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V. Yasmin, M.B.A., M.B.B.S., M.H.S.

Deputy Director, West Virginia University School of Medicine

Vast majority have primarily obstructive apnea with occlusion in the upper airway. Symptoms include snoring, excessive daytime sleepiness, memory loss, and impotence. Sleep apnea, in the absence of co-morbidity causing daytime hypoxia, is not a cause of substantial pulmonary hypertension (present in 50% of pts) or right heart failure. Weight loss often reduces disease severity but infrequently obviates the need for other therapy. Hyperventilation may also occur with some types of lung disease, particularly interstitial disease and pulmonary edema. Etiologies include ischemia; nephrotoxic injury due to drugs, toxins, or endogenous pigments; sepsis; severe renovascular disease; or conditions related to pregnancy. Pts are initially nonoliguric and may have recent flulike symptoms; later, oliguric renal failure with uremic symptoms supervenes. Pulmonary manifestations range from asymptomatic infiltrates to life-threatening hemoptysis. Later, manifestations include anorexia, nausea, vomiting, insomnia, weight loss, weakness, paresthesia, bleeding, serositis, anemia, acidosis, and hyperkalemia. Causes include diabetes mellitus, severe hypertension, glomerular disease, urinary tract obstruction, vascular disease, polycystic kidney disease, and interstitial nephritis. Indications of chronicity include long-standing azotemia, anemia, hyperphosphatemia, hypocalcemia, shrunken kidneys, renal osteodystrophy by x-ray, or findings on renal biopsy. Can be idiopathic or due to drugs, infections, neoplasms, multisystem or hereditary diseases. Complications include severe edema, thromboembolic events, infection, and protein malnutrition. Asymptomatic Urinary Abnormalities Hematuria may be due to neoplasms, stones, infection at any level of the urinary tract, sickle cell disease, or analgesic abuse. Hematuria with low-grade proteinuria may be due to benign recurrent hematuria or IgA nephropathy. Renal causes include diabetes mellitus, amyloidosis, or other causes of glomerular disease. Levels between 102 and 105/mL may indicate infection but are usually due to poor sample collection, especially if mixed flora are present. Fanconi syndrome is a generalized tubular defect that can be hereditary or acquired, due to drugs, heavy metals, multiple myeloma, amyloidosis, or renal transplantation. Nephrogenic diabetes insipidus (polyuria, polydypsia, hypernatremia, hypernatremic dehydration) and renal tubular acidosis are additional causes. Hypertension is usually asymptomatic until cardiac, renal, or neurologic symptoms appear. In most cases hypertension is idiopathic and becomes evident between ages 25 and 45. Staghorn calculi are large, branching radiopaque stones within the renal pelvis due to recurrent infection. For a more detailed discussion, see Part 11: Disorders of the Kidney and Urinary Tract, pp. Maintaining optimal renal perfusion and intravascular volume appears to be important in most clinical circumstances. There, intrinsic disease due to glomerulonephritis or pyelonephritis predominates. Postrenal failure is due to urinary tract obstruction, which is also more common among ambulatory rather than hospitalized pts. More common in men than women, it is most often caused by ureteral or urethral blockade. Occasionally, stones or sloughed renal papillae may cause more proximal obstruction. An associated impairment of urinary concentrating ability often "protects" the pt from complications of volume overload. There are conflicting data regarding the utility of glucocorticoids in allergic interstitial nephritis. Many practitioners advocate their use with clinical evidence of progressive renal insufficiency despite discontinuation of the offending drug, or with biopsy evidence of potentially reversible, severe disease.

