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Conflict of interest: I. Oslo Economics has performed projects financed by Novartis and several other public and private organizations. In clinical practice, many patients do not reach the recommended treatment targets for LDL-cholesterol levels. We aimed to examine treatment patterns and adherence for patients on lipid lowering drugs in Norway to inform future strategies to improve therapies. Treatment gaps were assessed assuming patients take one tablet per day and were defined to occur if a patient did not refill a prescription when the previous one should have been depleted. Treatment was defined as discontinued when the preceding prescription would have been used and no new subsequent prescription was filled. The mean proportion of days covered PDC was calculated by aggregating the total number of tablets dispensed during each calendar year and dividing by Patients 80 years were excluded. A considerable proportion of statin users in Norway had long treatment gaps or discontinuation in treatment. The Similar results were found for patients on antidiabetics and hypertensives. PDC ranged from The most common lipid lowering drugs in were atorvastatin, simvastatin, and ezetimibe. There is a great potential for improving drug adherence and optimizing lipid lowering therapy by switching to more effective statins in greater doses, and more often add ezetimibe and PCSK9 inhibitors to treatment. Pharmacological treatment with statins to reduce hypercholesterolaemia is crucial for primary and secondary prevention of atherosclerotic cardiovascular and cerebrovascular disease CVD. National and international studies indicate that a majority of patients in clinical practice fails to achieve the recommended lipid goals 6 , 7 which in turn increase their risk of CVD events 6. Furthermore, many patients are treated with suboptimal statin doses and rarely are prescribed combination therapy with non-statin drugs. Today, poor drug adherence i. It is well known that estimates of adherence are strongly influenced by the applied definition of adherence, 13 as well as the measurement method. Knowledge about temporal trends in treatment practice and adherence to lipid lowering drugs are lacking in Norway. Such information may enhance clinical and public awareness, potentially paving the way for more optimized lipid management in clinical practice. This observational study aims to evaluate treatment patterns dispensed drugs and doses and adherence for patients on lipid lowering drugs in Norway during and using nation-wide prescription data. For patients with at least one such dispensing, we obtained information on their use of pharmacy dispensed diabetes drugs ATC-code A10 , diuretics C03 , beta-blockers C07 , calcium channel blockers C08 , and renin-angiotensin modulating drugs C9 during the period — For each dispensing, we received information on patient characteristics age, sex, and month of death if applicable , dispensing date, ATC code of drug, number of defined daily doses DDDs , and number of tablets or milligram active substance. The dataset encompassed patients and 72 prescription fills. There were no missing data. Norway has flexible reimbursement rules for statins except rosuvastatin , ezetimibe, less flexible rules for rosuvastatin and ezetimibe combinations while PCSK9 inhibitors have very strict rules. For example, prescriptions for patients born in were excluded from analysis from 1 January The exclusion was motivated by weak evidence of statin benefit among older people, especially for primary prevention. We also excluded patients with one or more prescription fills of pitavastatin patients , prescription fills with a negative number of tablets two prescription fills ; and prescription fills with more than 20 tablets on one prescription one prescription fill. A total of patients remained for analysis. Descriptive statistics and patient characteristics for the total population extracted raw data and the study population are provided in Supplementary material online , Table S1 and S2. We present frequencies of patients and prescription fills, as well as their distributions by type of drug and drug dose, during the period — Patients at high CVD risk have lower LDL-cholesterol targets than others, and their drug use, doses, and adherence are particularly important. Mean proportion of days covered PDC was estimated by drug and year, by summing up the number of tablets statins and ezetimibe or milligrams PCSK9 dispensed during each calendar year and dividing by Patients were defined to be on a lipid lowering drug if they had at least one prescription fill of that drug during the year. One patient can therefore be present in more than one drug group. Because patients may start or discontinue drug treatment any day