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Difficult to tell if intent to treat population was included in overall clinical event analysis wellbutrin 300 mg low cost depression symptoms guilt. Fair in quality to assess differences in clinical events discount 300 mg wellbutrin with visa depression organizations. 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.

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Treating asymptomatic CMV patients with CMV agents remains controversial wellbutrin 300 mg online depression symptoms light headed. There is some evidence that preemptive therapy lowers the incidence of CMV end-organ disease in some patients with CMV viremia (Mizushima 2013) cheap 300mg wellbutrin mastercard mood disorder criteria. However, monitoring of potential treatment-related side effects is required. Treating a positive CMV IgM serology (without any further diagnosis) is not only expensive, but also usually an unnecessary risk. Systemic treatment Valganciclovir, a prodrug of ganciclovir with good oral absorption, is the first choice in CMV treatment. In a randomized study (Martin 2002) on 160 patients with retini- tis valganciclovir tablets were just as effective as ganciclovir infusions. However, the toxicity profile of both agents was comparable. This means that the blood count has to be as frequently monitored as for infusions and that the indication has to be equally carefully set. However, there are some experts in the field who prefer intra- venous CMV treatment to oral treatment in advanced cases. Other options for systemic treatment have become less important, and are only used in cases of recurrence. If there is intolerability or more rarely (Martin 2007) resist- ance to valganciclovir (Drew 1999), then foscarnet remains an option. Further problems with this drug include nephrotoxicity, and very painful penile ulcers. Very intensive hydration of the patient is therefore nec- essary in all circumstances. The benefit of the long half-life (once weekly dosing possible) is out- weighed by the considerable renal toxicity of this drug (Plosker 1999). We observed creatinine elevations in every second patient treated, despite the fact that a strict infusion plan was closely followed (see Drugs section). Maribavir failed to show a benefit in Phase III studies (Snydman 2011). Letermovir is a new agent with a novel mech- anism of action targeting the CMV terminase. In a Phase II trial, letermovir was effec- tive in reducing the incidence of CMV infection in recipients of allogeneic hematopoietic-cell transplants, with an acceptable safety profile (Chemaly 2014). The drug has been granted fast track status by FDA and orphan drug status by EMA. Additional treatment with G-CSF (filgrastim) improved survival in one analysis of three large studies enrolling patients with CMV retinitis in the years 1990–1997. In particular, there was a reduction of bacterial infections. However, the reason for this positive effect remains unclear. Thus, administration of filgrastim is presently not generally recommended (Davidson 2002). Local treatment Several options for local treatment of CMV retinitis have been tested (Review: Smith 1998). Although such treatments can be safely administered by experienced ophthalmologists and are associated with few complications (infections, hemor- rhage), disadvantages remain. Weekly intravitreal injections of ganciclovir or fos- carnet, or pellet implantation (Vitrasert, must be replaced every 6–9 months) do not protect from infection of the contralateral eye or from extraocular manifesta- tions (Martin 1999). The same is true for fomivirsen (Vitravene), an antisense- oligonucleotide for intravitreal injection, which is astonishingly effective even with multiresistant CMV strains (Perry 1999). These local treatments have become less important since ART and valganciclovir and some have been taken off the market.

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