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Fair-good in quality to (ACAPS) determine differences in clinical events buy super cialis 80 mg low price. However super cialis 80 mg line, there Coronary was a trend observed in favor of fluvastatin. In this Atherosclerosis study, there were 909 patients screened, but only 429 Study (LCAS) randomized. The major reasons were for lipid ineligibility and lack of cooperation. There were some minor difference in baseline characteristics between groups. Fair-poor in quality to determine differences in clinical events. The Regression The only significant difference in individual events Growth Evaluation was the reduced need for unscheduled PTCA in the Statin Study pravastatin vs. This significant (REGRESS) reduction accounted for the overall reduction in new clinical events in the pravastatin group. Difficult to tell if intent to treat population was included in overall clinical event analysis. Fair in quality to assess differences in clinical events. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 241 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Study Mean Percent LDL- Year Patient Duration Baseline LDL- c Reduction Study Name Study Characteristics Characteristics Intervention (mean) c from baseline Pitt et al. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 242 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Primary Endpoint Year Results (clinical Clinical Outcomes Study Name Primary Endpoint health outcome only) Measured Clinical Outcome Results Pitt et al. Although not statistically significant, Atherosclerosis in coronary arteriography. CHD death, nonfatal there were 37 PTCA in placebo vs. A total of 81 events occurred in (PLAC- I) any cause and total clinic placebo vs. However, there was a Prevention Study ultrasound examinations in the trend to less clinical cardiovascular events in (KAPS) average of maximum carotid the pravastatin group, primarily MI. All-cause progression as assessed by nonscheduled PTCA or mortality was significantly reduced in the coronary angiography. Placebo-controlled trials of patients with atherosclerosis Author Year Study Name Comments/Conclusions Pitt et al. The Pravastatin only significant difference in individual events was a Limitation of reduction in the rate of MI in the pravastatin vs. All randomized patients were Coronary Arteries included in the clinical event analysis. Fair in quality (PLAC- I) to assess differences in clinical events, although a relatively small study population. Atherosclerosis However, there was a trend in favor of pravastatin. Prevention Study Fair-poor in quality to determine differences in clinical (KAPS) events between groups. There was a trend to a reduction in clinical cardiac events in the pravastatin vs. There was a significant reduction in overall mortality with pravastatin vs. Fair in quality to assess difference in clinical events. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 244 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Study Mean Percent LDL- Year Patient Duration Baseline LDL- c Reduction Study Name Study Characteristics Characteristics Intervention (mean) c from baseline Simoons 1994 Randomized, double- 404 men and women 30- Simvastatin 20 mg 4 years 169 mg/dl 31% Multicentre Anti- blind, placebo- 67 years with 2 or > qpm or placebo (4. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 245 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Primary Endpoint Year Results (clinical Clinical Outcomes Study Name Primary Endpoint health outcome only) Measured Clinical Outcome Results Simoons 1994 Per-patient average of mean N/A Clinical events were After 4 years, there was no difference in clinical Multicentre Anti- lumen diameters of all coronary reported spontaneously. There were a greater Atheroma Study segments(diffuse number of MI in the simvastatin vs placebo atherosclerosis) and the per- groups. There were more revascularizations in patient average of MLD of all the placebo vs. Neither of segments that were these were statistically different. Overall, there atheromatous at baseline, follow were 40 cardiac events in the simvastatin vs. Placebo-controlled trials of patients with atherosclerosis Author Year Study Name Comments/Conclusions Simoons 1994 There were no statistical differences in clinical events Multicentre Anti- in the simvastatin vs. Fair to poor in Atheroma Study quality to assess differences in clinical event due to duration of trial, however was a relatively small sample size. Simvastatin/Enala No differences were noted in any other clinical pril Coronary events.

