scholarly journals The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient

2021 ◽  
Vol 70 (6 Supplement) ◽  
Author(s):  
Lillo
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Cardiovascular Risk ◽  
Patient Education ◽  
Statin Therapy ◽  
Common Reason ◽  
Nocebo Effect ◽  
Statin Intolerance

KEY TAKEAWAYS • Discontinuing statin therapy results in increased cardiovascular risk. • The nocebo effect is a common reason for perceived statin intolerance. • Statin intolerance is much less commonly reported in clinical trials than in clinical practice, suggesting that patient education and other safeguards employed in clinical trials are important to include in clinical practice. • Several strategies are available that can enable continuation of statin therapy in patients who are truly statin-intolerant.

scholarly journals Prevention and management of statin adverse effects: A practical approach for pharmacists

2018 ◽  
Vol 151 (3) ◽  
pp. 179-188 ◽  
Author(s):  
Arden R. Barry ◽  
Jessica E. Beach ◽  
Glen J. Pearson
Keyword(s):  
Clinical Practice ◽  
Patient Education ◽  
Adverse Effects ◽  
Statin Therapy ◽  
Working Group ◽  
Compelling Evidence ◽  
Statin Intolerance ◽  
Relative Paucity ◽  
Cardiovascular Benefit

Statin-associated adverse effects, primarily muscle-related symptoms, occur in up to approximately one-third of patients in clinical practice. Recently, a Canadian Consensus Working Group outlined 6 key principles to assess and manage patients with goal-inhibiting statin intolerance, defined as a syndrome characterized by symptoms or biomarker abnormalities that prevent the long-term use of and adherence to indicated statin therapy, which includes a trial of at least 2 statins and precludes reversible causes of statin adverse effects. These principles ensure patients are appropriately receiving a statin and aware of both the benefits and risks of therapy. As well, they address factors that may increase the risk of statin-associated myopathy. A thorough assessment of patients’ clinical and laboratory history should be performed in any patient presenting with muscle symptoms on statin therapy, followed by a systematic dechallenge/rechallenge approach. In practice, most patients with statin intolerance due to muscle symptoms will be able to tolerate another statin. This is of particular importance because of the relative paucity of compelling evidence demonstrating a cardiovascular benefit with nonstatin therapies. Pharmacists are ideally situated to provide patient education, recommend changes to therapy and monitor patients with goal-inhibiting statin intolerance.

scholarly journals Features and main problems of treating patients with high and very high cardiovascular risk with statins in real clinical practice (according to the data of the “PRIORITET” research)

2018 ◽  
Vol 17 (6) ◽  
pp. 52-60 ◽  
Author(s):  
S. Yu. Martsevich ◽  
Yu. V. Lukina ◽  
N. P. Kutishenko ◽  
N. A. Dmitrieva ◽  
T. A. Gomova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Risk ◽  
Statin Therapy ◽  
Working Group ◽  
Target Level ◽  
High Cardiovascular Risk ◽  
Lipid Pattern ◽  
Very High ◽  
Real Clinical Practice ◽  
Group 1

Aim. To determine the features and main problems of statin therapy, as well as assess the possibility of achieving the target level of lipid pattern in patients with high and very high cardiovascular risk (CVR) in real clinical practice.Material and methods. The design of the “PRIORITET” observational program is an open observational study. Patients with high and very high CVR were divided into 3 groups in accordance with the initial data: (1) not taking statins, (2) taking statins, but not reaching the target low-density lipoprotein cholesterol (LDL-C) level, (3) taking statins with the achievement of the target LDL-C level, which is justified in replacing the statin inside the class — adverse effects (AE), high price, etc. Within 12 weeks 3 visits of patients to hospitals were carried out: baseline visit (B0), visit 1 month after the study initiation (B1) and visit 3 months after the study initiation (B3). The choice of atorvastatin or rosuvastatin was assessed by the doctors.Results. Groups 1, 2 and 3 included 112, 170 and 16 people, respectively. At B0, 145 (48,7%) patients were prescribed atorvastatin, and 153 (51,3%) — rosuvastatin. Three people dropped out of the study to B3, 295 patients completed the program. Lipid pattern of 285 patients were analyzed: 121 (41%) people (101 with very high CVR and 20 with high CVR) achieved the target LDL-C level, the remaining 164 (59%) patients (CVR — 156 and 8, respectively) — no. The most pronounced dynamics of LDL=C level was revealed in group 1, the differences between group 1 and groups 2 and 3 are highly statistically significant (p<0,0001). There were no differences in the frequency of reaching the target LDL-C level between patients taking atorvastatin or rosuvastatin. The target level of LDL-C (p=0,003) in the treatment of rosuvastatin in patients with high CVR was reached significantly more often than in patients with very high CVR. Also 3 non-serious AEs were reported. On average, in 9% of cases, reaching the target level of LDL-С during visits B1 and B3 was wrong interpreted by the attending physicians.Conclusion. The main problems of statin therapy in real clinical practice are the wrong interpretation of reaching the target level of LDL-C, inertness of doctors in titrating of statins doses and achieving the target level of lipid pattern. It may be the cause of reduced efficiency and deterioration of lipid-lowering therapy results in patients with high and very high CVR. The results of the “PRIORITET” study demonstrated the possibility of improving the practice of statins use and its accordance with clinical guidelines.Skibitsky V. V. on behalf of the working group of the “PRIORITET” researchWorking Group of the “PRIORITET” study: Voronina V. P. (Moscow), Zelenova T. I. (Moscow), Sladkova T.A. (Moscow), Alekseeva A. I. (Tula), Barabanova T. Yu. (Tula), Zotova A. S. (Tula), Kolomeitseva T. M. (Tula), Prikhod’ko T. N. (Tula), Pazelt E. A. (Nizhny Novgorod), Khramushev N. Yu. (Nizhny Novgorod), Skibitsky A. V. (Krasnodar), Alekseeva V. V. (Saratov), Lazareva E. V. (Saratov).

