gemfibrozil has been researched along with Rhabdomyolysis in 71 studies
Rhabdomyolysis: Necrosis or disintegration of skeletal muscle often followed by myoglobinuria.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To review the association between the use of cerivastatin sodium and the risk of rhabdomyolysis in an effort to illustrate the operation and limitations of the current US postmarketing safety-surveillance system." | 8.82 | Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. ( Furberg, CD; Psaty, BM; Ray, WA; Weiss, NS, 2004) |
| "Gemfibrozil therapy alone can induce severe myopathy and rhabdomyolysis." | 7.72 | Acute rhabdomyolysis after gemfibrozil therapy in a pregnant patient complicated with acute pancreatitis and hypertriglycerdemia while receiving continuous veno-venous hemofiltration therapy. ( Chang, CT; Huang, CC; Wu, MS; Yen, TH, 2003) |
| "Gemfibrozil monotherapy of hyperlipidemia may predispose to rhabdomyolysis with acute renal failure." | 7.72 | Rhabdomyolysis and renal failure associated with gemfibrozil monotherapy. ( Layne, RD; Sehbai, AS; Stark, LJ, 2004) |
| "Domestic cases of statin- and statin/gemfibrozil-associated rhabdomyolysis were culled from FDA's database and reviewed." | 7.72 | Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy. ( Chang, JT; Green, L; Parks, M; Staffa, JA, 2004) |
| "Patients receiving combination therapy with colchicine and gemfibrozil, especially those with renal and hepatic dysfunction, should be monitored for rhabdomyolysis, and concomitant colchicine and gemfibrozil therapy should be considered in the differential diagnosis of rhabdomyolysis." | 7.71 | Rhabdomyolysis associated with gemfibrozil-colchicine therapy. ( Akpolat, T; Atmaca, H; Demircan, N; Külah, E; Sayarlioglu, H, 2002) |
| "We report a patient with renal insufficiency who developed rhabdomyolysis 1 month after initiating cerivastatin and gemfibrozil for hyperlipidemia." | 7.71 | Rhabdomyolysis from the combination of a statin and gemfibrozil: an uncommon but serious adverse reaction. ( Kind, AH; McBride, PE; Zakowski, LJ, 2002) |
| "To report a case of rhabdomyolysis resulting from concurrent use of cerivastatin and gemfibrozil." | 7.71 | Cerivastatin and gemfibrozil-associated rhabdomyolysis. ( Bruno-Joyce, J; Dugas, JM; MacCausland, OE, 2001) |
| "Rhabdomyolysis occurring in transplant patients receiving both cyclosporine and the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor lovastatin has been well documented." | 7.71 | Rhabdomyolysis after concomitant use of cyclosporine, simvastatin, gemfibrozil, and itraconazole. ( Limanni, A; Maxa, JL; Melton, LB; Ogu, CC; Sills, MN, 2002) |
| "Gemfibrozil-statin combination therapy is a well-known risk factor for myopathy and rhabdomyolysis." | 7.70 | A case with severe rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy--a case report. ( Boran, M; Gökçe, V; Koçak, B; Korkmaz, S; Ozdemir, O; Uzun, Y, 2000) |
| "The findings in this case indicate that atorvastatin, like other DL-3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, may increase the risk of myositis and rhabdomyolysis when used in combination with gemfibrozil." | 7.70 | Rhabdomyolysis after taking atorvastatin with gemfibrozil. ( Connor, WE; Duell, PB; Illingworth, DR, 1998) |
| "The occurrence of rhabdomyolysis is one of the rare side-effects of the cholesterol-lowering agent simvastatin." | 7.69 | Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil. ( Du Buf-Vereijken, PW; Spooren, PF; van Doormaal, JJ; van Puijenbroek, EP, 1996) |
| " We describe a case of severe myopathy and rhabdomyolysis associated with concomitant use of simvastatin and gemfibrozil." | 7.69 | Rhabdomyolysis associated with simvastatin-gemfibrozil therapy. ( Isley, W; Rajeshawari, M; Tal, A, 1997) |
| "Severe rhabdomyolysis complicated by respiratory and renal failure developed three weeks after initiation of low dose lovastatin therapy in a 79 year old, non-immunocompromised patient." | 7.68 | Lovastatin-induced acute rhabdomyolysis. ( Kogan, AD; Orenstein, S, 1990) |
