New Molecular Entity: Estradiol valerate/dienogest (Natazia) was approved in May 2010 for the prevention of pregnancy.
It is estimated that nearly 12 million women in the United States currently use oral contraceptives. Estradiol valerate and estradiol valerate/dienogest is a unique addition to the US market because it is a 4-phasic alternative (the doses of progestin and estrogen varying at 4 times throughout each 28-day treatment cycle) and because it contains an estrogen called estradiol valerate (a synthetic estrogen that is converted to estradiol in a woman's body). All previously marketed combination oral contraceptives contained ethinyl estradiol. Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. However, other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Efficacy. Estradiol valerate and estradiol valerate/dienogest was found to be an effective hormonal contraceptive in 2 multicenter, open-label, single-arm phase 3 clinical trials conducted in North America and Europe. Combined, the trials involved 1,867 women followed for nearly 30,000 28-day treatment cycles. The Pearl Index (PI) was the primary measure for assessing contraceptive reliability for 2 of the trials. The PI calculation was based on criteria established by FDA (pregnancies that occurred in women aged 18 to 35 years during cycles 1 to 13 including pregnancies 7 days post-treatment). In the North American study, 5 pregnancies occurred over 3,969 exposure cycles (PI=1.64; failure rate at the end of year 1 was 0.016). Similarly, 9 pregnancies occurred over 11,275 exposure cycles in the European trial (PI=1.04; failure rate at the end of year 1 was 0.010). The efficacy of estradiol valerate and estradiol valerate/dienogest in women with a body mass index >30 kg/m2 has not been evaluated.
Safety. Approximately 11% of women taking estradiol valerate and estradiol valerate/dienogest dropped out of the clinical trials because of an adverse reaction. The most common treatment-emergent adverse reactions (≥2%) were: headache (including migraines) (13.2%), metrorrhagia and irregular menstruation (8.0%), breast pain, discomfort, or tenderness (6.6%), nausea or vomiting (6.5%), acne (3.9%), and increased weight (2.8%). The most concerning adverse effects of estradiol valerate and estradiol valerate/dienogest (all combination oral contraceptives) are increased risks of venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst, and uterine leiomyoma. Consequently, estradiol valerate and estradiol valerate/dienogest should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant), or liver disease. The excess risk of thromboembolic events is highest during the first year of use. The risk also increases with age, particularly in women >35 years of age, and with the number of cigarettes smoked. For this reason, estradiol valerate and estradiol valerate/dienogest should not be used by women who are >35 years of age and smoke.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.