It turns out that tartaric acid, it actually changes the absorption of levodopa in the gut. This gave us an ability to monkey with the pharmacokinetic profile in ways that had not been done previously. When we looked at this, what we found is that people have a reduction in off time against both products, with and without entacapone. They had this sort of full repository of tools in the bag to manage the disease state and we still saw these improvements. Motor fluctuations accompanied by troublesome dyskinesias not controlled by amantadine are usually considered as an indication for referral for device-native therapy. We have the mainstay of levodopa-carbidopa has been known for a long time and the pharmacokinetics; I think we have a good overview of how all that all works there, too. Optum makes the recommendation the board consider these clinically and therapeutically equivalent. And, then moving towards the brand name and the Stalevo, this is the carbidopa-levodopa entacapone product; this is the branded version of it. For non-preferred, we would have the generic of Stalevo, the Duopa and the Inbrija. The trial that I would love to see, and the speaker kind of alluded to that, would be versus the controlled release product rather than immediate release for the triple therapy. Sapandeep Khurana: That would make sense if someone was on the extended release and having significant off episodes, then failing two agents would be challenging. I would make a motion that we request to modify this class so that you only would need to fail one preferred agent before moving on to the non-preferred. Gabriel Lither - Yes Holly Long - My question would be, how is that provided to the public You see the ibuprofen is still by far the favorite followed by the meloxicam and the naproxen regular release. Biologic Response Modifiers - Multiple Sclerosis Agents - Injectable Opened for public comment - No public comment. The Avonex and Copaxone are almost high with the utilization with the Rebif and Tysabri also with some decent utilization. Obviously Gilenya is on the left so I will forego that discussion unless you all have any questions. I want to point out that the pivotal trials for Mayzent studied a unique population. In fact, Mayzent is the only oral agent studied and proven in a secondary progressive patient population to delay disability progression. We will also point out Mayzent is an S1P receptive modulator; however, it is more specific, so the majority of these patients do not need a first dose observation unlike for Gilenya. I want to thank you for having Tecfidera preferred for your patients here and maintaining the status of. We just got that information submitted but they just know that the label will be similar unless we have a drug that shows non-active independent of active. You can see the clarity trial, pretty good number of patients in there, about 1300 patients did a dose comparison study with 2 different doses compared to placebo, looked at the annual relapse rate after 96 weeks. It was originally developed as a cytotoxic agent for chemotherapy for cancer, so it has an interesting history with that one. The oral ones are Tecfidera as the number one, Aubagio second; no claims yet for the two new products. Chances are pretty slim of them getting to that point without not having tried something. We do have a uniquely indicated drug now, but the toxicity of cladribine, I think it leads to second line for sure.

Both animal and human studies indicate that chronic steroid use may result in reduced amounts of neural tissue mass. Outcomes at school age after postnatal dexamethasone therapy for lung disease of prematurity. After that time surface area and volume within the lung continue to increase with growth, but new alveoli are no longer added. The baby typically becomes increasingly cyanotic, agitated, and inconsolable, with a marked deterioration in overall pulmonary status. Oxygen and ventilatory assistance often need to be increased during these episodes. At times they may be quite acute and severe, occasionally resulting in sudden death. Bronchospasm is often cited as the cause of this deterioration, but personal experience suggests that many such episodes, especially the more acute, severe forms, are more commonly the result of airway collapse caused by tracheobronchomalacia. If the clinician does suspect bronchospasm, prebronchodilator and postbronchodilator therapy can be evaluated with pulmonary function testing. Flexible fiberoptic bronchoscopy is also valuable to detect granulomas or tracheobronchial malacia that might be causing airway obstruction. Furosemide is a more potent diuretic than either chlorothiazide or spironolactone. Spironolactone helps prevent potassium loss and reduces the severity of metabolic alkalosis resulting from diuretics. Furosemide also has a greater tendency to produce nephrocalcinosis when used on a chronic basis, which is less likely to occur with thiazide diuretics. Pathologic apnea refers to cessation of breathing for more than 20 seconds; cessation of breathing for less than 20 seconds and accompanied by bradycardia 20% below the baseline heart rate; or cessation of breathing for less than 20 seconds with oxygen desaturation below 80%. Obstructive apnea occurs when an infant makes a respiratory effort but no airflow is present because of the presence of obstruction (see Figure 18-17, bottom). Many prematurely born infants demonstrate periodic breathing for as much as 20% to 30% of total sleep time. Because of the frequency of this finding, some neonatologists consider periodic breathing to be a normal maturational process. On the other hand, it also may be a reflection of significant immaturity of respiratory control and a variant of apnea. About two thirds of these children have central apnea or periodic breathing, and one third have obstructive or mixed apnea. Less clear are the long-term effects on infants who have had a history of severe apnea of prematurity. Clinical studies suggest apnea of prematurity, particularly with oxygen desaturation, may affect learning and other aspects of childhood development. Cardiorespiratory events detected by home memory monitoring and one-year neurodevelopmental outcome. Chronic physiologic instability is associated with neurodevelopmental morbidity at one and two years in extremely premature infants. Recent evidence indicates that apnea persists longest in the most immature infants. Caffeine is the preferred treatment because of its once-a-day dosing and fewer side effects. The improved outcomes seen at 18 months were not seen at 5 years after birth, but the trends toward improvement in outcome still favored use of caffeine over placebo for the treatment of apnea. Patients are typically loaded with 20 mg/kg of caffeine citrate and maintained on 7 to 8 mg/kg daily. Survival without disability to age 5 years after neonatal caffeine therapy for apnea of prematurity. Since that time hundreds of thousands of premature infants have been discharged with these monitors. Although people of all ages die suddenly, the rate of sudden death is highest for those younger than 1 year of age. The rate is substantially higher in urban areas, particularly among African-American infants.