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Adverse effect: An adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility generic 80 mg super cialis fast delivery. Active-control trial: A trial comparing a drug in a particular class or group with a drug outside of that class or group effective super cialis 80mg. Allocation concealment: The process by which the person determining randomization is blinded to a study participant’s group allocation. Applicability: see External Validity Before-after study: A type nonrandomized study where data are collected before and after patients receive an intervention. Before-after studies can have a single arm or can include a control group. Bias: A systematic error or deviation in results or inferences from the truth. Several types of bias can appear in published trials, including selection bias, performance bias, detection bias, and reporting bias. Bioequivalence: Drug products that contain the same compound in the same amount that meet current official standards, that, when administered to the same person in the same dosage regimen result in equivalent concentrations of drug in blood and tissue. Black box warning: A type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The US Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. A way of making sure that the people involved in a research study — participants, clinicians, or researchers —do not know which participants are assigned to each study group. Blinding usually is used in research studies that compare two or more types of treatment for an illness. Case series: A study reporting observations on a series of patients receiving the same intervention with no control group. Case study: A study reporting observations on a single patient. Case-control study: A study that compares people with a specific disease or outcome of interest (cases) to people from the same population without that disease or outcome (controls). Clinical diversity: Differences between studies in key characteristics of the participants, interventions or outcome measures. Clinically significant: A result that is large enough to affect a patient’s disease state in a manner that is noticeable to the patient and/or a caregiver. Cohort study: An observational study in which a defined group of people (the cohort) is followed over time and compared with a group of people who were exposed or not exposed to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective cohort study identifies subjects from past records and follows them from the time of those records to the present. Combination Therapy: The use of two or more therapies and especially drugs to treat a disease or condition. Confidence interval: The range of values calculated from the data such that there is a level of confidence, or certainty, that it contains the true value. The 95% confidence interval is generally used in Drug Effectiveness Review Project reports. If the report were hypothetically repeated on a collection of 100 random samples of studies, the resulting 95% confidence intervals would include the true population value 95% of the time. Confounder: A factor that is associated with both an intervention and an outcome of interest. Controlled clinical trial: A clinical trial that includes a control group but no or inadequate methods of randomization. Control group: In a research study, the group of people who do not receive the treatment being tested. The control group might receive a placebo, a different treatment for the disease, or no treatment at all. Convenience sample: A group of individuals being studied because they are conveniently accessible in some way. Convenience samples may or may not be representative of a population that would normally be receiving an intervention. Crossover trial: A type of clinical trial comparing two or more interventions in which the participants, upon completion of the course of one treatment, are switched to another. Direct analysis: The practice of using data from head-to-head trials to draw conclusions about the comparative effectiveness of drugs within a class or group. Results of direct analysis are the preferred source of data in Drug Effectiveness Review Project reports. Dosage form: The physical form of a dose of medication, such as a capsule, injection, or liquid. The route of administration is dependent on the dosage form of a given drug. Various dosage forms may exist for the same compound, since different medical conditions may warrant different routes of administration. Triptans Page 56 of 80 Final Report Update 4 Drug Effectiveness Review Project Dose-response relationship: The relationship between the quantity of treatment given and its effect on outcome. In meta-analysis, dose-response relationships can be investigated using meta- regression. Double-blind: The process of preventing those involved in a trial from knowing to which comparison group a particular participant belongs.