| "The Food and Drug Administration documents the receipt of 12 case reports of severe myopathy or rhabdomyolysis associated with concomitant use of lovastatin and gemfibrozil, including 10 voluntary postmarketing, and 2 required, reports." | 7.68 | Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. ( Gross, TP; Pierce, LR; Wysowski, DK, 1990) |
| "Rhabdomyolysis is a rare but serious complication due to lipid-lowering therapy with statins and fibrates." | 5.48 | Delayed presentation of severe rhabdomyolysis leading to acute kidney injury following atorvastatin-gemfibrozil combination therapy: a case report. ( Dalugama, C; Kularatne, SAM; Pathirage, M, 2018) |
| "Simvastatin is a cholesterol-lowering medication heavily prescribed to treat and prevent vascular disease." | 5.35 | Recovery time in a case of gemfibrozil and simvastatin-associated rhabdomyolysis. ( Baker, E; Cummins, D; Mackey, M, 2009) |
| "The development of rhabdomyolysis is increased when the HMG-CoAs are used concurrently with certain other medications, specifically gemfibrozil and macrolide antibiotics." | 5.30 | Rhabdomyolysis associated with the combined use of hydroxymethylglutaryl-coenzyme A reductase inhibitors with gemfibrozil and macrolide antibiotics. ( Freeman, NJ; Landesman, KA; Stozek, M, 1999) |
| "Concomitant use of gemfibrozil with statins, particularly with cerivastatin, increases the risk of rhabdomyolysis, but the mechanism of this potentially fatal drug interaction remains unclear." | 5.10 | Gemfibrozil greatly increases plasma concentrations of cerivastatin. ( Backman, JT; Kyrklund, C; Neuvonen, M; Neuvonen, PJ, 2002) |
| "To review the association between the use of cerivastatin sodium and the risk of rhabdomyolysis in an effort to illustrate the operation and limitations of the current US postmarketing safety-surveillance system." | 4.82 | Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. ( Furberg, CD; Psaty, BM; Ray, WA; Weiss, NS, 2004) |
| "Cerivastatin, a lipid-lowering agent, was voluntarily withdrawn from the market because of high risk of rhabdomyolysis when used as monotherapy and as comedication with fibrates, especially gemfibrozil." | 3.73 | [Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States]. ( Hasegawa, R; Hirata-Koizumi, M; Miyake, S; Saito, M, 2005) |
| "An increased risk for adverse events was observed with gemfibrozil relative to fenofibrate, predominantly driven by an increased rate of rhabdomyolysis." | 3.72 | Risk of adverse events with fibrates. ( Alsheikh-Ali, AA; Karas, RH; Kuvin, JT, 2004) |
| "Gemfibrozil monotherapy of hyperlipidemia may predispose to rhabdomyolysis with acute renal failure." | 3.72 | Rhabdomyolysis and renal failure associated with gemfibrozil monotherapy. ( Layne, RD; Sehbai, AS; Stark, LJ, 2004) |
| "Gemfibrozil therapy alone can induce severe myopathy and rhabdomyolysis." | 3.72 | Acute rhabdomyolysis after gemfibrozil therapy in a pregnant patient complicated with acute pancreatitis and hypertriglycerdemia while receiving continuous veno-venous hemofiltration therapy. ( Chang, CT; Huang, CC; Wu, MS; Yen, TH, 2003) |
| "Patients receiving combination therapy with colchicine and gemfibrozil, especially those with renal and hepatic dysfunction, should be monitored for rhabdomyolysis, and concomitant colchicine and gemfibrozil therapy should be considered in the differential diagnosis of rhabdomyolysis." | 3.71 | Rhabdomyolysis associated with gemfibrozil-colchicine therapy. ( Akpolat, T; Atmaca, H; Demircan, N; Külah, E; Sayarlioglu, H, 2002) |
| " We report a case of fatal rhabdomyolysis caused by the combination of simvastatin and gemfibrozil." | 3.71 | Fatal rhabdomyolysis caused by lipid-lowering therapy. ( Federman, DG; Hussain, F; Walters, AB, 2001) |
| "We report a patient with renal insufficiency who developed rhabdomyolysis 1 month after initiating cerivastatin and gemfibrozil for hyperlipidemia." | 3.71 | Rhabdomyolysis from the combination of a statin and gemfibrozil: an uncommon but serious adverse reaction. ( Kind, AH; McBride, PE; Zakowski, LJ, 2002) |
| "The findings in this case indicate that atorvastatin, like other DL-3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, may increase the risk of myositis and rhabdomyolysis when used in combination with gemfibrozil." | 3.70 | Rhabdomyolysis after taking atorvastatin with gemfibrozil. ( Connor, WE; Duell, PB; Illingworth, DR, 1998) |
