ABSTRACT
Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments. Over 6 months, none of 125 patients identified fulfilled the entry criteria. The commonest reasons for ineligibility were the use of an excluded concurrent drug (45, 36%), brain metastases (22, 18%), poor performance status (21, 17%) and current chemotherapy (15, 12%). A phase III trial of clarithromycin using these entry criteria is not feasible in this setting. Other macrolides that have a lower risk of a drug-drug interaction may be more practical to pursue.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Cachexia/drug therapy , Carcinoma, Non-Small-Cell Lung/complications , Clarithromycin/administration & dosage , Lung Neoplasms/complications , Anti-Bacterial Agents/pharmacology , Cachexia/mortality , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/pathology , Clarithromycin/pharmacology , Clinical Trials, Phase III as Topic , Disease-Free Survival , Double-Blind Method , Feasibility Studies , Female , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Macrolides , Male , Medication Adherence , Neoplasm Staging , Placebos , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Primary care pharmacological management of new musculoskeletal conditions is not consistent, despite guidelines which recommend prescribing basic analgesics before higher potency medications such as opioids or non-steroidal inflammatory drugs (NSAIDs).The objective was to describe pharmacological management of new musculoskeletal conditions and determine patient characteristics associated with type of medication prescribed. METHODS: The study was set within a UK general practice database, the Consultations in Primary Care Archive (CiPCA). Patients aged 15 plus who had consulted for a musculoskeletal condition in 2006 but without a musculoskeletal consultation or analgesic prescription in the previous 12 months were identified from 12 general practices. Analgesic prescriptions within two weeks of first consultation were identified. The association of socio-demographic and clinical factors with receiving any analgesic prescription, and with strength of analgesic, were evaluated. RESULTS: 3236 patients consulted for a new musculoskeletal problem. 42% received a prescribed pain medication at that time. Of these, 47% were prescribed an NSAID, 24% basic analgesics, 18% moderate strength analgesics, and 11% strong analgesics. Increasing age was associated with an analgesic prescription but reduced likelihood of a prescription of NSAIDs or strong analgesics. Those in less deprived areas were less likely than those in the most deprived areas to be prescribed analgesics (odds ratio 0.69; 95% CI 0.55, 0.86). Those without comorbidity were more likely to be prescribed NSAIDs (relative risk ratios (RRR) compared to basic analgesics 1.89; 95% CI 0.96, 3.73). Prescribing of stronger analgesics was related to prior history of analgesic medication (for example, moderate analgesics RRR 1.88; 95% CI 1.11, 3.10). CONCLUSION: Over half of patients were not prescribed analgesia for a new episode of a musculoskeletal condition, but those that were often received NSAIDs. Analgesic choice appears multifactorial, but associations with age, comorbidity, and prior medication history suggest partial use of guidelines.