NICE unlicensed evidence summary: Metformin in women with polycystic ovary syndrome not planning pregnancy
Source: NICE Area: Evidence > Drug Specific Reviews These evidence summaries review the published data for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. They provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies   The latest summary addresses the off-label use of metformin in women with polycystic ovary syndrome not planning pregnancy. Five small RCTs included in a Cochrane systematic review, and 4 RCTs publ...
Source: NeLM - Drug Specific Reviews - February 21, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Vandetanib for metastatic medullary thyroid carcinoma
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews Thyroid cancer is a relatively rare malignancy, representing approximately 1% of all cancers, although it is the most common type of endocrine malignancy. In the UK, there were 2,154 newly diagnosed thyroid cancer cases in 2008 (3.5 cases per 100,000). Medullary thyroid cancer (MTC) is an uncommon histological subtype of thyroid cancer that accounts for approximately 3 to 5% of all thyroid cancer cases (or approximately 0.1 to 0.2 cases per 100,000 population).   Vandetanib (Caprelsa®) is licensed for the treatment of aggressive and...
Source: NeLM - Drug Specific Reviews - February 20, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Brentuximab vedotin for Hodgkin's lymphoma
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews Due to the rarity of the condition and the licensing of brentuximab vedotin, randomised control trials are now unlikely to be conducted for brentuximab vedotin in this indication.   The best available data at this time come from a multinational Phase II study (n=102) that found brentuximab vedotin to be associated with an objective response rate of 75%, with a complete remission seen in 34%.  At the time of the analysis, the median duration of response for those in complete remission was 20.5 months and the estimated 12-month s...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Axitinib as an option for second line advanced renal
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews Axitinib (Inlyta®, Pfizer) is an orally administered multi-targeted kinase receptor inhibitor that has been licensed in the EU for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. There are currently no treatments approved by NICE for use in people with advanced RCC who have failed to respond to prior systemic therapy. However, sunitinib and everolimus are occasionally prescribed as second-line treatments through the Cancer Drugs Fund; and are also suggest...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Bendamustine for relapsed follicular lymphoma refractory to rituximab
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews The manufacturer of bendamustine (Napp Pharmaceuticals) was invited to submit evidence for a NICE single technology appraisal (STA) in May 2010. In June 2010, the manufacturer informed NICE that it would not be making an evidence submission because it was unable to identify comparative clinical evidence suitable for a NICE appraisal in people with rituximab refractory disease. The manufacturer indicated that further research was ongoing but data would not be available in a time frame that would allow NICE to produce timely guidance. NICE ther...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Brentuximab vedotin for Hodgkin's lymphoma
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews Due to the rarity of the condition and the licensing of brentuximab vedotin, randomised control trials are now unlikely to be conducted for brentuximab vedotin in this indication.   The best available data at this time come from a multinational Phase II study (n=102) that found brentuximab vedotin to be associated with an objective response rate of 75%, with a complete remission seen in 34%.  At the time of the analysis, the median duration of response for those in complete remission was 20.5 months and the estimated 12-month s...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Lenalidomide for 1st relapse multiple myeloma after bortezomib
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews NICE recommends the use of lenalidomide for relapsed multiple myeloma only in those who have received two or more prior therapies.   The best available evidence to support the use of lenalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma comes from two phase III studies (MM-009 and MM-010). Both trials compared lenalidomide/dexamethasone to dexamethasone alone, and both trials used a primary endpoint of time to disease progression. There was only a limited number of patients in the two phase III ...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Tegafur, gimeracil, and oteracil (known as S1)for first-line palliative treatment of advanced gastric cancer
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews The evidence to support tegafur/gimeracil/oteracil plus cisplatin for this indication derives from one pivotal phase III multicentre, randomised, open-label study to compare overall survival (OS) for cisplatin plus tegafur/gimeracil/oteracil (CS) with cisplatin plus 5-fluorouracil iv (CF) in adult patients with advanced gastric cancer, previously untreated with chemotherapy (FLAGS study). It is important to note that the comparator used in the FLAGS study (CF) is not relevant for UK practice, where patients would normally receive EOX or ECX. ...
Source: NeLM - Drug Specific Reviews - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Human chorionic gonadotrophin (hCG) for preventing miscarriage
Source: Cochrane Area: Evidence > Drug Specific Reviews Background Recurrent miscarriage (RM) is defined as the loss of three or more consecutive pregnancies. Further research is required to understand the causes of RM, which remain unknown for many couples. Human chorionic gonadotrophin (hCG) is vital for maintaining the corpus luteum, but may have additional roles during implantation which support its use as a therapeutic agent for RM.     Objectives To determine the efficacy of hCG in preventing further miscarriage in women with a history of unexplained RM.   Search methods ...
Source: NeLM - Drug Specific Reviews - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Thyroid hormones for acute kidney injury
Source: Cochrane Area: Evidence > Drug Specific Reviews Background Acute kidney injury (AKI), which is common in hospitalised patients, is associated with significant morbidity and mortality. Despite recent advances in treatment, AKI outcomes have not changed substantially during the past four decades, and incidence is increasing. There is an urgent need to explore novel therapeutic agents and revisit some older drugs to review their roles in the management of AKI. Although thyroid hormone therapy has shown promise in experimental animal studies, clinical efficacy and safety have not been systematically assessed f...
Source: NeLM - Drug Specific Reviews - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Tranexamic acid for reducing mortality in emergency and urgent surgery
Source: Cochrane Area: Evidence > Drug Specific Reviews Background Emergency or urgent surgery, which can be defined as surgery which must be done promptly to save life, limb, or functional capacity, is associated with a high risk of bleeding and death. Antifibrinolytic agents, such as tranexamic acid, inhibit blood clot breakdown (fibrinolysis) and can reduce perioperative bleeding. Tranexamic acid has been shown to reduce the need for a blood transfusion in adult patients undergoing elective surgery but its effects in patients undergoing emergency or urgent surgery is unclear.    Objectives To a...
Source: NeLM - Drug Specific Reviews - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

