrease in LDL was more with rosuvastatin than atorvastatin. However, since the number of patients receiving atorvastatin and rosuvastatin was different, the same cannot be compared.
| Discussion|| |
Statins are prescribed in various conditions because of their primary and pleiotropic effects. The guidelines and scope of statin use have further increased with the new AHA/ACC guidelines 2018. The objective of this study was to evaluate the prescription patterns of statins, indications for prescription, type of statins used, compliance with the guidelines, adequacy of prescription, adherence, and response to statin therapy.
In our study, 199 (81.8%) patients were above 40 years of age, whereas 44 (18.2%) patients were between 18 and 39 years of age. There were 140 (57.6%) males and 103 (42.4%) females, with a mean age of 52.12 years. This finding is in concordance with the findings of a study on the prescription patterns of hypolipidemic drugs by Prasad et al., where 89.5% patients were above the age of 40 years and 10.5% patients were between 18 and 39 years. The male and female distribution in this study was 72% and 28%, respectively. The studies by Dawalji et al. and Tamilselvan et al. also reported a male dominance with 72.94% and 69.1%, respectively. On the contrary, a similar study by Shankar et al. showed a female (51.94%) dominance over males (48.06%). Our findings are also consistent with a study by Sreedevi et al. that had the similar age distribution with predominant age group of 60–70 years in males and 50–60 years in females. As compared to females, more males in our study were on statin therapy that may be due to contributing risk factors, such as smoking, alcohol intake, and diet high in saturated fat. Similarly, in the study by Sreedevi et al. and Nagabushan et al., more males were prescribed the statin therapy as compared to females. In a study by Mahadeo et al., 648 prescriptions were analyzed to conclude that the incidence of ischemic heart disease was more in male patients as compared to their female counterpart. The results of our study are found to be consistent with most of the previously published reports and indicate that males are more prone to coronary artery disease as compared to females and hence are more commonly prescribed statin therapy.
In our study, 55.1% of the patients were prescribed statins for secondary prevention as compared to 44.9% of the patients who were prescribed statins for primary prevention. Therefore, secondary prevention was found to the more common indication of statins prescription than primary prevention (ratio 1.22:1). Overall coronary artery disease (37.03%) was the leading indication for the prescription of statins followed by diabetes mellitus without ASCVD (70.64%). Other indications of secondary prevention included newly diagnosed statin-naïve patients diagnosed with stable coronary artery disease, unstable coronary artery disease/acute coronary artery disease, ischemic cardiovascular accidents, and peripheral arterial disease. 64.22% of the patients in the primary prevention group were diabetics in our study. Other indications were primary dyslipidemia (16.51%) and obesity (3.6%). There were 5 patients (4.5%) in the age group of 40–79 years who were prescribed statins for primary prevention without ASCVD/other risk score calculation. Other indications were obesity (3.6%), osteoporosis (2.7%), and thyroid disorders (2.7%). These observations are consistent with the findings of a study by Prasad et al. in which statins was prescribed for secondary prevention in 53.5% patients and primary prevention in 46.5% patients respectively (ratio 1.15:1). In a study by Sreedevi et al., 279 prescriptions out of 306 prescriptions containing statins had cardiovascular disease as the indication for prescription followed by diabetes mellitus (199 prescriptions) as the next most common indication. The other indications were thyroid disease, osteoporosis, and renal insufficiency. Similarly, in a study by Raja et al., diabetes with hypertension (37%) was the most common disease for which hypolipidemic drugs were prescribed. In a study by Sudhram et al., the most common indication of statin prescription was hypertension with diabetes (37%) followed by hypertension and diabetes alone in 21.2% and 21% patients, respectively. Likewise, our study is in concordance to a study by Arul et al., where coronary artery disease was found to be the most common indication for secondary prevention (33%) followed by dyslipidemia (16.5%), hypertension (13.5%), myocardial infarction (10%), and angina (6.5%).