during the calendar year, and because some patients fill prescriptions unregularly, this simple method for estimating mean PDC, may entail bias. We explored potential bias in various sensitivity analyses, including by removing prescription filled 6 months before time of death, by prevalent and incident patients separately and by removing incident patients who had their first filling after 1st October 1st in the year of interest or patients who died during the year. In addition, we used the reverse waiting time distribution RWD with random index dates in a 1-year sampling window for each calendar year to estimate the days covered by a single prescription. We estimated the proportion of patients with gaps in statin use of more than 90, , , , and days duration, and of discontinuation. We assumed that patients on statins take one tablet per day. If a patient receives for example tablets and fills the next prescription after days, we assumed there had been a treatment gap of 90 days. Treatment was defined as discontinued when the preceding prescription would have been used assuming one tablet per day and no new subsequent prescription was filled. When calculating the proportion of patients with a discontinuation, individuals were censored if they were registered as dead or turned 81 years old during the study period. Analyses of adherence and treatment gaps were restricted to incident patients from washout period — Analyses were performed using R version 4. The proportion of the Norwegian population under 80 years with at least one lipid lowering drug prescription increased from 8. There were patients who had a dispensing of both an anti-diabetes and an anti-hypertension drug in Prevalence, incidence, number of prescriptions, and more detailed patient characteristics for patients on lipid lowering drugs are provided in Supplementary material online , Table S1 and S2. In , In , these proportions were In total, patients switched from pravastatin or simvastatin to atorvastatin during the study period, while 24 switched to rosuvastatin. PCSK9 inhibitors were introduced in Norway in , and the number of patients on these drugs increased from 54 in to in In , patients on PCSK9 inhibitors represented 0. Of the patients with at least one prescription of anti-diabetes and one anti-hypertension drug during through , Number of patients on lipid lowering drugs in Norway according to type of drug and year. For example, for atorvastatin, Patients on antidiabetics and antihypertensives had somewhat higher doses, but the differences were small. The number of patients and prescription fills of lipid lowering drugs according to type of drug are presented in Supplementary material online , Table S3. Patients on anti-diabetes and anti-hypertension drugs diuretics, beta blockers, calcium channel blockers, and renin-angiotensin modulating drugs. For patients on lipid lowering drugs, adherence measured as mean PDC varied little across time and type of drug Figure 2. In , the mean PDC was For simvastatin, atorvastatin, and pravastatin, there were only minor changes in the mean PDC from to While the mean PDC increased from The trends were larger in magnitude for rosuvastatin 2. All time trend estimates were statistically significant. For PCSK9 inhibitors, the mean number of mg dispensed per day in was 7. This implies that a mean PDC in was Solid line on top of each bar shows confidence interval for mean PDC. Confidence intervals are small due to large sample size. In total, Among these patients, 65 had a gap of more than days before they started treatment again during the period — These 65 patients had a total number of 86 gaps of days or more. Gaps or discontinuation in statin treatment of days or more were observed in The proportion of patients with gaps was similar for patients receiving diabetes drugs and those aged 61 years or younger see Supplementary material online , Figure S1. Example: When a patient receives tablets and fill the next prescription after days, we define this as a day gap. For atorvastatin, women used The estimated gender difference in mean dose was 6. Younger patients 0—59 also used a lower dose There was no variation in mean PDC according to gender. Patients with at least one prescription of a diabetes and a hypertension drug used somewhat higher doses, and those in the older age cohorts had a higher mean PDC compared with the total patient population. Proportion of days covered a and mean mg drug per day for atorvastatin users in , according to age, sex, and the use of diabetes drugs. Total number of tablets dispensed in a calendar year divided by and the number of patients in that year. Our estimates of the proportions of days covered PDC presented above are influenced negatively by treatment gaps and initiation of treatment late in a calendar year. We found no