Efficacy and safety of subcutaneous

Cohen M, Demers C, Gurfinkel ER et al. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and safety of subcutaneous enoxaparin in non-Q-wave coronary events study group. N Engl J Med 1997 337 447-452. 

Cohen M, Demers C, Gurfinkel EP et al. (1998) Low-molecular-weight heparins in non-ST-segment elevation ischemia the ESSENCE trial. Efficacy and Safety of Subcutaneous Enoxaparin versus intravenous unfractionated heparin, in non-Q-wave Coronary Events. Am J Cardiol 82 19L-24L... 

Delorenzi C, Weinberg M, Solish N, Swift A. A multicenter study of the efficacy and safety of subcutaneous non-animal stabilized hyaluronic acid in aesthetic facial contouring interim report. Dermatol Surg 2006 32 205-211. 

Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes. Diabetes Care 2004 27 2622-7. 

A.E. Mehta, J.L. Milburn, K.S. Hershon, J.L. Chiasson, and S.R. Levin. 2004. Efficacy and safety of inhaled insulin (exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes results of a 6-month, randomized, comparative trial. Diabetes Care 27 2356-2362. 

ExTRACT-TIMI 25 is a 21,000-patient trial evaluating enoxaparin versus UFH in STEMI patients receiving fibrinol54ic therapy (Fig. 7.4) (38a). Importantly, it will provide information on the efficacy and safety of reduced doses of enoxaparin in the elderly. Patients in ExTRACT-TIMI 25 may be treated with approved regimens of streptokinase, t-PA, reteplase (r-PA), or TNK within 6 hours of the onset of symptoms. They are randomized to either standard weight-adjusted therapy with UFH [bolus 60 U/kg (maximum 4000 U) followed by an initial infusion of 12 U/kg/h (maximum 1000 U/h)] for at least 48 hours or to enoxaparin. For patients under 75 years, the enoxaparin regimen consists of an intravenous bolus of 30 mg followed by subcutaneous injections of 1.0 mg/kg every 12 hours. Patients 75 years or older do not receive the initial intravenous bolus and receive only 75% of the maintenance subcutaneous doses (0.75 mg/kg every 12 hours). Treatment with enoxaparin continues until hospital discharge or day 8,... 

Wasserman RL, Melamed I, Rojavin MA, Zenker O, Orange JS. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous... 

Yorifuji T, Kawakita R, Hosokawa Y, Fujimaru R, Matsubara K, Aizu K, et al. Efficacy and safety of long-term, continuous subcutaneous octreotide infusion for patients with different subtypes of KATP-chaimel hyperinsulinism. Clin Endocrinol (Oxf) 2013 78(6) 891-7. 

In cUnical studies with standard, multicycle chemotherapy, a single subcutaneous dose of pegfilgrastim has been shown to have similar efficacy and safety as daily subcutaneous injections doses of filgrastim in patients with solid tumours [32]. 

Assuming that efficacy and safety margins can be achieved (not a given in all cases ), this leaves the administration of the drug as a further key requirement for optimization. Various methods of administration are feasible. Although parenterally administered drugs (e.g., intravenous, intramuscular, or subcutaneous injections) are common, in most circumstances a noninvasive oral or inhaled mode of administration will be considered desirable. 

Biologic response modifiers (BRMs) are indicated in patients who have failed an adequate trial of DMARD therapy.1 BRMs may be added to DMARD monotherapy (i.e., methotrexate) or replace ineffective DMARD therapy.22 The decision to select a particular agent generally is based on the prescriber s comfort level with monitoring the safety and efficacy of the medications, the frequency and route of administration, the patient s comfort level or manual dexterity to self-administer subcutaneous injections, the cost, and the availability of insurance coverage.23 In general, BRMs should be avoided in patients with serious infections, demyelinating disorders (e.g., multiple sclerosis or optic neuritis) or heart failure.21... 

Zbinden S, Zbinden R, Meier P, Windecker S, Seiler C. Safety and efficacy of subcutaneous-only granulocyte-macrophage colony-stimulating factor for collateral growth promotion in patients with coronary artery disease. J Am Coll Cardiol 2005 46 1636-1642. 

Chantelau E, Spraul M, Muhlhauser I, Gause R, Berger M. Long-term safety, efficacy and side-effects of continuous subcutaneous insulin infusion treatment for type 1 (insulin-dependent) diabetes mellitus a one centre experience. Diabetologia 1989 32(7) 421-6. 

Franchini M, Gandini G, de Gironcoli M, Vassanelli A, Borgna-Pignatti C, April G. Safety and efficacy of subcutaneous bolus injection of deferoxamine in adult patients with iron overload. Blood 2000 95(9) 2776-9. 

The nasal tissue is highly vascularized and provides efficient systemic absorption. Compared with oral or subcutaneous administration, nasal administration enhances bioavailability and improves safety and efficacy. Chitosan enhances the absorption of proteins and peptide drugs across nasal and intestinal epithelia. Gogev et al. demonstrated that the soluble formulation of glycol chitosan has potential usefulness as an intranasal adjuvant for recombinant viral vector vaccines in cattle [276]. 

The first study to demonstrate the activity of enfuvirtide in HIV-infected patients (Kilby et al. 1998) showed that patients receiving the maximum 100 mg intravenous dose had maximum median declines in HIV-1 RNA of -1.96 logjo copies/mL through 14 days. Several additional studies (Kilby et al. 2002 Lalezari et al. 2003a, b) further demonstrated the safety and efficacy of enfuvirtide and led to the selection of twice-daily subcutaneous injections of a 90 mg nominal dose for testing in the TORO (T-20 vs. optimized regimen only) pivotal clinical trials. 

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