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Self Care Pharmacy Blog

Archive for the ‘Gastrointestinal Health’ Category

 

The Purple Pill Goes OTC

Thursday, November 20th, 2014

By Josh Willoughby, Pharm.D. Student

Heartburn is a common health problem that affects 25% of Americans on average each year. It has been reported that in the United States alone, approximately $14 billion is spent annually.[1] Heartburn normally presents itself with a burning sensation in the chest or upper abdomen that moves upward into the throat. There are many different medications for treatment of heartburn, so it is important to know which one is the best option for self-treatment. Recently, the well-known “purple pill” for heartburn became available to patients without the need for a prescription. In late May of 2014, Pfizer Inc. announced the introduction of a new over-the-counter heartburn medication, known as Nexium 24HR.[2] Nexium, the popular “purple pill”, previously had been on the market as a prescription-only medication, but has now made the jump to over-the-counter (OTC), just as competitors Prilosec and Prevacid did years before. The switch to OTC will now allow consumers greater access and more affordable options for treatment of heartburn.

Nexium 24HR is a proton pump inhibitor or PPI, meaning that it blocks acid pumps in the stomach, which are the controlling factors in causing heartburn. PPIs are effective for treating frequent heartburn that occurs at least two days a week. Relief begins in two to three hours, but it may take between one and four days for the maximum effect to set in. Though this medication may have a slower onset of relief compared to antacids, PPIs last the longest out of any OTC heartburn treatment (approximately 12-24 hours). Nexium 24HR currently comes in a delayed-release, enteric coated form, allowing the medication to work in the body where it is needed. Nexium 24HR should be taken 30-60 minutes before meals for full effect. Taking the medication each morning would be the easiest way to ensure that the patient does not forget to take it. It is recommended that the medication be taken once daily for two weeks and then stopped for at least four months. If heartburn continues to occur, contacting the primary physician is suggested.1

Nexium 24HR comes in 22.3 mg strength, compared with the prescription-only 20 mg and 40 mg strengths. Even with the slight difference, compared with the prescription strengths, the 22.3 mg dose is equivalent to 20 mg esomeprazole, the medication’s active ingredient.[3] Nexium 24HR capsules should not be crushed or chewed. This will cause the medication to be released before it reaches the small intestine, where it needs to be activated. Nexium 24HR should not be taken by patients who have trouble swallowing food, are vomiting blood, or have black or bloody stools. Those who have lightheadedness, sweating, dizziness, or chest pain should not take Nexium 24HR and should contact a doctor. Nexium 24HR should not be taken by patients younger than 18 years old. Patients taking warfarin, clopidogrel, cilostazol, antifungals, anti-yeasts, digoxin, diazepam, tacrolimus, HIV medications, or methotrexate should ask a doctor before starting Nexium 24HR.[4]

Since prescription-strength Nexium originally came on the market in 2002, it quickly surpassed the other PPIs in sales through heavy marketing by AstraZeneca. The “purple pill” became the most purchased PPI over its competitors Prevacid (Lansoprazole) and Prilosec (Omeprazole). Based on Consumer Report’s data before the release of Nexium 24HR, Lansoprazole 20 mg and Omeprazole 20 mg (both OTC) were the cheapest effective PPI options.[5] Currently, a box of Nexium 24 HR costs about $18, while Omeprazole 20 mg only costs around $13 for a box of 28 capsules. Clinical evidence has shown no proof that Nexium is more effective than Prilosec (Omeprazole) in treating heartburn. In fact, both medications are nearly identical in their chemical structures. However, research studies have found that Nexium 20 mg and 40 mg are slightly more effective than Prilosec 20 mg in healing the esophagus, but no tests have been done to compare against Prilosec 40 mg.[6]

Because Nexium has not been tested against the higher strength of Prilosec, it remains unknown whether or not it is a better treatment option. Due to the fact that Nexium and generic Prilosec (Omeprazole) are almost identical in structure and have similar effectiveness, one should pause before choosing the more expensive option, Nexium. Most likely due to increased advertising, Nexium has become the preferred PPI on the market over the past decade. However, based on the current scientific and clinical data, I would recommend generic Prilosec OTC (Omeprazole) over Nexium 24HR to patients on the basis of increased cost savings. Paying more for a medication that has not been conclusively proven to be better than another medication is really not in anyone’s best interest. Hopefully, future studies will discover whether or not these medications significantly differ in efficacy, so that both medical professionals and patients alike will be better informed. With this information, what proton pump inhibitor would you recommend or choose for treating yourself and why?

