An Emerging Approach At The Treatment Of Td That Is Showing Potential

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Patients are intrigued by the idea that a medication will actually fight for them and be a powerful ally, in comparison to their current treatment that does “just enough” to get them by. They can

Moreover, none of the available medications for TS completely eliminates symptoms and in addition, all medications have side effects. Instead, the available TS medications are only able to help reduce specific symptoms. Some patients who require medication to reduce the frequency and intensity of the tic symptoms may be treated with neuroleptic drugs such as haloperidol and pimozide (Abuzzahab & Brown, 2001). These medications are usually given in very small doses that are increased slowly until the best possible balance between symptoms and side effects is achieved. Recently scientists have discovered that long-term use of neuroleptic drugs may cause an involuntary movement

While there is no medication which relieves every symptom of TS, there is the possibility of improvement if the patient does not have serious side effects to the medications, of which there are a variety (i.e. pimozide, risperidone, clonidine) (8). Researches have found that the drug haloperidol acts on dopamine and in turn calms the patient. Haloperidol works by blocking the receiving areas on receptor cells where dopamine passes on messages

Pt is currently on citalopram 20 mg one-half tablet by mouth once daily. Citalopram is appropriate as first line therapy for treatment of major depression per APA Practice guidelines. Starting dose of citalopram is also appropriate as patient is elderly. Citalopram has no major drug interactions with pt’s current medications or current medical conditions. Pt reports tolerating it well and has been adherent to

The trial involved four different treatment levels, and patients were encouraged to enter the next level of treatment if they failed to achieve remission or response (50% reduction in symptoms) after a specified number of

In 2008, the FDA approved tetrabenazine, which is used to help treat chorea. This was the first drug approved to treat symptoms of HD ("Huntington's Disease: Hope Through Research," n.d.). Additionally, the use of antipsychotic drugs are used to help lessen the extremity of involuntary movements and help moderate the individuals temperament ("Huntington's Disease: Hope Through Research," n.d.). In contrast, the use of antipsychotics are not used to help treat dystonia and may actually worsen these symptoms by causing stiffness in movement ("Huntington's Disease: Hope Through Research," n.d.). Many individuals with HD also suffer from depression and may be prescribed fluoxetine, sertraline, or nortriptyline ("Huntington's Disease: Hope Through Research," n.d.). Mood swings and anxiety are controlled with the use of tranquilizers and/or lithium ("Huntington's Disease: Hope Through Research,"

Option 2: Reviewing Neurocrine’s impending Phase 2 results for treating Tourette Syndrome (TS) with Valbenazine. What can we expect data-wise and what could this mean for the market?

The beers criteria states that antipsycotics are inappropriate medications in patients over 65 and can lead to cognitive decline, stoke, and mortality. This medication also has strong ant cholinergic side effects and can potentiate hypernatremia. Adverse events also include hypotension, orthostatic hypotension, extrapyramidal symptoms, constipation, neuropleptic malignant syndrome, CNS depression, esophageal dysmotility and aspiration. This patient needs to be monitored for CNS depression as it may enhance the CNS depression of other medications. If necessary in the geriatric population, the smallest amount available should be administered.

Belz and colleagues published the first randomized study in The Lancet, in 1981 (4). Verapamil co-administration with digoxin resulted in increased SDC by a range of 53-80% (3-8). In 1981, Pedersen showed 34% reduction in total digoxin

In 2016 the FDA gave breakthrough status and approval, which will allow hundreds of patients to be treated

None of the studies had consistency regarding which medications the participants were taking; the use of different medications in combination with BoNTA may have results different outcomes. The races of the participants were omitted in Relja et al (2010), Aurora et al (2007), and Cady & Schreiber (2007). Without a complete patient demographic, it is impossible to do a true comparison between the studies. All six studies had too narrow of a patient population. It is recommended to prevent exaggerated efficacy results, studies should also include patient’s that don’t have the condition, patient’s with risk factors for the condition, as well as patient’s with similar but different conditions15. Only two of the studies have proven to be precise by providing a confidence interval which were Aurora et al (2010) and Diener et al (2010). All siz studies had a loss of patient during the clinical trial which can lead to a false sense of effectiveness and all six studies utilize subjective outcome measures as their only source to report efficacy. This leaves all the studies open to bias due to patients self-reporting outcomes. At the review level, another limitation could be possibly incomplete retrieval of research trials.

A different study by Roberts et al (2005) evaluated the efficacy and tolerability of glimepiride in patients with type

Use of fluoroquinolones, which have been a cause for concern to their risk for TdP (23), are not promoted as first line (22). Safety issues have also been raised for use of QTc-prolonging antipsychotic medications (2; 24). Such drugs are frequently used in hospital inpatients as delirium can affect a fifth of acute medical admissions (25). NICE guidelines allow for the antipsychotics haloperidol and olanzapine to be used for up to one-week as a therapy for delirium (26). Whether QTc contributes to increased hospital mortality in those with delirium is unknown (27). Prolonged QT interval is known to predict mortality in a variety of other conditions that are frequently encountered in the AMU such as: coronary artery disease (28), heart failure (29) and diabetes mellitus (30; 31). Our data have shown in-hospital mortality of 3.8% in those with normal QTc and 6.0% of those with long QTc. The study was not powered for this outcome but such a difference would be clinically relevant; based upon these data, approximately 1500 patients in each group would need to be studied to detect a difference with 80% power and alpha of 5%. A more prolonged length of stay with long QTc in unadjusted analysis was unexpected but was no longer significant when correcting for patient age and presence of diabetes or electrolyte disturbance.

Wellbutrin XL from day 7 through the last treatment day (day 56) • Sexual functioning - ∆ in CSFQ total scores from baseline to week 8 were significantly reduced for escitalopram vs. Wellbutrin XL or placebo • Patient satisfaction – overall sexual functioning at week 8 less in escitalopram-treated patients (74%) vs. Wellbutrin XL (88%, P < 0.05) vs placebo (88%, P < 0.05) • AEs reported in ≥ 5% of patients & 1.5X placebo: - Escitalopram - fatigue, dizziness, flatulence, upper respiratory tract infection, yawning - Wellbutrin XL - dry mouth, insomnia, dizziness, constipation • Discontinuation due to AEs - Escitalopram (3%), Placebo (5%), Wellbutrin XL (10%) • No reports of seizure for any treatment • Suicidality - Escitalopram – no reports - Wellbutrin XL – no reports - Placebo – self-mutilation, intentional self injury (1 report each)