Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis.

Objective: To review the safety and efficacy of romosozumab (Evenity) in the treatment of osteoporosis in women. Data Sources: An English-language search of PubMed and Medline (1966 to August 2020) was conducted using the keywords romosozumab, sclerostin inhibitor, AMG785, and osteoporosis. Manufacturer prescribing information, abstracts, fda.gov, and ClinicalTrials.gov data were incorporated for additional materials. In addition, a review of bibliographies of retrieved articles was performed to identify additional references. Study Selection/Data Extraction: Articles selected included those that described clinical studies of pharmacokinetics, efficacy, or safety of romosozumab. Data Synthesis: Romosozumab is a human monoclonal antibody that inhibits the action of sclerostin and is the first agent in its class to reach Phase III trials. Significant increases in bone mineral density and decreases in vertebral and hip fractures are demonstrated in Phase III trials. Favorable results led to its marketing approval in several countries. Major adverse cardiac events were observed in one clinical trial. Other adverse effects include arthralgia, headache, and injection site reactions. Place in Therapy: Romosozumab is the first agent to inhibit bone resorption and stimulate bone formation. Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.

Perceptions of tenure and tenure reform in academic pharmacy.

OBJECTIVES: To determine the academic pharmacy community's perceptions of and recommendations for tenure and tenure reform. METHODS: A survey instrument was administered via either a live interview or an online survey instrument to selected members of the US academic pharmacy community. RESULTS: The majority of respondents felt that tenure in academic pharmacy was doing what it was intended to do, which is to provide academic freedom and allow for innovation (59.6%). Respondents raised concern over the need for faculty mentoring before and after achieving tenure, whether tenure adequately recognized service, and that tenure was not the best standard for recognition and achievement. The majority (63%) agreed that tenure reform was needed in academic pharmacy, with the most prevalent recommendation being to implement post-tenure reviews. Some disparities in opinions of tenure reform were seen in the subgroup analyses of clinical science vs basic science faculty members, public vs private institutions, and administrators vs nonadministrators. CONCLUSIONS: The majority of respondents want to see tenure reformed in academic pharmacy.

Estradiol valerate/dienogest: a novel oral contraceptive.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the new oral contraceptive estradiol valerate/dienogest. DATA SOURCES: Searches of PubMed (1966-July 2011) and International Pharmaceutical Abstracts (1970-July 2011) were conducted using the key words estradiol valerate, dienogest, Natazia, and Qlaira. Bibliographies of retrieved articles were reviewed to identify additional references. STUDY SELECTION AND DATA EXTRACTION: All identified studies published in English and involving efficacy and safety of estradiol valerate/dienogest as an oral contraceptive were reviewed. DATA SYNTHESIS: Estradiol valerate/dienogest is a 4-phasic oral contraceptive approved for the prevention of pregnancy. The 4-phasic design allows for acceptable cycle control with this hormonal combination. In efficacy trials of estradiol valerate/dienogest in women aged 18-35 years, the Pearl Index ranged from 0.40 to 1.64, a range comparable to that of other combination oral contraceptives. The safety profile was also similar to that of other oral contraceptives, with headache, metrorrhagia, breast tenderness, nausea or vomiting, acne, and weight gain reported as the most common adverse effects. Menstrual bleeding patterns and cycle control with estradiol valerate/dienogest were comparable to those of a monophasic oral contraceptive containing ethinyl estradiol/levonorgestrel. Estradiol valerate/dienogest differs from other oral contraceptives in that it necessitates more stringent dosing guidelines for maximum contraceptive efficacy. New starts should be on the first day of menses only, and a back-up method of contraception is required for the first 9 days, as compared to 7 days with other oral contraceptives. Back-up contraception is usually required for any pill taken more than 12 hours later than scheduled. CONCLUSIONS: Estradiol valerate/dienogest is an effective oral contraceptive. Because it has more stringent start times and requires a longer duration of backup contraception and stricter adherence, estradiol valerate/dienogest should be reserved for patients who are intolerant of other combination oral contraceptives.

Saxagliptin: a new dipeptidyl peptidase 4 inhibitor for type 2 diabetes.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of saxagliptin, a new dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes. DATA SOURCES: Searches of PubMed (1966-March 2010) and International Pharmacy Abstracts (1970-March 2010) were conducted using the key words saxagliptin, Onglyza, and BMS-477118. A review of bibliographies of retrieved articles was also performed to identify additional references. STUDY SELECTION AND DATA EXTRACTION: All identified studies published in English and involving efficacy and safety of saxagliptin in the treatment of type 2 diabetes were reviewed. DATA SYNTHESIS: Saxagliptin is a competitive inhibitor of DPP-4 that slows the degradation of incretin hormones, thereby stimulating insulin secretion, reducing postprandial glucagon, and decreasing glucose levels. Saxagliptin is well absorbed after oral administration and demonstrates a pharmacokinetic profile that is compatible with once-daily dosing. Clinical trials with saxagliptin monotherapy for the treatment of type 2 diabetes showed a reduction in hemoglobin A(1c) (A1C) of 0.43-0.9%. Saxagliptin has demonstrated similar reductions in A1C when used as add-on therapy with metformin, sulfonylureas, and thiazolidinediones. The combination of saxagliptin and metformin for initial therapy in treatment-naïve patients was associated with greater improvements in A1C than either agent alone. In general, saxagliptin therapy is well tolerated. The most common adverse effects occurring in clinical trials were headache, nasopharyngitis, upper respiratory tract infections, and urinary tract infections. CONCLUSIONS: Saxagliptin is effective as monotherapy or add-on therapy for the management of type 2 diabetes. Because saxagliptin has a higher cost and reduces A1C and other surrogate markers of glucose control to a lesser extent than other well-validated therapies, such as metformin, saxagliptin should be reserved for patients who fail or are intolerant of conventional treatments for type 2 diabetes.

Pharmacologic management of hypertension in patients with diabetes.

Hypertension is a common comorbidity in patients with diabetes, and adequate control of blood pressure significantly reduces the risk of macrovascular and microvascular complications. Patients with diabetes should achieve a target blood pressure of less than 130/80 mm Hg. The use of angiotensin-converting enzyme inhibitors may slow progression to kidney failure and cardiovascular mortality; these agents are the preferred therapy for managing coexisting diabetes and hypertension. Angiotensin receptor blockers can prevent progression of diabetic kidney disease and are a first-line alternative for patients intolerant of angiotensin-converting enzyme inhibitors. Thiazide diuretics provide additional antihypertensive effects when combined with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. With lower doses of these drugs, the risk of clinically significant metabolic alterations is minimal. Beta blockers and calcium channel blockers also have beneficial effects in managing hypertension in patients with diabetes. Beta blockers reduce cardiovascular events and are useful in a multidrug regimen. Dihydropyridine calcium channel blockers should be reserved for patients intolerant of preferred agents or those who need additional therapy to achieve target blood pressure. Many patients with diabetes require combination therapy with multiple antihypertensive agents.