| "Gemfibrozil-statin combination therapy is a well-known risk factor for myopathy and rhabdomyolysis." | 3.70 | A case with severe rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy--a case report. ( Boran, M; Gökçe, V; Koçak, B; Korkmaz, S; Ozdemir, O; Uzun, Y, 2000) |
| "The occurrence of rhabdomyolysis is one of the rare side-effects of the cholesterol-lowering agent simvastatin." | 3.69 | Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil. ( Du Buf-Vereijken, PW; Spooren, PF; van Doormaal, JJ; van Puijenbroek, EP, 1996) |
| " We describe a case of severe myopathy and rhabdomyolysis associated with concomitant use of simvastatin and gemfibrozil." | 3.69 | Rhabdomyolysis associated with simvastatin-gemfibrozil therapy. ( Isley, W; Rajeshawari, M; Tal, A, 1997) |
| "The Food and Drug Administration documents the receipt of 12 case reports of severe myopathy or rhabdomyolysis associated with concomitant use of lovastatin and gemfibrozil, including 10 voluntary postmarketing, and 2 required, reports." | 3.68 | Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. ( Gross, TP; Pierce, LR; Wysowski, DK, 1990) |
| "Severe rhabdomyolysis complicated by respiratory and renal failure developed three weeks after initiation of low dose lovastatin therapy in a 79 year old, non-immunocompromised patient." | 3.68 | Lovastatin-induced acute rhabdomyolysis. ( Kogan, AD; Orenstein, S, 1990) |
| " This review summarizes the pharmacokinetic properties of statins and emphasizes their clinically relevant drug interactions." | 2.42 | Safety of statins: focus on clinical pharmacokinetics and drug interactions. ( Bellosta, S; Corsini, A; Paoletti, R, 2004) |
| " The long term administration of statin and fibrate to patients with primary and secondary hyperlipidemia was considered safe on the basis of our experience and literature data." | 2.42 | [Antilipemic therapy and rhabdomyolysis]. ( Balogh, Z; Paragh, G; Romics, L, 2003) |
| " Adverse events occur more often with the statins that are metabolized via the CYP enzyme system and its 3A4, 2C9 or 2C19 paths." | 2.41 | Lipid-lowering drugs: are adverse effects predictable and reversible? ( Muscari, A; Puddu, GM; Puddu, P, 2002) |
| "Rhabdomyolysis is characterized by elevation of plasma creatine phosphokinase (CPK) level, and multiple organ disorders, especially renal failure, as well as approximately 50% of acquired rhabdomyolysis are caused by pharmaceuticals." | 1.51 | Establishment and characterization of a mouse model of rhabdomyolysis by coadministration of statin and fibrate. ( Akai, S; Matsubara, A; Oda, S; Watanabe, K; Yokoi, T, 2019) |
| "Rhabdomyolysis is a rare but serious complication due to lipid-lowering therapy with statins and fibrates." | 1.48 | Delayed presentation of severe rhabdomyolysis leading to acute kidney injury following atorvastatin-gemfibrozil combination therapy: a case report. ( Dalugama, C; Kularatne, SAM; Pathirage, M, 2018) |
| "Individuals susceptible to malignant hyperthermia (MH) have an impaired calcium homeostasis." | 1.36 | Statins alter intracellular calcium homeostasis in malignant hyperthermia susceptible individuals. ( Anetseder, M; Hager, M; Metterlein, T; Roewer, N; Schuster, F; Tadda, L, 2010) |
| "Simvastatin is a cholesterol-lowering medication heavily prescribed to treat and prevent vascular disease." | 1.35 | Recovery time in a case of gemfibrozil and simvastatin-associated rhabdomyolysis. ( Baker, E; Cummins, D; Mackey, M, 2009) |
| " We reviewed gemfibrozil- and fenofibrate-associated adverse event reports (AERs) submitted to the US Food and Drug Administration over a 5-year period." | 1.35 | Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use. ( Alsheikh-Ali, AA; Holoshitz, N; Karas, RH, 2008) |
| " We also observed a joint effect of high statin dosage and renal disease (p = 0." | 1.34 | Risk factors for statin-associated rhabdomyolysis. ( Andrade, SE; Blough, D; Burgess, M; Chan, KA; Graham, D; La Grenade, L; Platt, R; Schech, S; Shatin, D; Staffa, J; Stergachis, A, 2007) |