Latex-sensitive patients may have an allergic reaction to the needle shield within the white cap and the gray needle cap of the syringe. Once removed from the refrigerator, erenumab-aooe has a limited stability of 7 days. May be self-administered by patients in the abdomen, thigh, back of upper arm or buttocks. Once removed from the refrigerator, galcanezumab-gnlm has a limited stability of 7 days. A benefit/risk assessment should be taken into consideration prior to administering. Migraines have a spectrum of frequency and severity that can significantly affect the quality of life of patients. Cluster headache is less prevalent than migraine and characterized by attacks of severe, unilateral pain with ipsilateral autonomic symptoms, which occur every other day to multiple times daily during a cluster period. Cluster headache is more likely to occur in men, whereas migraines are more likely to occur in women. Galcanezumab-gnlm has an additional indication for the treatment of episodic cluster headache. Current evidence-based prophylactic migraine treatment options and guidance are limited for chronic migraine, and oral prophylactic medications prescribed for episodic migraine are often used for the preventive treatment of chronic migraine. Prophylactic migraine treatment options include oral agents (mainly anti-seizure agents, antidepressants, and beta blockers), injectable agents (onabotulinumtoxin A for chronic subtypes only), or neuromodulation devices for migraine or headache attacks. Certain oral therapies may not be appropriate for individual patients due to intolerability or eventual lack of efficacy. There is no optimal prophylactic migraine therapy and head-to-head trials are lacking. Additionally, sumatriptan nasal spray, zolmitriptan oral formulations, and sphenopalatine ganglion stimulation are probably effective for acute treatment per guidelines. Galcanezumab-gnlm has an additional indication for the treatment of episodic cluster headaches. Based on 3 to 6 month data, primary endpoint reductions are similar to many oral prophylactic therapies; however, comparisons are limited as endpoints have been inconsistently defined. There are limited analyses and trials examining efficacy in patients who failed 2 prior preventive therapies; however, available data suggest that these patients may achieve greater reductions in migraine/headache frequency. For the treatment of cluster headaches, galcanezumab-gnlm demonstrated efficacy compared to placebo in an unpublished 8-week trial, which allowed for acute/abortive treatments during therapy. Galcanezumab-gnlm significantly decreased the mean change from baseline in weekly cluster headache attack frequency by 3. Lack of information during pregnancy and breastfeeding is a consideration as many migraine patients are women of childbearing potential. The unknown risks of monoclonal antibodies and the effects on certain conditions are not fully characterized. Important co-morbid populations were excluded from trials (eg, anxiety, depression, hypertension, and fibromyalgia), which also limits the generalizability to broader groups. Fremanezumab-vfrm is the only agent in the class that may be administered quarterly, which may fulfill a niche in patients who are non-adherent with treatment. The following are required: a) concealed allocation; b) primary outcome(s) is/are clearly defined; c) exclusion/inclusion criteria are clearly defined; d) adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias; e) certain requirements are needed for noninferiority or equivalence trials claiming to prove efficacy for 1 or both drugs. Long-term safety and tolerability of erenumab: three-plus year results from an ongoing open-label extension study in episodic migraine. Patients should always seek the advice of a physician or other qualified health provider with any questions regarding a medical condition. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. A comparative effectiveness meta-analysis of drugs for the prophylaxis of migraine headache.