The New Drug Abstract

  • Uncategorized

TheNew Drug

Abstract

Highlevels of cholesterol in the body can lead to diseases that arelife-threatening. As such, researchers and pharmaceutical companieschannel their expertise in the development of drugs that areeffective. Although some of the available medications have been inuse for a long time, newer and more efficient ones keep on beingdeveloped and tried. These trials work towards ensuring that the bestdrug with the fewest side effects and highest outcomes are selectedfor use by the public. Statin-based medications such as Atorvastatin(Lipitor) have been widely used to reduce low-density lipoproteinssuccessfully. However, the resulting effects of its use have beenidentified as uncomfortable to the patients, who at times end updiscontinuing the medication. The advent of a new drug Repatha standsto be the alternative. Although its functions are somewhat similar tothat of Atorvastatin (Lipitor), the mechanism of action is quitedifferent. Also, the new drug produces different and less severe sideeffects compared to the older one. The weight of placing Repatha intouse is heavily burdened by its price which is several times higherthan that of Lipitor.

Sincethe 1980s, statins have been widely used as the drugs for reducingcholesterol levels in the body. Every single day, millions of peopletake statins with the aim of lowering the danger of having cloggedarteries. A common statin drug used by patients is the Atorvastatin(Lipitor). However, these types of drugs have been known to producesome side effects that are usually uncomfortable for the patients.These aftereffects include muscle pain, a higher risk of developingdiabetes and sometimes a loss of memory and reasoning. Studies haveindicated that between 5 and 20% of individuals using statins havehad to discontinue the medication because of the extreme muscle pain.As a result of this problem, scientists developed a new drug which isboth efficient and does not produce as severe side effects as theolder drug. Given the name Repatha, this medication has been approvedby the United States Food and Drug Administration.

1.Advantages touted by Pharmaceutical Manufacturer

Repatha®(evolocumab) Pushtronex is a new drug produced by the pharmaceuticalcompany called Amgen. Specifically manufactured due to the adverseeffects of statins, this new medication has been proven to have moredesirable outcomes among patients who need to lower their cholesterollevels. The drug works by blocking proprotein convertase subtilizingtype 9 (PCSK9), a protein that prevents the removal of low-densitylipoprotein from the bloodstream. First and foremost, the advantagesof this medication arise due to its ease of use. Options have beenprovided for a single monthly dose and also additional dosage whenneed be. Secondly, the company has employed a technology hands-freesystem for delivering the drug subcutaneously. Sufficient data showthat Repatha has greater effects in cholesterol reduction compared tothe statin counterpart (Spencer, 2016). Lastly, the side effects thatresult in most patients stopping statin medication are also quitediminished when this medicine is used for treatment. Although therelationship between Repatha and cardiovascular disorders has notbeen fully established, it is provided that the outcomes will be farmuch beneficial.

2.Evidence synthesis (literature review with critical analysis)

PSCK9targeted treatment of high cholesterol levels in the blood is a majorstep forward in the reduction of low-density lipoproteins.Atorvastatin (Lipitor) has been in use all over the world for a longtime. However, the side effects that come with its use has led todiscontinuation of medication, prompting scientists to come up with asolid answer to this problem. According to one of the researchers Dr.Bryce Chackerian, the new drug seems to be much more efficient thanthe use of statins. Tests performed in mice and macaques indicated asignificant decrease in LDL. The inference made suggested that thenew drug is more potent than the use of statins. This does not meanthat the older and common drugs do not work. They do, although theside effects they produce are not handled well by all users (Erin etal., 2015).

Theefficiency and approval of Repatha do not mean that it is one hundredpercent safe. There are cases where some patients develophypersensitive reactions against the drug for instance rash, andurticaria. Adverse events and side effects are also manifest, albeitsomewhat different from those of Atorvastatin (Lipitor) medication.The most common signs of adverse reactions to Repatha include backpains, influenza, infection of the respiratory tract and in somecases, nasopharyngitis. Similarly, musculoskeletal adverse events andgastroenteritis are present. Due to the monoclonal antibody nature ofthe medication, there is a possibility of some patients developingimmunogenicity reactions with Repatha. (Amgen, 2016). On the otherhand, Atorvastatin’s side effects range from muscle pain,tenderness and weakness, confusion, fever, blurred vision, nausea,stomach pain, diarrhea, loss of appetite and sometimes jaundice dueto liver involvement [ CITATION Ann15 l 1033 ].

Inanother study published in the JAMA medical journal, researchers dida study on patients who reported having muscle pains during statinuse. Out of a sample of 490 individuals, approximately 40% of thoseprovided with statins developed pain in high levels. Afterward, asecond trial involving 218 patients was done where they were givenRepatha and a statin-based drug ezetimibe. A 24-week follow-upindicated that participants who took Repatha saw a 52.8% reduction inthe levels of unwanted cholesterol. On the other hand, those whoreceived ezetimibe reported a 16.7% decline. Additionally, amongindividuals using Repatha, only 13% reported muscle pain, and asingle person discontinued medication due to intolerance.Furthermore, the inability of statins to be used to lower cholesterollevels in patients with high risk of cardiovascular diseases raiseshope that the more powerful Repatha could be the solution to theissue (Spencer, 2016).

Acloser look at the effects of Atorvastatin (Lipitor) reveals that itsapplication can cause the development of diabetes mellitus type 2 [ CITATION Sal12 l 1033 ].Myopathy and rhabdomyolysis occur at the rate of 2.3-9.1 per 10.000individuals taking it. As such, this medication isusually discontinued if these adverse effects occur. Additionally,liver problems may arise in close to 0.7% of patients and hence theneed to perform a thorough hepatic functional analysis before use. Ithas also been established that approximately 1-10% of Lipitor usersare likely to develop arthralgia, diarrhea, dyspepsia and nausea. Inpersons who received high doses, atorvastatin was discovered to havea relationship with deteriorating glycemic control [ CITATION Ann15 l 1033 ].