| "Monotherapy for the treatment of dyslipidemias is commonly insufficient to achieve all lipid targets recommended by current guidelines." | 1.33 | [Drug combinations: statins and fibrates]. ( Xavier, HT, 2005) |
| "Over the last three decades, hypolipemiants like fibric acid derivatives and statins have been increasingly recognised as causes of rhabdomyolysis and acute renal failure especially during combination therapy and in the presence of underlying renal impairment." | 1.31 | Rhabdomyolysis and acute renal failure following a switchover of therapy between two fibric acid derivatives. ( Kamaliah, MD; Sanjay, LD, 2001) |
| "The development of rhabdomyolysis is increased when the HMG-CoAs are used concurrently with certain other medications, specifically gemfibrozil and macrolide antibiotics." | 1.30 | Rhabdomyolysis associated with the combined use of hydroxymethylglutaryl-coenzyme A reductase inhibitors with gemfibrozil and macrolide antibiotics. ( Freeman, NJ; Landesman, KA; Stozek, M, 1999) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (1.41) | 18.7374 |
| 1990's | 14 (19.72) | 18.2507 |
| 2000's | 51 (71.83) | 29.6817 |
| 2010's | 5 (7.04) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Dalugama, C | 1 |
| Pathirage, M | 1 |
| Kularatne, SAM | 1 |
| Watanabe, K | 1 |
| Oda, S | 1 |
| Matsubara, A | 1 |
| Akai, S | 1 |
| Yokoi, T | 1 |
| Cummins, D | 1 |
| Mackey, M | 1 |
| Baker, E | 1 |
| Metterlein, T | 1 |
| Schuster, F | 1 |
| Tadda, L | 1 |
| Hager, M | 1 |
| Roewer, N | 1 |
| Anetseder, M | 1 |
| Kar, S | 1 |
| Chockalingam, A | 1 |
| Amend, KL | 1 |
| Landon, J | 1 |
| Thyagarajan, V | 1 |
| Niemcryk, S | 1 |
| McAfee, A | 1 |
| SantaCruz, PL | 1 |
| González, A | 1 |
| León, ME | 1 |
| Fernández, MY | 1 |
| Su, M | 1 |
| Hoffman, RS | 1 |
| Flomenbaum, M | 1 |
| Atmaca, H | 1 |
| Sayarlioglu, H | 1 |
| Külah, E | 1 |
| Demircan, N | 1 |
| Akpolat, T | 1 |
| Kind, AH | 1 |
| Zakowski, LJ | 1 |
| McBride, PE | 1 |
| Backman, JT | 1 |
| Kyrklund, C | 1 |
| Neuvonen, M | 1 |
| Neuvonen, PJ | 1 |
| Yen, TH | 1 |
| Chang, CT | 1 |
| Wu, MS | 1 |
| Huang, CC | 1 |
| Paragh, G | 1 |
| Balogh, Z | 1 |
| Romics, L | 1 |
| Shammas, NW | 1 |
| Kapalis, MJ | 1 |
| Deckert, J | 1 |
| Harris, M | 1 |
| Dippel, EJ | 1 |
| Labroo, A | 1 |
| McKinney, D | 1 |
| Morera, T | 1 |
| Gervasini, G | 1 |
| Carrillo, JA | 1 |
| Benitez, J | 1 |
| Layne, RD | 1 |
| Sehbai, AS | 1 |
| Stark, LJ | 1 |
| Bellosta, S | 1 |
| Paoletti, R | 1 |
| Corsini, A | 1 |
| Jamal, SM | 1 |
| Eisenberg, MJ | 1 |
| Christopoulos, S | 1 |
| Chang, JT | 1 |
| Staffa, JA | 1 |
| Parks, M | 1 |
| Green, L | 1 |
| Alsheikh-Ali, AA | 2 |
| Kuvin, JT | 1 |
| Karas, RH | 2 |
| Psaty, BM | 1 |
| Furberg, CD | 1 |
| Ray, WA | 1 |
| Weiss, NS | 1 |
| Strom, BL | 1 |
| Piorkowski, JD | 1 |
| Jones, PH | 1 |
| Davidson, MH | 1 |
| Farswan, M | 1 |
| Rathod, SP | 1 |
| Upaganlawar, AB | 1 |
| Semwal, A | 1 |
| Xavier, HT | 1 |
| Saito, M | 1 |
| Hirata-Koizumi, M | 1 |
| Miyake, S | 1 |
| Hasegawa, R | 1 |
| Schech, S | 1 |
| Graham, D | 1 |
| Staffa, J | 1 |
| Andrade, SE | 1 |
| La Grenade, L | 1 |
| Burgess, M | 1 |
| Blough, D | 1 |
| Stergachis, A | 1 |
| Chan, KA | 1 |
| Platt, R | 1 |
| Shatin, D | 1 |
| Barquero-Romero, J | 1 |
| Rodríguez Vázquez, C | 1 |
| Arrobas Vacas, I | 1 |
| Holoshitz, N | 1 |
| Brinton, EA | 1 |
| de Alava, E | 1 |
| Sola, JJ | 1 |
| Lozano, MD | 1 |
| Pardo-Mindán, FJ | 1 |
| Knoll, RW | 1 |
| Ciafone, R | 1 |
| Galen, M | 1 |
| Abdul-Ghaffar, NU | 1 |
| el-Sonbaty, MR | 1 |
| Górriz, JL | 1 |
| Sancho, A | 1 |
| Lopez-Martin, JM | 1 |
| Alcoy, E | 1 |
| Catalán, C | 1 |
| Pallardó, LM | 1 |
| van Puijenbroek, EP | 1 |
| Du Buf-Vereijken, PW | 1 |
| Spooren, PF | 1 |
| van Doormaal, JJ | 1 |
| Tal, A | 1 |
| Rajeshawari, M | 1 |
| Isley, W | 1 |
| Duell, PB | 1 |
| Connor, WE | 1 |
| Illingworth, DR | 2 |
| Pogson, GW | 1 |
| Kindred, LH | 1 |
| Carper, BG | 1 |
| Guyton, JR | 1 |
| Dujovne, CA | 1 |
| Landesman, KA | 1 |
| Stozek, M | 1 |
| Freeman, NJ | 1 |
| Bermingham, RP | 1 |
| Whitsitt, TB | 1 |
| Smart, ML | 1 |
| Nowak, DP | 1 |
| Scalley, RD | 1 |
| Ozdemir, O | 1 |
| Boran, M | 1 |