LCNDG Rapid Review: Bortezomib for first-line, transplant unsuitable multiple myeloma
Source: London Cancer New Drugs Group Area: Evidence > Drug Specific Reviews There are no trials directly comparing bortezomib, melphalan, and prednisolone versus thalidomide-based regimens in patients with multiple myeloma who are not able to receive high-dose therapy and stem cell transplant.   The phase III open-label randomised control trial investigating melphalan-prednisolone (control arm) against bortezomib-melphalan-prednisolone (bortezomib arm) reported a median time to progression of 24 months in the bortezomib arm and 16.6 months in the control arm (hazard ratio 0.48; P<0.001). The response cou...
Source: NeLM - Drug Specific Reviews - February 12, 2013 Category: Drugs & Pharmacology Source Type: news

SMC accepts linagliptin (Trajenta®) for restricted use in the treatment of type 2 diabetes
Source: Scottish Medicines Consortium (SMC) Area: Evidence > Drug Specific Reviews The Scottish Medicines Consortium (SMC) has accepted linagliptin (Trajenta®) for restricted use within NHS Scotland for the treatment of type 2 diabetes, in the following scenarios:   as monotherapy in patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance as combination therapy with a sulphonylurea and metformin when diet and exercise plus dual therapy does not provide adequate glycaemic control   The SMC is unable to recommend the use of linagliptin in comb...
Source: NeLM - Drug Specific Reviews - February 11, 2013 Category: Drugs & Pharmacology Source Type: news

SMC accepts ferumoxytol (Rienso®) for restricted use in the treatment of iron deficiency anaemia
Source: Scottish Medicines Consortium (SMC) Area: Evidence > Drug Specific Reviews The Scottish Medicines Consortium (SMC) has accepted ferumoxytol (Rienso®) for restricted use within NHS Scotland for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease. Its use is restricted to non-haemodialysis dependent adult patients with chronic kidney disease when oral iron preparations are ineffective or cannot be used.   The Detailed Advice accompanying the recommendation (see link below) summarises the evidence on efficacy and safety, the clinical effectiveness issues an...
Source: NeLM - Drug Specific Reviews - February 11, 2013 Category: Drugs & Pharmacology Source Type: news

SMC accepts etanercept (Enbrel®) for restricted use in the treatment of arthritis in children and adolescents
Source: Scottish Medicines Consortium (SMC) Area: Evidence > Drug Specific Reviews The Scottish Medicines Consortium (SMC) has accepted etanercept (Enbrel®) for restricted use within NHS Scotland for the treatment of the following:   polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate; psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate; en...
Source: NeLM - Drug Specific Reviews - February 11, 2013 Category: Drugs & Pharmacology Source Type: news