significant gender difference in prescription duration. In Norway, an increasing number of patients use lipid lowering drugs. Our long-term data indicate that considerable proportions of patients have suboptimal treatment with low-intensity statins, low statin doses, modest adherence, and lengthy treatment gaps. Few patients receive ezetimibe, combination therapy with ezetimibe, or PCSK9 inhibitors. Thus, there seems to be a substantial potential for improvements in patient and population health outcomes through optimized treatment with cost-effective lipid lowering drugs. The main strength of this study lies in almost complete national, longitudinal data on the use of lipid lowering drugs. Pharmacies in Norway are legally required to electronically report all prescription fills to the NorPD, thus our data cover the entire Norwegian population. Because the study was based on nationwide data rather than a sample, we remove potential selection bias and ensure generalizability. Additionally, the number of patients and prescriptions is large for almost all subgroups, reducing the uncertainty in the estimates as confirmed by the narrow confidence intervals. Still, there are important limitations. We do not have information on prescriptions that are not redeemed by the patients, and we do not know to what extent patients use the dispensed drugs. Consequently, the dispensed drugs represent the maximum treatment patients may receive. NorPD does not hold information on prescribed dosage. For statins and ezetimibe, we assume that patients are prescribed one tablet per day. NorPD lacks information on clinical data such as lipid parameters. Data on comorbid CVD and risk levels are also largely missing even though prescription data on drug treatment for diabetes and hypertension may serve as a proxy for these variables. Consequently, we were not able to distinguish between primary- and secondary prevention. To investigate patients with high CVD-risk subgroup, analyses were performed for patients with at least one anti-diabetes and one anti-hypertension drug prescription during the study period. Information on medical indication for prescriptions is missing and beta blockers, diuretics, calcium channel blockers, and ARBs may have been prescribed for non-CVD reasons. Unfortunately, our data do not allow inference on the causes of gaps and discontinuation. The occurrence of the phenomenon seems is about the same across all patient subgroups we have examined. We used mean PDC as the measure of adherence which can be estimated in several ways. This allows us to present adherence by calendar year which is important with our public health approach. This method, however, results in underestimating PDC for patients who initiate or discontinue treatment during a calendar year. Because relatively few patients are prescribed lipid lowering drugs for the first time during each calendar year see Supplementary material online , Table S2 and are expected to receive treatment lifelong, the bias is likely modest. The main explanation of the difference between the different PDC-methods seems to lie in the large number and magnitude of treatment gaps. We allowed for stockpiling regardless of switching between drugs. The beneficial effects of lipid lowering treatment with statins, 24 ezetimibe, 4 and PCSK9 inhibitors 25 , 26 on clinical outcomes are well documented. Further, high-intensity statin treatment is superior to standard-dose therapy, 24 and combination-therapy with ezetimibe and simvastatin, and likely also other statins, improve outcome compared with treatment with statins alone. Thus, increasing the prescribed dosage, or the use of these drugs, has negligible costs. Our results indicate that, despite excellent evidence on effectiveness, strong recommendations 1 , 27 , and modest drug costs, considerable proportions of patients use low-intensity statins, low doses, and relatively few are using ezetimibe. The modest use of rosuvastatin may be a consequence of higher generic prices and more strict reimbursement rules in Norway than for simvastatin and atorvastatin. Furthermore, reimbursement rules for PCSK9 inhibitors have been very strict and the utilization accordingly very low. Even though we in this study do not have information on LDL-cholesterol levels, other Norwegian studies find clear association between lipid lowering treatment, LDL-cholesterol levels and CVD risk. Even more disappointing is the finding that mean PDC or doses is not higher among patients on anti-diabetes and anti-hypertension drugs, and that a substantial proportion of these patients are observed to have long gaps in their statin treatment. International data 10 , 11 and data from Norway 31 show that statin non-adherence is associated with a greater than two-fold increased rate of subsequent cardiovascular