| Gökçe, V | 1 |
| Uzun, Y | 1 |
| Koçak, B | 1 |
| Korkmaz, S | 1 |
| Alexandridis, G | 1 |
| Pappas, GA | 1 |
| Elisaf, MS | 1 |
| Oldemeyer, JB | 1 |
| Lund, RJ | 1 |
| Koch, M | 1 |
| Meares, AJ | 1 |
| Dunlay, R | 1 |
| Mastroianni, CM | 1 |
| d'Ettorre, G | 1 |
| Forcina, G | 1 |
| Lichtner, M | 1 |
| Corpolongo, A | 1 |
| Coletta, S | 1 |
| Vullo, V | 1 |
| Tomlinson, B | 1 |
| Lan, IW | 1 |
| Vascónez Espinosa, F | 1 |
| Gómez Rodríguez, N | 1 |
| Martín Joven, A | 1 |
| Posada García, FJ | 1 |
| Lau, TK | 1 |
| Leachman, DR | 1 |
| Lufschanowski, R | 1 |
| Charatan, F | 1 |
| SoRelle, R | 1 |
| de Arriba Méndez, JJ | 1 |
| Gómez Merino, E | 1 |
| Sáez Barcelona, JA | 1 |
| Sáez Méndez, L | 1 |
| Wooltorton, E | 1 |
| Bruno-Joyce, J | 1 |
| Dugas, JM | 1 |
| MacCausland, OE | 1 |
| Tormo Molina, J | 1 |
| Gázquez Pérez, I | 1 |
| Matas Hoces, A | 1 |
| Federman, DG | 1 |
| Hussain, F | 1 |
| Walters, AB | 1 |
| Langford, NJ | 1 |
| Kendall, MJ | 1 |
| Hendriks, F | 1 |
| Kooman, JP | 1 |
| van der Sande, FM | 1 |
| Kamaliah, MD | 1 |
| Sanjay, LD | 1 |
| Bosch Rovira, T | 1 |
| Llompart Pou, JA | 1 |
| Forteza-Rey, J | 1 |
| Roca, B | 1 |
| Calvo, B | 1 |
| Monferrer, R | 1 |
| Maxa, JL | 1 |
| Melton, LB | 1 |
| Ogu, CC | 1 |
| Sills, MN | 1 |
| Limanni, A | 1 |
| Marsà Carretero, M | 1 |
| Alos Manrique, C | 1 |
| Valles Callol, JA | 1 |
| Muscari, A | 1 |
| Puddu, GM | 1 |
| Puddu, P | 1 |
| Bairaktari, E | 1 |
| Seferiadis, K | 1 |
| Liamis, G | 1 |
| Psihogios, N | 1 |
| Tsolas, O | 1 |
| Elisaf, M | 1 |
| Marais, GE | 1 |
| Larson, KK | 1 |
| Pierce, LR | 1 |
| Wysowski, DK | 1 |
| Gross, TP | 1 |
| Kogan, AD | 1 |
| Orenstein, S | 1 |
| Goldman, JA | 1 |
| Fishman, AB | 1 |
| Lee, JE | 1 |
| Johnson, RJ | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019[NCT04517396] | Phase 2 | 701 participants (Actual) | Interventional | 2020-08-18 | Completed | ||
| Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection[NCT02808299] | 600 participants (Anticipated) | Observational | 2016-12-31 | Not yet recruiting | |||
| A Multicenter Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)[NCT01152073] | 79 participants (Actual) | Interventional | 2009-10-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Death from any cause during the observation period (NCT04517396)
Timeframe: Up to 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Fenofibrate + Usual Care | 19 |
| Placebo + Usual Care | 22 |
The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization. (NCT04517396)
Timeframe: Up to 30 days
| Intervention | score on a scale (Median) |
|---|---|
| Fenofibrate + Usual Care | 5.03 |
| Placebo + Usual Care | 5.03 |
Number of days that participants were alive and out of the hospital during the 30 days following randomization (NCT04517396)
Timeframe: Up to 30 days
| Intervention | days (Median) |
|---|---|
| Fenofibrate + Usual Care | 30 |
| Placebo + Usual Care | 30 |
Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization (NCT04517396)
Timeframe: Up to 30 days
| Intervention | days (Mean) |
|---|---|
| Fenofibrate + Usual Care | 28.8 |
| Placebo + Usual Care | 28.3 |
The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale (NCT04517396)
Timeframe: 30 days
| Intervention | Ranked Severity Score (Median) |
|---|---|
| Fenofibrate + Usual Care | 5.32 |
| Placebo + Usual Care | 5.33 |
The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed). (NCT04517396)
Timeframe: Up to 30 days
| Intervention | score on a scale (Median) |
|---|---|
| Fenofibrate + Usual Care | 5.05 |
| Placebo + Usual Care | 5.05 |
A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death. (NCT04517396)
Timeframe: At 15 days
| Intervention | score on a scale (Median) |
|---|---|
| Fenofibrate + Usual Care | 1 |
| Placebo + Usual Care | 1 |
11 reviews available for gemfibrozil and Rhabdomyolysis
| Article | Year |
|---|---|
Statin-associated rhabdomyolysis with acute renal failure complicated by intradialytic NSTEMI: a review of lipid management considerations.
Topics: Acute Kidney Injury; Aged, 80 and over; Coronary Artery Disease; Drug Therapy, Combination; Gemfibro | 2013 |
[Antilipemic therapy and rhabdomyolysis].