References

  1. Heartburn and Dyspepsia. (2012). In D. Krinsky et al (Ed.), Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care (17th ed., pp. 219-228). Washington DC: American Pharmacists Association.
  2. Pfizer Brings Frequent Heartburn Relief Over-the-Counter with New Nexium 24HR. (2014, May 27).
  3. Esomeprazole (Lexi-Drugs). (2014, May 1).
  4. Nexium 24HR. (2014, May 27).
  5. Consumer Reports, Using the Proton Pump Inhibitors to Treat Heartburn and Stomach Acid Reflux, 1-15. (2013).
  6. Zablocki, E. (2004). Proton Pump Inhibitors are the Preferred Treatment for Ulcers. Managed Healthcare Executive, 48-49.

Proactive Use of Probiotics

Tuesday, October 28th, 2014

by Sarah Winey, PharmD candidate

According to the World Health Organization (WHO), two leading causes of death in young children, under the age of 5, are respiratory infections and diarrhea.1 Both respiratory tract infections (RTIs) and severe diarrhea are often caused by a bacterial infection, so an effective prevention therapy could reduce the incidence of these infections.  Currently, strategies are rarely employed for the prevention of these disease states, except avoidance of foods and conditions that may have an impact, such as fatty foods and environmental irritants. Avoidance of environment irritants can include avoidance of individuals who may carry infection and appropriate hygienic measures, such as hand washing. However, medical treatment frequently occurs only when the patient becomes symptomatic. The standard treatment for diarrhea involves fluid and electrolyte replacement or zinc supplementation, while the standard treatment for bacterial respiratory tract infections often involves antibiotic therapy.1 Probiotic therapy has been suggested as a potential preventative strategy for combating bacterial infections, including those associated with diarrhea and RTI’s.

Probiotics are live, healthy bacteria that are ingested in the form of a dietary supplement or cultured dairy products.2 The human body holds a significant amount of natural healthy bacteria in various locations, including the gastrointestinal (GI) tract.  When harmful bacteria enters the body, it competes for limited space with the healthy bacteria.  In the case of infection, the harmful bacteria overwhelms the system. The goal of probiotic supplementation is to overwhelm at risk areas, such as the GI tract, with healthy bacteria; in fact, the labeled dose is in terms of number of live cells or colonies, usually upward of one million.  In clinical testing, most patients do not experience side effects or experience only minor GI effects such as gas.3 According to current guidelines, probiotics have not been determined to replace standard treatment; nevertheless, the 2007 National Health Interview Survey found that probiotic-type products were the fifth most used natural product for children.3

In March 2014, the Pediatrics journal published a trial with the goal of determining whether a probiotic, Lactobacillus reuteri, had a significant impact on incidence of diarrhea in preschool children. The study was a forward-looking, random-sample, placebo-controlled trial (placebo- an identical substance to probiotic but has no effect) occurring from April 2011-June 2012 in four different day care centers in southeast Mexico City. The study population was comprised of healthy children aged six months to three years, born full term, and of similar socioeconomic status. The primary outcome, or goal, of the study was to determine if the number of days children experienced diarrhea was impacted by probiotic intervention. In addition, the number of days children experienced RTI’s, days of absence caused by diarrhea or RTI, days of antibiotic use, days of medical visits and cost impact due to intervention were studied. The study’s limitations included the possible lack of generalizability based on study location and choice of probiotic species.4

This study provided additional support to the theory that probiotic therapy can impact the prevention of bacterial infections, specifically diarrhea and RTI’s. The results showed that the intervention significantly reduced the incidence of both diarrhea and RTI.4 Additionally, the days of absence, number of medical visits, and antibiotic use were also significantly reduced as a result of probiotic intervention.4 Several other studies have found similar results. For instance, according to a Cochrane research review, probiotics were found to be a beneficial prevention strategy for infection; specifically, this study found that upper respiratory tract infection rate was reduced with probiotic use.5 Another research review of Randomized Control Trials (RCT’s) showed a decrease in duration and stool frequency as a result of probiotic intervention for diarrhea.6

In conclusion, probiotic therapy is a safe and seemingly effective for the prevention of respiratory infections and diarrhea.  This form of therapy may prove especially useful to parents of young children in daycare centers who are constantly in a crowded environment, which could lead to increased infection.  An additional option is the use of yogurt or other cultured dairy products, which also have the capability to reestablish normal, healthy bacteria in the GI tract. Currently probiotics are not an officially approved recommendation for children, should they be?

