Orilissa скачать в хорошем качестве

Orilissa

A recent high profile addition to the treatment armamentarium for endometriosis may neither provide substantive improvement over available therapy nor offer cure of this poorly understood condition. Orilissa acts to prevent the pituitary from manufacturing and releasing hormones necessary for ovarian function. In effect it creates a menopause-like state. In theory this should allow the estrogen driven endometrial tissue to rest and the condition to enter a dormant phase. Unfortunately by reducing ovary hormone production in premenopausal women, the bones begin to dissolve at an alarming rate. Six months of therapy at the low dose causes an average loss of bone mass by about 1% and rising to 3% with the higher dose. However up to 7% of women at the high dose lose more than 8% of bone mass at the lumbar spine, femur and hip. Even though Orilissa does not completely shut down ovarian hormone production, the effects on bone are worrisome. Whether this places women at substantially elevated risk for later osteoporosis and fracture remains unknown. Prescriptions for Orilissa at low dose are limited to 2 years while the higher dose must be discontinued within 6 months. Additionally since Orilissa does not completely eliminate ovarian function, it seems to provide less pain relief from endometriosis than its competitors – Lupron, Zoladex and Synarel. These drugs also adversely affect bone mass. Unlike other related drugs, Orilissa does not reliably halt ovulation which necessitates some form of contraception in sexually active women. Perhaps more disturbingly, Orilissa has the potential to reduce the effectiveness of contraceptives containing estrogen. This mandates use of 2 non-hormonal forms of birth control. Birth defects and spontaneous abortion may occur with in utero fetal exposure. Since Orilissa fails to reliably prevent ovulation but may cause altered menstrual bleeding, a monthly pregnancy test is required. It appears the drug may result in suicidal thinking and development of or worsening of depression. Obviously this warrants special care. Some women experience potentially large and dangerous elevation of blood cholesterol or triglycerides. In addition to these special situations, common side effects include hot flashes in as many as half the women; others experience headache, nausea and insomnia. When offered the opportunity after the initial 6 month trial to continue treatment at no cost for an additional 6 months, slightly less than half wished to proceed. Orilissa does offer some advantages during short term therapy with the higher dose demonstrating considerable advantages over the lower dose. Painful periods and non-menstrual pelvic pain diminish compared to an inactive placebo. Improvement with regard to pain during sexual activities may be statistically significant but appears to lack major advantages over placebo. The pharmaceutical company behind Orilissa stacked the deck with regard to the investigations. They funded and designed the major study; they gathered and analyzed the data; several of the co-authors were employed by the company. Most of the authors of the paper that appeared in the New England Journal of Medicine received some form of financial support from the pharmaceutical company. Actually the 13 page article was accompanied by 72 pages of potential conflicts of interest by the authors. Potential candidates unlikely to respond to treatment or with osteoporosis, ovarian cysts, fibroids, chronic back pain, fibromyalgia or abnormalities on blood chemistry examination or electrocardiogram were excluded. Those failing to respond to previous treatment with progestin or drugs related to Orilissa were not allowed to participate. In addition to all of this the drug was not evaluated against any other active medication. This led the Institute for Clinical and Economic Review, an independent non-profit organization, to conclude that sufficient evidence does not exist to evaluate the place of Orilissa in treating endometriosis. They did however issue an “affordability alert.” The cash price for 1 month of therapy is in excess of $1000 or more than $30 a day.