Topics: Anticholesteremic Agents; Cytochrome P-450 Enzyme System; Drug Therapy, Combination; Gemfibrozil; Hu | 2003 |
Effectiveness of statin-gemfibrozil combination therapy in patients with mixed hyperlipidemia: experience of a community lipid clinic and safety review from the literature.
Topics: Aged; Cholesterol, HDL; Cholesterol, LDL; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Red | 2003 |
Safety of statins: focus on clinical pharmacokinetics and drug interactions.
Topics: Binding, Competitive; Biological Availability; Calcium Channel Blockers; Chemical and Drug Induced L | 2004 |
Safety of statins: focus on clinical pharmacokinetics and drug interactions.
Topics: Binding, Competitive; Biological Availability; Calcium Channel Blockers; Chemical and Drug Induced L | 2004 |
Safety of statins: focus on clinical pharmacokinetics and drug interactions.
Topics: Binding, Competitive; Biological Availability; Calcium Channel Blockers; Chemical and Drug Induced L | 2004 |
Safety of statins: focus on clinical pharmacokinetics and drug interactions.
Topics: Binding, Competitive; Biological Availability; Calcium Channel Blockers; Chemical and Drug Induced L | 2004 |
Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme A reductase inhibitors.
Topics: Cyclosporine; Cytochrome P-450 CYP4A; Dose-Response Relationship, Drug; Drug Interactions; Gemfibroz | 2004 |
Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis.
Topics: Adverse Drug Reaction Reporting Systems; Conflict of Interest; Drug Industry; Drug Interactions; Gem | 2004 |
Does the addition of fibrates to statin therapy have a favorable risk to benefit ratio?
Topics: Atherosclerosis; Cardiovascular Diseases; Cholesterol, HDL; Clofibric Acid; Diabetic Angiopathies; D | 2008 |
Severe rhabdomyolysis associated with the cerivastin-gemfibrozil combination therapy: report of a case.
Topics: Aged; Drug Therapy, Combination; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors | 2001 |
[Severe rhabdomyolysis associated with cerivastatin and gemfibrozil].
Topics: Female; Gemfibrozil; Humans; Hypolipidemic Agents; Middle Aged; Pyridines; Rhabdomyolysis | 2001 |
Severe rhabdomyolysis and cerivastatin-gemfibrozil combination therapy.
Topics: Aged; Aged, 80 and over; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Male; Middle Aged; | 2002 |
Lipid-lowering drugs: are adverse effects predictable and reversible?
Topics: Aryl Hydrocarbon Hydroxylases; Bezafibrate; Cholesterol, LDL; Cytochrome P-450 Enzyme System; Digest | 2002 |
1 trial available for gemfibrozil and Rhabdomyolysis
| Article | Year |
|---|---|
Gemfibrozil greatly increases plasma concentrations of cerivastatin.
Topics: Administration, Oral; Adult; Area Under Curve; Cross-Over Studies; Double-Blind Method; Drug Interac | 2002 |
59 other studies available for gemfibrozil and Rhabdomyolysis
| Article | Year |
|---|---|
Delayed presentation of severe rhabdomyolysis leading to acute kidney injury following atorvastatin-gemfibrozil combination therapy: a case report.
Topics: Acute Kidney Injury; Adult; Atorvastatin; Creatinine; Cytochrome P-450 CYP2C8 Inhibitors; Drug Thera | 2018 |
Establishment and characterization of a mouse model of rhabdomyolysis by coadministration of statin and fibrate.
Topics: Animals; Caspase 3; Caspase 7; Disease Models, Animal; Drug Interactions; Female; Fibric Acids; Gemf | 2019 |
Recovery time in a case of gemfibrozil and simvastatin-associated rhabdomyolysis.
Topics: Acute Kidney Injury; Aged, 80 and over; Creatine Kinase; Creatinine; Drug Therapy, Combination; Gemf | 2009 |
Statins alter intracellular calcium homeostasis in malignant hyperthermia susceptible individuals.
Topics: Animals; Atorvastatin; Biopsy; Calcium; Electric Stimulation; Female; Gemfibrozil; Genotype; Heptano | 2010 |
Incidence of hospitalized rhabdomyolysis with statin and fibrate use in an insured US population.
Topics: Cohort Studies; Databases, Factual; Drug Therapy, Combination; Dyslipidemias; Electronic Health Reco | 2011 |
[Rhabdomyolysis, acute renal failure and use of cerivastatin combined with gemfibrozil. New evidence].
Topics: Acute Kidney Injury; Aged; Drug Therapy, Combination; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA | 2002 |
Cerivastatin and gemfibrozil-induced cardiac rhabdomyolysis.
Topics: Cardiomyopathies; Drug Therapy, Combination; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductas | 2002 |
Rhabdomyolysis associated with gemfibrozil-colchicine therapy.
Topics: Adult; Amyloidosis; Colchicine; Creatine Kinase; Drug Interactions; Drug Therapy, Combination; Gemfi | 2002 |
Rhabdomyolysis from the combination of a statin and gemfibrozil: an uncommon but serious adverse reaction.