events, more than four-fold increased risk of stroke and almost a four-fold increased risk of death. Non-adherence also contributes to significant healthcare expenditures. Several other studies have investigated patterns of statin use in the real-world setting. Optimizing lipid lowering drug treatment represents a potential for considerable health benefits at small additional costs and possibly cost savings elsewhere in the health care system. When people have treatment gaps of months or years duration, the problem is more than lack of memory. Statin intolerance, in particular self-perceived statin intolerance, is a leading cause of treatment gaps and discontinuations. A recent study utilizing data from more than four million patients finds a prevalence estimate of statin intolerance of 9. In order to improve adherence to lipid lowering treatment in general, counselling and education, self-monitoring reminders, and pharmacist-led interventions are documented cost-effective 43 and recommended measures. These prescription data on lipid lowering treatment indicate that Norway has considerable potential for better CVD health at modest costs. She is employed at Oslo Economics where she primarily works with health economic analyses, using registry data from national health registries. Her fields of interest include cardiovascular diseases, neuromuscular diseases, and cancer. Supplementary data can be accessed through the online publication. The supplementary data include a description of patient characteristics see Supplementary material online , Table S1 and S2 , number of patients and doses by lipid lowering drugs and year — see Supplementary material online , Table S3 , subgroup analyses of patients receiving diabetes drugs and patients 61 years or younger see Supplementary material online , Figure S1 , and sensitivity analyses of different methods to estimate mean PDC see Supplementary material online , Table S4. Access to study protocol, data application, approvals, programming code, etc. Access to raw data must be obtained from the Norwegian Prescription Database. Supplementary material is available at European Heart Journal Open online. Data from the Norwegian Prescription Database have been used in this publication. The interpretation and reporting of these data are the sole responsibility of the authors, and no endorsement by the register is intended nor should be inferred. Eur Heart J ; 42 : — Google Scholar. Eur Heart J ; 41 : — Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90, participants in 14 randomised trials of statins. Lancet ; : — Achievement of dual low-density lipoprotein cholesterol and high-sensitivity C-reactive protein targets more frequent with the addition of ezetimibe to simvastatin and associated with better outcomes in IMPROVE-IT. Circulation ; : — Unsatisfactory risk factor control and high rate of new cardiovascular events in patients with myocardial infarction and prior coronary artery disease. BMC Cardiovasc Disord ; 19 : Decline in cardiovascular mortality: possible causes and implications. Circ Res ; : — Atherosclerosis ; : — Medical and psychosocial factors and unfavourable low-density lipoprotein cholesterol control in coronary patients. Eur J Prev Cardiol ; 24 : — Impact of statin adherence on cardiovascular disease and mortality outcomes: a systematic review. Br J Clin Pharmacol ; 78 : — O'Connor PJ. Improving medication adherence: challenges for physicians, payers, and policy makers. Arch Intern Med ; : — Medication adherence: its importance in cardiovascular outcomes. Persistence of statin treatment—the impact of analytic method when estimating drug survival. Norsk Epidemiologi ; 29 : — Osterberg L , Blaschke T. Adherence to medication. N Engl J Med ; : — Low adherence to statin treatment during the first year after an acute myocardial infarction is associated with increased second year mortality risk- an inverse probability of treatment weighted study on 54, patients. Eur Heart J Cardiovasc Pharmacother ; 7 : — Association of statin adherence with mortality in patients with atherosclerotic cardiovascular disease. JAMA Cardiol ; 4 : — Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Using the waiting time distribution with random index dates to estimate prescription durations in the presence of seasonal stockpiling. Pharmacoepidemiol Drug Saf ; 29 : — Refining estimates of prescription durations by using observed covariates in pharmacoepidemiological databases: an application of the reverse waiting time distribution. Pharmacoepidemiol Drug Saf ; 26 : — In: Dataset; Proposal of standardization to assess adherence with medication records: methodology matters. Ann Pharmacother ; 50 : — A checklist for medication compliance and persistence studies using retrospective databases. Value Health ; 10 : 3 — Standardizing