3.Discussion of what the evidence shows

Theapproval of new cholesterol reducing drugs is a big step in both themedical and pharmaceutical sectors. Not only does it show theimprovements in the treatment of chronic diseases, but also providesan opportunity for affected patients to attain higher levels ofhealth. The acceptance of Repatha as the drug of choice is entirelybased on its intended effects as well as the frequency and depth ofits side effects. As such, a side-by-side comparison is a key to theselection and approval of a new drug.

Basedon the literature review, it is evident that Atorvastatin works asintended. The main issue surrounding the debate of whether the newdrug is better or not is founded on the side effects. We canacknowledge and appreciate that despite the fact that Atorvastatinhas been in use for a long period and has helped a lot of patients,the after effects have also caused harm to others. The pains andassociated complex issues have made others to discontinue treatmentand others to develop additional problems. In comparison, the newdrug Repatha has considerably less complicated outcomes thanAtorvastatin.

Apparently,Repatha is shown to reduce the cholesterol levels in the blood at arelatively higher percentage compared to the older statin drugs. Acloser scrutiny also reveals that concerning side effects, thesignificant levels of pain produced by Atorvastatin are greatlydiminished in patients who use Repatha. This outcome means that morepatients are likely to persist with the new medication unlike in theolder one where patients discontinue due to the pain and discomfort.It is clear that the new drug has less severe aftereffects comparedto the older one. Also, people with associated cardiovascular risksare not advised to use Atorvastatin. In contrast, medicalprofessionals suggest that the new drug can be utilized to treatindividuals who are exposed to such risks (Bodkin, 2016). Moreover,this breakthrough will be most beneficial for most if not all thepatients whom statins do not work at all.

4.Cost-benefit analysis

Thecost of a drug is a vital component that determines the acceptanceand utilization both regarding approval by the relevant institutionsand affordability by the patients. Due to its nature, Repatha isextremely expensive and a year’s worth is estimated to be between£4,500 and £6,100. To some people, this price is too highconsidering that its real impacts on cardiovascular diseases arestill under scrutiny (Spectator Health, 2016). Atorvastatin is theopposite. It is incredibly cheap in comparison to Repatha. Moststatins cost an approximately £20 in a year per patient andtherefore, Atorvastatin is affordable by most of the patients. Atsome point, this particular drug became the best-selling drug in theworld possibly because it worked as expected and it was affordable.

Inthe United States, the Wholesale cost of acquiring Repatha isapproximate $14,100 in a year. This price is regardless of the modeof delivery, which can either be monthly or twice in a month (onceevery two weeks). Despite this seemingly high cost of Repatha, theactual cost to the clients might be much lower due to theintroduction of discounts and rebates. Also, the extra cost topatients will depend on the insurance capabilities as well as theavailability of patient assistance programs. Several other drugs areupcoming with similar working strategies as Repatha. The only setbackis that treatments that employ the use of monoclonal antibodiesbecome too expensive as the cost of therapy spiral to very highheights (Amgen, 2016).

5.Conclusion

Realsustenance of health is facilitated by continuous research,collaboration and discovery of better methods of treatment andmanagement. The innovation of the new drug that has better outcomesis a huge step in the assistance of patients who are suffering fromhigh cholesterol-related disorders. Even though this medicine is notperfect, it is clear that the result is far much better than theAtorvastatin which has been in use to date. Despite the convincingcomparison, there is a need for more studies and analyses to becarried out to determine the effects of Repatha in patients withcardiovascular risks as well as its ability to work in patients whodo not respond well to Atorvastatin.

References

Amgen. (2016, July 11). FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor. Retrieved from Amgen: http://www.amgen.com/media/news-releases/2016/07/fda-approves-first-and-only-single-monthly-injection-for-a-pcsk9-inhibitor/

Bodkin, H. (2016, May 6). Drugs that replace statins but without the side effects approved for use by the NHS . Retrieved from The Telegraph: http://www.telegraph.co.uk/science/2016/05/06/statins-replacement/

Boyles, S. (2012, January 9). Statins May Raise Diabetes Risk in Older Women. Retrieved from WebMD: http://www.webmd.com/cholesterol-management/news/20120109/statins-may-raise-diabetes-risk-in-older-women

Erin, C., Marcelo, J.A., Amar, Maureen S., Julianne, P., John T. S., Bryce, C., Alan, T. R. (2015). A cholesterol-lowering VLP vaccine that targets PCSK9. Vaccine, 5747-5755.

Schaefer, A. (2015, September 17). Cholesterol Control: PCSK9 Inhibitors vs. Statins. Retrieved from Healthline: http://www.healthline.com/health/high-cholesterol/pcsk9-inhibitors-vs-statins#Overview1

Spectator Health. (2016, April 5). A new drug to replace statins? Don’t believe the hype. Retrieved from Spectator Health: http://health.spectator.co.uk/a-new-drug-to-replace-statins-dont-believe-the-hype/

Spencer, B. (2016, April 3). Drug to beat cholesterol WITHOUT statin side effects: Breakthrough treatment could get NHS green light by end of the month. Retrieved from MailOnline: http://www.dailymail.co.uk/health/article-3521954/Drug-beat-cholesterol-without-statin-effects-breakthrough-treatment-NHS-green-light-end-month.html

Close Menu