scholarly journals Unethical informed consent caused by overlooking poorly measured nocebo effects

2020 ◽  
pp. medethics-2019-105903
Author(s):  
Jeremy Howick
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Natural History ◽  
Adverse Events ◽  
Placebo Effect ◽  
Nocebo Effect ◽  
Control Groups ◽  
Nocebo Effects ◽  
Negative Outcome

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

scholarly journals Placebo and nocebo effects in the neurological practice

2015 ◽  
Vol 73 (1) ◽  
pp. 58-63 ◽  
Author(s):  
Caroline Bittar ◽  
Osvaldo J.M. Nascimento
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gold Standard ◽  
Neurological Diseases ◽  
Nocebo Effect ◽  
Double Blind ◽  
Positive Effects ◽  
Specific Effects ◽  
Randomized Clinical Study ◽  
Nocebo Effects

Knowledge of placebo and nocebo effects is essential to identify their influence on the results in clinical practice and clinical trials, and thereby properly interpret their results. It is known that the gold standard of clinical trials research is the double-blind, placebo-controlled, randomized clinical study. The objective of this review is to distinguish specific from non-specific effects, so that the presence of positive effects in the group that received placebo (placebo effect) and the presence of adverse effects in the group receiving placebo (nocebo effect) lead to confounding in interpreting the results. Placebo and nocebo effects have been considered in neurological diseases such as depression, pain, headache, multiple sclerosis, epilepsy. As placebo and nocebo effects are also present in clinical practice, the purpose of this review is to draw attention to their influence on neurological practice, calling attention to the development of measures that can minimize them.

scholarly journals Features and main problems of treating patients with high and very high cardiovascular risk with statins in real clinical practice (according to the data of the “PRIORITET” research)

2018 ◽  
Vol 17 (6) ◽  
pp. 52-61
Author(s):  
S. Yu. Martsevich ◽  
Yu. V. Lukina ◽  
N. P. Kutishenko ◽  
N. A. Dmitrieva ◽  
T. A. Gomova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Risk ◽  
Statin Therapy ◽  
Working Group ◽  
Target Level ◽  
High Cardiovascular Risk ◽  
Lipid Pattern ◽  
Very High ◽  
Real Clinical Practice ◽  
Group 1

