Case Studies

Case 1

MJ is a 44-year-old female who comes to the pharmacy to purchase a box of Oxytrol for Women. She states that she has been experiencing symptoms of urinary incontinence in which she “feels like I have to go but can’t control it,” and she feels embarrassed by the amount of times she has to go to the bathroom daily. Recently, she has had a few additional episodes of incontinence related to sneezing. She saw a commercial for Oxytrol on TV and thought she would try it before talking with her doctor. MJ denies any other significant medical history other than hypertension, which is well controlled by lisinopril 40 mg daily. She has no known allergies.

As the available pharmacist, do you believe MJ is a candidate for OTC Oxytrol for Women?

Case 2

BT is a 65-year-old male with hypertension, type 2 diabetes mellitus (DM), osteoarthritis, and benign prostatic hypertrophy. He had a myocardial infarction 2 years ago and has been taking Lipitor 80 mg daily ever since. BT has tolerated therapy very well and has no complaints of muscle aches and pains. His liver function test results have always been within normal limits. He expresses concern about the strength of his statin therapy and questions the need for such a high dose.

Is high-dose statin therapy appropriate for BT according to the new American College of Cardiology—American Heart Association guidelines for the treatment of high cholesterol?

ANSWERS

Case 1: Overactive bladder can be defined as urinary urgency with or without urge incontinence, usually accompanied by frequency and nocturia, in the absence of a urinary tract infection or other obvious pathology. Anticholinergic drugs are the treatment of choice for such incontinence, with several agents in the class having approval for this indication. Oxytrol, the transdermal delivery system of oxybutynin, has been available by prescription since 2003 but was recently approved for OTC use. Each patch delivers 3.9 mg of oxybutynin per day, although 1 patch is applied and worn for 4 full days before being removed and replaced with a new patch.

MJ does not appear to have any contraindications to OTC use, which include the presence of pain or burning during urination; blood in urine; unexplained lower back or side pain; cloudy or foul-smelling urine; male gender; younger than 18 years; only accidental urine loss during sneezing, laughing, or coughing; and diagnosis of urinary or gastric retention, glaucoma, or hypersensitivity. MJ should be counseled on proper patch application and the risk of pruritus and anticholinergic side effects, specifically xerostomia and constipation, which are commonly reported with use of the patch. She should contact her physician if she doesn’t experience a benefit within 2 weeks or if she has any bothersome side effects.

Case 2: The newest cholesterol treatment guidelines were published in November 2013. The following patients are considered candidates for high-intensity statin therapy: those with clinically evident atherosclerotic cardiovascular disease, those with a low-density lipoprotein (LDL) level of 190 mg/dL or greater, and those aged 40 to 75 years with type 1 or 2 DM and a 10-year risk of 7.5% or higher with an LDL level of 70 to 189 mg/dL. Clinically evident atherosclerotic disease includes acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or arterial revascularization, stroke, transient ischemic attack, or peripheral artery disease presumed to be of atherosclerotic origin. Statin daily doses that can achieve at least a 50% reduction in the LDL level (eg, atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily) are considered high intensity. For diabetics who have lower than a 7.5% 10-year risk, moderate-intensity statin therapy is recommended. For patients aged 40 to 75 years with an LDL level of 70 to 190 mg/dL with a 10-year risk of at least 7.5%, moderate- to high-intensity statin therapy is recommended. In general, moderate-intensity statin therapy is considered a daily dose of statin that can lower the LDL level by 30% to 50%.

BT has clinically evident atherosclerotic cardiovascular disease given his history of myocardial infarction and should continue his current Lipitor regimen. Routine LDL monitoring after initiation of statin therapy is no longer recommended, as there are no longer target levels to which clinicians should treat. BT should continue to be monitored for safety of the regimen, namely muscle and hepatic injury.

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Dr. Sobieraj is assistant professor of pharmacy practice, and Dr. Coleman is professor of pharmacy practice as well as codirector and methods-chief, at Hartford Hospital Evidence-Based Practice Center at the University of Connecticut School of Pharmacy.