terminology and definitions of medication adherence and persistence in research employing electronic databases. Med Care ; 51 : S11 — S Intensive lipid lowering with atorvastatin in patients with stable coronary disease. Evolocumab and clinical outcomes in patients with cardiovascular disease. Alirocumab and cardiovascular outcomes after acute coronary syndrome. Optimal use of lipid-lowering therapy after acute coronary syndromes: a position paper endorsed by the international lipid expert panel ILEP. Pharmacol Res ; : Medication adherence among persons with coronary heart disease and associations with blood pressure and low-density-lipoprotein-cholesterol. Eur J Clin Pharmacol ; 78 : — BMC Cardiovasc Disord ; 21; Eur J Prev Cardiol ; 28 : — Preventable clinical and psychosocial factors predicted two out of three recurrent cardiovascular events in a coronary population. BMC Cardiovasc Disord ; 20 : Adherence to statins, subsequent healthcare costs, and cardiovascular hospitalizations. Am J Cardiol ; : — Oslo Economics. In; National trends in statin use and expenditures in the US adult population from to insights from the medical expenditure panel survey. JAMA Cardiol ; 2 : 56 — Underutilization of high-intensity statin therapy after hospitalization for coronary heart disease. J Am Coll Cardiol ; 65 : — Patterns of statin use in a real-world population of patients at high cardiovascular risk. J Manag Care Spec Pharm ; 22 : — Switching, persistence and adherence to statin therapy: a retrospective cohort study using the Australian national pharmacy data. Cardiovasc Drugs Ther ; 36 : — Interventions to improve adherence to lipid-lowering medication. Cochrane Database Syst Rev ; 12 : Cd Prevalence of statin intolerance: a meta-analysis. Eur Heart J ; 43 : — A systematic review of statin-induced muscle problems in clinical trials. Am Heart J ; : 6 — Effect of atorvastatin on muscle symptoms in coronary heart disease patients with self-perceived statin muscle side effects: a randomized, double-blinded crossover trial. Statin non-adherence and residual cardiovascular risk: there is need for substantial improvement. Int J Cardiol ; : — The modeled lifetime cost-effectiveness of published adherence-improving interventions for antihypertensive and lipid-lowering medications. Value Health ; 13 : — Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Advertisement intended for healthcare professionals. Sign in through your institution. ESC Publications. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume 2. Article Contents Abstract. Author biography. Supplementary data. Supplementary material. Journal Article Editor's Choice. Gaps and discontinuation of statin treatment in Norway: potential for optimizing management of lipid lowering drugs. Ingrid Engebretsen , Ingrid Engebretsen. Corresponding author. Oxford Academic. John Munkhaugen. Christoffer Bugge. Sigrun Halvorsen. Department of Cardiology, Oslo University Hospital. Institute of Clinical Medicine, University of Oslo. Department of Public Health, University of Aarhus. Revision received:. Corrected and typeset:. Select Format Select format. Permissions Icon Permissions. Abstract Aims. Graphical abstract. Open in new tab Download slide. Figure 1. Table 1 Open in new tab. Figure 2. Figure 3. Table 2 Open in new tab. Sex Women Google Scholar Crossref. Search ADS. Google Scholar PubMed. For commercial re-use, please contact journals. Issue Section:. Download all slides. Comments 0. Add comment Close comment form modal. I agree to the terms and conditions. You must accept the terms and conditions. Add comment Cancel. Submit a comment. Comment title. You have entered an invalid code. Submit Cancel. Thank you for submitting a comment on this article. Your comment will be reviewed and published at the journal's discretion. Please check for further notifications by email. Views 2, More metrics information. Total Views 2, Email alerts Advance article alerts. Receive exclusive offers and updates from Oxford Academic. See also Commentary Adherence to statin therapy: it seems we know everything, yet we do nothing. More on this topic Prediction of first cardiovascular disease event in 2. Early and short-term use of proprotein convertase anti-subtilisin—kexin type 9 inhibitors on coronary plaque stability in acute coronary syndrome. Related articles in PubMed Ten-year trends in lipid management among patients after myocardial infarction in South Korea. Association between lipid-lowering agents with intervertebral disc degeneration, sciatica and low back pain: a drug-targeted mendelian randomized study and cross-sectional observation. Towards validating invalidated knowledge: a discourse analysis of firsthand accounts of hearing voices. Citing articles via Google Scholar. 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