References:

  1. World Health Organization.Children: Reducing mortality. Media centre: Fact Sheets Web site. http://www.who.int/mediacentre/factsheets/fs178/en/. Updated 2014. Accessed September 20, 2014.
  2. EBSCO CAM Review B. Probiotics. Salem Press Encyclopedia Of Health [serial online]. January 2014;Available from: Research Starters, Ipswich, MA. Accessed August 31, 2014.
  3. National Center for Complementary and Alternative Medicine. Oral probiotics: An introduction. 2012.
  4. Gutierrez-Castrellon P, Lopez-Velazquez G, Parra M, et al. Diarrhea in Preschool Children and Lactobacillus reuteri: A Randomized Controlled Trial. Pediatrics [serial online]. n.d.;133(4):E904-E909. Available from: Science Citation Index, Ipswich, MA. Accessed September 24, 2014.
  5. Hao Q. Probiotics for preventing acute upper respiratory tract infections. Cochrane Database Of Systematic Reviews [serial online]. July 26, 2011;(9)Available from: Cochrane Database of Systematic Reviews, Ipswich, MA. Accessed September 20, 2014.
  6. Applegate J, Fischer Walker C, Ambikapathi R, Black R. Systematic review of probiotics for the treatment of community-acquired acute diarrhea in children. BMC Public Health [serial online]. October 2, 2013;13(Suppl 3):1-8. Available from: Academic Search Complete, Ipswich, MA. Accessed September 1, 2014.

Protein Pump Inhibitors and Heart Disease Link

Tuesday, December 10th, 2013

By Yevgeniy Solokha, PharmD Student Cedarville University

Proton pump inhibitors (PPIs) are commonly used to prevent the symptoms and complications of gastroesophageal reflux disease (GERD).1 They work by reducing acid secretion in the stomach by inhibiting the gastric proton pump.2 With several products available over-the-counter (OTC), patients have also been able to use them for the self-treatment of heartburn and indigestion.3 Although these medications are effective, their long-term use has been associated with potentially serious health risks, including bone fractures and reduced magnesium levels in the blood.Not only that, but there has been some evidence suggesting that prolonged use of PPIs may also lead to heart disease.2

This association is the main topic of a recent study that has been published in the Circulation Journal of the American Heart Association. It has evaluated the effects of PPIs on mice and human endothelial cells using cell assays as well as blood samples collected from mice in vivo. The results show that PPIs lead to increased levels of asymmetrical dimethylarginine (ADMA) in the blood by inhibiting dimethylarginine dimethylaminohydrolase (DDAH), an enzyme that breaks it down. This, in turn, prevents nitric oxide synthase (NOS) from generating nitric oxide (NO), which decreases the ability of blood vessels to dilate.The article essentially calls for the need to perform additional studies to evaluate whether the general population using PPIs may be at risk for heart disease.2 This is the main limitation of the study because the results cannot be easily extrapolated to humans. Also, there may be other factors that can contribute to this association.

A similar relationship between ADMA elevations and cardiovascular events has also been discussed in an article published in the Annals of Medicine.It proposed essentially the same mechanism as the one mentioned in this study. Another Danish cohort study set out to investigate a relationship between the use of PPIs and clopidogrel with cardiovascular events. It concluded that, “the increased cardiovascular risk associated with PPI use independent of clopidogrel is caused by unmeasured confounders”.5 Basically, this means that there must be something else going on which has not been accounted for. The main objective of the mouse study discussed above was to try to identify a possible mechanism for this observation. Since this association seems to be fairly new, the literature largely seems to be inconclusive on the subject.

I feel like it is still too early to tell whether there truly is a valid relationship between PPI use and heart disease because there have not been any randomized-controlled trials conducted in humans yet. For this reason, I would not change my self-care recommendation for the short-term relief of persistent heartburn and indigestion because OTC PPIs are indicated for a limited duration of therapy consisting of 14 days, after which they have to be discontinued for at least four months.3 Nevertheless, I think that the results of this study may be good to just keep in mind in case we encounter patients who may be on unnecessary prolonged use of PPIs. The possible heart disease association would simply be another reason to contact their physician about discontinuation. In this regard, I believe that pharmacists are located within a unique position within the healthcare system to make sure that patient safety remains a priority.

Would this knowledge impact your self-care recommendation regarding PPIs?

References:

  1. Proton Pump Inhibitors for Gastroesophageal Reflux Disease (GERD). Available at: http://www.webmd.com/heartburn-gerd/proton-pump-inhibitors-for-gastroesophageal-reflux-disease-gerd. Accessed December 5, 2013.
  2. Ghebremariam YT, Lependu P, Lee JC, et al. Unexpected effect of proton pump inhibitors: elevation of the cardiovascular risk factor asymmetric dimethylarginine. Circulation. 2013;128(8):845-53.
  3. Berardi RR, Kroon LA, McDermott JH et al. Handbook of nonprescription drugs, an interactive approach to Self-care. APhA Publications; 2006.
  4. Böger RH. Asymmetric dimethylarginine (ADMA): a novel risk marker in cardiovascular medicine and beyond. Ann Med. 2006;38(2):126-36.
  5. Charlot M, Ahlehoff O, Norgaard ML, et al. Proton-pump inhibitors are associated with increased cardiovascular risk independent of clopidogrel use: a nationwide cohort study. Ann Intern Med. 2010;153(6):378-86.