Topics: Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibito | 2002 |
Acute rhabdomyolysis after gemfibrozil therapy in a pregnant patient complicated with acute pancreatitis and hypertriglycerdemia while receiving continuous veno-venous hemofiltration therapy.
Topics: Acute Disease; Adult; Dose-Response Relationship, Drug; Female; Gemfibrozil; Hemofiltration; Humans; | 2003 |
Early detection of drug interactions utilizing a computerized drug prescription handling system-focus on cerivastatin-gemfibrozil.
Topics: Drug Interactions; Drug Prescriptions; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhi | 2004 |
Rhabdomyolysis and renal failure associated with gemfibrozil monotherapy.
Topics: Acute Kidney Injury; Adult; Creatinine; Diabetes Mellitus, Type 1; Gemfibrozil; Humans; Hyperlipidem | 2004 |
Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy.
Topics: Adult; Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Drug Therapy, Combination; | 2004 |
Risk of adverse events with fibrates.
Topics: Aged; Chemical and Drug Induced Liver Injury; Female; Fenofibrate; Gemfibrozil; Humans; Hyperlipidem | 2004 |
Potential for conflict of interest in the evaluation of suspected adverse drug reactions: a counterpoint.
Topics: Adverse Drug Reaction Reporting Systems; Conflict of Interest; Drug Approval; Drug Industry; Drug In | 2004 |
Bayer's response to "potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis".
Topics: Adverse Drug Reaction Reporting Systems; Conflict of Interest; Drug Approval; Drug Industry; Drug In | 2004 |
Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin.
Topics: Adverse Drug Reaction Reporting Systems; Drug Therapy, Combination; Fenofibrate; Gemfibrozil; Humans | 2005 |
Protective effect of coenzyme Q10 in simvastatin and gemfibrozil induced rhabdomyolysis in rats.
Topics: Animals; Antioxidants; Blood Urea Nitrogen; Catalase; Coenzymes; Creatinine; Female; Gemfibrozil; Gl | 2005 |
[Drug combinations: statins and fibrates].
Topics: Age Factors; Clofibric Acid; Drug Interactions; Drug Therapy, Combination; Dyslipidemias; Female; Ge | 2005 |
[Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States].
Topics: Adverse Drug Reaction Reporting Systems; Consumer Product Safety; Cytochrome P-450 CYP3A; Cytochrome | 2005 |
Risk factors for statin-associated rhabdomyolysis.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Case-Control Studies; Comorbidity; Drug Therapy, Combin | 2007 |
[Gemfibrozil induced rhabdomyolysis in a patient with undiscovered hypothyroidism].
Topics: Adult; Gemfibrozil; Humans; Hypolipidemic Agents; Hypothyroidism; Male; Rhabdomyolysis; Risk Factors | 2006 |
Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use.
Topics: Adverse Drug Reaction Reporting Systems; Chemical and Drug Induced Liver Injury; Databases, Factual; | 2008 |
Rhabdomyolysis and acute renal failure in a heart transplant recipient treated with hypolipemiants.
Topics: Acute Kidney Injury; Gemfibrozil; Heart Transplantation; Humans; Hyperlipidemias; Leprostatic Agents | 1994 |
Rhabdomyolysis and renal failure secondary to combination therapy of hyperlipidemia with lovastatin and gemfibozil.
Topics: Acute Kidney Injury; Drug Therapy, Combination; Gemfibrozil; Humans; Hyperlipidemias; Lovastatin; Ma | 1993 |
Pancreatitis and rhabdomyolysis associated with lovastatin-gemfibrozil therapy.
Topics: Acute Disease; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hyperlipidemias; Hypolipidemi | 1995 |
Rhabdomyolysis and acute renal failure associated with gemfibrozil therapy.
Topics: Acute Kidney Injury; Aged; Angiotensin-Converting Enzyme Inhibitors; Bicarbonates; Diabetes Mellitus | 1996 |
Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil.
Topics: Drug Synergism; Gemfibrozil; Humans; Hypolipidemic Agents; Lovastatin; Male; Middle Aged; Rhabdomyol | 1996 |
Rhabdomyolysis associated with simvastatin-gemfibrozil therapy.
Topics: Anticholesteremic Agents; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hyperlipidemias; H | 1997 |
Rhabdomyolysis after taking atorvastatin with gemfibrozil.
Topics: Adult; Atorvastatin; Drug Interactions; Drug Therapy, Combination; Female; Gemfibrozil; Heptanoic Ac | 1998 |
Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy.
Topics: Aged; Drug Interactions; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hydroxymethylglutar | 1999 |
Dual hepatic metabolism of cerivastatin--clarifications.
Topics: Aged; Drug Synergism; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl- | 1999 |
Rhabdomyolysis associated with the combined use of hydroxymethylglutaryl-coenzyme A reductase inhibitors with gemfibrozil and macrolide antibiotics.
Topics: Adult; Aged; Anti-Bacterial Agents; Anticholesteremic Agents; Clarithromycin; Drug Therapy, Combinat | 1999 |
Rhabdomyolysis in a patient receiving the combination of cerivastatin and gemfibrozil.
Topics: Certification; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Red | 2000 |
A case with severe rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy--a case report.