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These effects were transient purchase 80mg super cialis amex, however generic super cialis 80mg, and propranolol was equivalent to placebo on those parameters after 24 weeks of treatment. Propranolol and placebo had similar effects on the number of weekly angina attacks, the number of attack-free days, maximum workload, and exercise duration at 8- and 24-week endpoints. The relevance of this trial was limited because since the time it was conducted, the rate of progression of angina may have been altered by advances in treatment of atherosclerosis (for example statin therapy). A good-quality meta-analysis identified 72 randomized controlled trials of a beta blocker 41 compared with a calcium channel blocker and 6 trials comparing a beta blocker to a nitrate. This meta-analysis found that, in general, beta blockers had similar efficacy but fewer discontinuations due to adverse events than calcium channel blockers, but the authors did not report results for each beta blocker separately. Beta blockers Page 24 of 122 Final Report Update 4 Drug Effectiveness Review Project Key Question 1c. For adult patients who have undergone coronary artery bypass grafting, do beta blockers differ in efficacy or effectiveness? We did not examine the short-term (4 to 10 days) use of beta blockers to prevent or control atrial 42-46 tachyarrhythmias after coronary artery bypass graft. In addition to the beta blockers included in our review, esmolol, a very short-acting, intravenous beta blocker, is used postoperatively to control tachyarrhythmias. In 7 trials, long-term use of a beta blocker after coronary artery bypass graft did not improve mortality or other outcomes (Evidence Tables 5 and 6). For example, the MACB Study 47 Group conducted a fair-quality trial that randomized 967 patients (85. No differences between metoprolol and placebo were found in mortality (3. For adult patients with recent myocardial infarction, do beta blockers differ in efficacy or effectiveness? Summary Table 6 summarizes evidence from meta-analyses and major trials of beta blockers in patients with recent myocardial infarction. Timolol was the first beta blocker shown to reduce total 48 mortality, sudden death, and reinfarction outcomes in the Norwegian Multicenter Study. In addition, similar benefits in sudden death were reported for propranolol and 51, 52 52 metoprolol tartrate and in reinfarction for metoprolol tartrate. Carvedilol reduced reinfarction rates in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction (CAPRICORN) trial, which recruited stable inpatients with recent myocardial infarction and a left ventricular ejection fraction of 40% or less. Carvedilol is the only beta blocker shown to reduce mortality in post-myocardial infarction patients who are already taking an ACE inhibitor. An extended-release form of carvedilol (carvedilol phosphate) was approved by the US Food and Drug Administration in October 2006. No studies of carvedilol phosphate in patients following myocardial infarction were identified through literature searches. Approval of the left ventricular dysfunction following myocardial infarction indication for carvedilol phosphate was based on pharmacokinetic and pharmacodynamic data that demonstrated bioequivalence with carvedilol. Indirect comparisons of beta blockers across these trials must be done with caution because the study populations differed in duration, the presence or absence of left ventricular dysfunction, the dose and timing of therapy, and the use of other medications. Beta blockers Page 25 of 122 Final Report Update 4 Drug Effectiveness Review Project Table 6. Comparison of outcomes of mortality-reducing beta blockers in patients following myocardial infarction Mortality reduction in Mortality general reduction in population of post-myocardial post- infarction myocardial patients with infarction left ventricular Reinfarction Beta blocker patients dysfunction Sudden death reduction reduction Acebutolol Effective Uncertain Insignificant effect Insignificant effect Not Carvedilol Effective Uncertain (trend) Effective established Carvedilol phosphate No evidence No evidence No evidence No evidence Metoprolol tartrate Effective Probable Effective Effective Insignificant effect Propranolol Effective Probable Effective (BHAT, Hansteen 1982) Timolol Effective Uncertain Effective Effective Head-to-Head Trials No consistent differences between beta blockers were found in 3 head-to-head trials in post- 53-55 myocardial infarction patients. A 6-week trial comparing atenolol 100 mg to propranolol 120 53 mg had inconclusive results. The second trial, an open-label study with a median follow-up of 1. Patients in this study had mean left ventricular ejection fraction 53. The primary outcome of the study was the change in left ventricular ejection fraction at 1 year; time to first serious cardiovascular event was a secondary endpoint. No significant difference was found between the 2 interventions in either change in left ventricular ejection fraction (P=NR) or time to occurrence of a serious cardiovascular event 56 (P=0. However, these results are not conclusive, as the study’s authors acknowledge that the study was underpowered to detect such a difference for this secondary outcome. A study of 313 patients comparing metoprolol tartrate 100 mg twice daily to carvedilol 25 mg twice daily for a mean of 13. There were statistically significant differences in 5 of 8 health-related quality-of-life domains measured using the Short Form-36 55 questionnaire (adjusted for age and baseline differences) favoring the carvedilol group. Placebo-controlled Trials Because there are so few comparative trials, inferences about the comparative effectiveness of beta blockers in post-myocardial infarction patients must be made on other grounds. The criteria for making these comparisons might include: 1. Demonstration of reduced mortality in large, multicenter placebo-controlled trials 2. Degree of mortality reduction compared with other beta blockers 3. Improvements in other outcomes Beta blockers Page 26 of 122 Final Report Update 4 Drug Effectiveness Review Project 4. Effectiveness studies and applicability of efficacy studies to current practice.

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