Aim. To determine the features and main problems of statin therapy, as well as assess the possibility of achieving the target level of lipid pattern in patients with high and very high cardiovascular risk (CVR) in real clinical practice.Material and methods. The design of the “PRIORITET” observational program is an open observational study. Patients with high and very high CVR were divided into 3 groups in accordance with the initial data: (1) not taking statins, (2) taking statins, but not reaching the target low-density lipoprotein cholesterol (LDL-C) level, (3) taking statins with the achievement of the target LDL-C level, which is justified in replacing the statin inside the class — adverse effects (AE), high price, etc. Within 12 weeks 3 visits of patients to hospitals were carried out: baseline visit (B0), visit 1 month after the study initiation (B1) and visit 3 months after the study initiation (B3). The choice of atorvastatin or rosuvastatin was assessed by the doctors.Results. Groups 1, 2 and 3 included 112, 170 and 16 people, respectively. At B0, 145 (48,7%) patients were prescribed atorvastatin, and 153 (51,3%) — rosuvastatin. Three people dropped out of the study to B3, 295 patients completed the program. Lipid pattern of 285 patients were analyzed: 121 (41%) people (101 with very high CVR and 20 with high CVR) achieved the target LDL-C level, the remaining 164 (59%) patients (CVR — 156 and 8, respectively) — no. The most pronounced dynamics of LDL=C level was revealed in group 1, the differences between group 1 and groups 2 and 3 are highly statistically significant (p<0,0001). There were no differences in the frequency of reaching the target LDL-C level between patients taking atorvastatin or rosuvastatin. The target level of LDL-C (p=0,003) in the treatment of rosuvastatin in patients with high CVR was reached significantly more often than in patients with very high CVR. Also 3 non-serious AEs were reported. On average, in 9% of cases, reaching the target level of LDL-С during visits B1 and B3 was wrong interpreted by the attending physicians.Conclusion. The main problems of statin therapy in real clinical practice are the wrong interpretation of reaching the target level of LDL-C, inertness of doctors in titrating of statins doses and achieving the target level of lipid pattern. It may be the cause of reduced efficiency and deterioration of lipid-lowering therapy results in patients with high and very high CVR. The results of the “PRIORITET” study demonstrated the possibility of improving the practice of statins use and its accordance with clinical guidelines.Skibitsky V. V. on behalf of the working group of the “PRIORITET” researchWorking Group of the “PRIORITET” study: Voronina V. P. (Moscow), Zelenova T. I. (Moscow), Sladkova T.A. (Moscow), Alekseeva A. I. (Tula), Barabanova T. Yu. (Tula), Zotova A. S. (Tula), Kolomeitseva T. M. (Tula), Prikhod’ko T. N. (Tula), Pazelt E. A. (Nizhny Novgorod), Khramushev N. Yu. (Nizhny Novgorod), Skibitsky A. V. (Krasnodar), Alekseeva V. V. (Saratov), Lazareva E. V. (Saratov).

scholarly journals Adherence to statin therapy in patients with high and very high cardiovascular risk in real clinical practice

2020 ◽  
Vol 11 (1) ◽  
pp. 38-48
Author(s):  
V. I. Podzolkov ◽  
A. E. Bragina ◽  
L. V. Vasil’eva ◽  
Yu. P. Grintsevich ◽  
Yu. N. Rodionova
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Risk ◽  
Statin Therapy ◽  
Charlson Comorbidity Index ◽  
High Cardiovascular Risk ◽  
Positive Correlation ◽  
Comorbidity Index ◽  
Very High ◽  
Real Clinical Practice

Despite the proven efficacy of lipid-lowering therapy, adherence to long-term statin therapy in patients with cardiovascular disease remains low.Aim. To study adherence to long-term statin therapy and factors associated with adherence in patients with high and very high cardiovascular risk (CVR) in real clinical practice.Materials and methods. The single-center cohort study included 53 patients (mean age 68.1 ± 10.2 years) with high or very high CVR on the SCORE scale and have been taking statins for at least 3 months prior to inclusion in the study. The level of low-density lipoprotein cholesterol (LDL-C), cognitive impairment (MoCA test), anxiety and depression (HADS scale), presence of senile asthenia (FRAIL scale), M. Charlson comorbidity index were assessed. Adherence to statin therapy was assessed using the original questionnaire. The correlation between patient adherence and ordinal variables for the scores of the studied scales was studied.Results. Completely adherent to statin therapy were only 12 (22%) patients, 14 (26%) were insufficiently adherent, 27 (51%) were non-adherent. The target level of LDL-С was achieved in 13 (25%) patients. 38 (72%) patients showed a decrease in cognitive functions; a positive correlation was found between adherence and the MoCA test (r = 0.44, p = 0.04). Clinical and subclinical depression and anxiety were noted in 12 (23%) and 14 (26%) patients, respectively. A statistically significant negative correlation was found between adherence and depression (r = –0.32; p = 0.04) and a positive correlation between adherence and anxiety (r = 0.44; p = 0.04). There was no statistically significant correlation between adherence and the FRAIL fragility scale, as well as the M. Charlson comorbidity index.Conclusions. Depression and cognitive decline are associated with decreased adherence to statin therapy.

Controlling Hypertension and Stroke Prevention – From Guideline to Clinical Practice

2011 ◽  
Vol 3 (1) ◽  
pp. 30
Author(s):  
Anding Xu ◽  
Zefeng Tan ◽  
◽  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Stroke Prevention ◽  
Modifiable Risk Factors ◽  
Cerebrovascular Events

Hypertension is the most important of the prevalent and modifiable risk factors for stroke. Based on evidence, blood pressure (BP) lowering is recommended in guidelines for the prevention of stroke. However, there are still some uncertainties in the guidelines for controlling BP and preventing stroke in patients with previous cerebrovascular events, such as the goal BP, who to treat and which class of BP-lowering drugs to use. This article discusses these questions by reviewing guidelines and corresponding clinical trials, with the aim of reducing the gap between guidelines and clinical practice.

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