Topics: Diabetes Mellitus; Drug Interactions; Drug Therapy, Combination; Electrocardiography; Fatal Outcome; | 2000 |
Rhabdomyolysis due to combination therapy with cerivastatin and gemfibrozil.
Topics: Aged; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase In | 2000 |
Rhabdomyolysis and acute renal failure after changing statin-fibrate combinations.
Topics: Acute Kidney Injury; Aged; Coronary Disease; Drug Therapy, Combination; Fenofibrate; Gemfibrozil; Hu | 2000 |
Rhabdomyolysis after cerivastatin-gemfibrozil therapy in an HIV-infected patient with protease inhibitor-related hyperlipidemia.
Topics: Acute Kidney Injury; Drug Therapy, Combination; Gemfibrozil; HIV Infections; HIV Protease Inhibitors | 2001 |
Combination therapy with cerivastatin and gemfibrozil causing rhabdomyolysis: is the interaction predictable?
Topics: Drug Therapy, Combination; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypo | 2001 |
[Rhabdomyolysis complicated with acute renal insufficiency in a patient treated with gemfibrozil and cerivastatin].
Topics: Acute Kidney Injury; Aged; Drug Interactions; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reducta | 2001 |
Bayer decides to withdraw cholesterol lowering drug.
Topics: Aged; Anticholesteremic Agents; Drug and Narcotic Control; Drug Therapy, Combination; Gemfibrozil; H | 2001 |
Baycol withdrawn from market.
Topics: Anticholesteremic Agents; Dose-Response Relationship, Drug; Drug and Narcotic Control; Gemfibrozil; | 2001 |
Bayer pulls cerivastatin (Baycol) from market.
Topics: Canada; Drug Industry; Drug Interactions; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase I | 2001 |
Cerivastatin and gemfibrozil-associated rhabdomyolysis.
Topics: Aged; Aged, 80 and over; Creatine Kinase; Drug Interactions; Gemfibrozil; Humans; Hydroxymethylgluta | 2001 |
[Cerivastatin and gemfibrozil: a dangerous combination].
Topics: Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypolipidemic Agents; M | 2001 |
Fatal rhabdomyolysis caused by lipid-lowering therapy.
Topics: Aged; Drug Interactions; Fatal Outcome; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inh | 2001 |
Rhabdomyolysis with HMG CoA reductase inhibitors: a class effect?
Topics: Biological Availability; Cholinergic Agents; Cytochrome P-450 Enzyme System; Drug Interactions; Gemf | 2001 |
Massive rhabdomyolysis and life threatening hyperkalaemia in a patient with the combination of cerivastatin and gemfibrozil.
Topics: Aged; Chest Pain; Drug Combinations; Electrocardiography; Female; Gemfibrozil; Humans; Hydroxymethyl | 2001 |
Rhabdomyolysis and acute renal failure following a switchover of therapy between two fibric acid derivatives.
Topics: Acute Kidney Injury; Aged; Bezafibrate; Coronary Disease; Gemfibrozil; Humans; Hyperlipidemias; Hypo | 2001 |
[Rhabdomyolysis associated with combined treatment of cerivastatin and gemfibrozil].
Topics: Drug Interactions; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypolipidemi | 2001 |
Rhabdomyolysis after concomitant use of cyclosporine, simvastatin, gemfibrozil, and itraconazole.
Topics: Antifungal Agents; Cyclosporine; Cytochrome P-450 CYP3A; Cytochrome P-450 Enzyme Inhibitors; Cytochr | 2002 |
Statin stories.
Topics: Drug Interactions; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pyridines; R | 2002 |
Rhabdomyolysis associated with cerivastatin plus gemfibrozil combined regimen.
Topics: Drug Therapy, Combination; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypo | 2002 |
Rhabdomyolysis-related renal tubular damage studied by proton nuclear magnetic resonance spectroscopy of urine.
Topics: beta 2-Microglobulin; Biomarkers; Drug Therapy, Combination; Gemfibrozil; Humans; Hyperlipidemias; K | 2002 |
Myopathy and rhabdomyolysis with lovastatin taken with gemfibrozil.
Topics: Adolescent; Creatine Kinase; Drug Synergism; Drug Therapy, Combination; Gemfibrozil; Humans; Isoenzy | 1990 |
Rhabdomyolysis and acute renal failure induced by combination lovastatin and gemfibrozil therapy.
Topics: Acute Kidney Injury; Biological Assay; Drug Interactions; Drug Therapy, Combination; Gemfibrozil; Hu | 1990 |
Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy.
Topics: Acute Kidney Injury; Adult; Aged; Creatine Kinase; Drug Interactions; Drug Therapy, Combination; Fem | 1990 |
Lovastatin-induced acute rhabdomyolysis.
Topics: Acute Disease; Age Factors; Aged; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Kidney Fai | 1990 |
The role of cholesterol-lowering agents in drug-induced rhabdomyolysis and polymyositis.
Topics: Aged; Drug Therapy, Combination; Female; Gemfibrozil; Humans; Lovastatin; Myositis; Rhabdomyolysis | 1989 |