In our study, the most common statin prescribed was atorvastatin (73.7%) followed by rosuvastatin in 26.3% patients. In the primary prevention group, 68.8% of the patients were prescribed atorvastatin and 31.2% were prescribed rosuvastatin, whereas in the secondary prevention group, 77.6% and 22.4% of patients, respectively, were prescribed atorvastatin and rosuvastatin. This finding is consistent with the observations of Sreedevi et al. and Raja et al. where atorvastatin was the most favored hypolipidemic drug prescribed as monotherapy. Similarly, a study by Arul et al. also showed that atorvastatin was the most commonly prescribed hypolipidemic drug (50%) followed by rosuvastatin (40%) and simvastatin (10%). On the contrary, our study differs from SCORE study, where rosuvastatin was found to be the most preferred statin therapy for primary (50.6%) and secondary prevention (49.4%). Similarly, in a prospective study that evaluated the use of low doses of the statins (PULSAR), in high-risk patients with hypercholesterolemia, rosuvastatin was found to be more effective at reducing LDL-C as compared to atorvastatin. LUNAR study also showed that rosuvastatin was more efficacious than atorvastatin in decreasing LDL-C and increasing HDL-C in patients with acute coronary syndrome.
In the primary prevention group, 91 out of 109 prescriptions were as per the guidelines. In this subset, 93.7% patients in the high-risk group, 71% patients in the moderate-risk group, and 100% patients in the low-risk group achieved LDL reduction as per the applicable guidelines. In the secondary prevention group, 108 out of 134 prescriptions were as per the guidelines. In this subset, 31.48% achieved more than 50% LDL reduction at the end of 3 months. In the atorvastatin group, the mean decrease in total cholesterol and LDL was 15.23% and 37.51%, respectively, in the primary prevention group and 13.65% and 38.43%, respectively, in the secondary prevention group. However, in the rosuvastatin group, the mean decrease in total cholesterol and LDL was 13.22% and 41.55% in the primary prevention group and 13.22% and 41.52% in the secondary prevention group, respectively. Therefore, rosuvastatin group was found to have more mean decrease in LDL as compared to atorvastatin although the same could not be compared due to the difference in the sample size. Our study confirms the findings of STELLAR trial that was the largest trial on the comparison of lipid-modifying efficacy of various statins and showed that rosuvastatin had greater efficacy in reduction of LDL-C as compared to atorvastatin, simvastatin, and pravastatin across dose ranges. In this trial, a significant mean difference (8.2%) in LDL reduction was achieved with rosuvastatin (dose 10–80 mg) as compared to atorvastatin (dose 10–80 mg). However, our study differs from a study by Arul et al., in which a significant reduction in total cholesterol levels was seen in patients taking atorvastatin (P < 0.0001) followed by rosuvastatin (P < 0.0001) and simvastatin (P < 0.0001). Further, the mean reduction in total cholesterol levels was higher in atorvastatin group (37.9%) followed by rosuvastatin (28.5%) and simvastatin (5.6%) in this study.
This study has some limitations. These include small number of participants from the cardiology, endocrinology, and medicine departments that may not be reflective of overall patient population, lack of direct supervision of patient compliance, use of single set of guidelines that may not be entirely representative of Indian cohort of patients and nonrepresentation of prescription practices of primary and secondary care physicians.
| Conclusions|| |
This study conclusively demonstrates the prescription of statins in different disease spectrums. Most common indication of statins was coronary artery disease followed by diabetes mellitus with or without ASCVD. Atorvastatin was found to be the most commonly prescribed statin in this study. As compared to the baseline, both atorvastatin and rosuvastatin lead to a significant change in the lipid profile at 3 months. About two-third of statin prescriptions were found according to latest AHA 2018 guidelines. However, the actual target LDL reduction was achieved in more than two-third patients in the primary prevention group and only one third patients in the secondary prevention group. Hence, there is a need to give adequate and effective counseling regarding diet and lifestyle modification along with the drugs. Further, proper adherence to the lipid-lowering drugs has to be ensured by calling patients for follow-up more frequently at the initiation of therapy as well as at adequate intervals. Still, there are some irrational prescribing practices such as inappropriate indication and dosage (under or over dosage), inadequate follow-up to check the compliance, and inadequate monitoring of lipid profile and other laboratory parameters among physicians affecting the performance of statin therapy in the primary and secondary prevention of ASCVD. This can be overcome by keeping up-to-date knowledge on the use of stain therapy, cross-checking of therapy for quality, dosage as well as substitutions and ensuring the regular follow-up of patients to check the compliance besides monitoring of lipid profile and other laboratory parameters. Hence, there is a need to rationalize the prescription practices by keeping abreast with the latest recommendations as well as effective patient counseling and education. Drug prescription studies of this kind are needed in institutes all over India to understand the country-wide prescription patterns of statin therapy. Further, large multicenter study seems warranted to confirm the findings of our study.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]